Misleading Claims for Seasilver™

Stephen Barrett, M.D.

Seasilver USA, Inc., headquartered in Carlsbad, California, markets Seasilver,™ a liquid multivitamin/multimineral/amino acid product that has been claimed to "balance your body chemistry," "cleanse your vital organs," "purify your blood and lymphatic system," "oxygenate your body's cells," "protect your tissues and cells against challenges" and "strengthen your immune system." [1] The company's founder, Bela Berkes, is said to have developed Seasilver in response to "health challenges" after he began "a life-long, world-encompassing quest to learn nature's secret to good health." [2] The current chief executive officer is his son, Jason E. Berkes, who also heads AmericAloe, the product's manufacturer. A news report stated that Seasilver was available through medical doctors in the 1980s and "relaunched" through a multilevel company in 1994 [2]. In recent years, its alleged benefits are touted through thousands of Web sites operated by distributors. The cost is $39.95 for a 30-day supply (1 bottle), $100 for 3 bottles, and $300 for 12 bottles [3]. In March 2003, Bela Berkes stated that Seasilver USA was earning $15 million a month and $180 million a year from selling Seasilver [4].

Many of the claims made for Seasilver have been illegal. For example, the company's 2001 booklet "Journey into Foundational Health" falsely stated that silver (one of its ingredients) "has been used successfully in the treatment of over 650 diseases." [3] In 2002, after the FDA issued a warning letter, some claims on the company's Web site were toned down, but many distributor sites still continued to display them. In 2003, coordinated actions by the FDA and FTC stopped the company from selling or distributing their product until it it radically changed its marketing. This article describes what happened and why I believe it it foolish to use the product.

Ingredients: Claims vs Facts

Seasilver's label lists more than 80 vitamins, minerals, amino acids, and enzymes. The company's brochure and many Web sites have made statements about each nutrient that were intended to suggest the product might produce various benefits. Some descriptions included alleged research findings that may or may not be true; and some contained therapeutic claims that were completely false. Some descriptions were accurate and merely described the biochemical role of the nutrient in the body. Such descriptions are potentially misleading because people who get enough in their diet will derive no benefit from obtaining more from the product. Moreover, no quantities are stated, which makes it difficult or impossible to judge whether the amounts of the individual ingredients are sufficient to actually affect the user's body. I suspect that in many cases they are not.

For several years, Seasilver was said to contain five proprietary ingredients:

The above claims are preposterous.

Do people taking Seasilver need any other multivitamin and mineral supplement? For several years, the Web sites of many distributors stated:

No. Seasilver™ contains vitamins, minerals, trace minerals, amino acids and enzymes known to man in nature's perfect balance. If you have health challenges, then you may require additional nutritional support, such as larger doses of Seasilver™, herbs, homeopathic, etc. Multiple vitamins that list the amount of each nutrient are all synthetic (man-made chemicals) that do no more than offer false energy, upset the balance of your body's chemistry and contribute to long-term negative side effects, such as cardio vascular disease and arthritis [9].

This advice is also dubious because:

Before the government clamped down, Seasilver USA's Web site contained testimonials from more than 30 users who claimed that the product led to increased energy, hair growth, nail growth, improved digestion, and/or better sex life. The writers also claimed to have been helped with acute gouty arthritis, allergy, chronic fatigue syndrome, chronic obstructive pulmonary disease, colds, depression, diabetes, Graves disease, insomnia, low hematocrit, lung cancer, Lyme disease, metastatic prostate cancer, migraine headaches, non-Hodgkin's lymphoma, nocturnal leg cramps, rheumatoid arthritis, severe breathing problems, stiffness of the fingers, stress, and swollen prostate [10]. Testimonials, of course, are extremely unreliable because the outcome may be due to other factors such as concomitant medical care or the natural course of the ailment [11]. Disease-related claims are also illegal unless experts generally regard a product as safe and effective for it intended purpose.

Many Seasilver distributors have claimed Kirlian photography has demonstrated that Seasilver effects the person's "energy field." [12] Many Web sites have shown Kirlian photographs taken before and after taking Seasilver. However, Kirlian photography does not measure "energy fields." During this procedure an object such as a person's hand is placed on photographic paper or film in an apparatus that generates a high-voltage, low-amperage, high-frequency electric current. The film is then exposed by air glow that occurs when electrical discharges pass between the subject and apparatus through the photographic material. Investigators have demonstrated that the pictures reflect the amount of perspiration, finger pressure applied to the camera, and about 20 other factors [13].

Today, although Seasilver's label lists the same ingredients, the product brochures no longer list Phyto-Silver™ as an ingredient and "4 concentrated juices" is listed instead of cranberry juice concentrate.

Advisory Board Hype

At the time of its regulatory problems, Seasilver's advisory board included one medical doctor and three chiropractors, none of whom had any significant standing in the scientific community. The most noteworthy, Daniel G. Clark,was described this way:

Dr. Clark is a Medical Doctor. In 1984, he was awarded the prestigious "Academic Award for Scientific Research in Cancer" in Rome, Italy. In 1988, he received the "Physician of the Year Award" in Broward County, Florida. He sponsors educational seminars for Physicians worldwide, providing lectures on quantum and molecular medicine. His special interests are chelation therapy for arteriosclerosis, alternative treatments for cancer and homeopathy and herbology for the prevention and treatment of chronic disease. He is actively involved with numerous professional associations, including a lifetime member of the National Health Federation. Dr. Clark is currently Managing BioActive Nutritional, Inc., and serves as Co-Chairman of the Seasilver USA Medical Advisory Board. [14]

This description is misleading. Clark's Florida medical license was revoked in 1983 for unprofessional practice. Clark's practice, which opened in 1979 in Ormond Beach, Florida, initially included gynecology, family practice, and general nutrition, but "metabolic therapy" for cancer eventually accounted for 15% to 20% of his patients. The disciplinary matter involved two cancer patients whom he treated with "metabolic therapy." One was a man with terminal throat cancer. The other was a breast cancer patient for whom he prescribed laetrile, herbal tea, salves, substandard doses of chemotherapy, and whole-body hyperthermia, none of which have any scientifically plausible rationale or proven effectiveness against cancer. The case records indicate that after concluding that the cancer had spread to the woman's lungs, Clark prescribed dark and yellow salves and instructed the patient to apply them to her cancerous breast and underarm area, explaining that they would draw out and break down the tumor. The salves—which apparently were caustic—caused pieces of gray tissue to fall off the breast and underarm area, but Clark reassured her that the salves were breaking down the cancerous tumor.[15]. The Medical Board concluded that Clark had shown "absolute reckless disregard for the health of his patient" [16].

Clark's "physician of the year award" was given by the Florida chapter of the International Association of Cancer Victors and Friends [17], a group whose primary activity is the promotion of quack cancer methods. The National Health Federation is another disreputable group whose goal is to weaken the government's ability to protect consumers against health frauds and quackery [18].

BioActive Nutritional, which Clark founded in 1986, markets a large line of homeopathic products claimed to be effective against hundreds of symptoms, diseases and conditions. As far as I know, none of these products has any proven therapeutic value or has even been scientifically tested. Clark is also identified as founder of the Institute of Quantum and Molecular Medicine and a staff member of the Florida College of Integrated Medicine, where, according to the school's Web site, he "lectures in Western biomedical sciences." Clark has also issued a letter of endorsement stating that "certified electrodiagnostic practitioners" have tested the phoenic hologram (a "healing symbol") and concluded that it can negate the negative effects of cell phones [19].

David R. Friedman, D.C., N.D., co-chairman of Seasilver's advisory board, holds a license to practice chiropractic in North Carolina. On a promotional tape, he was described as "chiropractor to the stars." The tape, "America's Unbalanced Diet," suggested that everyone needs to take Seasilver because our diets are deficient and synthetic nutrients are poorly absorbed [20]. The tape, which reminds me of Joe Wallach's "Dead Doctors Don't Lie," contained more than a hundred misleading statements. Friedman's biographical sketch on the Seasilver Web site stated that more than 100,000 copies of the tape had been sold [21].

Friedman also participated in radio and television infomercials in which he said that Seasilver could cure cancer and other diseases [22-24]. After the first version of this article was published, Friedman issued a "response" for distributors to use to attack my credibility. His response misrepresented my views on several topics, falsely stated that I was sued for slander by the American Chiropractic Association, and misrepresented the significance of a court case in which I participated.

Regulatory Action

It is illegal to market a dietary supplement with unsubstantiated claims that it can prevent, treat, cure, or mitigate disease. Seasilver USA made such claims for several years. In April 2002, the FDA warned Jason Berkes that Seasilver was breaking the law by with descriptions such as:

In June 2003, in a Nevada Federal District Court, the FTC charged Seasilver USA, Inc., AmericAloe, Bela and Jason Berkes, Dr. Friedman, and Brett Rademacher (a principal distributor and Web site developer) with deceptive marketing. The FTC's complaint noted that through brochures, Web sites, spam emails, and infomercials, the defendants had made a long list of unsubstantiated disease and safety claims [4]. The Court quickly issued a temporary restraining order prohibiting the defendants from selling or distributing their product without substantial changes to their labeling and marketing materials. The order prohibited the defendants from misrepresenting that any product or ingredient could cure or treat cancer; enable 9 out of 10 diabetics to stop their insulin; cause rapid, substantial and permanent weight loss; had been proven effective against over 650 diseases, including AIDS; had been clinically or scientifically proven to be nontoxic; or provided any other health benefit that had not been substantiated by competent and reliable scientific evidence. The court also ordered that defendants' assets related to income from product sales be frozen [26].

The court appointed former federal prosecutor Thomas W. McNamara as Receiver to examine the business and review plans to deal with the FTC complaint. A few days later, acting at the FDA's request, the United States Attorney for the Southern District of California filed a complaint seeking the seizure of Seasilver USA's Seasilver product; United States Marshals seized 132,480 bottles of Seasilver from Seasilver USA's San Diego headquarters [27].; and McNamara advised distributors:

Effective immediately, you must cease and desist from making any false or misleading statements or representations in connection with the marketing, distribution or sale of any Seasilver product, specifically including but not limited to representations that Seasilver cures or treats cancer, enables 9 of 10 diabetes patients to stop insulin, leads to weight loss without dieting, treats or cures typhoid or anthrax, is proven to be non-toxin, and/or provides any other health benefits without competent and reliable scientific evidence [28].

McNamara also sent a memo to "All Seasilver Business Associates Who Are Operating Websites to Promote and Sell Seasilver Products," stating that if they were operating an independent Web site not authorized by Seasilver they must take it down or risk termination as a distributor [29]. Seasilver posted a similar notice on its Web site [30].

Not long afterward, U.S. Marshals seized 63,000 bottles of Seasilver from a warehouse in Parma, Ohio, a Cleveland suburb. The combined retail value of the two seizures (at $39.95 per bottle) was about $7.9 million. A few weeks later, the defendants agreed to a temporary injunction under which were prohibited from making unsubstantiated claims about Seasilver, its ingredients, or any similar product. They also agreed to recall all previously distributed sales materials and to accompany future product distributions with the following notice:

Previously, Seasilver has claimed that its product can cure cancer, diabetes, and a host of other serious diseases and conditions, and that it results in significant and permanent weight loss without dieting. No clinical studies support these claims. In fact, medical experts state that these claims are highly implausible and likely false. If you are under a physician's care, it is very important that you not discontinue or reduce any prescription medication without consulting your physician.

In addition, at one time Seasilver claimed that its product provided the health benefits of natural cranberries, although it contained no natural cranberry. Rather Seasilver contained artificial cranberry flavoring [31].

In October 2003, Seasilver USA was permitted to resume sales after agreeing to institute some of the strictest compliance guidelines ever issued as a result of a health-related enforcement action. The guidelines, which are posted to a separate Web site, prohibit claims that Seasilver is effective against cancer, including multiple myeloma, non-Hodgkin's lymphoma, lung, breast, prostate cancer or brain tumors; diabetes; AIDS or HIV infections; pulmonary diseases; Lyme disease; heart disease; hypertension or stroke; hepatitis; depression; and typhoid or anthrax. They also forbid "ANY" use of claims about product performance, testing or ingredients (except as described on the product label and in product literature), as well as the use in weight control or blood pressure control. The new rules also state:

In the past, Seasilver USA, Inc. and its Independent Business Associates have used testimonials or testimonies of consumers who have used the product. Those testimonials have included the reported experiences of these individuals. NO TESTIMONIALS related to the performance of the Seasilver® product previously sold may be used because the product has changed and the claims made in many of those testimonials are prohibited. No new testimonials may be used unless they are pre-approved in writing by Seasilver USA, Inc. You should know that claims in testimonials must be claims that are substantiated by competent and reliable scientific evidence. The word of one person will not suffice [32].

The rules also prohibit distributors with Web sites from using Web site names or meta tags that suggest any prohibited claim, including such tags as absorption, alternative medicine, amino acids, antioxidant, assimilation, bio-elements, blood, cancer, Candida, cells, cellular level, colloidal silver, detoxification, diabetes, digestion, disease, elimination, enzymes, homeopathic, immune system, liquid nutrients, malabsorption, memory, minerals, natural health, naturopath, naturopathic, nutrient, nutrients, organic, oxygen, oxygenates, and phytonutrients [32].

In March 2004, the FTC and FDA wrapped up their enforcement actions with consent judgments. In the FTC case, Seasilver USA, Americaloe, Jason Berkes, Bela Berkes, Dr. David Friedman and Brett Rademacher are prohibited from:

The FTC orders against Seasilver, Americaloe, Jason Berkes, and Bela Berkes contain a $120 million judgment that will be suspended when they pay $3 million for restitution, based on their demonstrated inability to pay more. If it is found that the Berkes misrepresented their financial condition or failed to provide required security interests, the Berkes must pay the full amount of the judgment. Friedman was assessed $1 million, and Rademacher was assessed $500,000 [33]. Under the FDA judgment, the product seized in June 2003 must be destroyed and the companies and the Berkes' must refrain from manufacturing and distributing further violative products and would face severe financial penalties if they do so [34].

Current Claims

Seasilver USA appears to have taken the government action seriously. In August 2004, I could find no illegal health claims made through the Internet by the company or its distributors. However, its marketing materials are still misleading. Its "Foundational Health" brochure, issued in June 2004, provides this rationale for taking Seasilver:

We live in an environment that puts stress on our lives. The air we breathe and he water we drink is impacted by the same industrialization that makes out lives easier in many respects. Our food is no longer grown in the old fashioned way, but through modern agricultural techniques, using genetic modifications and chemicals. Our fast-paced lives push us to choose processed foods over freshly prepared foods. The many challenges of family, careers, and finances add to our daily stress. In light of all this, there has never been a greater need for a foundational health program. Seasilver™ is the leader in Foundational Health™. [35]

This statement is misleading because stress does not increase nutrient needs [36]; our food supply is adequate to meet nutrient needs [36]; and, as far as I know, no published study has shown that taking Seasilver leads to an improved health outcome.

The Bottom Line

Seasilver™ is an expensive, irrationally formulated supplement product that has been marketed with false and misleading claims. Its label lists more than 80 ingredients but does not disclose how much of each the product contains. The combined FTC/FDA action shut down Seasilver USA's business until it agreed to strict guidelines. There is still no logical reason to use the product.

References

  1. Seasilver home page, accessed March 12, 2003.
  2. Secret nutritional gem sweeping the nation with automated marketing system. Money Makers Monthly, June 2002.
  3. Journal into the world of foundational health (booklet). Seasilver USA, 2001.
  4. Complaint for injunctive and other equitable relief. Federal Trade Commission v. Seasilver USA Inc, Americaloe, Inc., Bela Berkes, Jason Berkes, Brett Rademacher, individually and d/b/a Netmark International and NetmarkPro, and David R. Friedman, D.C. United States District Court, District of Nevada. CV-S-03-0676-RLH(LRL), filed June 12, 2003.
  5. Proprietary ingredients. Seasilver Web site, accessed March 18, 2003.
  6. Barrett S. More oxygen hype: The Millennium Cooler. Quackwatch, March 17, 2002.
  7. Lulinski B, Kapica C. Some notes on aloe vera. Quackwatch, March 23, 1998.
  8. Tyler VE. P'au d'arco. Nutrition Forum 2:8, 1985.
  9. Product FAQs. Seasilver Web site, accessed March 18, 2003.
  10. Seasilver success stories. Seasilver Web site, accessed March 18, 2003.
  11. Smith GL. Common questions about science and "alternative" health methods. Quackwatch, Aug 27, 1997.
  12. Seasilver and Kirlian photography. Sea Vegetation Web site, accessed March 18, 2003. (In August 2004, seavegetatian.com has an identical article for a different silver product.)
  13. Barrett S. Kirlian photography. Quackwatch, June 2, 2001.
  14. Our medical advisory board. Seasilver Web site, accessed March 18, 2003.
  15. Department of Professional Regulation, Board of Medical Examiners vs. Daniel G. Clark, M.D. Recommended order, March 19, 1983.
  16. Department of Professional Regulation, Board of Medical Examiners vs. Daniel G. Clark, M.D. Final order, April 21, 1983.
  17. Unproven methods of cancer management: International Association of Cancer Victors and Friends. CA— A Cancer Journal for Clinicians 39:58-59, 1991.
  18. Barrett S. Be wary of the National Health Federation. Quackwatch Web site, July 18, 2003.
  19. Clark DG. Letter from Bio Active Nutritional, Aug 23, 2001.
  20. Friedman DR. America's unbalanced diet: "The shocking truth about what's on your dinner table!" Audiotape, ©2002.
  21. David R. Friedman, D.C., N.D. Co-Chairman. Seasilver Web site, accessed March 18, 2003.
  22. Friedman DR. Interview on "The Jane Donigan Nutrition Hour" (radio infomercial), broadcast in 2003.
  23. Friedman DR. (Another infomercial -- to be posted)
  24. Friedman DR. (Another infomercial -- to be posted)
  25. Cruse AE. Warning letter to Jason E. Berkes, April 3, 2002.
  26. Temporary restraining order with asset freeze and other equitable relief, and order to show cause why a preliminary injunction should not issue. Federal Trade Commission v. Seasilver USA Inc, Americaloe, Inc., Bela Berkes, Jason Berkes, Brett Rademacher, individually and d/b/a Netmark International and NetmarkPro, and David R. Friedman, D.C. United States District Court, District of Nevada. CV-S-03-0676-RLH(LRL), filed June 13, 2003.
  27. No silver lining for marketers of bogus supplement; federal agencies crack down on health fraud: FTC charges marketers of Seasilver with making false and deceptive claims; FDA seizes seasilver inventories. FTC news release, June 19, 2003.
  28. McNamara TW. Memo to all Seasilver associates, June 17, 2003.
  29. McNamara TW. Immediate termination of your websites. Memo, June 17, 2003.
  30. Notice to Seasilver Independent Business Associates, regarding FTC and FDA legal actions. Seasilver USA Web site, accessed June 27, 2003.
  31. Stipulated preliminary injunction with asset freeze and other equitable relief. Federal Trade Commission v. Seasilver USA Inc, et al. United States District Court, District of Nevada. CV-S-03-0676-RLH(LRL), July 15, 2003.
  32. Prohibitions and restrictions on the promotion of Seasilver. Seasilver Compliance Web site, accessed October 30, 2003.
  33. Marketers of Seasilver agree to pay $4.5 million to settle FTC charges. FTC news release, March 17, 2004.
  34. Supplement firms, Seasilver USA, Inc., and Americaloe, Inc., sign consent decree with FDA to stop selling product claiming to cure "over 650" diseases. FDA news release, March 17, 2004.
  35. Foundational Health Fast-Forward: A Basic Guide. Seasilver USA product brochure, June 2004.
  36. Barrett S., Herbert V. Twenty-five ways to spot quacks and vitamin pushers. Quackwatch, revised July 29, 2004.
This article was revised on August 14, 2004.