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The FD&C Act makes it clear it is not legal for any person to introduce or deliver for introduction into interstate commerce unapproved drugs

N.NexoE

GLP-1 receptor agonists like semaglutide are peptide drugs with strong randomized trial outcomes and clear FDA-approved indications: type 2 diabetes, chronic weight management, and since March 2024, cardiovascular risk reduction in adults with established heart disease who are overweight or obese

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And if, say, a cancer patient could demonstrate that BPC-157 use accelerated their tumor (a very difficult causal link to prove scientifically, but hypothetically), the liability could be enormous