TACA – FDA Warning Letter, Sep 30, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Distacart Inc. on November 17, 2025, following a review of their website, distacart.com, in September 2025. The FDA identified that Distacart Inc. is offering multiple drug products, including "SBL Malaria Officinalis Dilution," "Allen Depression Drops A79," and various eye drops like "Lord’s Eyerite Eye Drops," for sale in the United States. The primary violation is that these products are considered "unapproved new drugs" under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA determined that these products are not generally recognized as safe and effective for their intended uses and lack the required FDA approval. Specific concerns were raised about products making therapeutic claims for serious conditions such as malaria, depression, and asthma, which may lead consumers to delay or forgo conventional medical treatment. Furthermore, ophthalmic products pose a heightened risk due to their direct administration into the eyes. Distacart Inc. is required to notify the FDA in writing within fifteen working days of receiving the letter, outlining the specific steps taken to correct these violations and ensure compliance with federal law. Failure to adequately address these concerns could result in further regulatory or legal actions, including product seizure or injunctions.