EvoLife Wellness
1 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Website claims that compounded semaglutide and tirzepatide are 'FDA-Approved' and 'Clinically Proven' are false or misleading because compounded drugs are not FDA-approved.
Supporting FDA text
Source excerpt · automated text-match checkCompounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide a written response describing the specific steps taken to address any violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
- If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration.
- If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.