FDA WARNING_LETTER - Aja Health and Wellness Inc. - February 01, 2026

On May 18, 2026, the FDA issued a warning letter to Aja Health and Wellness Inc. following a February 2026 review of the company"s website. The agency determined that the product "Aja Migraine Relief" is being marketed as an unapproved new drug and is misbranded in violation of the Federal Food, Drug, and Cosmetic Act. The primary violations involve marketing the product with medical claims—such as providing relief from migraine pain and inflammation—without obtaining the necessary FDA approval or meeting the requirements for over-the-counter (OTC) drug monographs. Specifically, the product fails to comply with the regulatory framework for internal analgesics (Monograph M013) because it is administered as a nasal spray rather than an oral medication, and it contains a proprietary ingredient blend not permitted for this class of drug. Furthermore, the company failed to provide evidence that the product is generally recognized as safe and effective for its intended use. The FDA has ordered Aja Health and Wellness Inc. to immediately address these violations and investigate the root causes of the non-compliance. The company is required to submit a written response within 15 business days detailing the specific corrective actions taken and the measures implemented to prevent future recurrences. Failure to rectify these issues may result in legal action, including product seizure or an injunction.