FDA WARNING_LETTER - AAA Cosmetica, SA de CV - December 07, 2020

The FDA issued a Warning Letter to AAA Cosmetica S.A. de C.V. on February 3, 2021, following the detention and refusal of their "bio aaa ADVANCE HAND SANITIZER" at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethanol, actually contained 0% ethanol and 78-81% methanol, a toxic substance.

This constitutes adulteration under section 501(d)(2) of the FD&C Act due to substitution of the active ingredient. It also indicates a failure of quality assurance under 501(a)(2)(B) of the FD&C Act, demonstrating non-compliance with Current Good Manufacturing Practice (CGMP) requirements.

Furthermore, the product is an unapproved new drug, violating section 505(a) of the FD&C Act, as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It is also misbranded under sections 502(j), (a), (e), and (ee) of the FD&C Act because it is dangerous to health, its labeling is false/misleading regarding ethanol content, it fails to declare methanol, and it does not comply with nonprescription drug marketing requirements.

The FDA recommended a comprehensive investigation into the methanol substitution, including a CGMP failure analysis and CAPAs. They also