Healthy Foods & Nutrition Lab de Mexico S.A. de C.V.

Selected passages from the FDA letter

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

Passage 1

The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product labeled as manufactured at your facility is adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 351(c), in that its strength, purity, or quality falls below that which it purports or is represented to possess. 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. In addition, HF & NLab VERIO HEALTHCARE ALCOHOL ANTISEPTIC TOPICAL SOLUTION is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and is misbranded under sections 502(a), (x), and (ee) of the FD&C Act, 21 U.S.C.

Passage 2

HF& NLab VERIO HEALTHCARE ALCOHOL ANTISEPTIC TOPICAL SOLUTION, labeled as manufactured at your facility, is labeled to contain 70% volume/volume (v/v) of the active ingredient alcohol (ethanol). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average of only 13% 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 3

Additionally, 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, HF & NLab VERIO HEALTHCARE ALCOHOL ANTISEPTIC TOPICAL SOLUTION is labeled to contain ethanol 70% v/v. However, FDA laboratory analysis of a batch of this product demonstrate that the product contains a concentration of ethanol that is far less than that stated on its product label. Thus, the misleading representations of the concentration of the active ingredient ethanol on the HF & NLab VERIO HEALTHCARE ALCOHOL ANTISEPTIC TOPICAL SOLUTION labeling cause this product to be misbranded under section 502(a) of the FD&C

Passage 4

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

Passage 5

Lastly, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because HF & NLab VERIO HEALTHCARE ALCOHOL ANTISEPTIC TOPICAL SOLUTION 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.