FDA WARNING_LETTER - 4E Global, S.A.P.I. de C.V. - July 20, 2020

The FDA issued a Warning Letter to 4E Global S.A.P.I de C.V. on October 23, 2020, following the detention and refusal of their "blumen Advanced Instant Hand Sanitizer Clear Ethyl Alcohol 70%" and "blumen Clear Advanced Hand Sanitizer Extra Soft" products at the U.S. border. FDA testing revealed these hand sanitizers, labeled to contain 70% ethanol, actually contained significantly lower ethanol concentrations (e.g., 0.2% to 14%) and high levels of methanol (e.g., 65% to 74%), a toxic substance.

These products are deemed adulterated under section 501(d)(2) of the FD&C Act due to the substitution of ethanol with methanol, and under 501(a)(2)(B) for demonstrating a failure in quality assurance and CGMP. They are also unapproved new drugs, violating section 505(a), and misbranded under sections 502(j), (a), (e), (f)(2), and (ee) because they are dangerous, falsely labeled, omit methanol from ingredient lists, lack required warnings, and do not comply with nonprescription drug marketing requirements.

The FDA recommended the firm engage a qualified CGMP consultant to audit operations and ensure compliance. The company had previously initiated recalls of affected products. The firm