FDA WARNING_LETTER - Guangzhou Minghui Cosmetics Co., Ltd. - July 06, 2021

The FDA issued a Warning Letter to Guangzhou Minghui Cosmetics Co., Ltd. on July 6, 2021, following the detention and refusal of admission of their "Qi Yu® HAND SANITIZER GEL" product into the U.S. The firm had recently registered as a human drug manufacturer.

FDA laboratory testing revealed the hand sanitizer, labeled to contain 75% v/v ethyl alcohol, actually contained an average of only 52% v/v ethanol. This violates the CDC recommendation of at least 60% alcohol for hand sanitizers and falls below the declared strength, rendering the product adulterated under sections 501(c) and 501(a)(2)(B) of the FD&C Act due to subpotency and inadequate quality assurance.

Furthermore, the product is an unapproved new drug, violating section 505(a) of the FD&C Act, as it is not generally recognized as safe and effective (GRASE) and lacks FDA approval. It also does not conform to the 1994 Tentative Final Monograph or subsequent amendments for OTC topical antiseptics, nor does it meet conditions under section 505G(a)(3) for marketing without an approved application.

The product is also misbranded under sections 502(a), (c), (f)(2), (x), and (ee) of the FD&C