Varigard, LLC
1 extracted findings
FDA source excerpt, selected passage
The 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).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.