Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The FDA has observed that your websites offer alcohol-based consumer topical antiseptic products***1*** for sale in the United States and that the products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19***2*** and other serious infections in people. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under sections 502(a) and (ee) of the FD&C Act, 21 U.S.C. 352(a) and (ee).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.66(b)(2)
- 21 CFR 201.128
- 21 CFR 201.66(c)(5)(ii)(C)
- 21 CFR 207.77(b)
- 21 CFR 330