Genomma Lab USA, Inc. Warning Letter Details

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.