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Korean Aesthetic dba Korean Fillers was cited for introducing unapproved and misbranded botulinum toxin (Botox) injectable drugs into interstate commerce through their website, violating sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The FDA found that these unapproved injectable products circumvented regulatory safeguards and posed serious health risks to consumers, including potential contamination, counterfeit formulations, inconsistent active ingredient amounts, and life-threatening conditions such as sepsis. The agency emphasized that unapproved drugs lack the same safety and effectiveness assurances as FDA-regulated products and demanded the company cease offering these drugs for sale to U.S. consumers.