US Chem Labs

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your website offers “Semaglutide,” “Tirzepatide” and “Thymalin” products for sale in the United States. As described below, your “Semaglutide,” “Tirzepatide” and “Thymalin” 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 301(d).

Passage 2

your “Semaglutide,” “Tirzepatide” and “Thymalin” products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352, introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Passage 3

Despite statements on your product labeling marketing your products as “research chemicals only” and “not for human consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use.

Passage 4

Your 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 5

From your website www.uschemlabs.com: **Semaglutide** “What is Semaglutide?” “It's a carefully researched medication with approval from the U.S. Food and Drug Administration (FDA) that was discovered to be a ‘missing link’ for weight loss by accident.

Passage 6

Tirzepatide is a GLP-1 receptor agonist, it can promote feelings of fullness and reduce food intake, which may lead to weight loss as a secondary effect.

Passage 7

Thymalin is biologically regulating your thymus to produce more peptides that will help regulate your immune system and endocrine system.

Passage 8

Your “Semaglutide,” “Tirzepatide” and “Thymalin” 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 9

No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products.

Passage 10

In addition, FDA is particularly concerned that you market your “Thymalin” product for use in children. Your product has not been evaluated by FDA for safety, effectiveness, and quality.

Passage 11

Your “Semaglutide,” “Tirzepatide” and “Thymalin” products are also misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for their intended use(s).

Passage 12

Your “Semaglutide,” “Tirzepatide” and “Thymalin” products are indicated for conditions that are not amenable to self-diagnosis and treatment by a layperson, therefore adequate directions cannot be written such that a layperson can use the products safely for their intended uses.

Passage 13

your “Semaglutide,” “Tirzepatide” and “Thymalin” products are also prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. 353(b)(1)(A), in light of their toxicity or potential for harmful effects, methods of use, or collateral measures necessary for their use.