FDA WARNING_LETTER - DMM Vission, S.A. de C.V. - June 08, 2021

The FDA issued a Warning Letter to DMM Vission, S.A. de C.V., a human drug manufacturer, following the detention and refusal of their SYP HEALTH HAND SANITIZER ALCOHOL GEL and Cleaner BY CRYSTALWARE HAND SANITIZER alcohol gel products at the U.S. border. FDA testing revealed these products, labeled to contain 70% ethanol, were adulterated. SYP HEALTH HAND SANITIZER contained an average of 31% ethanol and 2.3% methanol, while Cleaner BY CRYSTALWARE HAND SANITIZER contained 22% ethanol and 10% methanol.

These products are adulterated under 21 U.S.C. 351(d)(2) due to the substitution of ethanol with dangerous methanol, and under 21 U.S.C. 351(a)(2)(B) for demonstrating a failure in quality assurance and CGMP. Methanol is toxic and not an acceptable ingredient.

Furthermore, the products are unapproved new drugs, violating 21 U.S.C. 355(a), as they are not generally recognized as safe and effective (GRASE) and lack FDA approval. They are also misbranded under multiple sections of 21 U.S.C. 352, including being dangerous to health (502(j)), having false/misleading labeling (50