Nasal sanitizer under FDA scrutiny for alleged misbranding. Here's what you need to know.
Key Takeaways
The FDA is calling out nasally administered antiseptic Nozin Nasal Sanitizer for misbranding violations and operating as an unapproved new drug.
Citing enthusiastic descriptions and testimonials on the company website, the agency says the company’s rhetoric could harm public health if people replace other infection control measures with this product.
The Food and Drug Administration sent a warning letter to healthcare company Global Life Technologies Corp earlier this month regarding its over-the-counter product Nozin Nasal Sanitizer.[]
Nozin is currently branded as an over-the-counter (OTC) drug for use inside the “nasal vestibule” to kill off pathogenic bacteria. However, according to the FDA, Nozin Nasal Sanitizer has been misbranded as a “health care topical antiseptic product,” has not followed the correct steps for a new drug approval, and is subject to violations.[]
In its letter, the FDA called the product an unapproved new drug and listed multiple quotes from the company’s website as examples of misbranded drug violations. The FDA is giving Global Life Technologies 15 days from Tuesday to respond to the letter and provide the agency with information on how they will address the issues raised.
Following the letter, doctors should prioritize proven public health measures to fight infections and not nasally administered antiseptics.
Nozin’s misbranding violations
According to the FDA, Nozin Nasal Sanitizer is misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as it does not follow proper regulatory guidelines for non-prescription drugs.
The product does not conform to the 1994 Tentative Final Monograph (TFM), any TFM, “any 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,” the FDA wrote.
The 1994 TFM pertains to the FDA’s regulatory efforts to evaluate the safety and effectiveness of over-the-counter drugs marketed in the United States. It provides information for which certain antiseptics (like some used in hand soaps) are generally recognized as safe and effective (GRASE), which allows them to bypass some FDA regulatory processes required of other drugs.[]
However, the FDA says that nasally administered antiseptics are not permitted under the 1994 TFM and that certain category III ingredients — like ethyl alcohol, which is used in Nozin – are required to undergo additional safety and effectiveness data before they can be used in consumer antiseptic rubs.
“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,” the FDA wrote in its warning letter.
In an emailed statement to MDLinx, a spokesperson wrote that “the company’s position is that Nozin® Nasal Sanitizer® antiseptic is lawfully marketed as an over-the-counter topical antiseptic drug product in accordance with the Tentative Final Monograph (TFM) for OTC topical antimicrobial drug products, which includes ethyl alcohol, the active ingredient in Nozin® Nasal Sanitizer® antiseptic.”[]
“Nozin® Nasal Sanitizer® antiseptic has been marketed for more than 15 years to reduce bacteria on the skin in the nasal vestibule, which is at the front of the nose,” the spokesperson said. “It is not intended to prevent, treat, or cure COVID-19.”
Overemphasizing benefits
The FDA is also calling out the company for over-emphasizing the alleged benefits of its product, which could be misleading and harm public health practices, the agency says.
Descriptions on the company website say the product can kill 99% of germs, protect vulnerable patients against risks of MRSA colonization, reduce risks of infections, and more. Testimonials applaud the product for helping users save on other public health protection measures, like using personal protective equipment (PPE) during COVID-19.
In one testimonial, users wrote that purchasing Nozin before the start of COVID-19 was a “game changer for us on saving on PPE.”
This unchecked enthusiasm could have a negative public health impact if people think too highly of this product and disregard important public health practices that fight infection, the agency wrote.
The rhetoric on Global Life Technologies Corp’s website “may lead to a false sense of security for the general public that may result in infrequent hand washing or the substitution of these products for protective gloves and clothing, which are the principal methods for protecting against the spread of diseases caused by pathogenic microorganisms,” the FDA wrote.
What this means for you
Doctors should emphasize the importance of public health measures like good hand hygiene, PPE where necessary, and vaccinations to protect patients against viral infections.