Global Life Technologies Corp.

Selected passages from the FDA letter

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

Passage 1

Nozin® Nasal Sanitizer® is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food & Cosmetic Act (FD&C Act,) 21 U.S.C. 355(a) and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).

Passage 2

your labeling claims, suggesting that Nozin® Nasal Sanitizer® is effective in preventing infection or disease from the novel coronavirus that causes COVID-19 and other pathogenic organisms, such as Staphylococcus aureus that is either Methicillin-resistant (MRSA) or Methicillin-susceptible (MSSA), go beyond merely describing the general intended use of an antiseptic as set forth in the 1994 TFM.

Passage 3

your labeling claims, suggesting that Nozin® Nasal Sanitizer® provides up to 12 hours of efficacy against serious-disease related pathogens, are not permitted under the 1994 TFM or any of the amendments to the TFM, as discussed above.

Passage 4

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 5

Nozin® Nasal Sanitizer® 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.