The popularity of dietary supplements continues to catch the attention of the federal government. Aside from the draft guidance recently released by FDA clarifying the requirements on dietary supplement distributors and manufacturers containing a new dietary ingredient, on June 30 U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) introduced the Dietary Supplement Labeling Act (S.1310).
The proposed legislation requires companies to submit to FDA a description of each dietary supplement product that they manufacture, a list of all ingredients in each product, and a copy of the label and labeling for each product. The Bill also requires FDA to work with the Institute of Medicine in determining dietary supplement ingredients and proprietary blends of ingredients that can cause potentially serious adverse events, drug interactions, contraindications, and other effects, and to establish a mandatory warning label requirement for these dietary supplement ingredients and blends of ingredients. In addition, the Bill requires FDA to establish a definition for the term "conventional food," taking into account conventional foods marketed as dietary supplements and products marketed dietary supplements that simulate conventional foods.
The Bill is purportedly in response to a recent controversy involving "Lazy Cakes" brownies, which contain the neurohormone melatonin. In his May 18, 2011 letter to FDA Commissioner Margaret A. Hamburg, M.D. , Durbin raised concerns with about Lazy Cakes and other baked goods containing melatonin that are marketed as dietary supplements and do not require FDA pre-market approval for safety and efficacy. And now with the proposed Billtion, Durbin is looking to curb this practice. Durbin points out that products such as Lazy Cakes, Drank, and Monster Energy Drink "market themselves as dietary supplements that are safe ways to relax or get a boost of energy, when in reality they are foods and beverages taking advantage of the more relaxed safety standards for dietary supplements."
However, critics have accused the Bill as undermining the dietary supplement industry and of giving FDA unnecessary power to address problems that it already has the authority to remedy. For example, some critics question why the provisions in the Bill apply to supplement manufacturers and do not address the issues surrounding the illegal sale of Lazy Cake, while others note that FDA already has the authority to take action against the producers of Lazy Cake for its violation of the law prohibiting the sale of a supplement as food, and yet FDA has not acted. Further, some point out that a new dietary ingredient (i.e., a new supplement) is already covered through the existing new dietary ingredient ("NDI") notification process. In a press release, the Council for Responsible Nutrition summarized many of these criticisms of the Bill: "The bill contains duplicative requirements that already exist under current law that gives FDA the proper legal authority to take action to protect consumers and maintain safety standards. FDA needs to continue working toward becoming a more efficient steward of its resources, and we continuously call on the Agency to use its power under the law."