Iotech International, LLC

Selected passages from the FDA letter

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

Passage 1

your website offers “ioRinse” (also referred to as “ioRinse™ RTU”) and “ioCleanse Molecular iodine Hand Cleanser” for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19***1*** in people.

Passage 2

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 3

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

Passage 4

“A New Super Class of Anti-microbials that kill #coronavirus . . . @iotech.international developed novel Anti-microbials that kill #coronavirus and surpass Chlorihexidine Gluconate in Efficacy. Safe . . . Highly engineered products created by a dentist and chemists. Order today: @iotech.international”

Passage 5

“The aim of the present study was to evaluate and compare the efficacy and cytotoxicity of four different mouthwashes containing 1.5% hydrogen peroxide, 0.2% povidone, 0.12% chlorhexidine and 100 ppm molecular iodine for the ability to inactivate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) . . . **Conclusion:** The spread of infection through aerosol and splatter has long been considered one of the main concerns in the dental community. A preprocedural rinse with 100 ppm molecular iodine will play a vital role in combating COVID-19 pandemic by preventing the spread of infection.”

Passage 6

“Iotech International’s formula 100-S [containing molecular iodine] displayed the greatest antiviral activity of all the tested rinses, completely inactivating SARS-COV-2 within 30 seconds.”

Passage 7

“Introducing ioCleanse . . . Non-Staining IoCleanse Hand Cleanser contains the most powerful form of iodine, Molecular Iodine . . . Successfully tested to destroy normal Coronavirus (strain #229E) within seconds. . . . Clinically Proven: Iodine is more effective as an ANTIVIRAL AGENT than Alcohol Sanitizers”

Passage 8

your “ioRinse” and “ioCleanse Molecular iodine Hand Cleanser” products do not conform to the 1994 TFM, the Oral Antiseptics Proposed Rule, or any other TFM, proposed rule, or final rule and do not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.

Passage 9

your labeling claims***5*** suggesting that your oral antiseptic rinse and topical antiseptic products are effective in inactivating and thus preventing infection or disease from the novel coronavirus that causes COVID-19 go beyond merely describing the general intended uses of an antiseptic

Passage 10

your “ioCleanse Molecular iodine Hand Cleanser” product contains an active ingredient, molecular iodine, which was not one of the three active ingredients classified as Category III in the 1994 TFM.