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Analysis of the Final WHCCAMP Report: Chapter 5, 30/3/2002
One of the fastest growing areas in CAM has been dietary supplements.

Sales of these products totaled $17 billion in 2000 , and more than 158 million consumers used them . Because they are classified as dietary supplements, these products are not subject to the rigorous testing and oversight required of prescription drugs, which are targeted toward disease conditions. For this reason, complete and accurate labeling and package insert information on ingredients and on potential benefits and risks is essential.

The current system does not make such information easily available to consumers.

They have consistently and deliberately avoided criticizing the majority of "CAM" methods that are irrational. In addition, consumers who call for information may be referred to unreliable sources.] Consumers and health care professionals can also obtain CAM- related information from NIH's National Cancer Institute and the Office of Dietary Supplements. The Food and Drug Administration's (FDA) Center for Food, Safety, and Applied Nutrition has a website with information on dietary supplements. Other government entities, such as the Department of Agriculture and the Federal Trade Commission (FTC), also have information related to specific CAM topics.

The availability and use of dietary supplements in the United States has grown significantly in the past several years. As a result, public interest in the safety and effectiveness of dietary supplements has also increased. Because they are regulated as foods rather than drugs, dietary supplements are regarded --from a regulatory perspective -- as generally safe for human consumption.

Some dietary supplements do not contain the ingredients or the amount of the ingredients declared on the label. For example, in laboratory testing of 25 separate Echinacea products, only 14 (56 percent) were found to have the amount and type of Echinacea and polyphenol (or marker compound) claimed on the label .

Some herbal preparations contain ingredients other than those listed on the label, including undeclared pharmaceuticals. Herbal products claiming to contain only natural ingredients were found to contain the prescription drugs glyburide and phenformin, which are used to treat diabetes . Two other herbal products were found to contain warfarin and alprazolam, prescription drugs that can cause serious health effects if not taken under medical supervision . Dietary supplements have been found to be contaminated with heavy metals, microorganisms, and pesticides, and toxic levels of mercury have been reported in some imported herbal products . In April and May 2001, two manufacturers recalled several products as a result of Salmonella contamination .

Public concern with dietary supplements includes not only possible contamination and adulteration, but also active ingredients that may be toxic or cause unwanted side effects. For example, aristolochic acid, a naturally occurring compound associated with cancer and renal failure, has been found in several herbal products, prompting a nationwide recall of products containing this substance .

Such examples raise questions about whether current regulations are adequate to ensure the safety of dietary supplements and whether regulatory agencies can respond quickly when a problem is identified.

Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, a manufacturer is responsible for determining that the dietary supplements it produces or distributes are safe and that its claims are substantiated by adequate scientific evidence.

However, DSHEA does not require manufacturers to disclose the source of the information they used to determine the safety of their products. The failure to require safety data weakens the current regulatory system, making it unable to provide consumers with sufficient and scientifically valid information.

Even though dietary supplements are regulated as foods, which are subject to the standards of Good Manufacturing Practices (GMP), DSHEA encouraged the FDA to develop separate GMPs for dietary supplements. The process of development has been an effective collaboration between many members of the dietary supplement industry and the Federal government. Implementation of GMPs for dietary supplements will help ensure the identity, purity, quality, strength and composition of these products. Formal publication and implementation of the GMPs are pending.

While implementation of GMPs for dietary supplements will address domestically produced products, finished products imported from some other countries may not meet these standards or the standards of responsible manufacturers. Such products may find their way into commerce. Appropriate government entities should work with manufacturers and importers to improve the monitoring of imported dietary supplements and prevent naturally or accidentally contaminated or adulterated products from entering the United States. Cooperation with appropriate international organizations should be encouraged in order to establish standards of quality for the ingredients in dietary supplements. These standards should include preventing the exploitation of endangered animal and plant species for the manufacture of dietary supplement products.

Since the passage of DSHEA in 1994, many new dietary supplements have been introduced into the United States. For many of these supplements, particularly botanicals, validated analytical methods have not been developed. Moreover, different analytic methods are used by different manufacturers, leading to varying test results regarding concentrations of active ingredients or other marker compounds.

Government, industry, and scientific organizations have begun developing analytical methods for botanicals and other dietary supplements so that consensus can be reached regarding the chemical and physical standards for composition and quality. These efforts need to be accelerated. Congress has included language in the fiscal 2002 appropriation bill for the Department of Health and Human Services in support of the development of standards, and the Commission recommends that this progress be continued.

A framework for reviewing data on the safety of ingredients in dietary supplements is being developed by the Institute of Medicine. While this is an important step that will assist in improving the safety of specific ingredients of dietary supplements, the Commission believes that an independent review process is needed to evaluate the safety of dietary supplements, many of which contain multiple ingredients that can interact with drugs, foods, and other ingested products. An external review process was recommended by the Presidential Commission on Dietary Supplement Labels in 1997 and more recently by a scientific conference . Continuous, enhanced cooperation between government and industry is needed to make certain that dietary supplements are safe.

14.1 The efforts of both the public and private sectors to ensure the development, validation, and dissemination of analytical methods and reference materials for dietary supplements should be accelerated.

14.2 The proposed Good Manufacturing Practices for Dietary Supplements should be published expeditiously, followed by a timely review of comments and completion of a final rule. The Food and Drug Administration should be provided with adequate resources to complete this task.

14.3 Adequate funding should be provided to appropriate Federal agencies, including U.S. Customs and Food and Drug Administration inspection authorities, to enforce current laws monitoring the quality of imported raw materials and finished products intended for use as dietary supplements.

14.4 Manufacturers should have on file and make available to the FDA upon request scientific information to substantiate their determinations of safety, and current statutory provisions should be periodically reexamined to determine whether safety requirements for dietary supplements are adequate.


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Illnesses and Injuries Associated with the Use of Selected Dietary Supplements, 31/5/2011
Illnesses and Injuries Associated with the Use of Selected Dietary Supplements

the Use of Selected Dietary Supplements

Products marketed as "dietary supplements" include a diverse range of products, from traditional nutrients, such as vitamins or minerals, to such substances as high-potency free amino acids, botanicals, enzymes, animal extracts, and bioflavanoids that often have no scientifically recognized role in nutrition.

There is currently no systematic evaluation of the safety of products marketed as dietary supplements. Dietary supplements routinely enter the marketplace without undergoing a safety review by FDA. Published studies on the safety of these products are extremely sparse. There is no systematic collection and review of adverse reaction reports for dietary supplements, as there is for drugs, and physicians rarely seek information about their patients' use of dietary supplements. Despite the lack of any system for gaining information about the risks of dietary supplements, an increased number of reports of adverse reactions to dietary supplement products has recently been recognized. Because of concern about these products, FDA has, in the last year, initiated an effort to collect and evaluate existing studies and case reports on safety problems associated with dietary supplements. As a result of that effort, FDA has begun to identify dietary supplements for which serious adverse reactions have been documented. A list of selected dietary supplements associated with serious safety problems follows. This list is not intended to include all hazardous ingredients in dietary supplements.

Herbal and other botanical ingredients of dietary supplements include processed or unprocessed plant parts (bark, leaves, flowers, fruits, and stems), as well as extracts and essential oils. They are available in a variety of forms, including water infusions (teas), powders, tablets, capsules, and elixirs, and may be marketed as single substances or in combination with other materials, such as vitamins, minerals, amino acids, and non-nutrient ingredients. Although data on the availability, consumer use, and health effects of herbals are very limited, some herbal ingredients have been associated with serious adverse health effects.

Lobelia, also known as Indian tobacco, contains pyridine-derived alkaloids, primarily lobeline. These alkaloids have pharmacological actions similar to, although less potent than, nicotine. There have been several reported cases of adverse reactions associated with consumption of dietary supplements containing lobelia.

Amino acids are the individual constituent parts of proteins. Consumption of foods containing intact proteins ordinarily provides sufficient amounts of the nine amino acids needed for growth and development in children and for maintenance of health of adults. The safety of amino acids in this form is generally not a concern. When marketed as dietary supplements, amino acids are sold as single compounds, in combinations of two or more amino acids, as components of protein powders, as chelated single compounds, or in chelated mixtures. Amino acids are promoted for a variety of uses, including body-building. Some are promoted for claimed pharmacologic effects.

The Federation of American Societies for Experimental Biology (FASEB) recently conducted an exhaustive search of available data on amino acids and concluded that there was insufficient information to establish a safe intake level for any amino acids in dietary supplements, and that their safety should not be assumed. FASEB warned that consuming amino acids in dietary supplement form posed potential risks for several subgroups of the general population, including women of childbearing age (especially if pregnant or nursing), infants, children, adolescents, the elderly, individuals with inherited disorders of amino acid metabolism, and individuals with certain diseases.

At least two of the amino acids consumed in dietary supplements have also been associated with serious injuries in healthy adults.

L-tryptophan is associated with the most serious recent outbreak of illness and death known to be due to consumption of dietary supplements. In 1989, public health officials realized that an epidemic of eosinophilia-myalgia syndrome (EMS) was associated with the ingestion of L-tryptophan in a dietary supplement. EMS is a systemic connective tissue disease characterized by severe muscle pain, an increase in white blood cells, and certain skin and neuromuscular manifestations.

A number of illnesses, including those similar to the eosinophilia myalgia syndrome (EMS) associated with L-tryptophan consumption, have been reported to FDA in individuals using dietary supplements containing phenylalanine. There are also published reports of scleroderma/scleroderma-like illnesses, which have symptoms similar to EMS, occurring in children with poorly controlled blood phenylalanine levels, as well as in those with phenylketonuria (PKU), a genetic disorder characterized by the inability to metabolize phenylalanine.

Vitamin and mineral dietary supplements have a long history of use at levels consistent with the Recommended Dietary Allowances (RDA's) or at low multiples of the RDA's, and are generally considered safe at these levels for the general population. Intakes above the RDA, however, vary widely in their potential for adverse effects. Certain vitamins and minerals that are safe when consumed at low levels are toxic at higher doses. The difference between a safe low dose and a toxic higher dose is quite large for some vitamins and minerals and quite small for others.

Vitamin A is found in several forms in dietary supplements. Preformed vitamin A (vitamin A acetate and vitamin A palmitate) has well-recognized toxicity when consumed at levels of 25,000 International Units (IU) per day, or higher. (Beta-carotene does not have the potential for adverse effects that the other forms of vitamin A do, because high intakes of beta-carotene are converted to vitamin A in the body at much lower levels). The RDA for vitamin A is 1,000 retinol equivalents (RE) for men, which is equivalent to 3,300 IU of preformed vitamin A, and 80 percent of these amounts for women.

Neurologic toxicity, including ataxia (alteration in balance) and sensory neuropathy (changes in sensations due to nerve injury), is associated with intake of vitamin B6 (pyridoxine) supplements at levels above 100 milligrams per day. As little as 50 milligrams per day has caused resumption of symptoms in an individual previously injured by higher intakes. The RDA for vitamin B6 is 2 milligrams. Vitamin B6 is marketed in capsules containing dosages in the 100-, 200-, and 500-milligrams range.

Niacin taken in high doses is known to cause a wide range of adverse effects. The RDA for niacin is 20 milligrams. Niacin is marketed in dietary supplements at potencies of 250 mg, 400 mg, and 500 mg, in both immediate and slow-release formulations. Daily doses of 500 mg from slow-release formulations, and 750 mg of immediate-release niacin, have been associated with severe adverse reactions, including gastrointestinal distress (burning pain, nausea, vomiting, bloating, cramping, and diarrhea) and mild to severe liver damage. Less common, but more serious (in some cases life-threatening), reactions include liver injury, myopathy (muscle disease), maculopathy of the eyes (injury to the eyes resulting in decreased vision), coagulopathy (increased bleeding problems), cytopenia (decreases in cell types in the blood), hypotensive myocardial ischemia (heart injury caused by too low blood pressure), and metabolic acidosis (increases in the acidity of the blood and urine).

Niacin (nicotinic acid) is approved as a prescription drug to lower cholesterol. Many of the observed adverse reactions have occurred when patients have switched to OTC formulations of niacin, and particularly when they have switched from immediate-release formulations to dietary supplements containing slow-release niacin formulations without the knowledge of their physicians.

IV. Other Products Marked as Dietary Supplements

Germanium is a nonessential element. Recently, germanium has been marketed in the form of inorganic germanium salts and novel organogermanium compounds, as a "dietary supplement." These products are promoted for their claimed immunomodulatory effects or as "health-promoting" elixirs. Germanium supplements, when used chronically, have caused nephrotoxicity (kidney injury) and death. Since 1982, there have been 20 reported cases of acute renal failure, including two deaths, attributed to oral intakes of germanium elixirs. In surviving patients, kidney function has improved after discontinuation of germanium, but none of the patients have recovered normal kidney function.

Dietary Supplement Health and Education Act (DSHEA), 2/2/2007
Most people think that dietary supplements and herbs are closely regulated to ensure that they are safe, effective, and truthfully advertised. Nothing could be further from the truth. Although some aspects of marketing are regulated, the United States Congress has concluded that "informed" consumers need little government protection. This conclusion was embodied in the Dietary Supplement Health and Education Act of 1994—commonly referred to as "DSHEA"—which severely limits the FDA's ability to regulate these products.

Alarmed by these developments, the health-food industry and its allies urged Congress to "preserve the consumer's freedom to choose dietary supplements." To whip up their troops, industry leaders warned retailers that they would be put out of business. Consumers were told that unless they took action, the FDA would take away their right to buy vitamins. These claims, although bogus, generated an avalanche of communications to Congress .

The end result was passage of DSHEA, which defined "dietary supplements" as a separate regulatory category and liberalized what information could be distributed by their sellers. DSHEA also created an NIH Office of Dietary Supplements and directed the President to appoint a Commission on Dietary Supplement Labels to recommend ways to implement the act . The Commission's final recommendations were released on November 24, 1997 .

DSHEA worsened this situation by increasing the amount of misinformation that can be directly transmitted to prospective customers. It also expanded the types of products that could be marketed as "supplements." The most logical definition of "dietary supplement" would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients.

Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.

Because manufacturers are not required to submit safety information before marketing "dietary supplements," the FDA must rely on adverse event reports, product sampling, information in the scientific literature, and other sources of evidence of danger.

Since the FDA is unable to monitor and regulate thousands of individual products, the public is virtually unprotected against supplements and herbs that are unsafe. In recent testimony, FDA Commissioner Jane E. Henney, M.D., even pointed out:

Products that contain substances similar to those found in prescription drugs are marketed for children as dietary supplements.

Likewise, products with ingredients that simulate illicit street drugs are marketed as dietary supplements to adolescents via the Internet and shops specializing in drug paraphernalia."

The 1994 Dietary Supplement Act does not require that dietary supplements (defined broadly to include many substances, such as herbs and amino acids, that have no nutritive value) be shown to be safe or effective before they are marketed. The FDA does not scrutinize a dietary supplement before it enters the marketplace.

The association of A. fangchi with urothelial carcinoma is not the first instance in which dietary supplements have caused potentially serious harm, although this is the strongest association of an herb with a cancer in humans. Among the other well-documented examples of adverse reactions are the association of germander with acute hepatitis, of comfrey with hepatic veno-occlusive disease, of yohimbe with seizures and renal failure, and of ephedra with death from cardiovascular causes. The use of amino acids, herbs, and a host of other supplements is more likely to arouse concern about public health than is the use of traditional vitamin and mineral supplements at reasonable potencies. Even with the use of conventional medicines, the cause of adverse effects that are not immediate and dramatic is hard to pinpoint. This is especially true for substances that are given outside the conventional health care setting, since there is no adequate system of reporting adverse events that may be associated with these products.

It took a tragedy—poisoning caused by the use of an elixir of sulfanilamide—to prompt Congress to pass the Food, Drug, and Cosmetic Act of 1938, and it took reports of birth defects among the children of women who took thalidomide during pregnancy to secure passage of the Kefauver-Harris Amendments to that act in 1962. Congress has shown little interest in protecting consumers from the hazards of dietary supplements, let alone from the fraudulent claims that are made, since its members apparently believe that few of these products place people in real danger. Nor does the public understand how potentially dangerous these products can be. Examples like that described by Nortier et al. should persuade Congress to change the law to ensure the safety and efficacy of dietary supplements before more people are harmed .

DSHEA allows dietary supplements to bear "statements of support" that: (a) claim a benefit related to classical nutrient deficiency disease; (b) describe how ingredients affect the structure or function of the human body; (c) characterize the documented mechanism by which the ingredients act to maintain structure or function; and (d) describe general well-being from consumption of the ingredients. The statement "calcium builds strong bones and teeth" is said to be a classic example of an allowable structure/function statement for a food. What constitutes an allowable statement for a supplement has not been established either by law or by regulation.

Actually, few statements about the biochemical or physiologic properties of nutrients have practical value for consumers. By definition, every essential nutrient is important to proper body function. Simple statements about nutrient function are more likely to be misleading than helpful. A statement such as "vitamin A is essential to good eye function" could suggest: (a) people need to take special steps to be sure they get enough, (b) extra vitamin A may enhance eyesight, and (c) common eye problems may be caused vitamin A deficiency or remedies by taking supplements.

To be completely truthful, a "nutritional support" statement about vitamin A would have to counter all three misconceptions and indicate that people eating sensibly don't need to worry about whether their vitamin A intake is adequate. In other words, truthful statements about nutrient supplements would have to indicate who doesn't need them. No vitamin manufacturer has ever done this or ever will. Since herbs are not nutrients, the concept of "nutritional support" statements for herbs is absurd.

Historically, the FDA has considered literature used directly in connection with the sale of a product to be "labeling" for the product. DSHEA exempts publications from "labeling" if they: (a) are not false or misleading, (b) do not promote a particular manufacturer or brand, (c) present a "balanced" view of pertinent scientific information, and (d) are physically separated from the items discussed. However, since most "dietary supplements" are either useless, irrationally formulated, and/or overpriced, the supplement industry is has little reason to provide literature that is not misleading. In addition, the FDA does not have the resources to police the huge numbers of "support" statements to ensure that they are appropriately "balanced."

On January 6, 2000, after receiving more than 100,000 protest messages from the supplement industry and its allies, the FDA published a revised final rule on health claims for dietary supplements . DSHEA permits claims that products affect the structure or function of the body, provided the manufacturer has substantiating documents on file. Without prior FDA review, products may not bear a claim that they can prevent, treat, cure, mitigate or diagnose disease. The final rule still prohibits express disease claims (such as "prevents osteoporosis"), and implied disease claims ("prevents bone fragility in postmenopausal women"), including claims made through a product's name ("CircuCure") or through pictures or symbols. The rule permits health-maintenance claims ("maintains a healthy circulatory system"); other non-disease claims ("for muscle enhancement," "helps you relax,"); and claims for common, minor symptoms associated with pregnancy, menopause, or other life stages (e.g., "for common symptoms of PMS," "for hot flashes"). However, osteoporosis and other serious conditions associated with aging, menopause or adolescence will still be treated as diseases.

The Federal Trade Commission (FTC) has jurisdiction over the advertising of "dietary supplements." In December 1998, it issued "Dietary Supplements: An Advertising Guide for Industry," a detailed document to clarify the need for substantiation . Although the FTC is far too small to control the dietary supplement industry, the threat of FTC action still causes some marketers to be cautious. Bills like the so-called "Dietary Supplement Fairness in Labeling and Advertising Act"—introduced in 1999 as H.R. 3305 by Representative Dan Burton (R-IN) and as S. 1749, by Senator Michael Crapo (R-ID)—would force the FTC to allow the same information in advertising of dietary supplements that the FDA allows in labeling of the same products. Fortunately, no such bill has been passed.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3546), enacted in December 2006, will require manufacturers of dietary supplements and nonprescription drugs to notify the FDA about serious adverse events related to their products. Beginning in December 2007, manufacturers must report deaths; life-threatening experiences; inpatient hospitalizations; persistent or significant disability or incapacity; birth defects; or the need for medical intervention to prevent any such problems. Manufacturers will also have to place a telephone number or address on product labels so consumers can contact them. The bill was passed in response to concerns about how difficult it was for the FDA to ban ephedra sales even though thousands of people had adverse effects. Congress reasoned that if notification could be increased, the FDA could do a better job of identifying and dealing with dangerous products. However, public protection is only slightly increased because other parts of DSHEA make it very cumbersome for the FDA to ban dietary supplements and herbs.

Several surveys have determined that consumers really want protection against false claims and unsafe products . A Roper survey of 1,480 persons age 50 or older conducted in 2001, for example, found that about 75% of the respondants wanted the government to review safety data and approve dietary supplements prior to sale and to verify all health-related claims before they can be included in advertisements and on product labels .


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Dietary Supplements, Herbs, and Hormones, 24/8/2005
Dietary Supplements, Herbs, and Hormones

"Dietary Supplements," Herbs, and Hormones

The most logical definition of "dietary supplement" would be something that supplies one or more essential nutrients missing from the diet. However, the Dietary Supplement Health and Education Act of 1994 -- commonly referred to as DSHEA -- defines "dietary supplement" as any product (except tobacco) that contains at least one of the following: (1) a vitamin, (2) a mineral, (3) an herb or botanical, (4) an amino acid, (5) a dietary substance "for use to supplement the diet by increasing total dietary intake," or (6) any concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients. Herbs ,of course, are not consumed for a nutritional purpose and often are marketed with therapeutic claims. The supplement industry, which lobbied vigorously for passage of this act, included them in this definition to weaken the FDA's ability to regulate their marketing. Since DSHEA's passage, hormones have also been marketed as "dietary supplements."

This page provides an index to Quackwatch's information on the wide variety of substances sold as "dietary supplements" by health-food stores, pharmacies, multilevel companies, health practitioners, and mail-order entrepreneurs, and Internet outlets. A few such substances are useful, but most are promoted with false or misleading claims. Quackwatch has assembled an expert advisory team to evaluate the claims made for them.

offers information about supplement products consumers have asked about. Its Web site also hosts the FDA Adverse Event Monitoring System, a searchable database of reports the FDA has received about dietary supplements and herbal products.

Appropriate Use of Dietary Supplements (revised 5/11/01)

Olympic Committee Finds Hormone Precursors in "Dietary Supplements"

Why the FDA Does Not Approve Supplements (posted 11/20/99)

Improvements Needed in Overseeing Dietary Supplements and "Functional Foods" (GAO report) (posted 7/21/00)

FTC Warning: Misleading Ads for Children's Dietary Supplements (link to NutriWatch)

Folate Fact Sheet (link to NIH Office of Dietary Supplements)

Magnesium Fact Sheet (link to NIH Office of Dietary Supplements)

Nutritional Supplements for Down Syndrome (updated 10/18/98)

Selenium Fact Sheet (link to NIH Office of Dietary Supplements)

Vitamin A and Carotenoids Fact Sheet (link to NIH Office of Dietary Supplements)

Vitamin B6 Fact Sheet (link to NIH Office of Dietary Supplements)

Vitamin B12 Fact Sheet (link to NIH Office of Dietary Supplements)

Vitamin D Fact Sheet (link to NIH Office of Dietary Supplements)

Vitamin E Fact Sheet (link to NIH Office of Dietary Supplements)

American Heart Association's Position on Vitamin and Mineral Supplements


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Nutritional Supplements for Down Syndrome, 29/7/2003
Nutritional Supplements for Down Syndrome

Nutritional Supplements for Down Syndrome:

Down syndrome formulas contain four main groups of ingredients: vitamins, minerals, amino acids and anti-oxidants. Newer additions include digestive enzymes and fat supplements.

Although sporadic reports of vitamin deficiencies have been published , most studies reveal none , and many studies have found that vitamin supplementation with either RDA doses or megadoses have no effect on mental ability or behavior . The present supplements tend to use RDA values, although levels of vitamin A high enough to be toxic are still occasionally promoted.

Amino acids. All three popular formulas (MSB Plus, NuTriVene-D, and Haps Caps) include amino acids. This supplementation is based on a study of adults with Down syndrome published in 1992 by Jerome Lejeune, M.D. This study reported a consistent deficiency of serine and excess of cysteine and lysine, which Lejeune felt were caused by overexpression of certain genes on the 21st chromosome. He postulated that the supplemental amino acids balanced the blood levels, making the biochemical workings of the body normal. However, a subsequent study of 22 children found no such abnormalities in serum or urinary amino acid levels . Amino acid supplements can cause an unpleasant odor in the user's urine and sweat.

Antioxidants. It has been known for many years that one of the genes overexpressed in Down syndrome is the one producing superoxide dismutase (SOD). This enzyme converts oxygen radicals, which are normal by-products of cell metabolism, to hydrogen peroxide and water. Glutathione peroxidase then converts the hydrogen peroxide to water and oxygen. One theory states that if there is more SOD without a corresponding increase in glutathione peroxidase, then more hydrogen peroxide will be available to cause peroxidative damage to the cell. Experiments with cell cultures and postmortem tests seem to show that this oxidative damage might cause premature aging, damage leading to senile dementia of the Alzheimer's type, and the early loss of brain cells seen in infants with Down syndrome . The theory claims that antioxidant supplements may prevent and even reverse damage by peroxidation.

Docosahexaenoic acid (DHA). This omega-3 fatty acid is an important constituent of cell membranes, especially in the retina and brain. Typically, DHA is synthesized in the body from other fatty acids in the diet. Studies have indicated that premature infants may not be able to synthesize enough on their own, so infant formulas for premature babies should be fortified with DHA. Because breast milk contains DHA, the World Health Organization and several other organizations have asked the FDA to include it in regular infant formulas in the US. (DHA is already a component in infant formula in several European countries.) Promoters of DHA for older children with Down syndrome claim that its use will improve eye and neurologic development. No research indicates that children with Down syndrome lack DHA, cannot make enough, or can benefit from DHA supplements. Further, studies have shown that the critical period for supplementing DHA in preterm infants is the first two months of life and little benefit beyond that should be expected. Likewise, the promotion of the use of other fatty acids has no proven benefit for children with Down syndrome. The use of DHA entails some risks. Too much can actually suppress the immune system, which is already impaired in people with Down syndrome.

Choline. Studies have shown that as children with Down syndrome age, there is a loss of neurons that produce the neurotransmitter acetylcholine. It is presumed that this loss may cause difficulties with memory and cognitive function. Choline is promoted for increasing myelinization of neurons and for increasing levels of the neurotransmitter acetylcholine. However, there is no evidence that oral choline supplements do either of these things in people with Down syndrome.

Vitamins A and E continue slightly above the RDA in several supplements.

There is still concern as to infants who are nursing or taking formula and being given these products getting too much vitamin A and a heavy protein load. Information on side effects is not being collected systematically. However, at a meeting in late 1997 of the Down Syndrome Medical Interest Group, doctors caring for these children reported instances of diarrhea, hyperactivity, and insomnia. Another notable effect has been loss of appetite, related to the fact that these supplements are not usually palatable.

Parents often hide them in food and drink. A few children have stopped eating, apparently suspicious that the supplement was in all their food. Orange skin coloring (carotenemia) was occasionally reported before vitamin A levels in these supplements were decreased.

Stating speculations as fact. Supplement promoters commonly claim that "infants with Down syndrome become retarded largely because of the overexpression of" superoxide dismutase, and that supplements can compensate for this. Some promoters append a long list of scientific articles to their promotional pieces, implying that they all support what the promoter has written.

Use of anecdotal evidence. Many parents report that their child improved after starting supplements. Stories of increased health, normal growth, children acting "brighter" or "more with it" are abundant and can be very alluring to the interested parent or doctor. However, such testimonials have been shown to be affected strongly by the parent's bias.

While a few vocal doctors have championed the idea that dietary supplements can help children with Down syndrome, most doctors who take care of these children on a day-to-day basis do not recommend supplements. In 1996, the American College of Medical Genetics stated that it knew of no scientific evidence that treatment with Piracetam or amino acid supplements can improve the mental functioning of people with Down syndrome . In 1997, the National Down Syndrome Society cautioned parents that:

Despite all this, however, the use of these supplements continue to be popular. An estimated 5,000 children with Down syndrome have been placed on one of these supplements.The number still taking them is unknown, but interest in these treatments remains high. Told that the nutritional therapies can't hurt and might help, many parents decide that the therapies are "worth a try." Also, with so much research in Down syndrome focusing on prenatal testing or presenile dementia, many parents feel abandoned by the medical establishment. For these parents, the supplement promoters seem to be the only ones interested in "ending the implications of Down syndrome," as one newsletter puts it.

Harrell RF and others. Can nutritional supplements help mentally retarded children? An exploratory study. Proceedings of the National Academy of Sciences USA 78:574-578, 1981.

Menolascino FJ, and others. Vitamin supplements and purported learning enhancement in mentally retarded children. Journal of Nutritional Science and Vitaminology 35:181-192, 1989.

Statement on Nutritional Supplements and Piracetam for Children with Down Syndrome, American College of Medical Genetics, 1996.

Nutritional Supplements for Down Syndrome, 16/6/2002
Nutritional Supplements for Down Syndrome

Nutritional Supplements for Down Syndrome:

Down syndrome formulas contain four main groups of ingredients: vitamins, minerals, amino acids and anti-oxidants. Newer additions include digestive enzymes and fat supplements.

Although sporadic reports of vitamin deficiencies have been published , most studies reveal none , and many studies have found that vitamin supplementation with either RDA doses or megadoses have no effect on mental ability or behavior . The present supplements tend to use RDA values, although levels of vitamin A high enough to be toxic are still occasionally promoted.

Amino acids. All three popular formulas (MSB Plus, NuTriVene-D, and Haps Caps) include amino acids. This supplementation is based on a study of adults with Down syndrome published in 1992 by Jerome Lejeune, M.D. This study reported a consistent deficiency of serine and excess of cysteine and lysine, which Lejeune felt were caused by overexpression of certain genes on the 21st chromosome. He postulated that the supplemental amino acids balanced the blood levels, making the biochemical workings of the body normal. However, a subsequent study of 22 children found no such abnormalities in serum or urinary amino acid levels . Amino acid supplements can cause an unpleasant odor in the user's urine and sweat.

Antioxidants. It has been known for many years that one of the genes overexpressed in Down syndrome is the one producing superoxide dismutase (SOD). This enzyme converts oxygen radicals, which are normal by-products of cell metabolism, to hydrogen peroxide and water. Glutathione peroxidase then converts the hydrogen peroxide to water and oxygen. One theory states that if there is more SOD without a corresponding increase in glutathione peroxidase, then more hydrogen peroxide will be available to cause peroxidative damage to the cell. Experiments with cell cultures and postmortem tests seem to show that this oxidative damage might cause premature aging, damage leading to senile dementia of the Alzheimer's type, and the early loss of brain cells seen in infants with Down syndrome . The theory claims that antioxidant supplements may prevent and even reverse damage by peroxidation.

Docosahexaenoic acid (DHA). This omega-3 fatty acid is an important constituent of cell membranes, especially in the retina and brain. Typically, DHA is synthesized in the body from other fatty acids in the diet. Studies have indicated that premature infants may not be able to synthesize enough on their own, so infant formulas for premature babies should be fortified with DHA. Because breast milk contains DHA, the World Health Organization and several other organizations have asked the FDA to include it in regular infant formulas in the US. (DHA is already a component in infant formula in several European countries.) Promoters of DHA for older children with Down syndrome claim that its use will improve eye and neurologic development. No research indicates that children with Down syndrome lack DHA, cannot make enough, or can benefit from DHA supplements. Further, studies have shown that the critical period for supplementing DHA in preterm infants is the first two months of life and little benefit beyond that should be expected. Likewise, the promotion of the use of other fatty acids has no proven benefit for children with Down syndrome. The use of DHA entails some risks. Too much can actually suppress the immune system, which is already impaired in people with Down syndrome.

Choline. Studies have shown that as children with Down syndrome age, there is a loss of neurons that produce the neurotransmitter acetylcholine. It is presumed that this loss may cause difficulties with memory and cognitive function. Choline is promoted for increasing myelinization of neurons and for increasing levels of the neurotransmitter acetylcholine. However, there is no evidence that oral choline supplements do either of these things in people with Down syndrome.

Vitamins A and E continue slightly above the RDA in several supplements.

There is still concern as to infants who are nursing or taking formula and being given these products getting too much vitamin A and a heavy protein load. Information on side effects is not being collected systematically. However, at a meeting in late 1997 of the Down Syndrome Medical Interest Group, doctors caring for these children reported instances of diarrhea, hyperactivity, and insomnia. Another notable effect has been loss of appetite, related to the fact that these supplements are not usually palatable.

Parents often hide them in food and drink. A few children have stopped eating, apparently suspicious that the supplement was in all their food. Orange skin coloring (carotenemia) was occasionally reported before vitamin A levels in these supplements were decreased.

Stating speculations as fact. Supplement promoters commonly claim that "infants with Down syndrome become retarded largely because of the overexpression of" superoxide dismutase, and that supplements can compensate for this. Some promoters append a long list of scientific articles to their promotional pieces, implying that they all support what the promoter has written.

Use of anecdotal evidence. Many parents report that their child improved after starting supplements. Stories of increased health, normal growth, children acting "brighter" or "more with it" are abundant and can be very alluring to the interested parent or doctor. However, such testimonials have been shown to be affected strongly by the parent's bias.

While a few vocal doctors have championed the idea that dietary supplements can help children with Down syndrome, most doctors who take care of these children on a day-to-day basis do not recommend supplements. In 1996, the American College of Medical Genetics stated that it knew of no scientific evidence that treatment with Piracetam or amino acid supplements can improve the mental functioning of people with Down syndrome . In 1997, the National Down Syndrome Society cautioned parents that:

Despite all this, however, the use of these supplements continue to be popular. An estimated 5,000 children with Down syndrome have been placed on one of these supplements.The number still taking them is unknown, but interest in these treatments remains high. Told that the nutritional therapies can't hurt and might help, many parents decide that the therapies are "worth a try." Also, with so much research in Down syndrome focusing on prenatal testing or presenile dementia, many parents feel abandoned by the medical establishment. For these parents, the supplement promoters seem to be the only ones interested in "ending the implications of Down syndrome," as one newsletter puts it.

Harrell RF and others. Can nutritional supplements help mentally retarded children? An exploratory study. Proceedings of the National Academy of Sciences USA 78:574-578, 1981.

Menolascino FJ, and others. Vitamin supplements and purported learning enhancement in mentally retarded children. Journal of Nutritional Science and Vitaminology 35:181-192, 1989.

Statement on Nutritional Supplements and Piracetam for Children with Down Syndrome, American College of Medical Genetics, 1996.

Testimony of John M. Taylor, 13/9/2001
I am pleased to be here this morning to participate in this discussion of "health fraud," specifically as it relates to dietary supplements. I will describe FDA's role, some successes, and challenges in combating this threat to public health - particularly as it is targeted to our senior citizens and other vulnerable populations.

Let me first provide a brief background on dietary supplements and drugs and the statutory framework under which they are regulated.

Dietary Supplements

Dietary supplements may be found in many forms, such as tablets, capsules, liquids, or bars. Information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Instead, DSHEA placed dietary supplements in a special category under the general umbrella of "foods" and requires that every supplement be labeled as a dietary supplement.

In the past, dietary supplements were mainly sold to adults in health food stores. These products can now be purchased in supermarkets, retail stores, and even through the Internet, making them available to a much wider range of consumers of all ages.

The Washington Post reported last month on just herbal supplements.

Between 1994 and 2000, consumer spending on dietary supplements nearly doubled, and sales continue to grow at better than ten percent a year. (2)

In a survey conducted last year by PREVENTION Magazine ("Survey of Consumer Use of Dietary Supplements," Rodale Press, 733 Third Ave., New York, New York 10017-2000) over 158 million consumers use dietary supplements. Further, the survey found that consumers use dietary supplements to help them achieve their self-care goals and as a means of ensuring good health. They also use them for "medicinal" purposes such as treating and preventing various illnesses, colds, flu, increasing mental sharpness, and alleviating depression.

The consumer's desire for self-care and the widespread use of dietary supplements raises a number of issues, including the possibility of:

harmful interactions between dietary supplements and prescription or over-the-counter (OTC) pharmaceutical products;

When Congress passed DSHEA, it created a unique regulatory framework for dietary supplements. Its purpose was to strike the right balance between providing consumers access to dietary supplements and truthful information about them, while preserving regulatory authority for FDA to take action against supplements that present safety problems or that are labeled or promoted in a false or misleading fashion.

As you know, the regulation of dietary supplements is, for the most part, a post-marketing program, and they are regulated by FDA's Center for Food Safety and Applied Nutrition (CFSAN).

Since Congress considered dietary ingredients marketed prior to the passage of DSHEA to be safe, dietary supplements containing these ingredients are permitted to be freely marketed, just like regular foods (e.g., fresh fruits and vegetables, processed foods and beverages, and seafood). Should safety problems arise after marketing, the adulteration provisions of the statute come into play. Under DSHEA, a dietary supplement is adulterated if, among other reasons, it or one of its ingredients presents "a significant or unreasonable risk of illness or injury" when used as directed on the label or under normal conditions of use (if there are no directions). The burden of proof is on FDA to show that a product or ingredient presents such a risk.

FDA shares Federal oversight of dietary supplements with the Federal Trade Commission (FTC). FDA regulates safety, product manufacturing and product labeling. FTC has primary responsibility for regulating the advertising of these products.

For dietary supplements, as with other products, initially, the Agency works with the marketer of the product to correct the problem voluntarily. If that fails, the Agency also can ask the marketer to recall a product voluntarily; seek, through the courts, seizure of violative products and/or injunction against firms or individuals who market violative products, and detain or refuse entry of products presented for import at U.S. ports. When warranted, criminal penalties - including prison sentences - are sought through the courts, as well as against those who violate the law.

ORA works in close cooperation and coordination with all of FDA's Centers (the Centers) in enforcing the law. With regard to health fraud specific to dietary supplements, CFSAN has the lead and is responsible for the oversight of dietary supplements.

CDER also has a role to play, as many of the most successful cases the Agency has brought concerned products purporting to be dietary supplements that were actually drugs within the meaning of the FD&C Act and failed to meet the regulatory requirements that drugs must meet prior to their introduction into interstate commerce.

The court found FDA's position on street drug alternatives "highly persuasive" and criticized the defendant's characterization of the products as dietary supplements as a "veiled attempt to circumvent" the FD&C Act. The court "decline to carve out a statutory loophole for drug manufacturers attempting to profit from the illegal drug epidemic by masquerading potentially dangerous substances as dietary supplements." This case was the Agency's first suit following issuance of a guidance document in

In his plea agreement, Mr. Cameron admitted that he and his company labeled Formula One as "all natural" but secretly spiked the product with synthetic ephedrine hydrochloride and caffeine anhydrous. He also admitted that the product's labeling failed to disclose the use of the chemicals on the list of ingredients, and that he and his employees had misled FDA investigators and hindered inspections of Chemins. The sentence marked the culmination of a three-year investigation. Mr. Cameron, whose company continues to make dietary supplements, began serving his sentence in September 2000.

In addition, FDA and DOJ have pursued seizures of a number of unapproved drugs that have been promoted on the Internet as dietary supplements, including GBL and 1,4 butanediol. FDA also has sought product recalls and achieved the voluntary destruction of 18 products containing these substances.


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Why the FDA Does Not Approve Supplements, 20/11/1999
Why the FDA Does Not Approve Supplements

Why the FDA Does Not Approve Supplements

This article is a slightly condensed version of a talk given at the Good Housekeeping Institute Consumer Safety Symposium on Dietary Supplements and Herbal Remedies, held in New York City on March 3, 1998. Dr. Kessler was FDA Commissioner from 1990 through 1997 and currently is dean of Yale University School of Medicine.

Where do dietary supplements fall, and where did they fall? And the answer to that was it depends. Many times dietary supplements were viewed as simply as foods. But the agency said if they made claims -- health claims, disease claims -- then they would be regulated as drugs. In the 1980s, foods, many different food manufacturers, started making health claims. You could sell a food or market a food on the basis of the fact that it was good for you -- today we take that for granted -- but back in the early 1980s, that was something that was new. And food companies wanted to start making health claims. So that raised the question and again blurred the line between what's a food and what's a drug and then the hard question, again, where do dietary supplements fit in?

What about dietary supplements? Well, Congress couldn't in 1990 reach a conclusion on that. Senator Hatch said, "I don't want the same standard for foods, for dietary supplements. Dietary supplements shouldn't have to go through preapproval." Other senators argued for preapproval on those health claims. Congress couldn't agree. So what did it do? In 1990, it said in the Nutrition Labeling Education Act, FDA you go decide whether foods and dietary supplements should have the same standard. Should they be required to both have a preapproval of those health claims or should dietary supplements be treated differently? That's where the controversy began and that's where -- that's where the real debate started.

FDA answered that question. It looked at the question and said that foods and dietary supplements should be treated similarly. If they want to go make health claims, there shouldn't be a different standard; and FDA should approve those health claims.

That conclusion -- that no health claim should be on dietary supplements, no health claim should be on food unless the agency reviewed the evidence -- set off one of the most intense lobbying campaigns that I certainly have ever witnessed. I still remember it to this day. I remember having to answer questions about why is FDA going to require prescriptions for vitamins? I remember the ad with Mel Gibson with FDA agents breaking into someone's home to take away his vitamins. It was a brilliant lobbying effort. It also was a lie.

And how did they get it off their plates? They passed the Dietary Supplement Health and Education Act of 1994. It's generally known in the trade as DSHEA. Some viewed it as a compromise. Some viewed it as caving in. Some viewed it as the right policy. . . . DSHEA says that dietary supplements should not make health claims without evidence, without FDA approval. Dietary supplements should not make disease or health claims. However . . . . they can make claims that supplements affect the structure or function of the body.

I went into my chain drugstore the other night and I walked back to the pharmacy counter. And certainly we could all do that, and you could also see what a number of you are reporting, the explosion, the exponential growth in dietary supplement sales. And you could see it in the drugstore. There next to the pharmacy counter -- not just in any of the aisles, but right there underneath the pharmacist, next to the pharmacist, I counted 26 different displays for dietary supplements making claims. Let me read to you what I just saw as I was looking at the different products:

I applaud Good Housekeeping for doing what it always does best, for standing up for informing the public. I think certainly there aren't a lot of people doing it these days, especially when it comes to dietary supplements.

"Nutrition Insurance": A Skeptical View, 12/12/2001
During the late 1980s, the Council for Responsible Nutrition (a supplement industry trade association) falsely suggested that average Americans were in danger of nutrient deficiency and should take supplements. This article was published in 1987 in response to a CRN pamphlet. For updated information about appropriate supplementation, see Dietary Supplements: Appropriate Use.

Vitamin deficiency diseases have not been encountered in the major health and nutrition surveys done recently in the United States. In fact, such diseases now occur so rarely in this country as to be medical curiosities. Nevertheless, large numbers of apparently healthy people take vitamin supplements. The reasons they give for this are a concern that they are not getting enough vitamins from their diets and the belief that they will be less healthy without supplements. These views are encouraged by nutrition supplement advertisers and others who suggest that dietary inadequacy is common and that many Americans have special nutrient needs for which supplementation is advisable.

One of the main points used to support recommendations for "insurance" with vitamin supplements is that health and nutrition surveys have found that intakes of some vitamins by some segments of the population are below the Recommended Dietary Allowances (RDA). It is true that surveys have made such observations. But proper interpretation of these results requires understanding how the RDA are established and how dietary surveys are done.

This is incontrovertible evidence that the food supply contains adequate amounts of essential nutrients. Families that were dependent on food stamp allotments were consuming less adequate diets, indicating that as income falls, food choices become more limited and intakes of some essential nutrients decrease. Inadequate intakes of food, and hence usually of nutrients also occur because of neglect, illness, alcoholism and ignorance. Dietary supplements are not an appropriate solution to these problems.

Another reason given for the use of vitamin supplements is deteriorating or haphazard eating habits. America's eating habits have changed, but whether this represents deterioration is certainly debatable. A pattern of eating three or more substantial meals a day is common in agricultural communities and others in which human energy expenditure is high. This was accepted as the most desirable pattern when our population was largely rural and when mechanization was much less in both the home and the workplace than it is today. One might well ask whether, in a society in which energy expenditure is low, it may not be preferable to eat several small meals throughout the day and to eat when hungry rather than when the clock says it is mealtime. There is much speculation but little evidence that "irregular" eating patterns result in consumption of inadequate amounts of essential nutrients except when total food intake is low.

Since there is little evidence that will stand up to scrutiny to suggest that any substantial proportion of the U.S. population is consuming a nutritionally inadequate diet for any length of time, there is little reason to assume that vitamin supplements will benefit a substantial portion of the population. Foods contain important nutrients that are not provided in vitamin supplements; they also contain many constituents whose significance for health is unknown. Learning how to select foods properly to meet nutritional needs, regardless of changing eating patterns or changes in the food supply, is the only reliable way to ensure lifelong nutritional health. Encouraging the use of vitamin supplements as a corrective for poor eating habits defeats the entire purpose of nutrition education, i.e., to learn the nutritional principles needed to select a healthful diet instead of accepting nutritional advice on faith.

In recent years it has been suggested that above-RDA amounts of vitamins are needed to counteract the effects of various environmental stresses. However, since the human subjects used in experiments which provided the information on which RDA are based were not protected from usual environmental stresses or infections, it is doubtful that vitamin supplements are needed in these conditions.

During illness, recovery from illness, and periods of drug therapy, food intake may be so low that it becomes difficult or even impossible to meet nutritional needs from foods. Nutritional supplements can be useful under such conditions, but as part of a comprehensive program of treatment under the guidance of a physician.

Advocates of vitamin supplements have suggested that many people belong to population groups that have special vitamin needs. Probably the most elaborate presentation of this concept is contained in "Personal Health Circumstances Benefited by Nutritional Supplementation," a six-page flyer published recently by the Council for Responsible Nutrition (CRN), a coalition of major food supplement manufacturers and distributors.

According to the flyer: "CRN believes that the analysis of personal nutrition need categories strongly suggests that large groups of people are at risk for a variety of reasons and that their nutritional status, overall quality of health, and consequent mortality and morbidity are affected. Thus it makes good sense to help guide those in these special need categories to take some action that will protect or improve their nutrition status. Nutrition is a dynamic, rapidly evolving science. CRN believes it is foolish for some old-fashioned health, medical and nutrition personnel to automatically exclude supplements as one worthwhile choice.

Premenopausal women of childbearing age are part of the population of normal healthy individuals. The RDA for healthy adult women are based on their needs. Many of these women need education about appropriate food use, but if they are eating wisely they should not need supplements except during pregnancy when they may not eat enough total food to build up adequate iron stores.

Most gastrointestinal disorders last only a few days and require no special nutrient supplements. For chronic or prolonged gastrointestinal disorders, management by a physician is essential and emphasis should be placed on identifying the cause and curing the condition.

Supplements may be desirable while nutrient loss is occurring but should be done under medical supervision. In malabsorptive diseases -- where absorption of specific vitamins is impaired -- specific supplementation is advisable until the condition can be brought under control.

People with osteoporosis: 20 million. There is no evidence that individuals with osteoporosis have any general need for nutrient supplements. Even the evidence of benefits from high intakes of calcium is inconsistent and controversial. For normal bone maintenance, a calcium intake that meets the RDA is needed throughout adult life. This can be obtained from foods, especially dairy products, but dietary surveys show that many elderly women have low total food and calcium intakes. Increased physical activity will enable them to eat more without gaining weight, and tends to reduce bone mineral loss. It is unclear whether calcium supplements alone are helpful in treating osteoporosis. Combined calcium and estrogen therapy is reportedly beneficial, but of course should be done under medical guidance.

Poor people: 33.1 million. The poor need a support system; they need food programs that provide them with adequate quantities of essential nutrients and energy sources. In other words, they need proper food. Supplements of essential nutrients cannot substitute for basic needs for energy sources and protein, and are expensive in relation to the income of this group of people.

They need nutrition advice, not supplements which tend to distract them from learning about sound food choices.

Alcoholics: 25 million. Supplements are not a solution for alcoholism. Alcoholics need food instead of alcohol and guidance to learn how to control the problem of addiction. If food intake of an alcoholic is extremely low, severe vitamin deficiencies can develop. These need prompt clinical attention and a program of rehabilitation. Inappropriate vitamin supplements may delay the appearance of certain deficiency signs and result in medical treatment being put off until serious deterioration of vital organs has occurred.

Strict vegetarians: 8.5 million. I do not believe there are 8.5 million strict vegetarians in the United States. Moreover, vegetarians are often more knowledgeable about nutrition than the average person because they have organizations that offer valid nutrition advice. Most vegetarians consume eggs and dairy products and obtain adequate quantities of all nutrients including vitamin B12, although some may not. For those who are strict vegetarians, a source of vitamin B12 is required. It is also particularly important for vegetarians to select a wide variety of different types of fruits and vegetables and cereal grains because serious malnutrition has been found to occur in individuals who have restricted their intake to a narrow range of foods from plant sources. Supplements are not a substitute for sound diet planning.

The most appropriate use of vitamin supplements is in conditions in which caloric intake is below 1,200 calories per day and particularly if, at the same time, requirements are increased, perhaps as the result of illness. A correctly balanced multivitamin supplement may also be appropriate for pregnant women. Supplements of vitamins A and D of appropriate potency can be justified for young infants as insurance against nutritional inadequacy. And supplementary fluoride is vital to help strengthen the teeth of children growing up in nonfluoridated communities -- a need that CRN does not address.

I see no evidence in the scientific literature that Americans generally require vitamin supplements. Rather, they need accurate nutrition information about food and health to counter the nutrition misinformation to which we are constantly exposed.


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Antioxidants and Related Phytochemicals, 15/11/2012
The most publicized phytochemicals with antioxidant properties have been vitamin C, vitamin E, and beta-carotene (which the body converts into vitamin A). Evidence exists that vitamin E can help prevent atherosclerosis by interfering with the oxidation of low-density lipoproteins (LDL), a factor associated with increased risk of heart disease. However, vitamin E also has an anticoagulant effect that can promote excessive bleeding. In 1993, The New England Journal of Medicine published two epidemiologic studies which found that people who took vitamin E supplements had fewer deaths from heart disease . These studies did not prove that taking vitamin E was useful because they did not rule out the effects of other lifestyle factors or consider death rates from other diseases. Moreover, other studies have had conflicting results.

The report covered 1,862 men aged 50 to 69 who were followed for a median of 5.3 years. The men had received dietary supplements of alpha-tocopherol (50 mg/day), beta-carotene (20 mg/day), both, or a placebo. There were significantly more deaths from coronary heart disease among those who took beta-carotene supplements, and a trend toward more deaths (but not enough to be statistically significant) in the vitamin E group .

There is no convincing evidence that taking supplements of vitamin C prevents any disease.

No one should take high-dose beta-carotene supplements .

A 1-year study of 153 patients found that supplements of vitamin C, vitamin E, beta-carotene and selenium may interfere with the ability of simvastatin (Zocor) and niacin to raise the HDL levels of patients with abnormally low HDL levels. The patients receiving antioxidants and drugs had an average HDL increase of 18%, whereas the patients who received drugs alone has a 25% increase. However, HDL2-C, an HDL component thought to account for much of HDL's cardioprotective benefit, rose by 42% with drugs alone but was unchanged in patients who also received antioxidants . Although the study was small, it casts further doubt on the value of antioxidant supplementation .

There is currently no such evidence from primary prevention trials, but results from secondary prevention trials have shown beneficial effects of vitamin E supplements on some disease end points.

In contrast, trials directly addressing the effects of beta-carotene supplements have not shown beneficial effects, and some have suggested deleterious effects, particularly in high-risk population subgroups.

To reach this conclusion, they analyzed seven randomized controlled trials of vitamin E treatment and eight of beta-carotene treatment, all of which included at least 1,000 patients. The dosage ranged from 50 to 800 IU for vitamin E and 15 to 50 mg of beta-carotene; and follow-up ranged from 1.4 to 12.0 years. The vitamin E trials involved a total of 81,788 patients, and the beta-carotene trials involved 138,113. Compared with control treatment, Vitamin E did not increase the overall death rate or significantly decrease the risk of cardiovascular death or stroke. Beta-carotene led to a small but significant increase in overall deaths and a slight increase in cardiovascular death. Thus, although epidemiologic evidence has suggested that these antioxidant supplements may be beneficial, clinical trials have found otherwise .

In 2003, the U.S. Preventive Services Task Force (USPSTF) has concluded there is insufficient scientific evidence to recommend vitamin supplements as a way to prevent cancer or heart disease and recommended against the use of beta carotene supplements in smokers because of a possible increased risk of lung cancer and death. The Task Force, sponsored by the Agency for Healthcare Research and Quality (AHRQ), is the leading independent panel of private-sector experts in prevention and primary care. A apokesperson commented:

Vitamin supplements may be necessary for individuals whose diets don't provide the recommended amounts of specific vitamins and especially important for pregnant and nursing women and people with specific illnesses. However, the benefits of vitamin supplements for the general population remain uncertain. . . . There are currently a number of important studies underway which might help answer this important question .

In 2007, Cochrane Collaboration team concluded that commonly taken antioxidant supplements may do more harm than good. Their review encompassed 68 randomized controlled trials with 232,606 participants who took various combinations of beta carotene, vitamin A, vitamin C, vitamin E, and/or selenium or a placebo or had no intervention . The reviewers concluded:

There was no convincing evidence that antioxidant supplements have beneficial effects on overall death rate.

In 47 trials with 180,938 participants, the antioxidant supplements significantly increased the death rate.

Beta carotene, vitamin A, and vitamin E given singly or combined with other antioxidant supplements significantly increase mortality

Considering that 10% to 20% of the adult population in North America and Europe may consume the assessed supplements, the public health consequences may be substantial.

Research is also being done to determine whether taking supplements or eating foods rich in antioxidants can protect against age-related macular degeneration (AMD), a disease in which the central portion of the retina deteriorates so that only peripheral vision remains.

A team of Australian researchers who followed 3,654 subjects age 49 or older found no statistically significant association between AMD and dietary intake of either carotene, zinc, or vitamins A or C, either from diet, supplements, or both . Other published studies have had conflicting results, with some finding correlations and others finding none.

Since publication of the 2001 AREDS report, many dietary supplements have been marketed through the Internet to ""promote" and/or "preserve" healthy vision. The most widely promoted product is Bausch and Lomb's Ocuvite PreserVision, which contains the amounts of beta carotene, vitamin C, vitamin E, and zinc oxide, used in the study. However, The Medical Letter has cautioned that (a) the magnitude of the reported effect was "modest"; (b) no data suggest any benefit for people who do not have AMD or who have only mild disease; and (c) the increased death rate from lung cancer in smokers who took beta carotene in other studies is evidence enough that high doses of vitamins and minerals are not necessarily harmless."

Rapola JM and others. Randomised trial of alpha-tocopherol and beta-carotene supplements on incidence of major coronary events in men with previous myocardial infarction.

Vitamin supplements. The Medical Letter on Drugs and Therapeutics 40:75-77, 1998.


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FDA Can't Protect Americans from Dangerous Supplements, 14/7/2009
FDA Can't Protect Americans from Dangerous Supplements

from Dangerous Dietary Supplements

Add dietary supplements to the growing list of products the beleaguered Food and Drug Administration is failing to regulate. The Government Accountability Office has reported to Congress that the FDA does not have even the most basic information to protect the public from hazardous supplements.

It doesn't have an accurate inventory of the supplement ingredients on store shelves. It doesn't have a firm handle on the number and nature of serious adverse reactions to dietary supplements. In fact, the GAO found, the agency doesn't even have a list of the names and locations of herbal supplement manufacturers. And several substances banned overseas are readily available on the Internet and in retail stores all over the U.S. even though they are variously linked to kidney damage, liver damage, seizures, and death.

"When it comes to dietary supplements, it's like the Wild West, and the bad guys know they don’t have to take the sheriff seriously," said CSPI legal affairs director Bruce Silverglade. "Even when confronted with people dying from a dangerous substance like ephedra, the FDA has limited authority to get the product off the market."

It took the FDA nearly 10 years to ban ephedra, also known as ma huang. Ephedra-containing dietary supplements, often marketed as weight-loss aids and performance enhancers, were linked to numerous deaths and thousands of adverse reactions, including irregular heartbeat and stroke. The herbal ingredients kava, lobelia, and supplements containing aristolochic acid are all banned in some countries, but FDA has taken no action short of issuing public warnings. Meanwhile, such products are available to consumers. St. John's wort, often marketed as an herbal anti-depressant, may interfere with birth control pills, a medicine used to treat HIV, and other prescription medications. While the FDA has issued alerts to that effect, it hasn't required warning labels on the products. As a result, some brands bear warnings while others do not.

Similarly, GAO pointed out that although such popular supplements as garlic, ginkgo biloba, ginseng, and Vitamin E may cause blood thinning and result in life-threatening complications during surgery, consumers are not warned of such risks. A CSPI market survey of warning labels on Vitamin E and other popular supplements found that such leading supplement manufacturers as GNC, Nature's Plus, and Rite Aid do not warn of the risks associated with Vitamin E.

Under current law, dietary supplements sold before 1994 are presumed safe, and manufacturers of new dietary ingredients only need to notify the FDA 75 days before marketing new products. The vast majority of the claims on the labels, like the substances themselves, do not require any FDA approval.

The GAO also found that the boundaries between dietary supplements and foods that contain herbal ingredients are not clear. The food industry often markets teas and other energy drinks as supplements to take advantage of weaker safety laws.

"This report highlights significant gaps in FDA’s ability to ensure the safety of dietary supplements," said Rep. Henry A. Waxman (D-CA), chairman of the Energy and Commerce Committee. "Because of limitations on FDA’s authority and its lack of resources, consumers don’t have the assurance they should that all supplements are safe."

CSPI has repeatedly urged the FDA to take enforcement action against supplements that contain ingredients the agency has told the industry are not recognized as safe for use in foods, including echinacea, ginkgo biloba, ginseng, chromium picolinate, guarana and gotu kola. Foods containing such ingredients include Arizona Rx Iced Teas, Snapple Awaken, and SoBe Lifewater Zingseng.

Appropriate Use of Supplements, 15/11/2010
Appropriate Use of Supplements

Dietary Supplements: Appropriate Use

In general, supplements are useful for individuals who are unable or unwilling to consume an adequate diet. Physicians commonly recommend vitamins for very young children until they are eating solid foods that contain enough vitamins. After a child reaches the age of two, however, it is seldom necessary to continue supplements "just to be sure." In 1980, the Committee on Nutrition of the American Academy of Pediatrics stated that supplements might be appropriate as follows:

Fluoride supplements should be given to children not drinking fluoridated water.

The U.S. Preventive Services Task Force recommends that all women planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400 to 800 µg) of folic acid in order to reduce the risk of birth defects in their offspring . Although a well-balanced diet will provide adequate amounts of folic acid, the task force feels that, for some women, achieving adequate dietary intake might be more difficult than taking supplements.

Women should be sure that their intake of calcium is adequate to help prevent thinning of their bones (osteoporosis). The National Academy of Sciences advises Americans and Canadians at risk for osteoporosis to consume between 1000 and 1300 milligrams of calcium per day . This can be done with adequate intake of dairy products, but some women prefer calcium supplements. Women should discuss this matter with their physician or a registered dietitian.

Unless they choose a proper balance of foods, vegetarians who completely avoid animal products re at risk for several deficiencies, especially vitamin B12. The other nutrients at risk are riboflavin, calcium, iron, and the essential amino acids lysine and methionine. Vegetarian children not exposed to sunlight are at risk for vitamin D deficiency. Zinc deficiency can occur in vegans because the phytic acid in whole grains binds zinc, and there is little zinc in fruits and vegetables. Since B12 is present only in animal foods and a limited number of specially fortified foods, vegans should probably take B12 supplements prescribed by a physician.

Antioxidants have received a lot of favorable publicity. For most people, however, using antioxidant supplements does not make sense .

High (above-RDA) doses of vitamins should be regarded as drugs rather than supplements. Although situations exist where above-RDA dosage can be beneficial, these should be managed with medical supervision. Most high-dose recommendations by the health-food industry and its allies are not valid . As the late John H. Renner, M.D., president of the National Council against Health Fraud, has aptly pointed out: "Nutrition is awfully important in a variety of illnesses as prevention and, in a few, as treatment. But you don't put out a fire with the same things you use to keep it from starting."

Renner JH. Interview in Jenkin D. Dietary supplements: Cure or curse.

A Skeptical Look at St. John's Wort, 20/9/2011
"Dietary Supplements," Herbs, and Hormones

The most logical definition of "dietary supplement" would be something that supplies one or more essential nutrients missing from the diet. However, the Dietary Supplement Health and Education Act of 1994—commonly referred to as DSHEA—defines "dietary supplement" as any product (except tobacco) that contains at least one of the following: (1) a vitamin, (2) a mineral, (3) an herb or botanical, (4) an amino acid, (5) a dietary substance "for use to supplement the diet by increasing total dietary intake," or (6) any concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients. Herbs ,of course, are not consumed for a nutritional purpose and often are marketed with therapeutic claims. The supplement industry, which lobbied vigorously for passage of this act, included them in this definition to weaken the FDA's ability to regulate their marketing. Since DSHEA's passage, hormones have also been marketed as "dietary supplements."

This page provides an index to information on the wide variety of substances sold as "dietary supplements" by health-food stores, pharmacies, multilevel companies, health practitioners, and mail-order entrepreneurs, and Internet outlets. A few such substances are useful, but most are promoted with false or misleading claims. Most of the articles are on Quackwatch, but some are on other sites.

Appropriate Use of Dietary Supplements

Olympic Committee Finds Hormone Precursors in "Dietary Supplements"

Illnesses and Injuries Associated with the Use of Selected Dietary Supplements (1993 FDA report)

Why the FDA Does Not Approve Supplements

Improvements Needed in Overseeing Dietary Supplements and "Functional Foods" (GAO report)

FTC Warning: Misleading Ads for Children's Dietary Supplements

Calorad (link to another site)

Carnitine (link to another site)

Folate Fact Sheet (link to NIH Office of Dietary Supplements)

Magnesium Fact Sheet (link to NIH Office of Dietary Supplements)

Nutritional Supplements for Down Syndrome

Pyruvate (link to another site)

Selenium Fact Sheet (link to NIH Office of Dietary Supplements)

Vitamin A and Carotenoids Fact Sheet (link to NIH Office of Dietary Supplements)

Vitamin B6 Fact Sheet (link to NIH Office of Dietary Supplements)

Vitamin B12 Fact Sheet (link to NIH Office of Dietary Supplements)

Vitamin D Fact Sheet (link to NIH Office of Dietary Supplements)


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Unethical and Ignorant Behavior of Pharmacists, 20/7/2011
Today nearly all pharmacies carry irrationally formulated dietary supplements, and many stock dubious herbal and homeopathic products in addition to standard drugs. Chain drugstores are more likely to do so than individually owned stores. Hospital pharmacies are less prone to do so. In the late 1990s, some pharmacy trade publications—most notably the now-defunct Natural Pharmacist—suggested that "natural products" offered opportunities to make up for prescription drug revenues lost as a result of managed care and other cost-containment programs. Two pharmacy suppliers aligned with this trend were The JAG Group of San Clemente, California and HealthTrust Alliance, of Lawrenceville, Georgia , both of which offered comprehensive programs through which pharmacists could market dietary supplements and herbal and homeopathic products to their customers. I thought that these programs were appalling because (a) few common ailments can be helped with dietary supplements or herbal products, (b) nutrient depletion related to drug use is not common, (c) homeopathic products are worthless, (d) pharmacists are not qualified or legally permitted to be "natural healthcare practitioners, and (e) recommending products for hundreds of ailments would be outside the scope of pharmacy practice, constitute the illegal practice of medicine, and violate state laws against theft by deception. As far as I can tell, neither of these programs is active today, but the percentage of pharmacists who sell dubious products has increased considerably.

If asked directly whether an ineffective product is worthwhile, most pharmacists will answer to the best of their ability. However, many surveys have shown that pharmacists are poorly informed about herbal products, many types of dietary supplements, and homeopathic products.

A study published in 1993 found that 47% of pharmacy students at two Philadelphia schools were taking supplements. The study demonstrated that many of them mistakenly believed that supplements could improve energy and relieve stress and that a year of school had only a modest influence on these beliefs .

Merlin Nelson, M.D., Pharm.D., coauthor of the above-mentioned 1987 survey, has asked pharmacists why they promote and sell food supplements to healthy individuals who don't need them. He concluded:

In March 1998, at a symposium sponsored by the Good Housekeeping Institute, former FDA Commissioner David A. Kessler, M.D, J.D., sharply criticized the willingness of a neighborhood chain drugstore to sell supplements whose labels made improper claims. Next to the pharmacy counter, he had counted 26 displays with such claims as: "targeted mind improvement," "advanced memory and concentration formula," memory support complex," helps increase serotonin level," "immune enhancer," "leg health," "cartilage rejuvenation and repair," and "As featured in the book, 'The Arthritis Cure.'" He told the symposium audience:

The American Society of Health-System Pharmacists (ASHP), which mainly represents pharmacists who work in hospitals and managed care programs, has issued a position statement on the use of dietary supplements which states (in part):

ASHP believes that the widespread, indiscriminate use of dietary supplements presents substantial risks to public health and that pharmacists have an opportunity and a professional responsibility to reduce those risks. . . .

ASHP believes that the criteria used to evaluate dietary supplements for inclusion in health-system formularies should be as rigorous as those established for nonprescription drugs and that the self-administered use of dietary supplements during a health-system stay may increase risks to patients and liabilities to health care professionals and institutions

Instead, he reports how, for more than ten years, nearly every communication channel through which pharmacists receive information about dietary supplements, herbs, and homeopathic products has portrayed them more favorably than they deserve. To counter this, he urges pharmacy schools to provide the naked truth in a course that minces no words and even asks students to complain to the FTC about misleading product advertising .

Pharmacists and their customers have millions of conversations per year about dietary supplements, herbs, and homeopathic products. Can you imagine what would happen to quackery in America if pharmacists discouraged inappropriate purchases of these products? Do you think that will ever happen?

Bell LS, Fairchild M. Evaluation of commercial multivitamin supplements. Journal of the American Dietetic Association 87:341-343, 1987.

Nelson MV and others. A survey of pharmacists' recommendations for food supplements in the U.S.A. and the U.K. Journal of Clinical Pharmacy and Therapeutics 15:131-139, 1990.

Ranelli PL, Dickerson RN, White KG. Use of vitamin and mineral supplements by pharmacy students.

Nelson MV. Promotion and selling of unnecessary food supplements: Quackery or ethical pharmacy practice? American Pharmacy NS28(10):34-36, 1988.

Kessler DA. Why the FDA does not approve supplements. Speech at Good Housekeeping Institute Consumer Safety Symposium: Dietary Supplements & Herbal Remedies. New York, March 3, 1998.

ASHP statement on the use of dietary supplements. American Journal of Health-System Pharmacists 61:1707-1711, 2004 (reviewed and considered "still appropriate" in 2009).

Teastimony of Joyce C. Lashof, MD, 13/9/2001
I would like to thank the members of this Committee for inviting me to participate in this investigation into the marketing of nutritional supplements to the elderly.

If the claims were true, dietary supplements were surely the magic bullet everybody was seeking. If they weren't true - as many of our readers already suspected - and the supplements were just a waste of money, were the products at least safe?

As the years passed, a significant portion of our efforts and print space has been devoted to carefully examining the claims, debunking the ones that could not be substantiated and helping our readers navigate through the slick and mostly misleading advertising for dietary supplements. One of the very first that we tackled (in 1992) was Gero Vita. At that time they were only marketing GH3 as an anti-aging formula and we were extremely forceful in recommending that our readers disregard all the claims made for this product. Later we went on to warn our readers not to believe any of the claims made in Gero Vita's Journal of Longevity. Today Gero Vita's website features no less than 12 products which claim to have anti-aging properties. They have names like TMG Force: An Anti Aging Breakthrough and ACF 223: A Patented Anti-Aging Formula. Not one of these 12 so-called anti-aging preparations has ever been tested and proven to be effective.

Although the ingredients in dietary supplements are required to be listed on the label, the amounts of individual ingredients in so-called "proprietary blends" is not required. The lack of a system of Good Manufacturing Practices and more stringent ingredient labeling regulations makes it impossible to know how much, if any of the purported active ingredient is actually in the products and perhaps more importantly, whether it is uncontaminated. The Wellness Letter has now carefully reviewed more than 70 dietary supplements, including conventional vitamins and minerals. Our complete supplement review is available on our website (www.wellnessletter.com) and a print out of this material has been made available to the Committee.

While we have acknowledged that some of these supplements appear to be useful in certain situations (e.g.

St. John's Wort, Glucosamine), the only supplements we currently recommend to our readers are Vitamin C (if dietary sources are insufficient), Vitamin E, Folic Acid and a multivitamin for older adults. Our reasoning for this is that whereas vitamin preparations are standardized and regulated, other dietary supplements reside in a murky netherworld somewhere between drugs and food. Exempt from all but the most minor of labeling regulations (yet again thanks to DSHEA) the manufacturers of these products have nonetheless been allowed to make claims in their advertisements that are almost completely unsupportable by scientific review. They are not required to prove efficacy or safety before they bring a product to market. DSHEA has put the burden of proof on the FDA to show that something is not safe and the FDA must rely on the reporting of adverse events, which in this case turns out to be a voluntary, inefficient and unwieldy system.

While dietary supplements are legally precluded from making health claims on their labels - they cannot say they cure cancer, heart disease or even acne - they are nonetheless being marketed as cure-all "drugs" and medical miracles.

It is a historical fact that many of today's most important drugs have botanical origins. It is not unreasonable to assume that some of the herbal and other botanical preparations now being sold as dietary supplements may one day be shown to have predictable therapeutic outcomes. If, in fact these products have drug like properties, they are drugs and they should be regulated and controlled like drugs. However, the common perception that the so-called natural products used in dietary supplements are always safe, is completely unfounded and dangerously misguided.

By and large, most young, healthy people who take dietary supplements do so without adverse consequences, except to their pocketbook.

Perhaps the most insidious aspect of marketing dietary supplements to the elderly under the terms of DSHEA is that companies like Gero Vita can knowingly exploit the hopes and fears of a population for whom safety issues are extremely complicated and which, by and large, has more reasons to be concerned about the economic impact of useless substances. When you promise older people (either explicitly or implicitly) that by taking your product they will slow down the aging process, live longer, have more energy, have fewer wrinkles, remember more and perform better sexually, you have touched a raw nerve.

Some of the most common dietary supplements have known adverse effects in the presence of certain conditions, many of which are common in the elderly. One example of this is ginkgo biloba which is heavily marketed to improve memory and has a potent inhibitory effect on the platelet activating factor.

But even for those supplements which do not have adverse effects, the amount of money spent on worthless products is of great concern. Again, according to AARP, of the 31.7 million older persons reporting income in 1998, 36% reported less than $10,000. The median income reported was $13,768. About 3.4 million elderly persons were below the poverty level in 1998.

It is particularly disturbing to think that older people might choose to spend money on dietary supplements instead of prescription drugs which are known to be efficacious and safe.

Obviously the subject of dietary supplements could be discussed and debated almost indefinitely. The existence of a law like DSHEA makes it nearly impossible to change a situation which is complex and confusing and with issues that range from medical to economic to ethical. As long as the FDA and FTC are precluded from doing for dietary supplements what they have been able to do for food, prescription and over the counter drugs, we will never bring reason to this unreasonable and untenable situation. To this end we make the following recommendation.

Repeal or amend DSHEA to give the FDA the power to regulate nutritional supplements as they now do OTC drugs and thus require scientific proof of efficacy and safety.

Require that the labels of dietary supplements instruct consumers to report adverse events directly to the FDA and provide a toll free phone number and website.

Twenty-Six Ways to Spot Quacks and Vitamin Pushers, 7/9/2014
Most vitamin pushers suggest that everyone is in danger of deficiency and should therefore take supplements as "insurance." Some suggest that it is difficult to get what you need from food, while others claim that it is impossible. Their pitch resembles that of the door-to-door huckster who states that your perfectly good furnace is in danger of blowing up unless you replace it with his product. Vitamin pushers will never tell you who doesn't need their products. Their "be wary of deficiency" claims may not be limited to essential nutrients. It can also include nonessential chemicals that nobody needs to worry about because the body makes its own supply.

It is true that food processing can change the nutrient content of foods. But the changes are not so drastic as the quack, who wants you to buy supplements, would like you to believe. While some processing methods destroy some nutrients, others add them.

The RDAs have been published by the National Research Council approximately every five years since 1943. They are defined as "the levels of intake of essential nutrients that, on the basis of scientific knowledge, are judged by the Food and Nutrition Board to be adequate to meet the known nutrient needs of practically all healthy persons." Neither the RDAs nor the Daily Values listed on food labels are "minimums" or "requirements." They are deliberately set higher than most people need. The reason quacks charge that the RDAs are too low is obvious: if you believe you need more than can be obtained from food, you are more likely to buy supplements.

While it is true that the need for vitamins may rise slightly under physical stress and in certain diseases, this type of advertising is fraudulent. The average American—stressed or not—is not in danger of vitamin deficiency. The increased needs to which the ads refer are not higher than the amounts obtainable by proper eating. Someone who is really in danger of deficiency due to an illness would be very sick and would need medical care, probably in a hospital. But these promotions are aimed at average Americans who certainly don't need vitamin supplements to survive the common cold, a round of golf, or a jog around the neighborhood! Athletes get more than enough vitamins when they eat the food needed to meet their caloric requirements.

Many vitamin pushers suggest that smokers need vitamin C supplements.

12. They Recommend "Supplements" and "Health Foods" for Everyone.

By the way, have you ever wondered why people who eat lots of "health foods" still feel they must load themselves up with vitamin supplements? Or why so many "health food" shoppers complain about ill health?

to Indicate Whether You Need Dietary Supplements.

No questionnaire can do this. A few entrepreneurs have devised lengthy computer-scored questionnaires with questions about symptoms that could be present if a vitamin deficiency exists. But such symptoms occur much more frequently in conditions unrelated to nutrition. Even when a deficiency actually exists, the tests don't provide enough information to discover the cause so that suitable treatment can be recommended. That requires a physical examination and appropriate laboratory tests. Many responsible nutritionists use a computer to help evaluate their clients' diet. But this is done to make dietary recommendations, such as reducing fat content or increasing fiber content. Supplements are seldom necessary unless the person is unable (or unwilling) to consume an adequate diet.

Be wary, too, of questionnaires purported to determine whether supplements are needed to correct "nutrient deficiencies" or "dietary inadequacies" or to design "customized" supplements. These questionnaires are scored so that everyone who takes the test is advised to take supplements.

Sure-fire cellulite remedies include creams (to "dissolve" it), brushes, rollers, "loofah" sponges, body wraps, and vitamin-mineral supplements with or without herbs. The cost of various treatment plans runs from a few dollars for a bottle of vitamins to many hundreds of dollars at a salon that offers heat treatments, massage, enzyme injections, and/or treatment with various gadgets. The simple truth about "cellulite" is that it is ordinary fat that can be lost only as part of an overall reducing program.

"Dietary Supplements" as Part of Their Practice.

Although vitamins are useful as therapeutic agents for certain health problems, the number of such conditions is small. Practitioners who sell supplements in their offices invariably recommend them inappropriately. In addition, such products tend to be substantially more expensive than similar ones in drugstores—or even health-food stores. You should also disregard any publication or Web site whose editor or publisher sells dietary supplements.

are based on notions that, as a result of intestinal stasis, intestinal contents putrefy, and toxins are formed and absorbed, which causes chronic poisoning of the body. This "autointoxication" theory was popular around the turn of the century but was abandoned by the scientific community during the 1930s. No such "toxins" have ever been found, and careful observations have shown that individuals in good health can vary greatly in bowel habits. Quacks may also suggest that fecal material collects on the lining of the intestine and causes trouble unless removed by laxatives, colonic irrigation, special diets, and/or various herbs or food supplements that "cleanse" the body. The falsity of this notion is obvious to doctors who perform intestinal surgery or peer within the large intestine with a diagnostic instrument.

Hair analysis has limited value (mainly in forensic medicine) in the diagnosis of heavy metal poisoning, but it is worthless as a screening device to detect nutritional problems . If a hair analysis laboratory recommends supplements, you can be sure that its computers are programmed to recommend them to everyone.

Other tests used to hawk supplements include amino acid analysis of urine, muscle-testing (applied kinesiology), iridology, live-cell analysis (also called dark-field video analysis, nutritional blood analysis, vital hematology, and biocytonics), genetic testing, blood typing, "nutrient-deficiency" and/or lifestyle questionnaires, and "electrodiagnostic" gadgets.

At least 25 diagnostic labels classifiable as fads have been in vogue during the past fifty years . Some unscientific practitioners apply one or more of these diagnoses to almost every patient they see. The common ones includde adrenal fatigue, candidiasis hypersensitivity, hypothyroidism, "leaky gut," chemical sensitivity, electrical hypersensitivity, amalgam toxicity, Lyme disease, "parasites," hypoglycemia, vertebral subluxation complex, and even "magnetic deficiency." Some refer to actual disease (which the patients do not have), whereas others are not recognized by the scientific community. In many cases, nonstandard tests are used to "diagnose" them and recommend "dietary supplements," "detoxification," and/or various procedures to treat them.

Quacks also claim there is a "controversy" about facts between themselves and "the bureaucrats," organized medicine, or "the establishment." They clamor for medical examination of their claims, but ignore any evidence that refutes them. The gambit "Do you believe in vitamins?" is another tactic used to increase confusion. Everyone knows that vitamins are needed by the human body. The real question is "Do you need additional vitamins beyond those in a well-balanced diet?" For most people, the answer is no. Nutrition is a science, not a religion.

LifeScript Customized Vitamins Are a Ripoff, 21/5/2006
LifeScript, of Mission Viejo, California, which began operating in 1999, claims to be "the most refined personal vitamin and supplement on the market today." It also claims that its program "will give you the nutritional boost to help you achieve optimal health." Its primary products are "customized packs of nutritional supplements specifically designed for your body, life and health." To provide this, LifeScript offers a free "customized nutritional report" based on answers to an online "Personal Health Profile" questionnaire. In 2002, the company's Web site stated:

LifeScript knows exactly what nutritional supplements you need because you tell us. By quickly completing our online gender specific health profile questionnaire, we gather specific information about your physical, nutritional and emotional condition. Things like lifestyle cues, job-related conditions, family medical history and medical characteristics. Built on solid medical expertise, our system carefully analyzes this data and generates a unique health profile detailing your nutritional needs in just seconds.

Thanks to the power of the Internet, we offer you the advice of medical doctors to help you choose your Nutritional Supplements.

We apply your unique Health Profile Questionnaire to create a custom "prescription" for you. And we can fill your prescription and ship it directly to your door. Taking your supplements—the right supplements—has never been so easy .

In 2002, the LifeScript Web site stated that the company's Scientific and Medical Advisory Board "oversees the research and development of the company's nutritional supplements, analyzes published research, and makes recommendations regarding LifeScript's nutrition, diet, supplement, and wellness health services." The current (2006) members are:

For women: Are you pregnant or lactating?

In addition, most such conditions are not a reason to take supplements.]

For men: Do you have any of the following kidney or genitourinary conditions? Prostate enlargement; frequent nighttime urination; urinary tract infections; or other prostate disorders.

For women: do you have any of the following gynecological conditions? Menopause; peri-menopause; breast tenderness; PMS; or hysterectomy.

Do you have any of the following musculoskeletal conditions? Frequent joint pain; pulled muscles; muscle or back pain; shoulder, knee, hip, ankle, foot, or spine surgery; tendonitis; osteoarthritis; or degenerative disc disease.

Do you have or have you had any of the following cancer conditions? Lung; colon; brain; melanoma; breast; uterine; ovarian; leukemia; hodgkin's lymphoma.

Have any of your family members (parents, siblings, grandparents, aunts, or uncles) had any of the following medical problems or diseases? Heart attack (myocardial infarction); chest pain (angina pectoris); congestive heart failure (CHF); cardiovascular disease (CVD); stroke (CVA) or Cancer (any type)?

The Scientific and Medical Advisory Board provides input, when requested, on aspects of the medical and nutritional properties of components utilized in the development of the company's nutritional supplements, evaluates published research, and makes recommendations regarding LifeScript's nutrition, diet, supplement, and wellness health services. The advice of the board members is a key component of LifeScript's ability to provide its customers with personalized products and services. The final products that LifeScript markets represents a team approach to product development; however, LifeScript itself and not the advisory board, bears final responsibility for the design of their questionnaire and formulation of their marketed products .

Regardless of their answers, everyone who takes the test gets a "baseline recommendation" to take Daily Solution Pro and Calcium Complete which the Web site states are "packed with the daily essential vitamins and nutrients your body needs to support your immune system as well as overall systemic health." This statement is misleading because there is no scientific evidence that supplements given to people with an adequate diet will improve their immune system or overall health. People whose diet does not contain enough calcium should improve their diet or take supplements, but LifeScript's evaluation is not adequate to determine the amount.

LifeScript's questionnaire fails to do this. Even if it were better designed, it would not provide a legitimate basis for recommending supplements.

LifeScript —Personalized nutritional supplements. LifeScript Web site, accessed May 19, 2002.

Barrett S. Dietary supplements: Appropriate use. Quackwatch Web site. Updated May 20, 2002.

LifeScript and US Wellness enter into agreement to promote customized nutritional supplements. News release, Jan 7, 2002.

A Critical Look at Robert Barefoot and Coral Calcium, 13/9/2012
"Over 200 degenerative diseases are caused by calcium deficiency. That includes cancer, heart disease, diabetes, Alzheimer's, you name it." These diseases are caused by acidosis—acidification of the body—lack of minerals, especially calcium. When you start taking coral calcium, your body alkalizes and drives out the acid . All of these statements are incorrect. Calcium deficiency can weaken bones (osteoporosis), but it does not make the body more acidic or cause a wide range of diseases. The idea that calcium supplements (or dietary strategies) can change the acidity of the body is nonsense. The only acid level that diet or supplements can modify is the degree of acidity (pH) of the urine .

"The body can cure itself of all disease if given the nutrients it needs." Ninety percent of the disease in America can be wiped out if people get on appropriate nutrients. Not true. Although nutritional strategies can help prevent and manage some diseases (most notably cardiovascular diseases), they are rarely curative. Moreover, the vast majority of diseases have little or nothing to do with nutrient levels; and few diseases are treatable by administering dietary supplements.

The study indicated that increased attention to calcium might find a role in cancer prevention, but the study had nothing to do with either calcium supplements or the "reversal" of an established cancer.

Laboratory analyses have shown that some calcium supplements contain significant amounts of lead and other heavy metals . The UC Berkeley Wellness Letter has warned:

There has been little or no good research on coral as a source of calcium or as a treatment for disease. But that doesn't stop the marketers from making their claims, since dietary supplements are virtually unregulated. You have no idea what's really in the bottle or if the stuff is safe. Historically, calcium supplements haven't always been safe: years ago calcium carbonate from bone meal or oyster shells, for instance, was used in some supplements —but was later found to contain high levels of lead. Since then the government and manufacturers took action to reduce lead levels in existing calcium supplements. But new supplements can go untested .

The Wellness Letter statement turned out to be prophetic. In June 2003, ConsumerLab reported that Bob Barefoot's Coral Calcium Supreme contains 2.5 micrograms of lead per gram of calcium . This might not pose a physical threat (except, perhaps, to a developing child when taken by a woman who is pregnant or breastfeeding). However, there is no logical reason to take such aproduct when many other calcium supplements have a lower lead level. California requires that products exceeding the "no significant risk level" of 1.5 micrograms of lead provide a warning label—which Barefoot's product did not.

The body absorbs coral calcium better than other calcium supplements in the market.

Scientific research published in JAMA and elsewhere proves that calcium supplements are able to reverse or cure cancer in the human body.

Calcium intake is an important factor in bone health and may play some role in the prevention of colon cancer. Your best bet for osteoporosis prevention is to follow a medically approved program that includes adequate calcium, exercise, and other measures. The National Academy of Sciences advises Americans and Canadians at risk for osteoporosis to consume between 700 and 1,300 milligrams of calcium per day, depending on age . This can be done with dairy products, supplements, or both. Readily absorbable supplements need not cost more than a few cents a day, which means that taking coral calcium products for their calcium conent is a waste of money.

Government regulatory actions have caused marketers of coral calcium claims to be much more cautious in their claims. Most current promotions suggest that trace mineral deficiencies are common and coral calcium products are ideal for preventing them. Some also claim that coral minerals also improve health by correcting pH imbalances. Such statements are misleading because (a) people who eat sensibly do not need supplements of trace minerals, and (b) unless someone is severely ill, the body pH will remain within its proper range.

Packer-Tursman J. From the depths: Many experts don't swallow extraordinary claims for calcium supplements derived from sea coral. Washington Post May 20, 2003.

Barrett S. Dietary supplements: Appropriate Use. Quackwatch, revised May 20, 2002.

Ross EA and others. Lead content of calcium supplements. JAMA 284:1425-1429, 2000.

Written Submission by Rep. Dan Burton, 23/1/2003
The role of dietary supplements is even more important for the aging population given that many seniors are not able to obtain all of their daily vitamin and mineral requirements through food consumption alone.

the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;

there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis;

consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;

national surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition;

dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare.

It is often misreported in the media that with the passage of DSHEA the FDA lost the ability to regulate supplements. The fact is that the FDA has seven points of authority to regulate dietary supplements. The FDA has the power to:

Seize dietary supplements that pose an" unreasonable or significant risk of illness or injury"

Stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard

Require dietary supplements to meet strict manufacturing requirements (Good Manufacturing Practices), including potency, cleanliness and stability

When asked about the FDA's power to regulate supplements, Dr.

Jane Henney, then FDA Commissioner testified to the Committee on Government Reform in 1999 that the FDA had adequate authority to regulate dietary supplements. One issue of major importance is the full implementation of DSHEA, including most specifically the formation of Good Manufacturing Practices (GMPs) for dietary supplement manufacturers. Until GMPs are in place and the FDA becomes active in looking at enforcing GMPs, we will not have a full implementation of DSHEA. In the mean time, the FDA has the authority to enforce each of its authority including the current GMPs. Many of the concerns the public expresses about quality assurance are directly connected to the FDA's need to enforce GMPs. The FDA's written testimony provides information on a series of actions taken over the last decade but provides not a single example of scams against the elderly.

Additionally the Federal Trade Commission has jurisdiction on advertising claims for dietary supplements. The FTC published guidelines for manufacturers and has been very active in regulating these products.

There is also significant government funded research showing the benefit in the senior population for such nutritional supplements as vitamins C and E, folic acid, coenzyme Q10, and Omega-3 fatty acids. The Office of Dietary Supplements has done a terrific job of providing accurate information and links to public and private resources on their Internet site.

In 1998, the Department of Health and Human Services announced a five year project, "The Healthy Aging Initiative" to identify the best ways to promote health and prevent physical decline among older Americans. To date, this project has focused entirely on clinical services provided under Medicare such as cancer screenings. This may be an appropriate avenue to coordinate a review of the existing science and traditions regarding aging-related nutrition, including supplementation in order to better understand the role of dietary supplements in healthy aging.

Quality dietary supplements can and do offer benefits to the structure and function of the aging body when used wisely. We have laws that should be fully implemented and enforced. Americans deserve nothing less.

Nutrabalance Is a Gimmick to Sell Supplements, 22/10/2012
Nutrabalance Is a Gimmick to Sell Supplements

to Sell Supplements

The evaluation was based on the results of a blood chemistry profile and a urinalysis performed at a legitimate laboratory and submitted to Nutrabalance for interpretation. Nutrabalance then issued a lengthy computerized report which classified the patient according to 14 "metabolic types," listed supposed health problem areas, and recommended dietary changes and food supplements from one of four manufacturer chosen by the patient's doctor. The metabolic types were called "hypothalamus," "pineal," "anterior pituitary," "posterior pituitary," "thyroid," "adrenal," "gonadal," "parathyroid," "pancreas," "gastrointestinal," "liver/spleen," "immune," "high gear," and "low gear." A 95-page manual, which cost $50, listed about 25 types of problems allegedly associated for the first 12 of these types. (Lists were not given for "high gear" and "low gear," because they were "composites" of several other types. The manual also contained an "informed consent" form—for the patient to sign—which stated: "I am fully aware that these dietary and/or nutritional recommendations are experimental and medically unproven." .

In 1985, an undercover investigator who enjoyed excellent health sent two sets of blood and urine test results to Nutrabalance for interpretation. The blood test values were almost identical, but the investigator drank two glasses of water between urine specimens, which made their pH (acidity) and specific gravity differ. The first report classified the "patient" as: "Primary Type: Adrenal, Secondary Type: Posterior Pituitary, Acid/Alkaline Condition: Acid" and recommended an "acid food plan" plus 13 supplement pills per day. The second report classified the "patient" as: "Primary Type: Adrenal, Secondary Type: Liver Spleen, Acid/Alkaline Condition: Balanced" and recommended a "balanced food plan" plus 10 supplement pills per day. Both reports claimed that the patient had many glandular "imbalances," which was untrue. The recommended supplements—which practitioners typically sell in their offices at a 50% to 100% markup—would have cost several dollars a day.

In 1985, during a telephone call, Montante told me that the company had about 400 clients and was processing about a thousand reports per month and that the program had been adapted from a metabolic-typing system developed by a dentist named William C. Kelley . In the 1960s, Kelley developed a program for cancer patients that involved dietary measures, vitamin and enzyme supplements, and computerized "metabolic typing." He claimed that his "Protein Metabolism Evaluation Index" could diagnose cancer before it was clinically apparent and that his "Kelley Malignancy Index could detect "the presence or absence of cancer, the growth rate of the tumor, the location of the tumor mass, prognosis of the treatment, age of the tumor and the regulation of medication for treatment." None of these claims were valid.

In 1970, Kelley was convicted of practicing medicine without a license after witnesses testified that he had diagnosed lung cancer based on blood from a patient's finger and had prescribed dietary supplements, enzymes, and a diet as treatment. In 1976, following court appeals, his dental license was suspended for five years . He didn't practice dentistry again, but he continued to promote his offbeat methods until the mid-1980s through his Dallas-based International Health Institute. Under the institute's umbrella, licensed professionals and "certified metabolic technicians" throughout the United States would administer a 3,200-item questionnaire and send the answers to Dallas. The resultant computer printout provided a lengthy report on "metabolic status" plus detailed instructions covering foods, supplements (typically 100 to 200 pills per day), "detoxification" techniques, and lifestyle changes. Montante became a "Certified Kelley Physician" in 1980 .

Shusterman MD, Montante JR. The science and art of nutritional therapy: Vitamin and glandular supplements. The American Chiropractor, Aug 1984, pp 13-15.

Dietary Supplements: What Seniors Need To Know, 19/6/2010
Dietary Supplements: What Seniors Need To Know

Dietary Supplements: What Seniors Need To Know

Senator Herbert Kohl announced that the hearing would address concerns that have arisen over whether the marketing and manufacturing of dietary supplements meet the standards that American consumers deserve."

Greg Kutz, Managing Director, Forensic Audits and Special Investigations, US Government Accountability Office, presented a report titled "Herbal dietary supplements: Examples of deceptive or questionable marketing practices and potentially dangerous advice." To conduct its investigation, GAO investigated a nonrepresentative selection of 22 storefront and mail-order retailers of herbal products. Posing as elderly consumers, GAO investigators asked sales staff (by phone and in person) at each retailer a series of questions regarding herbal dietary supplements. They also reviewed written marketing language used on approximately 30 retail Web sites and also had an accredited lab test 40 unique popular single-ingredient herbal products for the presence of lead, arsenic, mercury, cadmium, organichlorine pesticides, and organophosphorous pesticides.The investigators found several cases where written sales materials for products sold through online retailers claimed that herbal dietary supplements could treat, prevent, or cure conditions such as diabetes, cancer, or cardiovascular disease. In addition, while posing as elderly customers, investigators were often that a given product would prevent or cure conditions such as high cholesterol or Alzheimer's disease. The investigators were also given potentially harmful medical advice. GAO also found trace amounts of at least one potentially hazardous contaminant in 37 of the 40 products tested, though none in amounts considered to pose an acute toxicity hazard.

Steve Mister, President and CEO, Council for Responsible Nutrition, who testified on behalf of CRN and four other trade associations, described industry self-regulatory efforts and suggested that most of the problems were due to "bad actors in the industry—those companies, whether they are manufacturers or retailers, that are either unaware of the extensive regulatory framework governing dietary supplements or are willfully breaking the law."

Joshua Sharfstein, Principal Deputy FDA Commissioner, reviewed the current laws and stated that the agency's enforcement actions related to dietary supplements target products that pose the greatest risk to public health.

Olympic Committee Finds Hormone Precursors in "Dietary Supplements.", 25/9/2002
Olympic Committee Finds Hormone Precursors in "Dietary Supplements."

IOC Nutritional Supplements Study

Based on the results of a study of 634 nutritional supplements, the Medical Commission of the International Olympic Committee (IOC) today reissued its warning to athletes against their use and strengthened its call for industry and government action to ensure their quality.

The 634 non-hormonal nutritional supplements were gathered from 215 different providers in 13 countries from October 2000 to November 2001. Ninety-one percent of them were purchased in stores or over the Internet. The others were obtained from the manufacturers.

The IOC-accredited laboratory in Cologne, Germany, tested all supplements.

The IOC Medical Commission has been warning against the potential risks linked to the use of nutritional supplements since 1997.

The IOC Medical Commission recommends controls, similar to those pertaining to the manufacture of pharmaceuticals, be applied to the production of nutritional supplements.

The IOC also will recommend to National Olympic Committees (NOCs), International Federations (IFs) and Organizing Committees (OCOGs) that they adopt a cautious stance toward forming relationships with companies that produce nutritional supplements of which the quality cannot be guaranteed.

FTC Dietary Supplement Advertising Cases 1984 to July 2003, 5/6/2011
Kevin Trudeau; Robert Barefoot, Shop America (USA), LLC, and Deonna Enterprises, Inc. Civ. Action No. 03 C 904 (June 9, 2003) (N.D. Ill.) (Complaint for Permanent Injunction and Other Equitable Relief) Alleged false and unsubstantiated claims that Coral Calcium Supreme can treat or cure cancer and other diseases, such as multiple sclerosis and heart disease, and is superior to other calcium supplements.

A. Glenn Braswell; JOL Management Co.; G.B. Data Systems, Inc., Gero Vita International, Inc., Theraceuticals, Inc.; and Ron Tepper; Civ. Action No. CV 03-3700 DT (PJWx) (C.D. Cal.) (filed May 27, 2003)(Complaint for Permanent Injunction and Other Equitable Relief) Alleged false and unsubstantiated advertising claims for numerous dietary supplements marketed under the Gero Vita and Theraceuticals brand names.

Dr. Clark Research Association, et al., d/b/a Dr. Clark Zentrum, Civ. Action No. l:03CV0054, (N.D.Ohio) Complaint for Permanent Injunction and Other Equitable Relief (filed 01/08/03)Alleged unsubstantiated AIDS, terminal cancer, and other disease cure claims for dietary supplements and devices.

No. 9068-8425 Quebec, Inc. a/b/a Bio Lab, Cellu-Fight, and Quick Slim, and Jean-Francois Brochu, Civ. Action No. 1:02:CV-1128, U.S. District Court, Northern District of NY (September 3, 2002)(Complaint for Permanent Injunction and Other Equitable Relief) Alleged false weight-loss and cellulite-treatment claims by Canadian company marketing dietary supplements to U.S. consumers using mainstream U.S. media.

Streamline International, Inc., et al., Civil Action No. 01-6885-CIV-Ferguson (Complaint filed in U.S. District Court for the Southern District of Florida)(June 20, 2001) (Alleged false and deceptive earnings claims by operators of fraudulent business opportunity pyramid marketing scheme purportedly distributing a line of dietary supplements and health-care products. Complaint also alleges false and misleading claims that the company sells only dietary supplement products containing ingredients that appear on the FDA’s list of ingredients generally recognized as safe. In fact, a number of products contain the herbal ingredient comfrey, which is not on that list and is known to pose a significant risk to humans, including liver damage, when used internally or externally on open wounds.

Enforma Natural Products, Inc., et al., Civ. Action No.: 04376JSL(CWx), U.S. District Court, Central District of California, (filed April 25, 2000) Complaint and Stipulated Final Order filed with the court; $10 million in consumer redress ordered.( False and unsubstantiated weight loss claims alleged for “Fat Trapper” and “Exercise in a Bottle” containing the dietary supplements chitosan and pyruvate, respectively)

AST Nutritional Concepts and Research, Inc., et al. (Civ. No. 99-WY-2197, U.S. District Court for the District of Colorado)(May 4, 2000)(Permanent Injunction)(Alleged unsubstantiated safety claims made for purported body-building supplements that contain androstenedione, “androgen,” and other steroid hormones, and in some cases, stimulants.

Met-RX USA, Inc., et al., (Civ. No. SACV99-1407 DOC(ANX), U.S. District Court for the Central District of California)(Nov. 24, 1999)(Stipulated Final Order For Permanent Injunction and Other Equitable Relief)Unsubstantiated safety claims made for purported body-building supplements that contain androstenedione,“androgen,” and other steriod hormones, and in some cases, stimulants.

Arthritis Pain Care Center (APCC), et al., File No. C-3896 (September7, 1999)(Consent order)(unsubstantiated health benefit claims regarding dietary supplements and false claims regarding scientific studies)

New Vision International, Inc., et al., File No. C-3856(March 3, 1999)(consent order) (unsubstantiated claims that dietary supplements called “God’s Recipe” would cure ADD/ADHD)

Nu Skin International, Inc., United States v., No. 2:97-CV-0626G (D. Utah Aug. 6, 1997) (stipulated permanent injunction and $1.5 million civil penalty for violation of 1994 order) (fat loss, muscle maintenance, and other claims for dietary supplements, Metabotrim, OverDrive, GlycoBar, Appeal Lite, and Breakbar, containing chromium picolinate and L-carnitine)

Body Wise International, Inc., C-3617 (Sept. 25, 1995) (consent) (dietary supplements for weight loss and cholesterol reduction; failure to disclose that healthcare professionals and others who gave testimonials for the products had a financial interest in promoting them)

Nature's Bounty, Inc., C-3593 (Jul. 21, 1995) (consent and $250,000 in consumer redress) (health related claims for 26 nutrient supplements, including Sleeper’s Diet for weight loss during sleep; L’Arginine and L-Ornithine to increase muscle mass while decreasing body fat; L-Cysteine to promote hair growth; Octacosanol to improve reaction time, reduce cholesterol levels, and strengthen muscles; New Zealand Green Lipped Mussel Extract to prevent arthritis and relieve its symptoms; Eye-Vites to reduce the risk of developing cataracts; and Ginsana to improve physical endurance and mental alertness)

HealthComm Inc., United States v., No. C95-5024 RJB (W.D. Wash. Jan. 19, 1995) stipulated permanent injunction and $45,000 civil penalty for violation of Nu-Day order, below) (Nu-Day Meal Replacement Formula, UltraMeal, and other weight-loss products and programs; and UltraClear and UltraClear Sustain nutritional supplements for "metabolic clearing" and nutritional support of persons suffering from various ailments)

American Life Nutrition, Inc., 113 F.T.C. 906 (1990) (consent) (bee pollen, fish oil, royal jelly, vitamin, oyster shell, and calcium food supplements to prevent or treat diseases such as breast cancer, heart disease, diabetes, rubella, arthritis, colds, tuberculosis, asthma, kidney disease, high blood pressure, cerebral apoplexy, low sex drive, among others)

General Nutrition, Inc., 111 F.T.C. 387 (1989) (consent agreement and $600,000 in nutrition, obesity, and physical fitness research) (dietary supplement for reducing the risk of some forms of cancer; six food supplements, including L-Arginine and L-Ornithine, to promote weight loss and muscle growth or retard aging)

Weider Health and Fitness, Inc., 106 F.T.C. 584 (1985) (consent and $400,000 in consumer redress) (Anabolic Mega-Pak and Dynamic Life Essence nutritional supplements for rapid and substantial muscular development and strength)

OTA Report: Dietary Treatments, 13/1/2006
The wheatgrass regimen eliminates all meat, dairy products, and cooked foods from the diet, while emphasizing "live foods" (including uncooked sprouts, vegetables, fruits, nuts, and seeds), wheatgrass juice, "detoxification" (enemas and high colonics), enzyme supplements and chlorella (green algae tablets). Proponents believe that wheatgrass is the key element of the program and claim that it bolsters the immune system, kills harmful bacteria in the digestive system, and rids the body of waste matter and toxins (405,959). Anecdotal case reports of tumor regressions and life extension among cancer patients who followed the wheatgrass regimen have been published in the proponent literature (see, e.g., (344)), but thus far, no studies of its clinical role in the treatment of cancer have been reported.

It is unknown whether Gerson's formal medical training included study of the therapeutic use of diet (939). Early on in his medical career, he devised a dietary regimen to treat his own severe migraine headaches. After reported success with his condition, he used his diet in the treatment of a variety of other disorders, including skin tuberculosis (lupus vulgaris), asthma, pulmonary tuberculosis, and arthritis (337). In 1928, he began treating cancer patients with the diet he used on tuberculosis, at the insistence of a patient with cancer of the bile duct, who reportedly recovered following Gerson's treatment (336). By the time he established his practice in New York in the mid-1940s, he concentrated on treating cancer patients. His first paper published in English (see footnote 3) on dietary treatment for cancer appeared in 1945 (331). In that paper, Gerson outlined his high potassium, low sodium, fatless diet regimen, which included foods, mineral and vitamin supplements, and crude liver injections (preparations of raw calves liver).

At present, the dietary part of the Gerson treatment offered at the clinic consists of low-sodium, low-fat, low-animal protein and high-carbohydrate foods, with vitamin and mineral supplements. The diet relies on large amounts of fresh and raw fruits and vegetables. Until late 1989, raw fresh calves liver juice was included in the regimen (see discussion below). The current patient brochure lists the dietary components as: "13 glasses daily of various fresh raw juices prepared hourly from organically grown fruits and vegetables" and "three full vegetarian meals, freshly prepared from organically grown vegetables, fruits, and whole grains" (328).

The Gerson treatment also consists of a variety of other substances, including potassium supplements, thyroid hormone, Lugol's solution (an inorganic solution of iodine plus potassium iodide), injectable crude liver extract with vitamin B12, pancreatic enzymes, and enemas of coffee or chamomile tea (317,328).

An exploratory study of the clinical effects of some components of the Gerson regimen is currently under way in Austria. According to an unpublished interim report (522), Peter Lechner, MD, of the Second Department of Surgery of the Landeskrankenhaus in Graz, Austria, is conducting a study using a modified Gerson regimen as an adjunctive treatment. The modified regimen is described as a high fiber, low sodium, high iodine and potassium, lactovegetarian diet with regular coffee enemas. It reportedly omits certain elements of the original Gerson regimen, such as liver juice, thyroid supplements (unless the patient is hypothyroid), and niacin supplements. It also limits the number of coffee enemas to two per day; Lechner noted in previous experience with patients following the Gerson regimen that a higher frequency of enemas was associated with the development of colitis (inflammation of the large intestine, often leading to diarrhea) in some patients.

In the 1960s, William Donald Kelley, an orthodontist by training, developed and publicized a nutritional program for cancer patients based on dietary guidelines, vitamin and enzyme supplements, and computerized metabolic typing.

Kelley described his treatment as ecological since "the total person and his total environment must be considered in order to give proper treatment." The program consisted of five components: taking sufficient nutritional supplements (vitamins, enzymes, minerals, etc.); detoxifying the body (purging, fasting, coffee enemas, colonic irrigations, cleansing the kidneys, the lungs, and the skin, and exercising); maintaining an adequate diet; (see footnote 4) providing proper neurological stimulation (e.g., osteopathic manipulation, chiropractic adjustments, "mandibular equilibration to reshape the skull," or physiotherapy); and taking a positive spiritual attitude ("purifying the emotions and spirits") (472).

The Kelley nutritional program gained popularity in the 1970s, when Kelley gave many interviews and made unequivocal claims that his program was regularly able to cure a wide range of cancers: "It is extremely effective and rather inexpensive. Those who are willing to faithfully and tediously follow it will be successful. Those who follow it in part or haphazardly will be completely unsuccessful" (472). He also developed a mail-order approach to nutritional-metabolic treatment in which he was able to use "technicians" who assisted patients in getting on and following his program. Specific recommendations for patients were generated by his computer system. In addition, Kelley developed his own supply houses for the supplements, (see footnote 5) water filtration systems, and even the coffee ("Kelley Koffee").

The nutritional supplementation recommended by Kelley consisted of 25 supplements (enzymes, vitamins, glands, minerals, hydrogen peroxide, aloe vera, bile salts, freeze- dried liver, etc.) that were to be taken for a two-year period. In the standard protocols, patients were classified as "hard tumor" and "soft tumor" patients and were recommended the same list of supplements, although "soft tumor" patients were advised to take a few extra foods. Some patients were given specific recommendations tailored to them and in these, patients often were advised to take additional supplements beyond the 25 listed in the standard protocol. Patients were referred to Kelley's Nutritional Counseling Service in Texas for additional information.

These supplements were intended to stimulate the release of "wastes and debris" from the body. Ridding the body of these wastes through detoxification was advised as essential to the program's success. Kelley recommended that patients take at least one strong coffee enema each day, to clean out the liver and gallbladder and to rid the body of toxins produced during tumor digestion (see also discussion in Box 3B). In addition to coffee enemas, Kelley recommended regular purging, fasting, and colonic irrigation (high enemas, between 18 and 30 inches into the body). He also advised cleansing the kidneys, nostrils, lungs, and skin (761).

To support his program and make his teachings more widely known, Kelley created the International Health Institute in Dallas, consisting of a group of doctors, dentists, chiropractors, naturopaths, metabolic technicians (nutritional counselors certified by the institute), and attorneys. Under the umbrella of this institute, Kelley's Nutritional Counseling Service was developed, whereby patients attended workshops to find out about the Kelley program and then answer the 3,200-question Metabolic Evaluation Survey (which reportedly took about eight hours to complete). This questionnaire, analyzed entirely by computer, formed the basis for the Kelley nutritional prescription, a program designed according to each patient's individual nutritional needs. Questions were answered on computer cards and sent to Kelley's headquarters. Kelley claimed that the cards gave him a detailed picture of the patient's metabolic type and of the efficiency of 50 physiological functions. In response to the questionnaire, patients received a lengthy, detailed computer printout of their metabolic status along with step-by-step instructions for following their particular version of the Kelley regimen--covering foods, supplements (in the range of 100- 200 pills per day), detoxification techniques, psychological approaches, and lifestyle changes (341). With the cooperation of physicians unaffiliated with Kelley's institute, cancer patients were advised by Kelley to submit the questionnaire every 6 months until, according to Kelley, their nutrient levels reach normal ranges, and after that, about once a year.

large doses of nutritional supplements, as many as 150 pills a day (356), including vitamins, digestive enzymes (e.g., pancreatic enzymes, pepsin, hydrochloric acid, bile), and concentrates in pill-form of beef organs and glands.

Case reports of serious nutritional deficiencies and disorders resulting from extreme use of the Zen macrobiotic diet +7 and some types of vegetarian diets not specifically associated with macrobiotics have been published in the medical literature (267,760,797,799). The relevance of those case reports to currently recommended macrobiotic practices has been greatly reduced since the introduction of the general "standard macrobiotic diet" outlined above. Partly in response to the evidence of nutritional deficiencies, however, macrobiotic instructors reportedly adjusted some of the dietary recommendations (502,550). In current macrobiotic recommendations, for instance, small amounts of whitemeat fish and seafood are allowed a few times per week, although dairy products, eggs, poultry, and red meat are generally excluded (509). Vitamin and mineral supplements are not recommended in the macrobiotic regimen.

5. Kelley believed that the supplements commercially available in health food stores and drug stores did not meet his standards of purity and potency, so he initiated a custom-made line of products made according to his specifications (353).

Statemnent of Senator John Breaux, 15/4/2002
We will examine the marketing of dietary and specialty supplements that target our nation's elderly. I would also like to thank the Committee's Ranking Member, Senator Larry Craig, for his support throughout this investigation. Finally, and most importantly, I would like to thank the witnesses for being here today. Your testimony will assist the Committee greatly in determining how best to address the vital issues raised today.

I would like to say up front that this hearing will focus on companies that mislead consumers with regard to dietary and specialty supplements. As with any industry, the vast majority of manufacturers and marketers of supplements are reputable and law abiding. It is the bad actors that we are concerned with today.

Supplements are becoming increasingly popular. Today, it is estimated that $27 billion or more is spent on supplements and that 60% of these consumers are older Americans. Individuals who are both healthy and ill take supplements for a variety of reasons.

Some take supplements to increase energy, build muscles or lose weight. While others have begun taking them as alternatives to traditional medicine and escalating prescription drug costs. More and more our nation's seniors are turning to these supplements.

Unlike new prescription and over-the-counter drugs, the law does not require supplements to undergo pre-market approval for safety and efficacy. The current U.S. regulatory system provides little assurance that commercial supplements have predictable pharmacological effects or that product labels provide accurate information. Furthermore, manufacturers of supplements are not required to register with any government agency. This is of great concern to me. Surveys have shown that the use of complementary and alternative medicine in the U.S. increased an amazing 380% between 1990 and 1997. This trend will almost certainly continue as the Baby Boomers draw closer to retirement age and seek out new and different ways to maintain and improve their health. We need to know that the products our seniors are taking are safe and effective. I want to make it clear one more time that we are not here to talk about the science of complementary and alternative medicine, rather we are only looking at the bad apples in the supplement industry; those folks who market misleading and/or ineffective products.

These products are marketed to our seniors in a variety of ways. Not too long ago my wife received in the mail a magazine entitled the Journal of Longevity. At first glance it appeared to me to be a scientific journal extolling the virtues of supplements, focusing on those that have alleged "anti-aging" effects. I was drawn in and amazed by the startling new discoveries to slow the aging process, give you more energy, a better sex life and a healthier heart, until I realized that the mailer was simply a fancy advertisement for one company's products. The Journal of Longevity appears to simply be a series of articles that discuss health issues that seniors face and then provides a simple solution- the solution being a dietary supplement developed and distributed by the same parent company that publishes the magazine.

In an effort to convey the nature of and the methods used by companies that mislead the elderly, today we are going to examine the operations of one of the largest companies that sells so-called anti-aging and other dietary supplements. GB Data Systems, Inc.

is the holding company for at least 10 businesses selling dietary supplements. A. Glenn Braswell is the President and owner of GB Data Systems. Gero Vita International and Heathquest Publications which publishes the Journal of Longevity are both controlled by GB Data Systems. As I stated earlier, the Journal of Longevity

We've also invited experts with extensive background in the area of complementary and alternative medicine, in particular dietary and nutritional supplements, to testify as to the impact, both physically and financially on our nation's elderly. We'll hear from Dr. Joyce Lashof of the University of California at Berkeley School of Public Health's Wellness Letter, along with Dr. Robert S. Baratz and Dr. Timothy Gorski.

Finally, we've asked the government agencies tasked with monitoring dietary and nutritional supplements and protecting consumers from fraud to be here today to tell us about their efforts and concerns in this area. We have a representative from the Food and Drug Administration, the Federal Trade Commission, the Federal Bureau of Investigation and the Attorney General of the State of Maryland.


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