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

Source: https://www.keypedia.com/records/warning_letter/global-life-technologies-corp/27d64e67-6927-44a9-9e62-7089192eb74a

> FDA WARNING_LETTER for Global Life Technologies Corp. on February 13, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Global Life Technologies Corp.
- Inspection Date: 2024-02-13
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/tina-smith/5d590654-a270-4f3f-833f-d6fe13ca8c05)

Company: https://www.keypedia.com/companies/global-life-technologies-corp/f5ce5a31-3739-469c-8e49-a752ef20d090

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c