synthetix inc. – FDA Warning Letter, Oct 31, 2023

The FDA issued a Warning Letter to Matthew Lucks regarding the sale of "Semaglutide" and "Tirzepatide" products on www.helixchem.com, observed in October 2023. The FDA determined these products are unapproved new drugs and misbranded drugs, despite being labeled "for research use only" and "not for human consumption."

The products are considered drugs under section 201(g)(1) of the FD&C Act due to claims on the website and accompanying documents indicating human use for conditions like lowering blood sugar, enhancing insulin secretion, improving heart/liver/lung function, and slowing Alzheimer's. Specific examples include dosage amounts and references to "Mounjaro."

Violations include: 1. **Unapproved New Drugs:** The products are "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their intended uses. Their introduction into interstate commerce without FDA approval violates sections 505(a) and 301(d) of the FD&C Act. 2. **Misbranded Drugs:** The products are misbranded under section 502(f)(1) because their labeling lacks adequate directions for human use, as they are prescription drugs not safe for layperson self-diagnosis or treatment due to potential harmful effects. This violates section 301(a) of the FD&C Act