AlzClipp / UniUni – FDA Warning Letter, Aug 26, 2025

The FDA issued a warning letter to AlzClipp on July 29, 2025, following a review of the company"s product labeling and website. The inspection identified that AlzClipp"s nasal product is marketed as an unapproved new drug, violating sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The product is intended for use in diagnosing, curing, mitigating, treating, or preventing disease, classifying it as a drug under section 201(g)(1) of the FD&C Act. However, it lacks FDA approval, making its introduction into interstate commerce illegal.

Additionally, the product is misbranded under section 502(a) of the FD&C Act. AlzClipp"s website misleadingly suggests FDA approval by displaying an FDA logo and claims of endorsement, despite no approved applications existing for the product. This misrepresentation violates section 301(a) of the FD&C Act.

The FDA requires AlzClipp to address these violations by investigating their causes and implementing corrective actions. The company must respond in writing within 15 working days, detailing the steps taken to rectify the issues and prevent recurrence. Failure to comply may result in legal actions, including seizure and injunction. AlzClipp is instructed to send their response to the FDA"s Office of Unapproved Drugs and Labeling Compliance, including the unique identifier "CMS 711274" in correspondence.