WASHINGTON, D.C., October 7, 2009 — In response to a “Perspective” article published on-line today by the New England Journal of Medicine, which discusses the regulatory status of dietary supplements, the Council for Responsible Nutrition (CRN), the leading trade association representing the dietary supplement industry, issued the following statement by Andrew Shao, Ph.D., vice president, scientific and regulatory affairs, CRN:
“We question how a perspective article about the regulatory status of dietary supplements was accepted for publication in a leading scientific journal, yet facts were not checked. This article contains numerous errors, omissions or misinterpretations with regard to the regulation of dietary supplements, including the misstatement of how botanical supplements were regulated prior to the passage of the Dietary Supplement Health and Education Act (DSHEA). The author may be a credible doctor, but his expertise in understanding the practicalities of the regulatory framework for dietary supplements is questionable.
Contrary to what has become an urban myth, DSHEA did not lessen the oversight of dietary supplements—in fact, DSHEA actually provided the Food and Drug Administration (FDA) with new enforcement authority not previously available. For example, DSHEA provided FDA with additional authority to remove adulterated or unsafe supplement products from the market. Further, DSHEA gave FDA authority to issue good manufacturing practices (GMPs) specific to dietary supplements to help ensure the quality and safety of dietary supplements, a critical component of dietary supplement regulation, conspicuously absent from this article. It is already against the law to manufacture and market adulterated or contaminated dietary supplements.
The author chooses to focus on select isolated examples of incidents, as if they were representative of the industry as a whole and fails to place the information into any kind of context. In the first full year that mandatory reporting of serious adverse events was in existence, FDA received only 1,080 total adverse event reports, 672 of which were considered serious. For context, these numbers are minute in comparison to the hundreds of thousands of adverse event reports FDA receives each year for other regulated products such drugs, biologics and medical devices. The overwhelming majority of dietary supplements are safe and well-made and consumers value the benefits these products can provide.
The problems presented by outliers are not isolated to dietary supplements. Like any regulated industry, there are unscrupulous manufacturers that don’t follow the law—but that is not the fault of the law itself nor of responsible manufacturers and changing the law will not deter rogue companies from breaking the law. What is needed are more resources for both FDA and FTC to step up enforcement efforts. The best bet for consumers is to learn as much as they can about the companies from which they plan to purchase supplement products. Stay away from companies making product claims that purport to cure diseases or promise magic bullet results; focus on companies with good reputations, well-known brands, or third-party certifications; and discuss with your physician or other healthcare professional what products or companies he or she recommends. More than 150 million Americans take dietary supplements each year as part of their healthy lifestyle.”
I post this as a voting member of the Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement manufacturers and ingredient suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements in the areas of manufacturing, marketing, quality control and safety, our 70+ manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as CRN’s Code of Ethics. Visit www.crnusa.org.