FDA WARNING_LETTER - Global Life Technologies Corp. - February 13, 2024

On February 6, 2024, the FDA issued a Warning Letter to Mr. Willimann regarding the distribution of Nozin® Nasal Sanitizer®. The FDA reviewed the firm's website and social media on October 19-20, 2023.

The FDA determined that Nozin® Nasal Sanitizer® is an unapproved new drug, violating sections 505(a) and 301(d) of the FD&C Act, and is misbranded under section 502(ee) and 301(a) of the FD&C Act. The product is considered a drug due to claims of preventing disease and affecting body function, specifically as a consumer and healthcare topical antiseptic.

Violations stem from labeling claims on the website and social media, including: "kills pathogenic bacteria," "helps reduce risk of infection," "safeguard your most vulnerable patients from the risks of MRSA colonization," "kills 99.99% of germs and is clinically proven to decrease nasal bacteria carriage," "12-hour duration," and testimonials suggesting reduction in MRSA and surgical site infections. These claims indicate the product is intended for preventing infection from specific pathogens like MRSA/MSSA and COVID-19, and offers extended efficacy (12 hours).

The product's active ingredient, ethyl alcohol, is classified as Category III for consumer and healthcare antiseptics