Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Preliminary testing indicates that the CovaGuard formula kills 99.9% or greater of SARS-CoV2 virus (COVID-19) within 60 seconds of contact
Passage 2BAC [(benzalkonium chloride)] is highly effective at deactivating and killing a wide variety of pathogens, including coronaviruses
Passage 324hr Protection
Passage 4All day protection from bacteria and germs. One spray protects for 24 hours. Yup, 24 hours.
Passage 5Our technology not only kills germs on contact, but unlike traditional sanitizers, continues to kill bacteria and pathogens for up to 24 hours.
Passage 6With CovaGuard, you can rest easy knowing that your hands are protected for 24 hours. One spray protects all day!
Passage 724-hr protection against germs
Passage 8No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these drug products
Passage 9your consumer topical antiseptic products do not conform to the 1994 TFM, as further amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, nor any other TFM, proposed rule, or final rule
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128
- 21 CFR 330