Maquiladora Miniara SA de CV

Selected passages from the FDA letter

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

Passage 1

Shine and clean Hand Sanitizer Gel, labeled as being manufactured at your facility, is labeled to contain 70% of the active ingredient ethyl alcohol (ethanol). However, FDA laboratory testing of a batch of this product detained at the border found the drug product to contain an average of 2.2% ethanol, 43% methanol and 15% isopropanol volume/volume (v/v FDA laboratory testing of a second batch of this product detained at the border found the drug product to contain an average of 1.0% ethanol and 77% methanol v/v. FDA laboratory testing of a third batch of this product detained at the border found the drug product to contain an average of 49% ethanol, 3.3% methanol, and 9% isopropanol. FDA laboratory testing of a fourth batch of this product detained at the border found the drug product to contain an average of 1% ethanol and 75% methanol v/v. Therefore, this hand sanitizer drug product is adulterated under section 501(d)(2) of the FD&C Act in that the active ingredient, ethanol, was substituted wholly or in part with methanol, a dangerous chemical when in contact with human skin or ingested.

Passage 2

The substitution and contamination with methanol in a drug product labeled as manufactured in your facility demonstrates that the quality assurance within your facility is not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.

Passage 3

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 under 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 Shine & clean Hand Sanitizer 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 4

However, Shine & clean Hand Sanitizer Gel does not conform to the1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.

Passage 5

According to the product label, Shine & clean Hand Sanitizer Gel purportedly contains the active ingredient ethyl alcohol 70%. However, as previously discussed, FDA laboratory analyses of batches of this product detained at the border demonstrated that Shine & clean Hand Sanitizer Gel contains ethanol in a concentration that is less than the 70% stated on its product label and less than the amount of ethanol described in the 1994 TFM.

Passage 6

FDA laboratory analyses also demonstrated that batches of Shine & clean Hand Sanitizer Gel contain significant concentrations of the undeclared ingredient methyl alcohol (methanol). Use of methanol as an active ingredient is not in conformance with the 1994 TFM, nor is methanol included in the formulations described in FDA’s Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. Furthermore, methanol is not acceptable as an inactive ingredient in hand sanitizers. As previously discussed, methanol has significant and sometimes fatal toxic effects and, therefore, does not meet the requirements under 21 CFR 330.1(e) that a product’s inactive ingredients be safe and suitable.

Passage 7

It is misbranded under section 502(j) of the FD&C Act, 21 U.S.C. 352(j), because it is dangerous to health when used according to its labeling as a hand sanitizer. As previously stated, skin exposure to methanol could lead to systemic absorption, and substantial methanol exposure can potentially result in, among other things, blindness, permanent nervous system damage, and even death.

Passage 8

This hand sanitizer is misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because its labeling is false or misleading. As noted above, Shine & clean Hand Sanitizer Gel is labeled to contain ethyl alcohol 70% v/v. However, FDA laboratory analysis of batches of this product demonstrate that the product contains a concentration of ethyl alcohol (ethanol) that is less than what is stated on the product label and contains a significant concentration of methyl alcohol (methanol), an ingredient that is not declared on the product label.

Passage 9

The failure of this product to list methyl alcohol (methanol) as an ingredient on its label also causes it to be misbranded under section 502(e)(1)(A) of the FD&C Act, 21 U.S.C. 352(e)(1)(A).

Passage 10

In addition, Shine & clean Hand Sanitizer Gel is misbranded under section 502(x) of the FD&C Act because the product 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 11

Lastly, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because Shine & clean 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.