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FDA Proposes Collection of Information on Structure/Function Claim Notification Procedures

Structure/function claims commonly appear on dietary supplement labeling, both as a marketing tool and as a means of conveying the benefits of the supplement. Structure/function claims are claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function of the human body (for example, “vitamin A supports eye health”). They may also describe the mechanism by which a nutrient or dietary ingredient supports such structure or function (for example, “fiber supports healthy digestion by maintaining bowel regularity”).

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA be notified within 30 days of initial marketing of a dietary supplement bearing a structure/function claim. Notice can be made in writing or online.  The manufacturer, packer, or distributor of the product should submit the notification.

Submissions must include:

  • The name and address of the manufacturer, packer, or distributor of the product

  • The text of the structure/function claim being made on the product label

  • The name of the dietary ingredient or supplement that is the subject of the claim

  • The name of the dietary supplement, including the brand name

  • The signature of a responsible individual who can certify the accuracy of the information presented.

It’s important to distinguish between structure/function claims, which are permitted on dietary supplement products, and drug claims, which can render a supplement misbranded. A drug claim is a claim that states or implies that the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Dietary supplements that make claims exceeding what is appropriate for the supplement category may be deemed unapproved new drugs and, consequently, face enforcement action.

On June 13, 2022, FDA announced that a proposed collection of information had been submitted to the Office of Management and Budget for review and clearance regarding FDA’s procedures for receiving structure/function claim notifications. Historically, FDA has used this data to evaluate the permissibility of claims made on dietary supplement products. FDA invites the submission of written comments and recommendations through July 13, 2022.

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