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Belmont Eyecare LLC was cited for distributing six unapproved ophthalmic drug products—including Colloidal Silver Eye Drops, MSM Eye Drops, and various organic oil eye drops—in violation of sections 301(d) and 505(a) of the FD&C Act. The company's website made therapeutic claims indicating the products were intended to diagnose, cure, mitigate, treat, or prevent disease and affect body functions, establishing them as drugs requiring FDA approval before marketing. The FDA emphasized that ophthalmic products pose heightened public health risks due to direct eye administration bypassing natural body defenses. The company was instructed to cease introduction of these unapproved drugs into interstate commerce.