Contains Nonbinding Recommendations
Draft-Not for Implementation
- Available in PDF (927B)
- Federal Register Notice
- Docket No. FDA-2011-D-0376 for commenting starting August 12, 2016
- More Dietary Supplements Guidance Documents & Regulatory Information
This guidance is being distributed for comment purposes only.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on this draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2011-D-0376, which is listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document, contact the Food and Drug Administration, Office of Dietary Supplement Programs, 5001 Campus Drive (HFS-810), College Park, MD 20740, Toll Free (855) 543-3784, or 240-402-2375.
Replaces draft guidance issued July 2011
Under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)(2)), the manufacturer or distributor of a new dietary ingredient (NDI) that has not been present in the food supply as an article used for food, or a dietary supplement containing such an NDI, must submit a premarket safety notification to FDA at least 75 days before introducing the product into interstate commerce. This guidance is intended to help manufacturers and distributors of dietary ingredients and dietary supplements (“you”) decide whether to submit a premarket safety notification to FDA (“we” or “us”) for a product that is or contains an NDI. These premarket safety notifications are commonly referred to as NDI notifications. The guidance is also intended to help you to prepare NDI notifications that we will be able to review more efficiently and respond to more quickly.
The guidance answers frequently asked questions about NDI notifications and related issues. The major topics it addresses are:
- What qualifies as an NDI;
- When an NDI notification is required;
- What are the procedures for submitting an NDI notification;
- What types of data and information FDA recommends you consider when you evaluate the safety of NDIs and dietary supplements containing an NDI; and
- What FDA recommends you include in an NDI notification.
In addition, the guidance contains questions and answers about parts of the definition of “dietary supplement” that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement. We encourage you to consult this guidance during your safety review of dietary supplements that contain an NDI and when you prepare NDI notifications.
The guidance focuses on interpreting the FD&C Act’s requirements relating to NDIs and dietary supplements that contain an NDI. It does not discuss other parts of the FD&C Act that may affect the regulatory status of a particular ingredient or product, such as provisions of the FDA Food Safety Modernization Act (FSMA) that may apply to dietary ingredients and/or dietary supplements.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.
This guidance has been prepared by the Office of Dietary Supplement Programs in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.