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.
Learn more about Structure/Function Claim Notification for Dietary Supplements, including how to make written submissions.
FDA provides an ePortal (COSM) for electronic submissions.
Change in the Submission Process from FURLS to COSM
Users who currently have draft submissions pending in FURLS must complete and submit their notification within 30 days of initiating the process. For assistance with completing an application in FURLS, please contact FURLSSupport@FDA.hhs.gov. After the 30-day period, notifications must be resubmitted in COSM for agency review.