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321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body." FDA's letters to the other manufacturers are similar in their complaints about why their products fall under the agency's regulatory oversight and why the companies are not allowed to market them, despite their oft-cited claims that the products, especially the triple agonists, are for research only
Aronne et al ., 2025, "Tirzepatide as compared with semaglutide for the treatment of obesity"
2013 Jun 10;184:1-5
