FDA WARNING_LETTER - Tropicosmeticos SA de CV - July 10, 2020

The FDA issued a Warning Letter to Tropicosmeticos SA de CV, a registered human drug manufacturer, following the detention and refusal of admission of their Britz HAND SANITIZER product at the U.S. border. FDA laboratory testing revealed the product, labeled to contain 70% ethyl alcohol, contained 0% ethanol and over 50% methanol.

This constitutes adulteration under section 501(d)(2) of the FD&C Act due to the substitution of ethanol with dangerous methanol, and under 501(a)(2)(B) for demonstrating a failure in quality assurance and CGMP. Methanol is toxic and can cause severe health issues, including blindness and death.

Furthermore, Britz HAND SANITIZER 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) because it is dangerous, its labeling is false and misleading (claiming ethanol but containing methanol), it fails to list methanol as an ingredient, and it does not comply with nonprescription drug marketing requirements under section 505G.

The FDA previously notified the firm and the public about the methanol contamination, leading to a distributor-initiated recall. The firm has not responded to repeated FDA communications