FDA WARNING_LETTER - Allovate Therapeutics, LLC - September 01, 2025

On September 30, 2025, the FDA issued a Warning Letter to Allovate Therapeutics, LLC, citing significant violations related to their product, Allerdent, an allergenic toothpaste. The FDA"s Center for Biologics Evaluation and Research (CBER) conducted a review of the company"s marketing materials, including a brochure last visited in September 2025, which promotes Allerdent for allergy immunotherapy through daily tooth brushing.

The core issues identified are that Allerdent is marketed as an unapproved new drug, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and as an unlicensed biological product, violating section 351(a)(1) of the Public Health Service Act (PHS Act). The FDA determined that, by its intended use to diagnose, treat, or prevent disease, Allerdent falls under the definitions of both a drug and a biological product. Consequently, it requires either an approved Biologics License Application (BLA) or a New Drug Application, neither of which Allovate Therapeutics possesses.

Allovate Therapeutics is required to submit a written response within fifteen working days of receiving the letter. This response must outline the specific corrective actions taken or planned to address these violations and prevent their recurrence, accompanied by supporting documentation. If the company cannot meet this timeframe or disputes the findings, an explanation or justification is expected. Failure to adequately address these matters may result in further regulatory enforcement, such as product seizure or injunction.