FDA WARNING_LETTER - Harmonic Nature S. de R.L. MI. - August 12, 2020

The FDA issued a Warning Letter to Harmonic Nature S. de R.L. MI. (Mr. Martinez) on November 16, 2020, following the detention and refusal of admission of their "Alcohol Antiseptic 75% Topical Solution Hand Sanitizer" product at the U.S. border. FDA laboratory testing revealed the product, labeled to contain 75% ethyl alcohol, actually contained 0% ethanol and 38% 1-propanol, a dangerous chemical not permitted in hand sanitizers.

This constitutes adulteration under section 501(d)(2) of the FD&C Act due to substitution of the active ingredient, and 501(a)(2)(B) due to a non-functioning quality assurance system. The product is also an unapproved new drug (505(a)) and misbranded (502(a), (e), (ee)) because its labeling is false/misleading, it fails to list 1-propanol as an ingredient, and it does not comply with OTC drug marketing requirements or FDA's temporary COVID-19 policies for hand sanitizers.

The FDA recommended a voluntary nationwide recall, which the firm initiated on August 14, 2020. The firm is required to provide a detailed investigation into the substitution, a list of all raw materials and suppliers, a list and reconciliation of all batches shipped to the