FDA WARNING_LETTER - Kalani AB dba Kalani Sunwear - May 07, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to Kalani Sunwear, based in Stockholm, Sweden, on August 6, 2025, following a review conducted on May 7, 2025. The review focused on the company"s product, "Kalani Sunwear SUN MOUSSE SPF 50," which is marketed in the United States as an over-the-counter sunscreen drug without a prescription. The FDA identified several regulatory violations concerning the product"s labeling and marketing practices.

Key issues include the product being classified as a drug under sections 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is intended to prevent disease and affect the body"s structure or function. The product lacks an FDA-approved application under section 505 of the FD&C Act and does not comply with the requirements for marketing nonprescription drugs under section 505G. The product is also misbranded under section 502(ee) of the FD&C Act, as it does not conform to the conditions specified in the applicable OTC monograph for sunscreen drug products.

The FDA requires Kalani Sunwear to address these violations by submitting a written response within 15 working days, detailing corrective actions taken and plans to prevent future violations. Failure to comply may result in legal actions, including product seizure and injunctions. The response should be sent to the FDA"s Office of Unapproved Drugs and Labeling Compliance, including the firm"s name and the identifier "710998."