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Elle Pharm was cited for introducing unapproved and misbranded injectable botulinum toxin products into interstate commerce via its website in violation of the Federal Food, Drug, and Cosmetic Act sections 301(a), 301(d), 503(b), and 505(a). The company failed to obtain FDA approval for these new drug products and offered them without proper labeling, creating serious safety risks to consumers given the inherent dangers of injectable drugs that bypass the body's natural defenses. The FDA specifically warned that unapproved drugs may be contaminated, counterfeit, contain inconsistent active ingredient amounts, or pose life-threatening conditions such as sepsis, and requested the company immediately cease offering these products to U.S. consumers.