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Talk to a SpecialistTalk to a SpecialistFiller Lux was cited for selling unapproved injectable lipolytic drugs including "LemonBottle Ampoule Solution," "Dr. Lipo+," "Lipo Lab PPC Solution," "DermaHeal LL," and "Wonderfit" through their website and social media, violating sections 505(a) and 301(d) of the FD&C Act. The company failed to obtain FDA approval before introducing these new drug products into interstate commerce, despite marketing them with claims indicating they are intended to treat or affect body structure and function. The FDA emphasized that injectable drug products pose particular public health risks because they bypass the body's natural defenses and can be delivered directly into the bloodstream, potentially causing serious and life-threatening conditions.