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Mel Honey US was cited for marketing "Jimerito (Melipona) Honey" as an unapproved new drug, specifically as an ophthalmic product intended for eye administration, in violation of sections 301(d) and 505(a) of the FD&C Act. The FDA identified drug claims on the company's website and Instagram, including statements that the product treats eye infections like conjunctivitis, cataracts, and dry eyes through its antimicrobial properties and moisturizing effects. The agency emphasized that ophthalmic drug products pose heightened public health risk because the eye route of administration bypasses the body's natural defenses, making approval particularly critical for this product category.