Kalani Gets an FDA Warning Letter

The US Food and Drug Administration issued a Warning Letter to Kalani Sunwear. FDA reviewed the company’s product labeling, social media accounts and website. It concluded Kalani Sunwear Sun Mousse SPF 50 makes drug claims. According to FDA, the formula is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B). FDA said it is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.

FDA Cites Label Errors

Examples that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:

• “SUNSCREEN MOUSSE SPF 50… Sunscreen SPF 50… WARNINGS:… Reducing the quantity of sunscreen product applied will lower the level of protection significantly” [product website]

• “Introducing our Kalani sunwear Sun Mousse SPF 50: your ultimate defence against the sun’s rays!” [product website]

• “High Sun Protection (SPF 50). Experience top-tier protection against harmful UV rays, ensuring your skin stays safeguarded in the sunniest conditions…Wide Spectrum Protection. Guard your skin against UVA and UVB rays with our broad-spectrum formula, leaving no room for compromise.” [product website]

• “Say goodbye to sunburns and hello to radiant, protected skin! Discover the ultimate sun mousse that feels as light as a cloud while giving you SPF 50 protection…” [Instagram page]

FDA Takes Aim at Sunscreen Claims

Based on the above labeling, FDA concluded “Kalani sunwear Sun Mousse SPF 50” is intended for use as an over-the-counter (OTC) sunscreen drug product. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for the drug product.

Interestingly, there are no sunscreen products listed on the Kalani page.

Suncare is top-of-mind at FDA. In recent weeks, the Agency issued Warning Letters to Supergoop! and Vacation Classic for similar claims.