Synthetix Inc. DBA Helix Chemical Supply
FDA issued a warning letter to Synthetix Inc. DBA Helix Chemical Supply (Bronx, NY) in February 2024 after reviewing their website and finding unapproved Semaglutide and Tirzepatide products being sold for human use despite 'research use only' labeling. The products were deemed unapproved new drugs under FD&C Act sections 505(a) and 301(d), and misbranded under section 502(f)(1) for lacking adequate directions for use. FDA cited website claims referencing human dosing schedules, therapeutic effects, and explicit references to the branded drug Mounjaro as evidence of intended human use. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.
Flagged claims (4)
Semaglutide is a derivative of the naturally occurring GLP-1, a peptide known to lower blood sugar levels and enhance insulin secretion. Research shows that Semaglutide may also improve heart, liver, and lung function while helping to slow or prevent the effects of Alzheimer's disease.
If additional glycemic control is needed. . . This is the standard schedule for the medication, Mounjaro.
Dose Amounts Each vial contains: Weeks 1-4 – 8 doses (reconstituted vial expires after 8 weeks.) Weeks 5-8 – 8 doses (reconstituted vial expires after 8 weeks.)
Dose Amounts Each vial contains: Weeks 1-4 – 4 doses Weeks 5-8 – 2 doses
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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