Loading…
OcluMed LLC was warned for distributing unapproved new drug products—specifically "OcluMed Nutritional/Lubricant Eye Drops"—in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company's website made drug claims including statements that the product was "scientifically proven" to "prevent or improve cataracts" and contained testimonials describing use for disease treatment and prevention, establishing intended use as a drug without FDA approval. The FDA emphasized that ophthalmic products pose heightened public health risk due to direct eye administration, which bypasses natural body defenses.