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The FDA found that www.semaspace.com was selling unapproved and misbranded semaglutide drug products directly to U.S. consumers online in violation of the Federal Food, Drug, and Cosmetic Act sections 301(a), 301(d), 301(k), 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 required for lawful drug distribution. The FDA emphasized that unapproved drugs circumvent regulatory safeguards and may be contaminated, counterfeit, or contain inconsistent or incorrect active ingredients, posing significant public health risks.