Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your “Semaglutide” and “Retatrutide” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).
Passage 2Despite statements on your product labeling marketing your products for “research purposes only” and “not for human consumption or clinical use,” evidence obtained from your website establishes that your products are intended to be drugs for human use.
Passage 3Your products are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1) because they are intended to prevent, treat, or cure disease conditions and/or affect the structure or function of the body.
Passage 4“Semaglutide reduces cardiovascular events. The SELECT trial showed that semaglutide reduced major adverse cardiovascular events by 20% in adults with preexisting cardiovascular disease and obesity. This included fewer heart attacks and strokes compared to those on placebo.”
Passage 5“Retatrutide improves glycemic control. In a study involving patients with type 2 diabetes, retatrutide reduced HbAlc levels by up to 2.02% at 24 weeks. This indicates better blood sugar control, which is crucial for managing diabetes.”
Passage 6“Semaglutide can help people who are obese or overweight lose a considerable amount of weight and lower their risk of heart disease, diabetes, and cancer when used in combination with diet and exercise.”
Passage 7“Thanks so much for sharing your experience. We’re so happy to hear you’re loving the benefits! Semaglutide is a GLP-1 receptor agonist known for its significant impact on weight loss, glycemic control, and cardiovascular risk reduction. . . Safe & Effective: Trusted by health professionals worldwide . . . #shareyourexperience #sharingexperience . . . #fitness”
Passage 8Your “Semaglutide” and “Retatrutide” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 9No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).