Dietary Supplements Under Attack

Find out what steps you can take to counter recent attacks on the dietary supplement industry.

By Todd Harrison

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

The FTC

The Federal Trade Commission (FTC) announced on January 4th that it reached settlements in four separate cases against dietary supplement manufacturers for deceptive marketing. The marketers of four well-known products—Xenadrine EFX, CortiSlim, TrimSpa, 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, ultimately considering them 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 12th, 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 into during 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.

The Media

A new book that is very critical of the dietary supplement industry is also grabbing national headlines. Journalist Dan Hurley authored a book called Natural Causes: Death, Lies and Politics in America’s Vitamin and Herbal Supplement Industry, which was published on De­cember 26th last year. In short, it contends that the dietary supplement industry is unregulated, dangerous and largely built on fraud. Mr. Hurley also claims that the dietary supplement 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 16th in which he conveyed the same message contained in his book. CBS News also ran with the story by airing two segments in connection with the book on January 16th and 17th, touting the same message: dietary supplements are unregulated, dangerous, and wholly ineffective.

The real truth is, these claims are far from true. The dietary supplement industry is regulated by the FDA and the FTC, as well as by government agencies in each of the 50 states. DSHEA provided FDA with additional enforcement authority, including the ability to remove products the agency deems unsafe from the market. The agency actually has two mechanisms—FDA may immediately remove a product it considers to be an immediate safety concern, and it may remove a product it considers to pose an unacceptable risk of illness or injury.

Moreover, both the FDA and the 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.”

What You Can Do

In the face of such negativity, what can dietary supplement companies do to help clean up the industry’s image?

Support the new adverse event reporting (AER) requirements: On December 22nd, President Bush signed into law 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 U.S. 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 in this column, there are other myths in Mr. Hurley’s book and essay that should be dispelled. For example, Mr. Hurley 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. But just like homeopathics, salves are not dietary supplements. By definition, dietary supplements must be ingested (via the stomach); as such, topical products cannot be dietary supplements. Being vocal about these and other inaccuracies spread by Mr. Hurley may 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 such as 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. CRN has long supported mandatory adverse event reporting for dietary supplements, confident that such a system will reveal the strong safety record of dietary supplements. CRN has been very active in countering the publicity of Mr. 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 like the American Herbal Products Association (AHPA), The Natural Products Association and the United Natural Products Alliance (UNPA) can be a great tool in helping to clean up the industry’s image.NW