Broncolin, S.A. de C.V. – FDA Warning Letter, Jul 29, 2020

The FDA issued a Warning Letter to Broncolin S.A. de C.V. on December 21, 2020, following the detention and refusal of their HERBACIL Antiseptic Hand Sanitizer at the U.S. border. FDA testing revealed the product, labeled to contain 70% ethanol, actually contained an average of 4.7% ethanol and 66% methanol, or even lower ethanol and higher methanol in other samples.

This substitution of ethanol with toxic methanol renders the product adulterated under section 501(d)(2) of the FD&C Act, and demonstrates a failure of quality assurance under CGMP requirements (501(a)(2)(B)). Methanol is dangerous, causing dermatitis, systemic toxicity, and potentially blindness, nervous system damage, or death.

Furthermore, the product is an unapproved new drug (505(a)) because it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It does not conform to the 1994 TFM or temporary COVID-19 policies for hand sanitizers due to the incorrect active ingredient concentration and the presence of undeclared methanol.

The product is also misbranded under sections 502(j), (a), (e), and (ee) for being dangerous to health, having false and misleading labeling regarding active ingredients, failing to list methanol as an ingredient,