US Chem Labs – FDA Warning Letter, Feb 13, 2024
On February 7, 2024, the FDA issued a Warning Letter to US Chem Labs following an October 2023 review of their website, www.uschemlabs.com. The FDA observed the sale of "Semaglutide," "Tirzepatide," and "Thymalin" products, which are marketed as "research chemicals only" but are deemed intended for human use based on website claims.
The products are cited as unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 301(d)), as no approved applications are in effect. Specific concern was raised regarding "Thymalin" being marketed for children without FDA evaluation for safety, effectiveness, and quality.
Furthermore, the products are misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) because their labeling lacks adequate directions for use by a layperson. As prescription drugs, they require professional supervision. The introduction of these misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act (21 U.S.C. 331(a)).
US Chem Labs must respond in writing within 15
ID · 2d610114-5e26-4046-9892-61c474d9b4fb
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