WARNING LETTER

Genomma Lab USA, Inc. MARCS-CMS 628381 — April 13, 2022

Product:: Drugs

Recipient:: Recipient Name

Bradley Johnson; Genomma Lab USA, Inc.; 4550 Post Oak Place Dr, Suite 326
Houston, TX 77027-3167
United States; johnson.bradley@genommalab.com

Issuing Office:: Center for Drug Evaluation and Research | CDER; United States

WARNING LETTER

Date: April 13, 2022

Dear Mr. Johnson,

This letter concerns your firm’s distribution of drug products to bleach and/or lighten the skin. Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food Drug & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), and are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.

Unapproved New Drug and Misbranded Drug Violations

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 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.

Examples of the claims observed on your product labels that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products include, but may not be limited to, the following:

Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM
“Lightens dark spots . . . Using products without a specialized active ingredient may not be sufficient to lighten dark spots . . . Drug Facts . . . Active ingredient . . . Hydroquinone 2% . . . Skin Lightener . . . Use Lightens dark (brownish) spots, freckles and discolorations of the skin. . . .” [from the Drug Facts panel of the Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM product label]

teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM
“Lightens dark spots . . . This cream gradually fades dark (brownish) spots and discolorations. Your skin will look clearer . . . Drug Facts . . . Active ingredient . . . Hydroquinone 2% . . . Skin Lightener . . . Use Lightens dark (brownish) spots, blotches, freckles and discolorations of the skin. . . .” [from the teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM product label]

Cicatricure® 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 330.¹ Thus, Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM are deemed to be new drugs under section 201(p)(1) of the FD&C Act and subject to the requirement to have an approved new drug application for marketing under section 505 of the FD&C Act, 21 U.S.C. 355, beginning on September 23, 2020.²

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 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).

Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Moreover, 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.

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations regarding your products nor are the skin bleaching/skin lightening drug products named in this letter intended to be an all-inclusive list of products you have manufactured, registered, and/or listed in FDA’s electronic drug registration and listing system (eDRLS), or introduced into interstate commerce. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Failure to address violations of the FD&C Act may be cause for FDA to withhold approval of requests for export certificates and approval of pending new drug applications or supplements listing your facility as a supplier or manufacturer.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. 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.

Please direct your email response to Office of Unapproved Drugs and Labeling Compliance at the following email address to FDAADVISORY@fda.hhs.gov and include your firm name in the subject line of your email.

Sincerely,
/S/

Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

cc:
(b)(4)

_______________________

1 On August 29, 2006, FDA issued a proposed rule (71 FR 51146) setting forth a determination that OTC skin bleaching drug products, including but not limited to those that contain hydroquinone as an active ingredient, are not generally recognized as safe and effective.

2 Section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), authorized FDA to take action before September 23, 2020 to extend the period during which a drug subject to that section may be marketed without an approved new drug application if the Agency determined that such an extension is in the interest of public health. However, FDA did not make such a determination for skin bleaching products.