Synthetix Inc. DBA Helix Chemical Supply

Selected passages from the FDA letter

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

Passage 1

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

Passage 2

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 3

Your “Semaglutide” and “Tirzepatide” 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 4

No 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).

Passage 5

Your “Semaglutide” and “Tirzepatide” 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 6

Your “Semaglutide” product is indicated for a condition that is not amenable to self-diagnosis and treatment by a layperson, therefore adequate directions cannot be written such that a layperson can use the product safely for its intended use.

Passage 7

In addition, your “Semaglutide” and “Tirzepatide” 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. For these reasons, your “Semaglutide” and “Tirzepatide” products are misbranded under section 502(f)(1) of the FD&C Act.