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Ozempen.com was selling unapproved and misbranded semaglutide drug products to U.S. consumers via the internet 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 before introducing these new drugs into interstate commerce, and the products lacked proper labeling and regulatory oversight. The FDA warned that unapproved drugs pose inherent safety risks to consumers as they may be contaminated, counterfeit, contain inconsistent active ingredient amounts, or include undisclosed ingredients. The FDA requested that Ozempen.com cease offering these unapproved and misbranded drugs for sale immediately.