New Dietary Ingredient Guidance Set to Transform the U.S. Supplement Industry6 Jun, 2011 By: Jeffrey D. Knowles, Venable LLP’s Advertising, Claudia Lewis-Eng
This summer, the Food and Drug Administration (FDA) is expected to issue its much-anticipated “new dietary ingredient” guidance. Many believe this new guidance will clarify and expand the scope of those dietary ingredients that are considered “new.”
The supplement industry is subject to a unique federal regulatory scheme. Although manufacturers and distributors are responsible for ensuring that the supplements they market are safe and comply with certain other requirements, companies are not required to secure FDA approval before marketing supplements. However, when marketing dietary supplements that contain a “new dietary ingredient,” (defined as a dietary ingredient not marketed in the United States in a dietary supplement or was not present in the food supply as an article used for food before October 15, 1994) manufacturers and marketers are required to notify the FDA about these novel ingredients.
Because no authoritative list of dietary ingredients marketed before 1994 exists, companies must determine whether an ingredient is a “new dietary ingredient.” If the answer is yes, “premarket notification” must be submitted to the FDA at least 75 days before the dietary ingredient is marketed. This document outlines why the company believes there is a reasonable expectation that the supplement containing the new ingredient will be safe when used under the conditions recommended or suggested in the labeling.
Once a company has submitted a premarket notification for a new dietary ingredient, the FDA may request further information – or even reject the new dietary ingredient submission – if it believes that the information in the notification is inadequate to provide reasonable assurance of the new ingredient’s safety or has questions or concerns about information contained in the notification. If FDA does not respond further to the notification, the supplement may be marketed 75 days after the notification’s filing date.
However, there is great debate over the second half of the definition of a new dietary ingredient because the FDA has a very narrow definition of what constitutes an article used for food. The agency has been clear that nutrients extracted from a food may still be considered new dietary ingredients. Another complicating factor is that the FDA recently has objected to more new dietary ingredient notifications than it has in the past.
Depending on how the FDA interprets the statutory definition of a new dietary ingredient, the supplement industry will be greatly impacted. Many dietary ingredients already in the marketplace may soon require a 75-day notification to the agency. In addition to overhauling the regulatory landscape, observers expect the FDA’s guidance to clarify several unanswered questions, including:
• What and how much information should be contained in the new dietary ingredient submission to establish that an ingredient, used under the recommended or suggested conditions, will have a reasonable expectation of safety?
• If a product contains a higher concentration of an ingredient present in food prior to October 15, 1994, would at ingredient be viewed as a new dietary ingredient?
• Can a company market a new dietary ingredient even if the FDA has objected or expressed concerns about the product?
The FDA is not the only entity interested in new dietary ingredients. Increasingly, we are seeing consumer class actions and other lawsuits identifying the lack of a new dietary ingredient 75-day notification as a cause of action. In short, no matter how slow or fast the agency decides to move in terms of enforcement action, this issue cannot be ignored.
Jeffrey D. Knowles is a partner at Venable LLP and chair of the firm’s Advertising, Marketing and New Media Group. Claudia Lewis-Eng is a partner at Venable LLP. They can be reached at (202) 344-4000.