Consumer Health Digest #03-10

Your Weekly Update of News and Reviews
March 11, 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.

Rexall/Cellasene cases may be settled. Rexall Sundown, Inc, has agreed to pay up to $12 million to resolve FTC charges that it falsely advertised that its product "Cellasene" could effectively remove "cellulite" without exercise or dieting. The agreement bars Rexall from claiming without substantiation that Cellasene or any other product eliminates or substantially reduces cellulite, body fat, or weight. The agreement will become final when state courts approve settlements pending in class-action suits in Florida and California, a process that may take several months. The FTC will then administer a redress fund of up to $12 million for dissatisfied consumers. Consumers seeking redress should call the FTC's settlement hotline at (202) 326-3793. [Rexall Sundown to pay up to $12 million to settle charges regarding cellulite treatment product: company allegedly made false and unsubstantiated claims for "Cellasene." FTC news release, March 11, 2003.] Medical authorities agree that cellulite is simply ordinary fatty tissue that assumes a waffled appearance because fibrous tissue prevents the skin from fully expanding in areas where fatty tissue accumulates. Waffling may be decreased if an individual loses weight, but no pill or potion can selectively reduce a body part. Quackwatch has further information on this topic.

New dietary supplement regulations proposed. The FDA wants to require "current good manufacturing practices (CGMPs)" in the manufacturing, packing, and holding of "dietary supplements." The proposed rule is intended to ensure that dietary supplements, herbs, and similar products are not adulterated with contaminants or impurities, and their labels accurately reflect their ingredients. The proposal covers designing and constructing physical plants; establishing quality control procedures; testing manufactured dietary ingredients and dietary supplements; maintaining records; and handling consumer complaints related to CGMPs. Manufacturers would be required to evaluate the identity, purity, quality, strength, and composition of their products, and products that are contaminated or lack any ingredient listed on the label would be considered adulterated. [FDA proposes labeling and manufacturing standards for all dietary supplements. FDA news release, March 7, 2003] The proposed rule is a response to many instances in which products have been contaminated or contain more or less of an ingredient than claimed on the label.

Orrin Hatch takes two media hits. Senator Orrin Hatch (R-UT), whose 1994 Dietary Supplement Health and Education Act has greatly weakened the FDA's ability to protect consumers, has been rebuked for suggesting that the FDA has not done enough to protect the public from ephedra's dangers. Calling Hatch's remarks "a dazzling display of hypocrisy," Time senior science writer Leon Jaroff said, "The time has come for drastic revision of DSHEA, the re-empowerment of the FDA and the rejection of cynical proposals by legislators like Orrin Hatch." [Jaroff L. It's time to rethink ephedra regulation. March 5, 2003] Meanwhile, the Los Angeles Times noted:

Warning signs of "bogus science." Physicist Robert Park, Ph.D., has identified seven indicators that a scientific claim lies "well outside the bounds of rational scientific discourse":

  1. The discoverer pitches the claim directly to the media.
  2. The discoverer says that a powerful establishment is trying to suppress his or her work.
  3. The scientific effect involved is always at the very limit of detection.
  4. Evidence for a discovery is anecdotal.
  5. The discoverer says a belief is credible because it has endured for centuries.
  6. The discoverer has worked in isolation.
  7. The discoverer must propose new laws of nature to explain an observation.

[Park RL. Seven warning signs of bogus science. Quackwatch March 5, 2003]

NCAHF protests against veterinary quackery. The National Council Against Health Fraud's Board of Directors and more than 40 other individuals have endorsed an open letter urging the American Medical Veterinary Association (AMVA) to press for exclusion of irrational methods if veterinary practice laws are revised. The issue arose because an AMVA task force is revising its Model Veterinary Practice Act that to include "complementary and alternative methods" within the scope of veterinary practice. The signatories believe that licensing laws should clearly limit veterinary practice to science-based therapies. The Task Force on Veterinary Science Web site debunks veterinary quackery.

Nu-Zymes/CalMax marketer ordered to stop illegal claims. On January 28, 2003, the FDA warned MediaPower that promotional material for Nu-Zymes, CalMax, and another product contained illegal therapeutic claims. The warning letter, addressed to CEO Kenneth Byers with a copy to company president Christopher M. Homer, objected to claims that Nu-Zymes is useful in treating or preventing conditions such as acid reflux, arteriosclerosis, arthritis, colon cancer, diabetes, fibromyalgia, high blood pressure, heart disease, and irritable bowel. The letter also warns that a promotional statement that "Nu-Zymes is manufactured in an FDA . . . approved facility" is illegal because the FDA does not approve facilities that manufacture dietary supplements. Nu-Zymes has been advertised through infomercials and a Web site featuring the views of chiropractor Michael Pinkus. Quackwatch has additional information about Nu-Zymes.

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This page was posted on March 11, 2003.