FDA and Structure/Function Claims

FDA and Structure/Function Claims

As a manufacturer or distributor of dietary supplements, it is your responsibility to ensure that the claims made about your products are truthful and not misleading. This includes structure/function claims, which describe how a product works to support normal body structure or function. In this short article, we will discuss why it is important to notify the FDA about structure/function claims and how to do it properly to comply with the regulations.

Structure/function claims are statements about the role of a food or dietary supplement in maintaining the normal structure or function of the human body. These claims describe the general well-being effects of a product, such as “supports a healthy immune system,” “promotes digestive health,” or “enhances focus.” They are different from disease claims, which state that a product can treat or cure a specific disease or medical condition.

The FDA regulates structure/function claims to ensure that they are truthful and not misleading. All structure/function claims must be substantiated by scientific evidence, and the label of the product must include a statutory disclaimer that the claims have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease. If you make structure/function claims about your product, you must submit all of them for review to the FDA no later than 30 days after the first marketing of the product.

To notify the FDA about structure/function claims, you must submit a pre-market notification (PMN) to the Office of Dietary Supplement Programs (ODSP). The PMN must include the following information:

•  The name and address of the manufacturer or distributor
•  The brand name of the product
•  The exact language of the structure/function claim as it appears on the label of the product
•  The dietary ingredient for which the claim is made
•  The label of the product (optional, but highly recommended)

The PMN must be submitted electronically through the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) portal. The FDA will review the PMN usually within one month’s time but can take a longer amount of time in some cases. If the FDA has objections to the claim notification, they will usually send a courtesy letter to the submitter. The FDA may object to a claim notification if they deem that the product is not an dietary supplement, the claim is intended for an ingredient that is not a nutrient or dietary ingredient, or the ingredient may diagnose, treat, cure, mitigate, or prevent diseases. If the FDA does not have any objections, they typically will not send a letter or notify the submitter. In this case, no news is good news. Although the FDA may approve a claim to be used for a product, it is important that companies have substantiation to back up their claim in case the FDA does an inspection.