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MJS Medicals, a South Korea-based company, was cited for introducing unapproved new drugs and misbranded injectable botulinum toxin products into U.S. interstate commerce through its website (www.mjsmedicals.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 drug products prior to marketing them to U.S. consumers and did not provide proper labeling, creating significant safety risks including contamination, counterfeit formulations, variable active ingredient concentrations, and potential life-threatening conditions such as sepsis. The FDA requested immediate cessation of all unapproved and misbranded drug sales to protect public health.