A Skeptical Look at
Designs for Health and Its Affiliates

Stephen Barrett, M.D.

Many companies market irrationally formulated supplement products exclusively or primarily through practitioners. Some of these companies (or their distributors exhibit at professional meetings and/or sponsor educational activities that promote the use of supplements to treat disease. Some companies issue newsletters and/or product literature that provide dubious advice. One company that does all of these things is Designs for Health (DFH), which is headquartered in Connecticut and has distributors in Canada and a few other countries. This article describes my concerns about the marketing of its products.

Background History

Designs For Health's Web site describes the the company's founding this way:

Jonathan and Linda Lizotte, RD, CDN, founded Designs for Health in 1989 with a local team of nutritionists. Managing 22 Northeastern offices, the company's initial focus was to provide nutrition counseling services for the treatment of a variety of health conditions. The success of this endeavor grew, as did the demand for nutritional products to satisfy the specific treatment needs of the company's clinical nutritionists. Realizing that a genuine need existed for a line of nutritional supplements designed by health care professionals, for health care professionals, Designs for Health focused its efforts in this direction. . . . The formation of a Designs for Health branded supplement line led to mass requests from clinicians for further education and support. Advanced training courses were offered, dealing with nutritional approaches to chronic disease [1].

Shortly after the company was founded, the Lizottes were joined by Robert Crayhon, M.S., who later founded the Designs for Health Institute (DFHI) in Boulder, Colorado. The DFHI's stated goal was to create "a network of nutritionally aware practitioners nationwide who can best meet the nutritional needs of the public." [2] .From 1998 through 2001, the Institute offered seminars, taught mainly by Crayhon, on how to treat Alzheimer's disease, arthritis, asthma, autism, benign prostatic enlargement, cancer, candida overgrowth, cardiac arrhythmia, cervical dysplasia, chronic fatigue syndrome, colitis, Crohn's disease, diabetes, detoxification, eating disorders, fibromyalgia, hepatitis C, HIV, hormone replacement therapy, hyperactivity, hyperinsulinism, hypertension, hypothyroid, immune dysregulation, inflammation, irritable bowel syndrome, mood disorders, osteoporosis, Parkinson's disease, premenstrual syndrome, and weight loss [3]. Crayhon divested his interest in Designs for Health In 2005 and died in 2010 [4].

A 2017 DFH catalog [5] includes the following background information about the company's leadership:

In 2018, DFH's most visible distributors appeared to be Hong Kong-based Biorna-Quantics and Designs for Health – Canada, which operates from a shared office building called Northspace in North York, Ontario. Products can also be obtained from Amazon.com and a few practitioner sites that sell products without practitioner involvement.

The Biorna Quantics Facebook page promised "the science to know your body" and "the tools to optimise it." [6] In addition to DFH supplement products, the company marketed home-collection laboratory kits that lead to supplement recommendations. Visitors to its Web site were invited begin their health journey with a free online BQ iAppraisal, during which they entered data on their height, weight, exercise activities, diet (whether vegetarian), environmental stresses, diseases, and symptoms. I took the test several times. First I pretended to be a 30-year man or woman who exercised moderately, had no significant envirionmental stresses, and had no health problems. In both cases, the test report recommended purchasing four supplement products and undergoing home laboratory tests. Then I took the appraisal several more times, pretending to be older and have various health problems. The more problems I mentioned, the greater the number of recommended supplements and tests. I do not believe that any of the recommendations I received were medically valid. In April 2019, the Bioran Quantics home page announced that it had permanently closed its business.

Product Claims

DFH's 2017 catalog lists 260 products and describes their uses in vague, general terms. Adrenal Complex, for example, is said to be a glandular-based product designed to support overall adrenal function. Berb-Evail is said to support healthy blood sugar levels and exhibit antimicrobial properties. CraveArrest is said to promote an optimal balance of the major neurotransmitters. GI Microb-X is said to have a long history of use for supporting a healthy gastrointestinal microbial balance. Oil of Oregano is said to have powerful antioxidant and intestinal cleansing benefits and help to maintain a healthy microbial balance. Ingredients in Olive Leaf Extract have been shown to have antimicrobial properties, antioxidant power, have the ability to support phagocytosis, and can also be used to support the health of the cardiovascular system. Phosphatidylcholine is said to be excellent for emulsifying fat, making it extremely valuable for liver health and supporting absorption of all fat-soluble nutrients. And so on [5].

None of the above descriptions claim that the products are effective against any chronic diseases. But that information is readily available from DFH's weekly "clinical rounds," monthly "nutrient roundtable" discussions "functional medicine" webinars, and "clinical and scientific insight" (CASI) lectures. These are posted to the Web site as one-hour audio or video files, more than 100 of which are downloadable. The site also offers additional ideas through blog articles.

Designs for Health – Canada has also published a 101-page "Protocol Manual" that includes lifestyle, dietary, and supplement product recommendations for preventing or "supporting" ADHD, Alzheimer's, asthma, Candida albicans, Crohn's disease, depression, diabstes, epilepsy, gallstones, hepatitis C, HIV, hypothyroidism, kidney failure, Lyme disease, Parkinson's disease psoriasis, ulcers, and about 75 other types of problems [7]. The average number of recommended products per protocol is four plus unspecified "core nutrients."No supporting references were provided.

DFH also produces "Tech Sheets" that discuss the ingredients, safety, supposedly relevant research, and suggested usage. Most are one- or two-page PDFs, but a few are longer. In January 2019, I downloaded 60 Tech Sheets from the Web site of Biorna-Quantics, 28 others from designsforhealth.ca, and a few others on the sites of practitioners who prescribe DFH supplements. Most of the Tech Sheets from the Biona Quantics site were co-authored by David Brady. Most from the Canadian site have no identifiable author. Most of the Canadian tech sheets provide Canadian contact information, but some contain only DFH's U.S.-based contact information. The Tech Sheets differ from DFH's catalog descriptions in that most of the Tech Sheets contain blatant health claims. For example, those for the products mentioned in the first paragraph in this section say the following:

Product Claims
Adrenal Complex Taking Adrenal Complex during exposure to chronic stress may reduce stress-related side effects such as anxiety and weight gain in the midsection
Berb-Evail Berberine may also help improve dyslipidemia and other features of metabolic syndrome. Additionally, berberine has been shown to exhibit antimicrobial properties. berberine has long been recognized as an antimicrobial, antiviral, and anti-parasitic compound. Berberine extracts have demonstrated bactericidal effects against diarrhea-causing strains of Vibrio cholera and Escherichia coli, and anti-parasitic effects against Giardia lamblia, Entamoeba histolytica, and Trichomonas vaginalis. Berberine may be as effective as the common antibiotic Flagyl against giardiasis. Other common organisms shown to be subject to the antimicrobial action of berberine include Candida, Chlamydia, Salmonella, Klebsiella, Clostridium, Shigella, and Cryptococcus
CraveArrest Increasing neurotransmitters may be helpful for: Food cravings. Appetite control, Smoking cessation, Insomnia, Depression, Anxiety, Mood swings, Premenstrual syndrome, Obsessive compulsive disorders, Addictions, Stress, Type II diabetes
GI Microb-X Tribuleus extract: antibacterial and antiviral effects. Berberine: treatment of chronic trachome, bacterial diarrhea; antimicrobial activity against bacteria, viruses, fungi, protozoans, helminths (worms), and chlamydia. Artemisinin: kills parasites (worms), Bearberry extract: astringent, antiseptic and treatment for urinary tract and gastrointestinal infections Caprylic acid: effective in combating certain lipid-coated bacteria, such as Staphylococcus aureus, various species of Streptococcus, and intramucosal Candida
Oil of Oregano Powerful plant extract with highly effective antimicrobial properties. May be effective against intestinal parasites, yeast overgrowth, fungal infections, bacterial infections.
Olive Leaf Extract Extremely effective anti-viral, anti-retroviral, and bactericidal substance. Found to be beneficial in the treatment of conditions caused by or associated with a virus, retrovirus, bacterium, or protozoan. Such conditions include influenza, the common cold, meningitis, Epstein-Barr virus (EBV), encephalitis, herpes I and II, human herpes virus 6 and 7, shingles, HIV/ARC/AIDS, chronic fatigue, hepatitis B, pneumonia, tuberculosis, gonorrhea, malaria, dengue, bacteremia, severe diarrhea, blood poisoning, and dental, ear, urinary tract and surgical infections
Phosphatidyl Choline Improves mental energy and memory. Lowers cholesterol and homocysteine. Prevents plaque build-up in arteries by. optimizing fat metabolism. Combined with liver supporting nutrients, like inositol, helps reverse PMS, fibroid. tumors, and other female hormonal disorders. Helps prevent estrogen-related cancers by. promoting healthy estrogen metabolism. Is useful in the treatment of a wide range of. liver ailments, including hepatitis, fatty liver and cirrhosis. Helps protect the liver from damage caused. by alcohol, viruses, medications, and toxins in the environment and food. Helps enhance the digestion and. assimilation of all nutrients. Slows the aging process by protecting cell. membranes from damage. PC is very valuable in the treatment of the forms of hepatitis. PC can also be useful in the treatment of tardive dyskinesia, colitis and malaria. PC is . . . helpful in managing problems related to female hormone imbalance including PMS, uterine fibroids, fibrocystic breast syndrome, and endo­metriosis. Such problems usually improve dramatically after a month or two of using PC with inositol and other liver supporting nutrients.

Clinical Considerations

Do you think claims like those above are valid? To demonstrate efficacy, treatments have to undergo clinical trials in which people who take them are compared to similar people who do not. And, for conditions for which effective standard treatment available, they would have to undergo trials in which they were compared to standard treatment. For products with more than one ingredient, the combination product and not just individual ingredients would need to be tested. Safety would also have to be demonstrated.

The Tech Sheets for the above products cite references for many of their claims, but the references are far from sufficient to establish efficacy. Many of the studies were done in animals or cell cultures, the results of which do not provide evidence of efficacy or safety in humans. Many of the Tech Sheet claims have no supporting references, and some studies represented as supportive actually reported no benefit. The Tech Sheet for Olive Oil Extract, for example, lists 12 references, but eleven of them were laboratory studies and the twelfth was an uncontrolled study of 14 people with parasites, some of whom improved after taking an oil of oregano supplement with ten times the dosage of DFH's product. The phosphatydyl choline Tech Sheet had six references, two of which were laboratory studies. One human study that was controlled found no benefit, and the other reports may have some relevance to a few of the 25+ claims but had nothing to do with most of them. And so on.

Even if it could be established that some of DFH's products were useful or potentially useful, should you trust the practitioners who prescribe them? DFH's practitioner registration page has a drop-down menu with that enables applicants to select their "specialty" from 27 choices: ARNP, BCHN, CCN, CNS, CTNC, DC, DDM, DDS, DMD, DN, DO, DOM, DPM, DVM, LAc, MD, MS Nutrition, NC, ND, NP, OD, PA, PharmD, PhD, PT/DPT, RD, and RPh. Do you think that the average acupuncturist, chiropractor, naturopath, or nutritionist who prescribes DFH products is qualified to diagnose or treat the diseases for which the products are promoted?

Amazon's product information includes this statement:

OVER 50,000 DOCTORS AGREE—Designs for Health is the physician's choice for top quality professional strength supplements since 1989. Our "Science First" philosophy ensures our products are based on the most recent research and use the highest quality raw ingredients [8].

I would be very surprised if Designs for Health has 50,000 physicians prescribing its products. I also doubt that the products actually reflect current research. Searching the PDFs for all 60 of the Tech Sheets I downloaded from the Biorna-Quantics site, I found that the publication dates for their references ranged from 1931 to 2009, with about half published before 2000 (at least 18 years ago).

Regulatory Considerations

The Federal Food, Drug, and Cosmetic Act (FDC Act) defines "drug" as any article (except devices) "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease." All drugs must be labeled with adequate directions for all intended uses. Products not generally recognized as safe and effective by experts are considered "new drugs." It is illegal to market a new drug that lacks approval or does not bear adequate directions for its intended use. Simply put, it is illegal for manufacturers and distributors to market supplements with unapproved claims that they are effective against diseases. The 1994 Dietary Supplement Health and Education Act permits dietary supplements to be marketed with "structure/function" claims that are truthful and supported by scientific evidence. Structure/function claims typically allege that the product "supports" or "balances" one or more body functions. The FDA often acts when supplements are marketed with disease-related claims but rarely challenges structure/function claims, even if they are false or misleading. Claims made by practitioners to their patients are outside the FDA's jurisdiction.

Designs for Health would like its products to be sold only through practitioners. In August 2018, the company indicated that it has successfully sued two companies that were selling its products through unauthorized Web portals and was taking steps to curb the unauthorized sale of its products through Amazon.com [9/,10]. In one of the lawsuits, DFH stated that since, December 1, 1999 its gross product sales had totaled more than $400 million [11].

My Overview and Opinion

Designs for Health is marketing many products—mostly through practitioners—that appear to be intended for preventing and/or treating a wide range of diseases and conditions. I do not believe that most of the claims made for its products have been substantiated by the studies cited in their product Tech Sheets. I doubt that most of the practitioners who prescribe DFH products are trained or licensed to diagnose or treat most problems for which the products are marketed. I hope that the FDA will examine whether or not DFH's promotional activities are legal.

References

  1. About us. Designs for Health Web site, accessed Dec 27, 2018.
  2. Health conditions you will learn to treat during our seminar. DFHI Web site, archived March 2, 2001.
  3. History of the Designs for Health Institute. DFHI Web site, archived Dec 1998.
  4. Stafford L, Schauss AG. Robert Crayhon, 1961-2010. Herbalgram, 2010.
  5. Designs for Health product catalog, Vol 29, Nov 20, 2017.
  6. About. Biorna Quantics Facebook Page, accessed Feb 2, 2019.
  7. Protocol Manual. Designs for Health, Canada Web site, downloaded Feb 2, 2019.
  8. Search results. Amazon.com, Feb 2, 2019. To see the statement quoted above, click on any product and then click the "More" tab in the description.
  9. Krawiec S. Practitioner supplement brand wins lawsuit against unauthorized reseller removing barcodes and selling on Amazon. Nutritional Outlook, Aug 8, 2018.
  10. Consent final judgment for permanent injunction. Designs for Health Inc., v. Fruitful Longevity and others. U.S. District Court for the Southern District of Florida, Case No. 17-cv-23898, filed June 8, 2018.
  11. Amended complaint. Designs for Health Inc., v. Fruitful Longevity Inc. d/b/a Health Powerhouse, and others. U.S. District Court for the Southern District of Florida, Case No. 17-cv-23898, filed March 16, 2018.

This article was revised on June 30, 2019.

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