Consumer Health Digest #11-19

Your Weekly Update of News and Reviews
June 30, 2011

Consumer Health Digest is a free weekly e-mail newsletter edited by Stephen Barrett, M.D., with help from William M. London, Ed.D., M.P.H. 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.

Consumers Union explains new health law. The Patient Protection and Affordable Care Act, which became law last year, will be phased in over a five-year period. Consumers Union has issued a 6-page guide that explains what benefits are available so far. [The Affordable Care Act: The first year. Consumer Reports Web site, June 2011]

Court orders halt to alleged oral chelation product claims. Howard Sousa, doing business as the Artery Health Institute LLC and DeSousa LLC in New York, N.Y., has signed a consent decree of permanent injunction that prohibits him claiming that products he distribute can cure, treat, mitigate or prevent diseases. In October 2010 the FDA warned Artery Health Institute and seven other companies to stop promoting unapproved over-the-counter chelation products with claims to treat and diagnose a range of serious diseases. Sousa responded to the warning letter by promising to remove all such claims from his website, but the FDA discovered that he continued to make them. Under the consent decree: (a) Sousa must remove the drug claims from his Web site, (b) Sousa must hire an independent expert to review claims he makes for his product and to certify that he has omitted all violative claims, and (c) Sousa can be required to pay $1,000 per violation and twice the retail value of each product shipment that violates the consent decree.

FDA enforcement history examined. Dr. Stephen Barrett has posted an article and several little-known documents that reveal what happened during the 1980s when FDA enforcement against dietary supplement fraud was very weak. From the early 1960s through the mid-1980s, the agency ignored the vast majority of products marketed with illegal claims and there was only one criminal prosecution. The article describes how the FDA field officers gathered sufficient evidence to send an "oral chelation" product marketer to jail, but top enforcement officials would not permit prosecution to proceed and later denied a petition to make prosecution more common. [Barrett S. The Dr. Rinse case: An Inside Look at FDA dietary supplement regulation in the 1980s. Quackwatch, June 20, 2011]

The 1994 Dietary Supplement Health and Education Act (DSHEA) made the situation worse by enabling marketers to make huge numbers of misleading claims that dietary supplements and herbal products can influence body function. Products can also be marketed without claims. Claims that these products are effective against specific diseases remain illegal. During the past two years, the number of FDA enforcement actions (warning letters, seizures, and criminal prosecutions) against illegal health claims has increased sharply and a few types of products appear to have been driven from the marketplace. However, the quack product marketplace cannot be tamed unless sellers have more to lose than to gain by breaking the law. That will not occur without (a) a sharp increase in the number of criminal prosecutions, (b) repeal of DSHEA, and (c) new legislation that enables the government to assess penalties that exceed profits.

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This page was posted on July 1, 2011.