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FDA Warning Letter Explorer
FDA warning letter · Drugs

Joi and Blokes dba Joi + Blokes

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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.

Passage 2

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.

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.1(h)(2)
  • 21 CFR 201.1(a)