CofixRx, LLC

Selected passages from the FDA letter

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

Passage 1

Based 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 2

CofixRX Nasal Spray is misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because its labeling is misleading.

Passage 3

CofixRX Nasal Spray is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

Passage 4

DESTROYS SARS CoV-2 and other COLD & FLU viruses in 15 seconds

Passage 5

CofixRX™ is an antiviral nasal spray that offers up to 8 hours of protection from many cold and flu viruses.

Passage 6

Lasts for up to 8 hours per application.

Passage 7

CofixRX utilizes patent-pending technology that is effective 45 seconds after application and lasts up to 8 hours, reducing the need for constant re-applications.

Passage 8

Consumer and health care antiseptic products intended for administration inside the nostrils are not permitted under the 1994 TFM, as further amended by the Consumer Antiseptic Rubs Proposed Rule and the Health Care Antiseptics Proposed Rule.

Passage 9

Is CofixRx approved by FDA? The active ingredient in CofixRX, Povidone-iodine, is FDA approved to be used in over-the-counter products…