Joi and Blokes dba Joi + Blokes
2 extracted findings
FDA source excerpt, selected passage
The compounded semaglutide and tirzepatide products displayed on your website identify “Joi + Blokes” on the pictured label, suggesting Joi + Blokes is the compounder of those drugs when in fact it is not.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
The compounded semaglutide and tirzepatide products displayed on your website identify “Joi + Blokes” on the pictured label, suggesting Joi + Blokes is the compounder of those drugs when in fact it is not.
Source passage selected by the model
02
Compounded drug products are not FDA-approved. Your claims represent that the compounded drug products you offer have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.