The U.S. Food and Drug Administration (FDA) has intensified its enforcement actions against companies marketing compounded GLP-1 products, issuing warning letters to 30 telehealth firms for allegedly making false or misleading claims. The agency is particularly focused on advertisements implying equivalence with FDA-approved drugs such as Novo Nordisk’s Wegovy, and on attempts to bypass the regulatory approval process through compounded formulations. This marks the second major wave of warning letters in six months, signaling a broader and more aggressive compliance push against unlawful promotion, misbranding, and the online sale of unapproved drug products.
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