Curex
5 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
“Clinically proven weight loss treatments”
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The website claims the compounded products are clinically proven, which is false or misleading because compounded drugs are not FDA-approved.
Supporting FDA text
Source excerpt · automated text-match check“Clinically proven success”
The website claims the compounded products are clinically proven weight loss treatments, which is false or misleading because compounded drugs are not FDA-approved.
Supporting FDA text
Source excerpt · automated text-match check“Clinically proven weight loss treatments”
The website claims the compounded products have the same active ingredients as Ozempic or Mounjaro, implying they are the same as FDA-approved products when they are not.
Supporting FDA text
Source excerpt · automated text-match check“The same active ingredients as Ozempic or Mounjaro”
The website claims prescription weight loss with the same active ingredients as Mounjaro & Zepbound, implying the products are the same as FDA-approved products when they are not.
Supporting FDA text
Source excerpt · automated text-match check“Prescription weight loss with the same active ingredients as Mounjaro & Zepbound.”
The website claims the compounded products may be prescribed with the same active ingredients as Ozempic, Wegovy, Zepbound, or Mounjaro, implying they are the same as FDA-approved products when they are not.
Supporting FDA text
Source excerpt · automated text-match check“While we don’t prescribe Ozempic, Wegovy, Zepbound, or Mounjaro directly, we may prescribe treatments containing the same active ingredients.”
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
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What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide a written response describing specific steps taken to address the violations.
- Include an explanation of each step to prevent recurrence of violations.
- Provide copies of related documentation.
- If products are believed not in violation, include reasoning and supporting information.
- If unable to address within 15 working days, state reason for delay and time frame.