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Dermacare dba Filler Outlet was cited for introducing unapproved and misbranded injectable botulinum toxin products into interstate commerce through its website (www.filleroutlet.com) in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company failed to obtain FDA approval for these new drug products and did not ensure they carried proper branding and labeling. The FDA emphasized that unapproved injectable drugs pose serious health risks including contamination, counterfeit ingredients, inconsistent potency, and potentially life-threatening conditions such as sepsis, and requested the company immediately cease offering these products to U.S. consumers.