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, 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).
Passage 2Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352.
Passage 3“Our statement regarding COVID-19 on our Product[,] With the growing concern over Coronavirus, we want to reassure our customers that our products have recently been tested at Institute for Antiviral Research lab at Utah State University in May 2020, and been found to be effective against Human Coronavirus COVID-19.[,] ‘Puriton was an effective virucidal after 1-hour incubation with SARS-CoV-2 (COVID-19), reducing virus by >2.8 log10 (>99.8%). . . ..”
Passage 4“Promising Results: Puriton Testing to COVID-19 . . . Puriton was an effective virucidal after 1-hour incubation with SARS-CoV-2 (COVID-19), reducing virus by >2.8 log10 . . . (>99.8%). . . . Yes!!! Puriton is an effective virucidal after a 1-hr incubation with COVID-19! . . . According to the Antiviral Research lab at Utah State University in May 2020, Puriton has been found to be effective against Human Coronavirus COVID-19. . . . #coronavirus . . . #covid #covid19 . . ..”
Passage 5“‘[I]t is quite significant that Puriton which is extracted in forms of nano-particle is alkaline. After seeing the test result from Utah State University showing its effectiveness in treating COVID-19, I have a high hope mineral science can be a breakthrough in this Corona Catastrophe’” followed by an image with the text “’Puriton Medical Mineralogy Research Center has announced their development of a cure for Coronavirus”’