Federal health officials are warning Americans to avoid sunscreens marketed in whipped, mousse and foam because they aren’t approved as effective methods for applying the product.
The Food and Drug Administration (FDA) has sent warning letters to several companies – including Supergoop – over sunscreen products sold in whipped, mousse and foam forms. According to the agency, these products are labeled and marketed as drugs but have not been FDA-approved in those forms.
FOX Business reached out to Supergoop for comment.
The FDA says the products are misbranded because they do not meet the marketing requirements outlined in the agency’s rulebook for over-the-counter drugs. Selling misbranded drugs, the agency warns, is illegal under federal law.
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The FDA regulates sunscreens as over-the-counter (OTC) drug products to help make sure that consumers have access to safe and effective sun protection products. This means it has strict regulations for them, including the form they can be marketed in. Under current regulations, oils, lotions, creams, gels, butters, pastes, ointments and sticks are the only forms of sunscreen that are considered safe and effective.
To date, the FDA hasn’t given official permission for sunscreens to be sold in foam, mousse or whip form. In order to use these formats, companies would have to submit a new application for the product. However, the FDA didn’t receive any approved new drug application for their product format for the products.
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The companies were given 15 days to respond to the FDA’s letter with corrective actions.
In 2019, the FDA issued new rules on sunscreen to ensure they are up-to-date with the latest science. The FDA proposed revising the requirements for sunscreen active ingredients; maximum sun protection factor levels; broad spectrum requirements (protection against both ultraviolet A and B rays); and dosage forms (for example, cream, lotion, or spray), among other things. The proposed rule also included updates on how sunscreens are labeled to make it easier for consumers to identify key information.
Following the FDA’s proposed rules, the Skin Cancer Foundation issued a statement underscoring the importance of strong oversight.
As science and technology advance to “dramatically improve the efficacy of sunscreens, continued evaluation of the regulations associated with them is necessary, as is the evaluation of new UV filters that are currently available outside the U.S.,” the foundation said.
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