Confer With
1 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
Vivant True Tone is a drug as defined by section 201 (g)(1)(B) of the FD&C Act, 21 U.S.C. 321 (g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201 (g)(1)(C) of the FD&C Act, 21 U.S.C. 321 (g)(1)(C), because it is intended to affect…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The product is an unapproved new drug and misbranded because it is marketed as a skin bleaching product without an approved application.
Supporting FDA text
Source excerpt · automated text-match checkVivant True Tone is a drug as defined by section 201 (g)(1)(B) of the FD&C Act, 21 U.S.C. 321 (g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201 (g)(1)(C) of the FD&C Act, 21 U.S.C. 321 (g)(1)(C), because it is intended to affect the structure or any function of the body.
The product is an unapproved new drug and misbranded because it is marketed as a skin bleaching product without an approved application.
Supporting FDA text
Source excerpt · automated text-match checkNo FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for Vivant True Tone. Accordingly, this skin bleaching drug product is an unapproved new drug and its introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act, 21 U.S.C. 355(a).
The product is an unapproved new drug and misbranded because it is marketed as a skin bleaching product without an approved application.
Supporting FDA text
Source excerpt · automated text-match checkMoreover, Vivant True Tone is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because it is deemed as such under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), and because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355, and does not comply with the requirements under section 505G of the FD&C Act, 21 U.S.C. 355h.
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.
- Respond in writing within 15 working days specifying what you have done to address any violations and to prevent their recurrence
- If you cannot completely address violations within 15 working days, state your reasons for delay and schedule for completion
- If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.