Healthy Foods & Nutrition Lab de Mexico S.A. de C.V. – FDA Warning Letter, Jul 29, 2021

The FDA issued a Warning Letter to Healthy Foods and Nutrition Lab de Mexico, S.A. de C.V., regarding their HF & NLab VERIO HEALTHCARE ALCOHOL ANTISEPTIC TOPICAL SOLUTION. FDA testing of a product batch, labeled as containing 70% v/v ethanol, found it contained only 13% v/v ethanol. This renders the drug adulterated under section 501(c) and 501(a)(2)(B) of the FD&C Act due to subpotency and failure of quality assurance to meet CGMP requirements.

The product is also an unapproved new drug, violating section 505(a), and misbranded under sections 502(a), (x), and (ee) of the FD&C Act. It does not conform to the 1994 Tentative Final Monograph or FDA's temporary policies for hand sanitizers. Misbranding includes false labeling of active ingredient concentration, failure to disclose a domestic address/phone for adverse event reporting, and non-compliance with Section 505G for nonprescription drugs.

The FDA recommended a market recall in July 2020, but the firm has not acted. The letter requires a detailed investigation into the subpotency, a list of raw materials and suppliers, reconciliation of all batches shipped to the U.S., complete batch records, and comprehensive independent assessments of