Guangzhou Minghui Cosmetics Co., Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average of only 52% v/v ethanol. This hand sanitizer drug product is adulterated under section 501(c) of the FD&C Act in that the active ingredient of ethanol is present at levels in the product lower than that which is declared on its labeling.

Passage 2

In addition, this product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), in that the subpotency demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.

Passage 3

your firm has since exhibited a pattern of not providing adequate or complete responses to FDA’s requests for information, or meeting deadlines for FDA’s information requests. For example, while you provided a material safety data sheet and testing results for heavy metals, you have not provided FDA with all requested information, such as assay results and the specific testing methods used by your firm. Such testing and documentation thereof is required by 21 CFR 211.165.

Passage 4

This topical antiseptic product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. New drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless they are lawfully marketed under Section 505G of the FD&C Act (which is not the case for this product, as further described below) or other exceptions not applicable here. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your Qi Yu® HAND SANITZER GEL drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. Accordingly, this product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

Passage 5

It is misbranded under 502(a) of the FD&C Act, 21 U.S. C. 352(a), because its labeling is false or misleading. As noted above, Qi Yu® HAND SANITIZER GEL is labeled to contain ethyl alcohol 75% (V/V). However, FDA laboratory analysis of a batch of this product demonstrate that the product contains concentrations of ethanol that are far less than that stated on its product label.Thus, the misleading representations of the concentration of the active ingredient ethanol on the Qi Yu® HAND SANITIZER GEL labeling cause this product to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a).

Passage 6

Qi Yu® HAND SANITIZER GEL is misbranded under section 502(c) of the FD&C Act, because the product is not labeled in accordance with the Drug Facts labeling requirements as described in 21 CFR 201.66. Specifically, the information that is required to appear on the labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Passage 7

In addition, Qi Yu® HAND SANITIZER GEL is also misbranded under section 502(f)(2) of the FD&C Act, 21 U.S.C. 352(f)(2), because the product label does not include all of the applicable warnings as required under 21 CFR 330.1(g) Specifically, the label does not include the warning statement required for drugs used topically that reads “If swallowed, get medical help or contact a Poison Control Center right away.”

Passage 8

Furthermore, Qi Yu® HAND SANITIZER GEL is misbranded under section 502(x) of the FD&C Act, 21 U.S.C. 352(x), because the product’s label fails to disclose a complete domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such drug.

Passage 9

Lastly, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because Qi Yu® HAND SANITIZER GEL is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.