Yara Elena De La Garza Perez Nieto

Selected passages from the FDA letter

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

Passage 1

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

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 DAESI Hand Sanitizer 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

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.

Passage 5

DAESI Hand Sanitizer is labeled to contain ethyl alcohol 70%. However, FDA laboratory analyses 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, contains undeclared isopropanol, and contains a significant concentration of methyl alcohol (methanol), an ingredient that is not declared on the product label.

Passage 6

The failure of this product to list methyl alcohol (methanol) and isopropyl alcohol (isopropanol) as ingredients 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 7

DAESI Hand Sanitizer is further misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the “FDA” logo is displayed on the product label above the NDC number, which creates the impression that the drug is approved or legally marketable (see 21 CFR 207.77(b)).

Passage 8

this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because DAESI Hand Sanitizer 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.