Laboratorios Jaloma S.A. de C.V. – FDA Warning Letter, Jul 22, 2020

The FDA issued a Warning Letter to Laboratorios Jaloma S.A. de C.V. on January 25, 2021, following the detention and refusal of a Jaloma Antiseptic Hand Sanitizer import into the U.S. FDA testing revealed the product, labeled to contain 62% ethyl alcohol, actually contained 32% ethanol and 32% methanol. This constitutes adulteration under 21 U.S.C. 351(d)(2) due to substitution of the active ingredient with methanol, a toxic substance. The substitution also indicates a failure of the firm's quality assurance system, violating CGMP requirements (21 U.S.C. 351(a)(2)(B)).

Furthermore, the product is an unapproved new drug (21 U.S.C. 355(a)) as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It is also misbranded under 21 U.S.C. 352(j), (a), (e), and (ee) because it is dangerous to health due to methanol, its labeling is false and misleading regarding ethanol content and undeclared methanol, and it fails to list methanol as an ingredient.

The FDA recommended the firm engage a qualified CGMP consultant to evaluate operations, conduct a comprehensive audit, and assess corrective actions. The