Understanding the Three Types of Claims Allowed by the FDA for Dietary Supplements

When it comes to dietary supplements and medications, the types of statements that can be made on their labels are different. Drug manufacturers may claim that their products diagnose, cure, mitigate, treat, or prevent a disease, but these claims cannot be legally made with respect to dietary supplements. Product claims provide consumers with information about the product and help them decide which one is most suitable for them. The Food and Drug Administration (FDA) regulates claims on dietary supplement labels. There are three basic types of legal claims allowed on the packaging of dietary supplements.

These include health claims, structure/function claims, and nutrient content claims. Health claims describe a relationship between a food, a food component, or an ingredient in a dietary supplement and the reduction in the risk of a disease or health-related condition. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans. Nutrient content claims describe the level of a nutrient in a food or dietary supplement. Ingredients in supplements sold in the United States before October 15, 1994 are not required to be reviewed by the FDA for safety prior to marketing, since they are presumed to be safe based on their history of use in humans.

However, manufacturers and distributors of dietary supplements must record, investigate and send to the FDA any reports of serious adverse events associated with the use of their products. In addition, FDA regulations require those who manufacture, package, or store dietary supplements to follow current good manufacturing practices that help ensure the identity, purity, quality, concentration and composition of dietary supplements. The FDA also considers advertising when evaluating the intended use of a product labeled as a dietary supplement. The FDA sends warning letters to CBD companies that promote their products for medical uses and for the treatment of diseases as this violates the FD&A Act. In addition, once a dietary supplement is marketed, the FDA must demonstrate that the product is not safe to restrict its use or recall it from the market. The FDA recommends that consumers consult with a health professional before deciding to take a dietary supplement. This will help them make an informed decision about which product is best suited for them.

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