FDA WARNING_LETTER - Homeopathic Educational Services dba Homeopathic Family Medicine - September 02, 2025

The FDA issued a warning letter to Homeopathic Educational Services, located at 812 Camelia Street, Suite C, Berkeley, CA, on August 25, 2025, following a review of their website in May 2025. The inspection identified significant regulatory violations concerning the sale of "Cineraria Maritima Eye Drops." The product is classified as an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as it is intended for use in diagnosing, curing, mitigating, treating, or preventing disease, and affects the structure or function of the body.

The FDA highlighted the public health risks associated with ophthalmic products, which bypass some of the body"s natural defenses. The "Cineraria Maritima Eye Drops" are not recognized as safe and effective for their intended use, and no FDA-approved application exists for this product, making its introduction into interstate commerce a violation of sections 301(d) and 505(a) of the FD&C Act.

Homeopathic drugs, like other drugs, must comply with FDA regulations, including those related to adulteration, misbranding, and approval. The FDA has requested a written response within fifteen working days detailing corrective actions taken to address the violations and prevent recurrence. Failure to comply may result in legal actions, including seizure and injunction, and potential detention of unapproved drugs without physical examination. The company must submit their response to the FDA"s Office of Unapproved Drugs and Labeling Compliance.