New FDA Draft Guidance on Premarket Notifications for Supplements

Under a recent revision of the US Food and Drug Administration (FDA) draft guidance on new dietary ingredient (NDI) premarket safety notifications, makers of dietary supplements will have to notify the agency within 75 days before starting to market a dietary supplement that has a new ingredient, the FDA announced Thursday.

Producers or distributors of supplements now must notify the agency if an ingredient was not marketed prior to Oct. 15, 1994 or the ingredient was chemically altered. If the company does not submit the required notification within 75 days, the supplement is considered “adulterated.”

“This revised draft guidance is an important step forward in the agency’s work to protect public health from potentially dangerous new dietary ingredients,” said Steven Tave, acting director of the FDA’s Office of Dietary Supplement Programs in a statement. “Notification of new dietary ingredients is the only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers. The revised draft guidance is intended to improve the quality of the industry’s new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements.”

More than 55,600 dietary supplements are sold in the US market, according to an FDA estimate, and over 5,560 new dietary supplement products are introduced each year. The initial draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” was issued in 2011.

The agency launched its Office of Dietary Supplement Programs in Dec. 2015, formerly a division of the Office of Nutrition, Labeling and Dietary Supplements. The public has an opportunity to comment on the revised draft guidance over the next 60 days.