FDA WARNING_LETTER - Halodine, LLC - June 23, 2021

On July 7, 2021, the FDA issued a Warning Letter to Halodine for selling unapproved new drug products, specifically Halodine Nasal Antiseptic Swabstick, Halodine Nasal Antiseptic, Halodine Oral Antiseptic Spray, and Halodine Oral Rinse. The FDA reviewed the company's websites (halodine.com, shop.halodine.com) and social media (Twitter, Facebook) on June 23, 2021, finding claims that these products mitigate, prevent, treat, diagnose, or cure COVID-19 and other conditions.

These products are deemed "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective (GRASE) for their labeled uses, violating section 505(a). No FDA-approved applications are in effect for these products. Furthermore, the products are misbranded under sections 502(a) and (ee) of the FD&C Act, as their labeling falsely claims FDA OTC compliance and they do not meet marketing requirements under section 505G.

Specific violations include claims like "Halodine Fights the Spread of COVID-19" and "kills SARS-CoV-2...in less than 15 seconds," and extended efficacy claims (e.g., "up to 4 hours").