FDA WARNING_LETTER - Melcare Biomedical Pty Ltd - September 10, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to Melcare Biomedical Pty Ltd on October 9, 2025, following a review of its product labeling and website on September 10, 2025. The letter addresses significant violations concerning the company"s Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops, which are available for purchase in the United States without a prescription.

The main violations identified are that these products are marketed as unapproved new drugs and are misbranded, contrary to sections 505(a), 301(d), 502(ee), and 301(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA determined that both products are intended as ophthalmic demulcent drug products. However, they fail to conform to the conditions outlined in the Over-the-Counter (OTC) monograph M018 for ophthalmic drug products. Specifically, the products contain honey (from Leptospermum spp.) which is presented as an active ingredient in the labeling. Honey is not a permitted active ingredient for OTC monograph ophthalmic demulcent drug products under M018.12. Consequently, these products cannot be legally marketed under section 505G without an approved new drug application.

The provided excerpt of the warning letter details these violations but does not specify immediate required actions or a response deadline from Melcare Biomedical Pty Ltd.