US FDA Dietary Supplement Structure/Function Claim Notification

Regulatory background

Dietary supplements in the United States are products intended for consumption that may contain one or more of the following dietary ingredients:

• vitamins,
• minerals,
• herbs or other botanicals,
• amino acids,
• dietary substances that supplement the diet by increasing the total dietary intake, or
• the concentrates, metabolites, constituents, extracts, or combinations of any of the above listed items.

Structure/function claims have historically appeared on the labels of dietary supplements. They may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, “calcium builds strong bones.” In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, “fiber maintains bowel regularity,” or “antioxidants maintain cell integrity.”

According to the Dietary Supplement Health and Education Act (DSHEA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act), structure/function claims do not require FDA pre-market approval, but a notification with the text of the claim must be submitted to FDA no later than 30 days after first marketing the dietary supplement with the claim.

Written submissions can be mailed to the FDA. However, to facilitate FDA review and faster processing of notifications, FDA encourages submitters to utilize the ePortal (CFSAN Online Submission Module or COSM). This also will allow submitters to receive confirmation of receipt and obtain status updates via email.

Required information

FAQs

Q1: How long it takes the FDA to review my notification?

A1: Reviewing a notification for a structure/function claim generally takes up to 1 month but may take longer in some cases. FDA reviews notifications in the order in which they are received.

Q2: Will I be notified when the review is completed?

A2: That depends on the outcome of the FDA’ s review.

The FDA typically notifies firms by letter (often referred to as a “courtesy letter”) if it objects to the statements that are the subject of the structure/function claim notification. For example, FDA may object if the statement suggests that the ingredient and/or product diagnoses, treats, cures, mitigates, or prevents a disease. FDA may also object for other reasons, such as the product at issue is not a dietary supplement or the claim is being made for an ingredient that is not a nutrient or dietary ingredient.

If the Agency does not object to a claim notification, they generally do not send a response or otherwise inform the notifier that our review is completed. The notifier need to regularly check their email or log into the system to track progress.

Q3: Can I submit different structure/function claims for multiple dietary supplements at the same time?

A3: Yes, you can submit multiple notifications at once.

Q4: How much does it cost?

A4: The FDA does not charge any fees for the structure/function claim notification. Only the service fee is required if you need assistance from an agent.

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