Shoplet

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

these products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).

Passage 2

these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).

Passage 3

they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.

Passage 4

“…Anti-Microbial. . . Kills bacteria on contact..” [from your https://www.shoplet.com/Ameriderm-AmeriWash-Antimicrobial-Lotion-Soap-with-Triclosan-1-Gallon/ADM210EA/spdv product page]

Passage 5

these products fall under section 505G(a)(5) of the FD&C Act, 21 U.S.C. 355h(a)(5), because FDA has determined that topical consumer and health care antiseptic nonprescription drug products containing triclosan are not GRASE under a final determination issued under 21 CFR part 330.

Passage 6

the “Ameriderm AmeriWash Antimicrobial Lotion Soaps with Triclosan” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.