March 2007 - Legal File

Dietary Supplements Are Still Getting a Bad Rap

By Jeffrey D. Knowles and Michelle Gayeski

There has been no shortage of highly publicized attacks on the dietary supplement industry in recent weeks. Both the government and the media have left the industry on the defensive. But what can companies do to help clean up the industry’s image?

The Federal Trade Commission (FTC) announced on January 4 that it had reached settlements in four separate cases against dietary supplement manufacturers for deceptive marketing. The marketers of four well-known products-Xenadrine EFX, CortiSlim, TrimSpa and One-A-Day WeightSmart-surrendered cash and other assets worth at least $25 million to settle charges that their weight-loss and weight-control claims were not supported by competent and reliable scientific evidence. The FTC also attacked the companies’ marketing practices as deceptive. The following marketing practices were among those objected to by the FTC in the complaints: failing to disclose that endorsers were paid in connection with their testimonials; deceptively formatting infomercials to appear as talk shows rather than advertisements; and representing 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.

On January 12, the FTC filed civil contempt charges against dietary supplement company Lane Labs Inc., its president Andrew Lane and consultant/spokesperson William Lane for violating FTC consent orders entered in 2000. The FTC alleges that claims made by the defendants for their Fertil Male and AdvaCAL dietary supplements are not supported by competent and reliable scientific evidence. The Commission charged that the defendants have made numerous unsubstantiated claims about the benefits of AdvaCAL and misrepresented test results and studies. Specifically, the FTC objected to claims that AdvaCAL is more absorbable than other types of calcium, is superior to other calcium or prescription drug products at building bone or increasing bone mineral density, and is superior to other calcium products in preventing or reducing the risk of fractures. The FTC charged that the studies are “fatally flawed.” The FTC is seeking to recover all revenues stemming from the order violations.

A new book that criticizes the dietary supplement industry also is grabbing national headlines. Journalist Dan Hurley’s book, entitled Natural Causes: Death, Lies and Politics in America’s Vitamin and Herbal Supplement Industry, published on December 26, 2006, contends that the industry is unregulated, dangerous and largely built on fraud. Hurley claims that the industry “strong-armed” the Dietary Supplement Health and Education Act (DSHEA) through Congress and that the Act rendered the FDA virtually powerless to regulate dietary supplements.

In addition to the press received by the book, the New York Times published an essay by Hurley on January 16 in which he conveyed essentially the same message. CBS News aired two segments in connection with the book, repeating the same theme: dietary supplements are unregulated, dangerous and wholly ineffective.

In fact, the assertions are unequivocally untrue. The dietary supplement industry is regulated by the FDA and FTC, as well as by agencies in every state. DSHEA provided the FDA with additional enforcement authority, including the ability to remove from the market products the agency deems unsafe. The agency actually has two mechanisms-the FDA may remove a product it considers to present an immediate safety concern, and one it considers to pose an unacceptable risk of illness or injury.

Moreover, both the FDA and FTC require that all claims made by dietary supplement manufacturers and distributors be substantiated. The FDA has adopted the FTC’s “competent and reliable scientific evidence” standard, meaning that all claims are required to be backed by “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”

So what can companies do to help clean up the industry image?

  • Support the new adverse event reporting (AER) requirements. On December 22, 2006, President Bush signed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which requires mandatory reporting of all serious adverse events for all dietary supplement and over-the-counter drug manufacturers selling products in the United States. Showing your support for the new law helps to demonstrate your company’s confidence in the safety of your products and helps build consumer confidence in dietary supplements generally.
  • Spread the facts. The dietary supplement industry can help counter the misinformation by spreading the truth. In addition to setting the record straight on the inaccuracies discussed above, there are other myths in Hurley’s book and essay that should be dispelled. For example, he repeatedly makes reference to safety concerns surrounding homeopathics. However, homeopathics are classified as drugs under federal law and are not dietary supplements. Similarly, Hurley describes injury to a woman who used a salve on her nose. However, salves are not dietary supplements. By definition, dietary supplements must be ingested; topical products cannot be dietary supplements. Being vocal about these and other inaccuracies can help counteract some of the negative press.
  • Advertise responsibly. In light of the recent attacks on the industry, it is crucial that marketers of dietary supplements market their products responsibly. Manufacturers and distributors should make certain that all marketing claims are supported by competent and reliable scientific evidence. In addition, marketers of dietary supplements should take extra care to avoid the marketing practices to which the FTC objected in the recent weight-loss product settlements. Specifically, marketers must be certain to disclose when endorsers are paid in connection with their testimonials, take care not to format infomercials to appear as talk shows rather than advertisements and disclose that consumer endorsers lost weight not only by taking the product, but also by engaging in rigorous diet and/or exercise programs, if that is the case.
  • Support industry trade associations. Industry trade associations like the Council for Responsible Nutrition (CRN) are fighting hard to clean up the industry’s tarnished image. CRN, which represents ingredient suppliers and manufacturers in the dietary supplement industry, focuses on the science in support of dietary supplement claims. This association has long supported mandatory adverse event reporting for dietary supplements, confident that such a system will reveal the strong safety record of dietary supplements. In addition, it has been very active in countering the publicity of Hurley’s book by writing letters to the editor and issuing press releases to correct the false information being disseminated in connection with the book. CRN and other industry trade associations can be great tools in helping to clean up the industry’s image.

By taking these steps, you can help to counter the recent, highly publicized attacks on the dietary supplement industry, and you can promote consumer confidence in the safety of dietary supplements at the same time.

Jeffrey Knowles manages Venable LLP’s Government Division and heads the firm’s Advertising and Marketing Practice Group. Knowles is the immediate past chairman of the ERA Board. He can be reached at (202) 344-4860. Michelle Gayeski is an associate at Venable. She can be reached at (202) 344-4492.


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