There was a flurry of activity on Capitol Hill during the last week of May with respect to dietary supplements, including new legislation introduced by Senators Harkin (D-IA) and Hatch (R-UT), the two principal sponsors of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Also, the Senate Special Committee on Aging held a hearing where it heard a report by the Government Accountability Office (GAO) on its investigation into the marketing practices of dietary supplement companies targeting seniors, and the presence of contaminants in the supplements it analyzed.
The new legislation is S. 3414, the “Dietary Supplement Full Implementation and Enforcement Act of 2010.” As the name of the bill suggests, it does not create new rules or restrictions; rather, it is intended to ensure that the law the two Senators championed in 1994 is fully implemented and enforced. It does so through several means. First, it would allocate funds to the FDA to implement and enforce DSHEA - $20 million (from funds appropriated to enhance food safety) in 2010, and a $30 million additional appropriation in 2011. Further, it would appropriate funds to the Office of Dietary Supplements at the National Institutes of Health for research and consumer information - $40 million in 2010.
Second, it would require the FDA to make annual reports to Congress on its implementation and enforcement of DSHEA. The reports would include, among other things: (1) the number of inspections of dietary supplement manufacturers for Good Manufacturing Practice (GMP) compliance; (2) a summary of all enforcement actions; (3) the number of dietary supplement claims the FDA determined to be false, misleading or unsubstantiated; and (4) recommendations for administrative or legislative actions to improve the regulation of dietary supplements.
Third, 180 days after the enactment of S. 3414, the FDA would be required to publish a guidance document on New Dietary Ingredients (“NDI”). An NDI is an ingredient that was not sold as a dietary supplement prior to the enactment of DSHEA in 1994. As an important safety measure included as part of DSHEA, with certain exceptions, prior to marketing an NDI, companies must submit a notification to the FDA with information showing why the ingredient is reasonably expected to be safe. This has been the cause of considerable confusion in the industry as it is often unclear whether an ingredient is an NDI, and what information the FDA expects to be in a notification. The mandated guidance should help increase compliance by addressing both sources of confusion.
At the May 26 hearing of the Senate Special Committee on Aging, the Senators heard testimony from the dietary supplement industry, consumer groups, the Federal Trade Commission, the FDA, and others. Perhaps the most compelling testimony came from the GAO, which reported the findings of its “undercover” investigation into the marketing practices of dietary supplement companies targeting seniors. The GAO found that the marketers it investigated illegally claimed that their supplements could treat diseases (such as Alzheimer’s) and made claims not supported by current science. Moreover, the GAO found that companies, through telephone sales representatives, retail store sales clerks, and otherwise, often gave inappropriate medical advice, such as that the supplements were safe to take with certain medications, or that the consumer would be able to stop taking medications.
In addition to investigating marketing practices, the GAO analyzed 40 dietary supplement products and found that 37 had “at least one potentially hazardous contaminant … though none in amounts considered to pose an acute toxicity hazard.” Among the trace contaminants were lead (found in all 37 samples) as well as cadmium, arsenic, and pesticide residues. The levels found did not exceed any FDA regulations, and FDA officials did not express concern about negative health consequences from consuming these supplements.
At the hearing, Senator Kohl, the Chairman of the Special Committee, stated: “Let’s be clear that no one is suggesting that consumers should not be able to take vitamins or other dietary supplements. Our concern is that they be able to do so safely. American consumers should have access to comprehensive, accurate information about these products, so they are empowered to make the best decisions about their own health.”
Why it matters: From the numerous stories of steroids and other substances being found in dietary supplements, to stories of adverse health effects and “quack” science, calls for an increase in the regulation of dietary supplements have been loud and this hearing is another sign that they are not abating. Much of the debate has been divided into two camps: (1) those that think DSHEA should be amended; and (2) those that think the FDA should just increase enforcement of the laws currently on the books. This new bipartisan legislation is a sign of hope for the second camp. We will continue to monitor the Hill and inform you of new developments.