Halodine, 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, 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 2

Halodine Nasal Antiseptic Swabstick, Halodine Nasal Antiseptic, Halodine Oral Antiseptic Spray and Halodine Oral Rinse are misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because their labeling is false or misleading.

Passage 3

In addition, these non-alcohol-based antiseptic products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

Passage 4

However, your non-alcohol-based antiseptic products do not conform to the 1994 TFM, the Oral Antiseptics Proposed Rule, nor any other TFM, proposed rule, or final rule and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.

Passage 5

Specifically, your labeling claims, suggesting that your non-alcohol-based antiseptic products are effective in shortening the duration of infection and preventing infection or disease from the novel coronavirus that causes COVID-19, go beyond merely describing the general intended use of an antiseptic as set forth in the 1994 TFM and the Oral Antiseptics Proposed Rule.

Passage 6

In addition, your labeling claims, suggesting that your non-alcohol-based antiseptic products provide up to 4 hours of efficacy against serious-disease related pathogens including the novel coronavirus that causes COVID-19, are not permitted under the 1994 TFM, the Oral Antiseptics Proposed Rule, or any of the amendments to the TFMs discussed above.

Passage 7

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.