FDA Warns Australian Eye Drop Company For Unapproved Claims

On 9 October 2025, the U.S. Food and Drug Administration (FDA) issued a formal Warning Letter (Ref. 717968) to Australian company Melcare Biomedical, for making unapproved drug claims regarding their over-the-counter (OTC) eye drops and eye gel: Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops.

According to the FDA, the products were marketed in the United States via the company’s website and linked YouTube content without an approved new‐drug application, and are considered “unapproved new drugs” under U.S. law. The agency also determined the products are misbranded, because the formulations include honey derived from Leptospermum spp. (Manuka honey) labelled as an “active ingredient” which is not permitted under OTC ophthalmic monograph M018. 

The FDA’s letter notes that the website included claims such as “for the temporary relief of irritation due to dryness of the eye” and “preservative free for moderate to severe dry eye”, as well as referencing clinical improvements in “meibomian gland dysfunction”. Because no FDA-approved application is in effect for these products, their introduction into U.S. interstate commerce is in violation of § 505(a) and § 301(d) of the Federal Food, Drug, & Cosmetic Act.

The FDA stated: "Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under sections 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a)."

The FDA’s recent warning to Melcare Biomedical highlights how Australian manufacturers and exporters can face overseas compliance risks when their products are marketed internationally. Even if based in Australia, companies promoting therapeutic or medical products online may fall under U.S. regulatory oversight.