Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Some examples of the claims on your labeling that establish the intended use (as defined in 21 CFR 201.128) of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include, but may not be limited to, the following: “INTRANASAL POVIDONE-IODINE EFFECTIVELY LIMITS COVID-19 SPREAD, FINDS STUDY HTTPS://PUBMED.NCBI.NL”
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