Hazards abound for dietary supplement marketers

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Dietary supplements are in the headlines and under attack - again. High-profile developments in the industry make it essential that you market your dietary supplement products responsibly.

On Jan. 4, the Federal Trade Commission announced that it reached settlements in four separate cases against dietary supplement manufacturers for deceptive marketing, with defendants surrendering cash and other assets worth at least $25 million.

The complaints filed by FTC against four well-known products - Xenadrine EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart - allege that weight-loss and weight-control claims were not supported by competent and reliable scientific evidence.

The FTC alleged that one of the marketers falsely represented that persons appearing in the ads achieved the reported weight loss solely by using the product, when in fact the consumer endorsers lost weight by engaging in rigorous diet and/or exercise programs.

In addition, the FTC alleged that the advertisements failed to disclose that endorsers were paid in connection with their testimonials. The FTC alleged that another marketer's product infomercials were deceptively formatted to appear as talk shows rather than advertisements. Accordingly, it is crucial that marketers of dietary supplements avoid these practices in their advertising.

Importantly, the National Advertising Division of the Council of Better Business Bureaus (NAD) referred two of the four cases to the FTC. This should serve as a reminder that marketers should take investigations by self-regulatory groups seriously.

On Dec. 26, journalist Dan Hurley published a book called "Natural Causes: Death, Lies and Politics in America's Vitamin and Herbal Supplement Industry," which attacks the dietary supplement industry as largely built on fraud. The book portrays the industry as unregulated and dangerous.

Mr. Hurley contends that the Dietary Supplement Health and Education Act rendered the Food and Drug Administration virtually powerless to regulate dietary supplements. The book has received a lot of press, including coverage by CBS News, BusinessWeek and The New York Times.

While the FDA has acknowledged that it has the power to regulate the industry, the book could provoke a public outcry and give impetus to regulatory agencies.

Trade associations like the Council for Responsible Nutrition (CRN) are fighting back. CRN, which represents ingredient suppliers and manufacturers in the dietary supplement industry, focuses on the science in support of dietary supplement claims.

CRN aggressively promotes the self-regulation of the dietary supplement industry and has long supported mandatory adverse event reporting for dietary supplements. The association strongly supported the passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which President Bush signed into law on Dec. 22.

The law, which takes effect on Dec. 22, 2007, requires mandatory adverse event reporting for all dietary supplements and over-the-counter drugs sold in the United States.

In a recent press release, CRN president/CEO Steven M. Mister said the organization is "confident that ultimately the [adverse event reporting] system will highlight the strong safety record of dietary supplements and allow consumers to feel increased confidence about the choices they make when taking dietary supplements."

Until that time, however, and given the recent high-profile negative press, it is extremely important that companies market dietary supplement products responsibly. The regulators and the public are watching closely.

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