Genomma Lab USA, Inc.

Warning LetterOpen

Bradley Johnson Genomma Lab USA, Inc. 4550 Post Oak Place Dr, Suite 326 Houston , TX 77027-3167 United States johnson.bradley@genommalab.comFEI 3021222336Issued Apr 13, 2022Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3021222336.

Violations1

Issue DateApr 13, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Genomma Lab USA, Inc.
Location: Bradley Johnson Genomma Lab USA, Inc. 4550 Post Oak Place Dr, Suite 326 Houston , TX 77027-3167 United States johnson.bradley@genommalab.com
FEI Number: 3021222336
Country: United States
Issue Date: April 13, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Genomma Lab USA, Inc. distributed two unapproved skin lightening drug products—Cicatricure® MEDICAL LIGHTENING SKIN LIGHTENING CREAM and teatrical® PRO-ACLARANT SKIN LIGHTENING NIGHT CREAM—in violation of federal law. The products violated section 505(a) of the FD&C Act by being marketed as unapproved new drugs and were misbranded under section 502(ee), with labeling claims including active ingredients like hydroquinone 2% and explicit "skin lightener" and "lightens dark spots" language that established their intended use as drugs rather than cosmetics. The firm failed to obtain FDA approval before introducing these drug products into interstate commerce, a prohibited action under sections 301(d) and (a) of the FD&C Act.

Genomma Lab USA, Inc. FDA Warning Letter, April 13, 2022