Consumer Health Digest #04-13
Your Weekly Update of News and Reviews
March 30, 2004
Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., and cosponsored by NCAHF and Quackwatch. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making.
FTC challenges QVC Home Shopping Channel ads. The Federal Trade Commission has charged QVC, Inc., the country's largest "home shopping" channel, with making improper claims for "For Women Only" weight-loss products, Lite Bites weight-loss products, Bee-Alive royal jelly dietary supplements, and Lipofactor Cellulite Target Lotion. QVC, a multi-billion dollar company based in West Chester, Pennsylvania, sells a wide variety of consumer products through live, 24-hour television programming that reaches nearly 85 million homes in the United States. QVC also maintains an interactive shopping service on the Internet. In 2000, QVC settled FTC allegations that the company made unsubstantiated claims that Cold-Eeze zinc lozenges prevented colds and alleviated allergy symptoms. The resulting FTC consent order requires QVC to have "competent and reliable scientific evidence" substantiating any claim that a dietary supplement "can or will cure, treat, or prevent any disease, or have any effect on the structure or function of the human body."
At the FTC's request, the U.S. Department of Justice is suing QVC in federal court in Philadelphia for civil penalties, consumer redress, and other relief. The suit states that QVC sold the challenged products through live broadcasts in which a product representative talked with the QVC host about the purported benefits of the featured product. The spokespersons frequently described how well the product had worked for them, as well as others. These programs also featured on-air conversations with consumers who called in and often provided personal testimonials. Throughout the program, the QVC host and product representative urged consumers to buy the products by calling a toll-free number displayed on the screen. The complaint alleges that QVC violated the 2000 FTC order by making false or unsubstantiated claims that:
- For Women Only weight control products cause substantial weight loss, for example, 50, 60, 100 pounds or more, and enable users to maintain their weight loss for a substantial period of time.
- For Women Only "Zero Fat" pills prevent absorption of dietary fat.
- For Women Only "Zero Carb" pills (with chromium, vanadium, glucosol, gymnema sylvestre leaf, and other ingredients) prevent sugar and carbohydrates from being stored as fat.
- Lite Bites products (including "Fat Fighting Bars" and "Fat Fighting System Shakes," containing chromium picolinate, garcinia cambogia, L-carnitine, herbs, vitamins, fiber, and other ingredients) enable users to lose substantial weight, including, for example, 52, 80, 110, 125 pounds or more, and enable users to maintain their weight loss for a substantial period of time.
- Bee-Alive dietary supplements containing royal jelly (a substance secreted from the salivary glands of nurse bees and fed to newly laid larvae) significantly reduce fatigue in users with chronic or severe fatigue; and significantly increase energy, strength, or stamina in users who recently have had surgery or suffer from fibromyalgia, Lupus, Epstein Barr virus, and other ailments.
In addition, the FTC alleges that QVC violated the FTC Act by making unsubstantiated claims that Lipofactor Cellulite Target Lotion (a topical product not covered by the 2000 FTC order) eliminates or significantly reduces cellulite without diet or exercise and causes measurable inch loss. Violations of FTC orders carry a penalty of up to $11,000 per violation. [FTC charges QVC Home Shopping Channel with making deceptive claims and violating FTC order. FTC news release, March 24, 2004]
Seasilver penalties announced. The FTC and FDA have wrapped up their Seasilver 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:
- Making or helping others to make, false or misleading claims about the health benefits, efficacy, or safety of Seasilver or any covered product.
- Misrepresenting that Seasilver is effective in the treatment of multiple myeloma; non-Hodgkin's lymphoma; lung, breast, and prostate cancer; brain tumors; diabetes; AIDS; typhoid; and anthrax, among other ailments.
- Representing that Seasilver or any other product causes rapid, substantial, or permanent weight loss without reducing caloric intake.
- Making any representation about the health benefits, efficacy, or safety of any covered product without reliable scientific evidence to support the representation.
The FTC orders against the companies and the two 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 [Marketers of Seasilver agree to pay $4.5 million to settle FTC charges. FTC news release, March 17, 2004] 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. [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]
Faulty manufacturing leads to vitamin D toxicity and product recall. Aloe Commodities International, Inc., Carrollton, Texas, is recalling 1,600 bottles of Solutions IE Ageless Formula II, Lot numbers P2207 and P2221 because they contain a significantly higher-than-labeled level of vitamin D3. (Approximately 188,640 International Units (IU) are present in each serving size of 6 capsules instead of the intended level of 400 IU). Excess consumption of vitamin D can result in hypercalcemia (abnormally high blood levels of calcium) that can cause weakness, fatigue, headaches, nausea, vomiting, diarrhea, mental status changes, and coma in severe cases. The recall was initiated after it was discovered that the product contained more than the labeled amount of vitamin D due to an error in manufacturing. The lot coding can be found on the bottom of the bottle. The product is distributed by Solutions International, Inc., Orem, Utah, which reported three complaints received in the past month of customers hospitalized for vitamin D toxicity. Purchasers of the product are urged to return it to either Aloe Commodities International, Inc., 2161 Hutton Drive, Carrollton, TX. 75006 or Solutions International, 1272 South 1830 West, Orem, Utah 84058. [Aloe Commodities International, Inc., recalls Solutions IE Ageless Formula II Due to excess vitamin D. FDA news release, March 26, 2004] The Aloe Commodities International Web site falsely claims that "aloe vera has shown to be . . . the single most beneficial natural substance grown on the planet today."
FDA attacks unapproved brain stimulator device claims.. The FDA has ordered Health Directions, Inc., of Middletown, Pennsylvania, to stop claiming that its Health Pax Cranial Electrotherapy Stimulator (CES) Device can modify brain wave patterns and is effective against epilepsy, stress-related disorders, and several other conditions. In a warning letter, the FDA indicated that -- based on substantial similarity to another approved device -- the CES had been approved for treat insomnia, depression, or anxiety but was being marketed for unapproved purposes. The warning letter also ordered the company to stop making false claims that its NeuroPax and NutriPax devices were registered with the FDA and were approved for marketing as legitimate medical devices. [Gardine TD. Warning letter to Harold D. Stecker, Ph.D., March 4, 2004] One distributor's Web site claims that (a) "The NutriPax Program combines two concepts: a small medical device and an individually designed nutrient program for the treatment of anxiety, depression and insomnia"; (b) "Most individuals suffering from disease have digestive and nutritional imbalances. Your emotional balance and well being requires the proper metabolism of amino acids, fatty acids, vitamins, and minerals found in our food"; and (c) "The NutriPax program enhances your capacity to utilize these nutrients and more rapidly correct nutritional deficiencies. You should experience less depression, anxiety, and/or insomnia as your physical health improves." Another distributor's Web site promotes CES for "neurotransmitter balancing, mood control, IQ gains, sleep, exploration of altered states, peak performance, and much more."
Medical Letter discourages autologous cord blood banking. Stem cells from blood remaining in the placenta after birth have been used to restore the bone marrow in treating several diseases, but nearly all of these transplants have been from sources other than the patient. Several private facilities provide processing and storage for potential future use by the child or family members. The highly respected Medical Letter on Drugs and Therapeutics has concluded that routine use of private storage is "unlikely to be worthwhile." [Private cord blood banks. The Medical Letter 46:21-22, 2004] See Quackwatch for additional information.
Third Neuralyn marketer pleads guilty. Thomas Vigil has pled guilty to charges of conspiracy, wire fraud and mislabeling drugs in connection with the marketing of Neuralyn. Prosecutors in the case reported that Vigil and his ex-wife Beverly treated more than 100 patients, most paraplegics or quadriplegics, who paid up to $10,000 each to come to clinics in Idaho, Utah, and Colorado. Prospective patients were falsely told that (a) Neuralyn was 85% to 95% successful and could enable them to move or even walk again by regrowing nerve cells; (b) Tom Vigil was a medical doctor with training in biochemistry, (c) Neuralyn had undergone clinical studies, and (d) a patent application and FDA approval were pending. The Vigils promoted Neuralyn as an all-natural substance made from plants from the Yucatan. In reality, it contained a topical anesthetic that gave some patients temporary pain relief and led them to believe that they were improving. Last year, Beverly Vigil was sentenced to 33 months in prison and ordered to pay $800,000 to victims of the scam and pharmacist David Taylor, who supplied the Neuralyn to the Vigils, was sentenced to five years of probation. Sentencing for Thomas Vigil is scheduled for July 1.
This page was posted on March 30, 2004.