Proposed Legislation for Dietary Supplement Labeling
On June 30, 2011, United States Senator Richard Durbin (D-IL) introduced the Dietary Supplement Labeling Act of 2011(the “Bill”). The Bill proposes to amend the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to improve the safety of dietary supplements. Critics argue that the Bill expands the FDA’s power to regulate dietary supplement manufacturers without clear guidelines and provides requirements that duplicate what is already accomplished under current law. The Washington Times published an article highlighting that the Bill would harm consumers through increased cost and decreased variety of dietary supplements.
The Bill proposes regulations requiring dietary supplement manufacturers to register their products with the U.S. Food and Drug Administration (FDA). In order to register products, manufacturers would be required to provide the FDA with a list of ingredients and copies of the label and labeling. Failure to register a dietary supplement or keep the information up to date would cause dietary supplements to be misbranded. Current law requires that all food facilities, including dietary supplement manufacturers, register with the FDA pursuant to the Bioterrorism Act. Dietary supplement manufacturers do not currently have to list their products with the FDA.
Additionally, the Bill mandates the FDA and the Institute of Medicine (IOM) to identify dietary supplement ingredients that could potentially cause serious adverse events, drug interactions, contraindications, or potential risks to subgroups such as children and pregnant women, and establish warning statements for dietary supplements containing these potentially unsafe ingredients. The Bill would require that if a potentially unsafe ingredient is part of a proprietary blend, the label must disclose the amount of that ingredient per serving. Currently, dietary supplements must be manufactured under Good Manufacturing Practices in order to ensure the ingredients are safe. Furthermore, before a substance may be added to a food, a Food Additive Petition must be submitted to the FDA and must include data demonstrating safety, unless the ingredient and the amount are Generally Recognized as Safe (GRAS). Accurate disclosure of the contents in the dietary supplement package is already required under the Fair Packaging and Labeling Act. Additionally, by definition, the amount of each ingredient in a proprietary blend is proprietary information.
Lastly, the Bill requires the FDA to establish a definition for “conventional foods” in order to differentiate conventional foods from dietary supplements. In 2009, the FDA issued draft guidance distinguishing conventional foods from dietary supplements. Under the current regulatory scheme, the FDA has the authority “ and has used that authority “ to take enforcement action against dietary supplements that are marketed as conventional foods. See Warning Letters issued by the FDA here and here to dietary supplement manufacturers marketing their products as conventional foods.
Fuerst Ittleman will continue to monitor the Bill as it is up for vote in the Senate. For more information about dietary supplement labeling or FDA regulatory compliance, please contact us at firstname.lastname@example.org.