Genomma Lab USA, Inc.
1 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM are drugs as defined by section 201(g)(1)(B) of th
Supporting FDA text
Source excerpt · automated text-match checkCicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are 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 they are intended to affect the structure or any function of the body. Specifically, these products are intended for use as skin bleaching products.
Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM are skin bleaching drugs subject to section 505G o
Supporting FDA text
Source excerpt · automated text-match checkCicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM are skin bleaching drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, these skin bleaching products fall under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), as added on March 27, 2020 with the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), because they are subject to a determination to be not generally recognized as safe and effective (GRASE) in a proposed rule that is the most recently applicable proposal issued under 21 CFR part 330.
No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and t
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 Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM. Accordingly, these skin bleaching drug products are unapproved new drugs and their introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act, 21 U.S.C. 355(a).
Moreover, Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM are misbranded under section 502(ee) of
Supporting FDA text
Source excerpt · automated text-match checkMoreover, Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they are deemed as such under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), and because they are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but are not the subject of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355, and do 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 for our consideration.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.