Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).
Passage 2Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352.
Passage 3“COVID-Aid Tincture . . . Directions: If illness [is] suspected, take 1 cc (1 dropperful) under tongue 4–6 times daily until symptoms subside.” [from your product label, the product catalog on your website http://draulslab.net/wp-content/uploads/2020/09/Catalog-Final1.pdf and the product page on the website https://drsarahsessentials.com/products/covid-aid].