U.S. Food and Drug Administration

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires a person or firm that markets a dietary supplement with certain types of claims in the product labeling to notify FDA about the claim within 30 days after first marketing the dietary supplement with the claim. The labeling claims covered by the notification requirement are:

• structure/function claims (defined as a statement that “describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans” or “characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function”);
• general well-being claims (a statement that “describes general well-being from consumption of a nutrient or dietary ingredient”); and
• classical nutrient deficiency disease claims (a statement that “claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such disease in the United States”).

These claims are referred to collectively as “403(r)(6) claims” because they are defined in section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) and must comply with the requirements of that provision. A dietary supplement for which a truthful and non-misleading claim is made in accordance with section 403(r)(6) is not a drug solely because the label or labeling contains the claim. 21 U.S.C. 321(g)(1).

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A claim made on the label or in the labeling of a dietary supplement is in accordance with section 403(r)(6) if:

• the claim is a structure/function claim, a general well-being claim, or a classical nutrient deficiency disease claim as defined in section 403(r)(6)(A);
• the entity making the claim has substantiation that the statement is truthful and not misleading;
• the statement is accompanied by the following standard disclaimer, prominently displayed and in boldface type: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”; and
• the statement does not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.

In addition, the entity making the claim must submit a notification with the text of the claim and other required information to FDA no later than 30 days after first marketing the dietary supplement with the claim. 21 U.S.C. 343(r)(6); 21 CFR 101.93.

Read more on Structure/Function Label Claims.

Submitting Notifications

Electronic Submissions

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FDA provides an ePortal (Centralized Online Submission Module (COSM)) for electronic submissions. You may use the same COSM account for future submissions.

To facilitate FDA review and faster processing of notifications, we encourage submitters to utilize the COSM portal. This also will allow submitters to receive confirmation of receipt and obtain status updates via email.

Visit Centralized Online Submission Module (COSM) for instructions and account management information. Also for your reference is a step-by-step guide for using COSM to file a structure/function or other section 403(r)(6) claim notification.

Launch the Structure/Function Claim Notification ePortal (via COSM)

Written Submissions

Although FDA encourages the use of the ePortal for electronic submissions, written submissions are also accepted. Required information for a section 403(r)(6) notification includes:

1. The name and address of the manufacturer, packer, or distributor of the dietary supplement that bears the statement on its label or in its labeling;
2. the text of the statement that is being made;
3. the name of the dietary ingredient or supplement that is the subject of the statement;
4. the name (including brand name) of the dietary supplement that bears the statement; and
5. the signature of a responsible individual or other person who can certify the accuracy of the information in the notification. The person who signs the notification must certify that the information in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading.

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Completed submissions should be mailed to:

Food and Drug Administration (HFS-810) Office of Dietary Supplement Programs 5001 Campus Drive College Park, MD 20740-3835

403(r)(6) Claim Notification FAQs

Questions?

If you have additional questions, please contact us at:

Via email at SFCN@fda.hhs.gov for questions related to structure/function claim notifications and other dietary supplement claim notifications required under section 403(r)(6) of the FD&C Act.

To reach FDA’s Food and Cosmetics Information Center, visit Industry and Consumer Assistance from HFP.

Guidance for Industry

• Small Entity Compliance Guide on Structure/Function Claims
• Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
• Small Entity Compliance Guide on Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements

Resources For You

• Label Claims for Conventional Foods and Dietary Supplements
• How to Submit Label Claim Petitions and Notifications
• Authorized Health Claims That Meet the Significant Scientific Agreement Standard
• Nutrient Content Claims
• Qualified Health Claims
• Structure/Function Claims

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