FDA WARNING_LETTER - La Crema De Rebeca - May 01, 2026

On May 14, 2026, the FDA issued a warning letter to the Austin-based company La Crema De Rebeca following a website review conducted in April 2026. The agency"s investigation revealed that the company is marketing "La Crema De Rebeca" with illegal medical claims, such as treating acne, rosacea, melasma, and fading spots. More alarmingly, laboratory analysis confirmed that the product contains high levels of mercury, a toxic substance that was not disclosed on the product labeling. Mercury exposure can lead to severe health consequences, including permanent kidney and neurological damage, posing significant risks to the general public, specifically children and pregnant individuals. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, the FDA has classified the product as both an unapproved new drug and a misbranded drug. It is considered unapproved because it has not undergone the necessary safety and effectiveness reviews for the conditions it claims to treat, and it is misbranded because its labeling is misleading by omitting the presence of mercury. The FDA has mandated that the company respond within 15 business days with a detailed plan describing the corrective and preventive actions taken to address these violations. Failure to resolve these issues promptly may result in legal enforcement, such as product seizures or court injunctions.