Structure/Function Claim Notification for Dietary Supplements
The Federal Food, Drug, and Cosmetic Act (the Act) requires that the manufacturer, packer, or distributor who wish to market a dietary supplement notify FDA regarding the statement on the label or in the labeling of its product, pursuant to § 403(r)(6) of the Act.
The law states that a dietary supplement may bear certain statements on its label or in its labeling
- if the claim(s) meets certain requirements,
- if the entities making the claims have substantiation that such a statement is truthful and not misleading, and if
- the standard disclaimer (see § 403(r)(6)(C)) is prominently displayed on the label.
Section 101.93(f) of the Code of Federal Regulations (CFR), Title 21, simply restates part of the definition of the types of claims that may be made under section 403(r)(6) of the Act.
Finally, the notification must be submitted to FDA no later than 30 days after the first marketing of the dietary supplement product.
Read more on the definition of Structure/Function Label Claims.
FDA now offers an electronic portal for the submission of Structure Function Notifications. We encourage submitters to utilize the portal in order to receive confirmation of receipt by FDA and to facilitate their review.
Request for Comments on Notification Procedures for Statements on Dietary Supplements
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(r)(6)) and § 101.93 (21 CFR 101.93) of our regulations require that, no later than 30 days after the first marketing, we be notified by the manufacturer, packer, or distributor of a dietary supplement that it is marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in section 403(r)(6) of the FD&C Act.
Our electronic form (Form FDA 3955) allows respondents to the information collection to electronically submit notifications to FDA via an electronic system. We are upgrading our current system (the FDA Unified Registration Listing System known as FURLS) to deploy the Food Applications Regulatory Management (FARM) system. FARM is modeled after FURLS and collects the same information, but improves our operational efficiency.
Firms that prefer to submit a paper notification in a format of their own choosing still have the option to do so.
FDA is seeking comments on the new system. Draft screenshots are available below for review and comments.
- Draft Screenshots (PDF: 2.2 MB)
The comment period opens May 31, 2019 for 30 days. Submit comments electronically to docket folder FDA-2013-N-0032 on http://www.regulations.gov. For more information on how to comment, see the Federal Register Notice.
Written submissions are accepted. Information that is required in the submission includes:
- The name and address of the manufacturer, packer, or distributor of the dietary supplement product;
- the text of the statement that is being made;
- the name of the dietary ingredient or supplement that is the subject of the statement;
- the name of the dietary supplement (including the brand name); and
- the signature of a responsible individual or the person who can certify the accuracy of the information presented, and who must certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.
Completed submissions should be mailed to:
Food and Drug Administration (HFS-810)
Office of Dietary Supplement Programs
5001 Campus Drive
College Park, MD 20740
If you have questions, please contact us at:
Office of Dietary Supplement Programs (HFS-810)
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740-3835
Telephone Number: (240) 402-2375
Guidance for Industry
- Guidance for Industry: Structure/Function Claims, Small Entity Compliance Guide
- Guidance for Industry: Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
- Guidance for Industry: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements; Small Entity Compliance Guide