Consumer Health Digest #03-01
Your Weekly Update of News and Reviews
January 7, 2003
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.
FDA announces tougher dietary supplement regulation. The U.S. Food and Drug Administration has announced new programs intended to protect consumers against improper marketing and safety risks of dietary supplements and herbs. [FDA announces initiative to provide better health information for consumers. News release, Dec 18, 2002] In a lengthy Dietary Supplement Enforcement Report, it stated:
Promotions for fraudulent products appear regularly in newspaper and magazine ads and in television "infomercials." They accompany products sold in stores and through mail-order catalogs. The Internet provides myriad opportunities for deception and, because it is a worldwide communications system, U.S. citizens are susceptible to fraud from sources outside this country.
This wave of promotions leads many consumers to buy fraudulent health products. Hoping to cure illness or improve their appearance, consumers often fall victim to products and devices that cheat them out of their money and steer them away from proven treatments. These fraudulent products pose specific dangers including: substituting unproven treatments for proven medical treatments; harmful interactions with prescription or over-the-counter drugs; taking products that have no health benefits or that have adverse effects; and economic loss.
To combat these problems, the FDA plans to carry out a new Consumer Health Information for Better Nutrition Initiative under which it will:
- Issue guidance on qualified health claims for conventional foods and dietary supplements. Any such claims must be preapproved by FDA and meet the "weight of the scientific evidence" standard, including support by a credible body of scientific evidence.
- Strengthen enforcement of rules against false or misleading claims about dietary supplements.
- Establish an FDA Task Force on Consumer Health Information for Better Nutrition to develop a framework to help consumers obtain accurate, up-to-date, and science-based information about conventional food and dietary supplements. This includes the development of additional scientific guidance on how a new "weight of the evidence" standard will be applied, as well as regulations that will give these principles the force and the effect of law.
The FDA also plans to deploy a new CFSAN Adverse Event Reporting System ("CAERS") in June 2003.
FTC restrains Trek Alliance. The U.S. Federal Trade Commission has charged Trek Alliance, Trek Education Corporation, VonFlagg Corporation, Jeffrey Kale Flagg, also known as (aka) Kale Flagg, Richard Von Alvensleben, aka Richard Von, Tiffani Von Alvensleben, aka Tiffani Von, and Harry M. Flagg with operating an illegal pyramid scheme in the form of a multilevel marketing company. On December 9, a U.S. District Court issued a temporary injunction freezing the company's assets and appointing a receiver to control company operations. FTC documents state that the defendants promised monthly income ranging from $2,000 to $20,000, but the vast majority of distributors made less money than they spent for front-end expenses and that many made little or nothing. [Temporary restraining order issued against Trek Alliance: "Multi-level marketing" plan is an illegal pyramid, agency alleges. FTC news release, Dec 16, 2002] The company's offerings have included dietary supplements, herbal products, water filters, and Internet services. The Trek Alliance home page now contains a notice from the receiver that all sales activities have been suspended. Two of the four individual defendants were top distributors with Equinox International, a similar company that in 2000 agreed to pay $40 million in consumer redress to settle charges that it was operating an illegal pyramid. Equinox International settles case with FTC, eight states: Nearly $40 million in restitution for alleged pyramid victims. FTC news release, April 25, 2000]
Craniosacral therapy blasted. Two basic science professors at the University of New England College of Osteopathic Medicine have concluded that "craniosacral therapy bears approximately the same relationship to real medicine that astrology bears to astronomy" and "should be removed from curricula of colleges of osteopathic medicine and from osteopathic licensing examinations." [Hartman SE, Norton JM. Craniosacral therapy is not medicine. Physical Therapy 82:1146-1147, 2002; and Interexaminer reliability and cranial osteopathy. Scientific Review of Alternative Medicine 6(1):23-34, 2002] Craniosacral therapy -- also called cranial therapy and cranial osteopathy -- is based on the notion that the skull bones can be manipulated to relieve pain (especially of the jaw joint) and remedy many other ailments. Its practitioners also claim that a rhythm exists in the flow of the fluid that surrounds the brain and spinal cord and that diseases can be diagnosed by detecting aberrations in this rhythm and corrected by manipulating the skull. However, the practice is senseless because:
- The bones of the skull fuse by the end of adolescence.
- No research has ever demonstrated that manual manipulation can move the individual cranial bones.
- Studies have found that practitioners who examine the same patient(s) disagree about what they are feeling.
- There is no logical reason why pressing the skull should influence the course of ailments throughout the body.
Most practitioners of craniosacral therapy are osteopaths, massage therapists, chiropractors, dentists, and physical therapists. The two professors appear to be the first osteopathic educators who have publicly called for its removal from their educational system. For additional information, see Quackwatch
Genetic test scams debunked. Quackwatch has severely criticized the marketing of genetic testing combined with guidance on diet and supplement strategies that are claimed to prevent chronic diseases. Although genetic testing and counseling have many valid uses, the test systems marketed by Sciona, Genovations, and NuGenix are a waste of money. [Barrett S, Hall H. Dubious genetic tests. Quackwatch, Dec 30, 2002]
Canada curbs Abtronic marketers. Canada's Competition Bureau has secured a consent agreement under which Thane Direct Canada has agreed to pay a CN$75,000 administrative penalty and to stop marketing the Abtronic and Abtronic Pro or any similar device without adequate evidence that they are effective for weight loss or muscle toning without exercise. Abtronics purchasers can apply for a refund by calling Thane at (800) 978-6329. [Abtronic muscle simulators removed from market by Competition Bureau. Bureau news release, Sept 16, 2002] The U.S. Federal Trade Commission and the Australian Competition and Consumer Commission took similar actions earlier this year. The FDA has noted that such devices can cause muscles to contract but do not increase muscle size enough to affect the user's appearance. [Consumer information on electronic muscle stimulators. FDA Center for Devices and Radiological Health, April 10, 2002]
This page was posted on January 7, 2003.