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Fancy Drops Beauty LLC was cited for marketing unapproved new drug products—color-changing eye drops—without FDA approval, violating sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company's website contained claims that the products "lighten & brighten" eye color and customer testimonials describing permanent eye color changes, establishing the products' intended use as drugs that affect body structure or function. The FDA emphasized that ophthalmic products pose heightened public health risks due to direct eye administration bypassing natural body defenses.