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 3The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).
Passage 4“A Chestnut Hill family is producing a sanitizing wipe that lasts 30 days and can be used 600 times . . . Even at nearly 91 years old, inventor Solomon Rosenblatt is still figuring out new ways to wipe away bacteria, fungi, and viruses. His latest product is especially relevant during COVID-19. IoWipe is a reusable, iodine-based sponge that can be used to wipe hands.”
Passage 5“Hill scientist, 90, invents ‘IoWipe’; combats pandemic . . . Though the invention was created years ago, an intensive need for it didn’t seem to exist until the COVID-19 global pandemic. The product came into existence in late 2019, just before the need materialized . . . ‘There is a definite need now for IoWipe in light of the global pandemic and future pandemics, which are likely to occur more frequently. It is a personal, convenient, reusable, cost-effective wipe that releases iodine in safe amounts. I believe it is a superior option, as compared to alcohol gels and disposable wipes.’”
Passage 6“After sending out our COVID-19 email about temporarily closing CAMA, our acupuncture center to our patients with a mention about IoWipes, our anti-viral wipes, we ended up with 30 orders, many of them local. So tonight we are driving around delivering anti-viral hand wipes and cell phone wipes in party bags two [*sic*] friends and patients!”