The Food and Drug Administration released new, revised draft guidance on dietary supplement companies’ new dietary ingredient notifications (NDI) to the agency on Aug. 11. The notifications are intended to help the FDA identify safety concerns before consumers start using products.
The Dietary Supplement Health and Education Act (DSHEA) requires that the manufacturer or distributor must notify the FDA at least 75 days before marketing a dietary supplement that contains a new dietary ingredient (defined as one not marketed in the U.S. before Oct. 15, 1994), unless the NDI is used in the food supply without chemical alteration.
If a dietary supplement contains an NDI not used in the food supply and the required dietary ingredient notifications have not been received by the FDA at least 75 days before the marketing began, the dietary 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“This revised draft guidance is an important step forward in the agency’s work to protect public health from potentially dangerous new dietary ingredients,” said Steven Tave, acting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. “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 The revised draft guidance is intended to improve the quality of industry’s new dietary ingredient reporting so the FDA can more effectively monitor the safety of dietary supplements.”
The FDA says that there are more than 55,600 dietary supplements on the market, with 5,560 new dietary supplement products added to the market annually. Despite that, the agency says it has received fewer than 1,000 new dietary ingredient notifications since DSHEA passed in 1994.
The agency has taken numerous actions on dietary supplements over the last three years, including those on several products containing new dietary ingredients that it said may pose safety concerns and which should have been the subjects of NDI notifications and were not.
The FDA announced the creation of the Office of Dietary Supplement Programs in December 2015, making it a separate office rather than a division under the former Office of Nutrition, Labeling and Dietary Supplements. With that move, the agency reaffirmed its commitment to:
- Remove products from the market that contain potentially harmful pharmaceutical agents, are otherwise dangerous to consumers, or are falsely labeled as dietary supplements
- Enforce the dietary supplement good manufacturing practices regulation
- Take action against claims that present a risk of harm to consumers (such as egregious claims of benefit in treating serious diseases) or economic fraud
Manufacturers may choose to implement the draft guidance recommendations before it becomes final. The FDA encourages public comments on the revised draft guidance during the 60-day period; Submit electronic comments to http://www.regulations.gov.
This new guidance adds to the growing pressure felt by nutraceutical companies. U.S. Attorney General Lynch stunned nutraceutical manufacturing companies when she issued a statement on dietary supplements in a short video on March 8, 2016, as part of National Consumer Protection Week.
For more information on the increasing threat of regulatory action, see our complimentary white paper, Nutraceutical Industry Faces Intensifying Scrutiny: Overview & Defense Strategies