FDA issues warning to Supergoop! over drug claims on sunscreen mousse
This approach aligns with the FDA’s broader policy that sunscreen products with sun protection claims are regulated as over-the-counter (OTC) drugs to ensure they meet safety and efficacy standards.
USA – The U.S. Food and Drug Administration (FDA) issued a warning letter to the skincare brand Supergoop! regarding its “PLAY SPF 50 BODY MOUSSE” sunscreen product.
The FDA’s primary concern is that this mousse sunscreen is classified as a drug under federal law due to its claims and intended uses, but has not received the required FDA approval to be marketed as such.
According to the FDA, The “PLAY SPF 50 BODY MOUSSE” is considered a drug under sections 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic (FD&C) Act because it is intended to prevent sunburn and protect the skin from harmful UV rays, thereby affecting the structure and function of the body.
The product’s labelling, website, and social media content make drug claims, such as “Broad Spectrum Sunscreen SPF 50,” “Helps prevent sunburn,” and describe the mousse’s sun protection properties, which support its classification as an over-the-counter (OTC) sunscreen drug.
The FDA noted that there is no approved drug application (under section 505 of the FD&C Act) for the mousse, making its marketing as a drug product noncompliant and rendering it misbranded.
Additionally, the FDA expressed concern over the mousse packaging resembling whipped cream containers, which could lead to consumer confusion and accidental ingestion.
The warning letter requires Supergoop! to respond within 15 working days, detailing corrective actions or contesting the violations.
Failure to comply could lead to legal actions, including seizure or injunction.
This warning is part of a broader FDA crackdown on mousse sunscreen products, which the agency cautions may not provide adequate sun protection due to the dosage form not being recognized under current sunscreen regulations.
The FDA’s stance highlights that mousse and foam sunscreen formulations lack sufficient safety and efficacy data required for approval, and this novel dosage form is not currently authorized for marketing without a new drug application.
This development underscores regulatory challenges for novel sunscreen formats like mousse, emphasizing the FDA’s commitment to ensuring that skincare and bodycare products like sunscreen are safe, effective, and clearly labelled to protect consumers from sun-related health risks.
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