Consumer Health Digest #04-15
Your Weekly Update of News and Reviews
April 13, 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.
IOM reports on dietary supplement safety regulation. The Institute of Medicine has published an analysis and recommendations for strengthening the FDA's ability to regulate the safety of herbal and dietary supplement products. The analysis concluded that the 1994 Dietary Supplement Health and Education Act (DSHEA) prevents the FDA from adequately protecting the American public. The recommendations include:
- Congress should amend DSHEA to require that a manufacturers and distributors report to the FDA, in a timely manner, any serious adverse event associated with use of its marketed product of which the manufacturer or distributor is aware.
- The FDA should increase efforts to inform health care professionals and consumers that they should use the MedWatch adverse event reporting program. To facilitate the process, product labels should include MedWatch's toll-free telephone number.
- Before products are marketed, marketers should be required to provide the FDA with all available data, both favorable and unfavorable, regarding safety of the product.
- Congress should ensure that the FDA is provided with adequate personnel and resources to protect the consumer under DSHEA.
"Prepublication" copies of the report, Dietary Supplements: A Framework for Evaluating Safety can be read online or purchased at a 10% discount from the NAS Web site. The final version offers better value because it is hardcover, indexed, and less expensive.
Common diet pill ingredients not proven effective. A systematic review of scientific reports, including reviews and meta-analyses, has concluded that chitosan, chromium picolinate, Garcinia cambogia, glucomannan, guar gum, hydroxy-methylbutyrate, plantago psyllium, pyruvate, yerba maté, and yohimbe have not been proven effective for reducing body weight. The reviewers concluded that "None of the reviewed dietary supplements can be recommended for over-the-counter use." The full text of the article is online. [Pittler MH, Ernst E. Dietary supplements for body-weight reduction: A systematic review. American Journal of Clinical Nutrition 79:529-536, 2004]
"Focus Factor" and "V-Factor" marketers settle FTC charges. Marketers of "Focus Factor," and "V-Factor" have agreed to settle Federal Trade Commission charges that they made many unsubstantiated advertising claims. In one complaint, the FTC charged Vital Basics, Inc. (VBI) of Portland, Maine, and its principals, Robert Graham and Michael Shane, with making unsubstantiated claims about the efficacy of "Focus Factor" and the safety of "V-Factor Natural Pack." The other complaint charged Creative Health Institute, Inc. (CHI) of Corinth, Texas, and its principal, Dr. Kyl Smith, with making unsubstantiated claims about Focus Factor's ability to improve users' focus, memory, mood, and concentration. Focus Factor contains vitamins, minerals, botanicals, and amino acids. Dr. Smith developed, advertised, and sold it through Creative Health Institute from at least 1997 to 2000, after which Vital Basics became the principal marketer. The product was alleged to improve the focus, memory, and concentration of healthy adults; alleviate stress; combat the fatigue, irritability, and mood swings that healthy adults experience; make children and teenagers feel more alert, focused, and mentally sharp; improve students' ability to concentrate and their academic performance; improve senior citizens' memory, mental clarity, and energy; improve adults' ability to absorb information in books and to recall facts, figures, and names; and have the desired effects in as little as one to 10 days. To settle the charges, the defendants agreed not to make unsubstantiated claims in the future. The agreement also calls for consumer redress of $1 million by VBI and its principals and $60,000 by CHI and Smith [Marketers of the supplements "Focus Factor" and "V-Factor" agree to settle FTC charges and pay $1 million. FTC news release, March 17, 2004] Focus Factor was extensively advertised on cable channels and in Parade Magazine.
FDA orders "homeostasis protocol" seller to stop. The U.S. Food and Drug Administration has ordered Triad of Fredricksburg, Texas and its owner Blake Sawyer to stop claiming that their "Homeostatic Protocols" are effective against a long list of serious diseases. [Rodrigues RR Jr. Warning letter to Joel Blake Sawyer, March 30, 2004] Triad's Web site states that "No matter what your physical condition is right now, from a professional athlete looking to fine-tune your body into perfection to someone dying of an 'incurable' disease, the most complete and effective thing you can do is The Homeostasis Protocol." The site further claims that the protocols been effective in "reversing, stopping, and/or slowing down . . . AIDS. Allergies. Alzheimer's. Anorexia. Arthritis. Asthma. ADD. Bell's Palsy. Cancer. Carpal Tunnel. Celiac Disease. Cerebral Palsy. Chronic Fatigue Syndrome. Chronic Pain. COPD. Crohn's Disease. Cystic Fibrosis. Depression. Diabetes. Eczema. Emphysema. Endometriosis. Fibromyalgia. Gastrointestinal disorders. Gulf War Syndrome. Heart Disease. Hepatitis. High Blood Pressure. Hypothyroidism. Hyperthyroidism. Impotence. Infertility. Kidney Disease. Lung Disease. Lupus. Mental Illnesses. Migraines. Multiple Sclerosis. Muscular Dystrophy. Myasthenia Gravis. Obesity. Osteoporosis. Paget's Disease. Parkinson. Psoriasis. Raynaud's Disease. Scleroderma. Scoliosis. Skin Disorders. Sleep Disorders. Spinal Cord Injuries. Stroke. Yeast Infections. Vision problems. Weight problems." The MS package cost $2,695.
This page was posted on April 13, 2004.