Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistSynthetix Inc. DBA Helix Chemical Supply was found selling unapproved new drugs—specifically Semaglutide and Tirzepatide—in violation of the Federal Food, Drug, and Cosmetic Act sections 505(a) and 301(d), despite labeling them as "research use only" and "not for human consumption." The FDA determined these products were intended for human use based on marketing claims about lowering blood sugar, enhancing insulin secretion, and improving organ function, establishing them as drugs requiring FDA approval. The products were also deemed misbranded under section 502 of the FD&C Act, as the "research only" disclaimers did not alter their true intended use for human consumption.