Picking up where the Food Safety Modernization Act ("FSMA") left off, under proposed S.1310, Congress is considering requiring dietary supplement manufacturers to notify FDA of all marketed products and within 30 days with respect to all new and reformulated products, identifying the ingredients, labeling, the weight of any proprietary blend, and lot numbers. The Act would also require notification when a product is discontinued. Under this proposed bill, FDA would contract with the Institute of Medicine ("IOM") to evaluate dietary supplement ingredients and proprietary blends, and FDA would thereafter establish mandatory warning requirements. FDA would consider non-compliance with the registration and warning requirements misbranding under Section 403 of the Food Drug and Cosmetic Act (21 USC § 343) subject to enforcement action. The proposed Act does not specify the enforcement action that would be taken, but misbranding under the FDCA can be subject to criminal prosecution.
Congress long ago set FDA's mission to "promote the public health by promptly and efficiently reviewing clinical research ...[to] protect the public health by ensuring that foods [including dietary supplements] are safe, wholesome, sanitary, and properly labeled..." 21 USC § 393(b)(1) and (2)(A). While expanding FDA with more and increasing responsibility and oversight may make political sense, adding more rules, regulations and governmental oversight will expand the bureaucracy while adding little more than window dressing to an already vigorous regulatory and enforcement regime for dietary supplements. FDA may better and more immediately achieve its mission by expending its limited resources to enforce the current rules and to inform consumers on how to educate themselves about the substances they ingest and to report adverse events (as well as bad actors) to FDA.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.