Strategia Project Management, Inc.

Selected passages from the FDA letter

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

Passage 1

No FDA-approved applications 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 microSURE Hand Sanitizer drug product is GRASE for use under the conditions suggested, recommended, or prescribed in their labeling. Accordingly, this drug 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 2

This antiseptic product is also misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it 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 it is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

Passage 3

The website claim described above for silica dioxide demonstrate that it is an “active ingredient” as defined in 21 CFR 201.66(b)(2) because the ingredient is intended to furnish pharmacological activity. “Silica dioxide” is not a permitted active ingredient, either as a sole ingredient or in combination with other ingredients like benzalkonium chloride for use in consumer antiseptic hand rub drug products under the 1994 TFM.

Passage 4

In addition, your labeling suggesting that your consumer topical antiseptic product is effective in preventing infection or disease from SARS-CoV-2, the novel coronavirus that causes COVID-19, is effective against murine coronavirus, Middle East Respiratory Syndrome (MERS), Severe Acute Respiratory Syndrome (SARS), mold, mildew, and algae, and that it is fungicidal and virucidal in general, go beyond merely describing the general intended use of a topical antiseptic as set forth in the 1994 TFM, as amended by the 2016 Consumer Antiseptic Rubs Proposed Rule.