Global Life Technologies Corp.

Warning LetterOpen

John Willimann President Global Life Technologies Corp. 4608 N. Park Avenue, 2nd floor Chevy Chase , MD 20815 United States john@nozin.comFEI 3007588545Issued Feb 6, 2024Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3007588545.

Violations1

Issue DateFeb 6, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Global Life Technologies Corp.
Location: John Willimann President Global Life Technologies Corp. 4608 N. Park Avenue, 2nd floor Chevy Chase , MD 20815 United States john@nozin.com
FEI Number: 3007588545
Country: United States
Issue Date: February 06, 2024
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Global Life Technologies Corp. distributed Nozin® Nasal Sanitizer® as an unapproved new drug in violation of section 505(a) of the FD&C Act and as a misbranded drug under section 502(ee), based on FDA's review of the company's website and social media channels in October 2023. The product was marketed with claims that it functions as a topical antiseptic to kill pathogenic bacteria in the nasal passages, thereby qualifying it as a drug requiring FDA approval that the company had not obtained. The company's labeling and promotional materials on their website and social media platforms (Facebook and Twitter) made disease prevention and treatment claims that established the unapproved intended use.

Global Life Technologies Corp. FDA Warning Letter, February 6, 2024