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These lawsuits assert legal theories, including: Trademark infringement Violating the corporate practice of medicine doctrine False advertising Unfair competition Violations of federal drug laws (misbranding, unapproved new drugs) FDA Enforcement On February 6, 2026, FDA announced its intent to use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns. The FDA explicitly announced steps to combat compounding pharmacies making these marketing claims: Compounded products are generic versions of FDA-approved drugs Compounded products are the same as FDA-approved drugs Compounded products use the same active ingredient as FDA-approved drugs Compounded products are clinically proven to produce results FDA has made clear that failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. This means the agency may bypass traditional warning letter procedures

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This suggests that the observed minor PK changes were not clinically relevant

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