SaNOtize – FDA Warning Letter, Feb 17, 2026

On April 17, 2026, the FDA issued a warning letter to SaNOtize following a review of the company’s product labeling and websites conducted on February 17, 2026. The agency determined that the firm’s "NOWONDER™ Nasal Cleanser" is being marketed as an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation involves marketing claims that suggest the product can treat or prevent diseases such as the common cold, influenza, and SARS-CoV-2. Specifically, promotional materials claim the spray"s nitric oxide content helps the immune system fight germs and pathogens. Under the FD&C Act, any product intended for medicinal use—including the prevention of illness—is classified as a drug. Because this product lacks an approved application and is not generally recognized as safe and effective (GRASE) for its stated purposes, its distribution in interstate commerce is illegal under sections 505(a) and 301(d) of the Act.

The FDA has directed SaNOtize to address these violations and ensure its products comply with all federal requirements. The company must provide a written response within 15 working days detailing the specific corrective actions taken to resolve these issues and prevent their recurrence. Failure to comply may result in legal consequences, such as product seizure or injunctions.