The US Food and Drug Administration (FDA) has recently issued a Warning Letter to skincare brand Supergoop! following a comprehensive review of the labeling, website, and social media content related to its Play SPF 50 Body Mousse. The core issue highlighted by the FDA is that the product makes claims that classify it as a drug under federal regulations, yet it has not met the necessary compliance requirements for marketing such a product.
According to the FDA, “Supergoop! PLAY SPF 50 BODY MOUSSE” falls under the definition of a “drug” as outlined in two sections of the Federal Food, Drug, and Cosmetic (FD&C) Act. Specifically, under section 201(g)(1)(B) of the FD&C Act (21 U.S.C. 321(g)(1)(B)), the product is considered a drug because it is intended for use in the prevention of disease—in this case, sun-related harm. Additionally, it may also qualify as a drug under section 201(g)(1)(C) (21 U.S.C. 321(g)(1)(C)) since it is intended to affect the body’s structure or functions, particularly in protecting the skin from the sun’s rays.
The FDA identified several pieces of evidence from Supergoop!’s product labeling, website, and social media platforms that support this classification. Even social media posts, such as one on Instagram describing it as “Sunscreen innovation at its finest: lightweight, whipped, antioxidant-rich sunscreen mousse with SPF 50 protection…”, were cited as indicators of the product’s intended use as an over-the-counter (OTC) sunscreen drug.
Central to the FDA’s warning is the finding that Supergoop! has failed to comply with key provisions of the FD&C Act. The agency noted that there is no FDA-approved application in effect for the product under section 505 of the FD&C Act (21 U.S.C. 355), which governs the approval of new drugs. Under section 502(ee) of the FD&C Act (21 U.S.C. 352(ee)), a nonprescription drug is deemed misbranded if it falls under section 505G but does not comply with its requirements and lacks an approved application under section 505.
