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WARNING LETTER

February 6, 2024

RE: 3007588545

Dear Mr. Willimann:

This letter concerns your firm’s distribution of the over-the-counter (OTC) drug product Nozin® Nasal Sanitizer®. The U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.nozin.com/ on October 19 and October 20, 2023. We have also reviewed your social media websites at https://www.facebook.com/NozinNasalSanitizer/wall/ and https://twitter.com/nozin; these websites direct consumers to your website https://www.nozin.com/ to purchase your products.

Nozin® Nasal Sanitizer® is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food & Cosmetic Act (FD&C Act,) 21 U.S.C. 355(a) and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.

Unapproved New Drug and Misbranded Drug Violations

Nozin® Nasal Sanitizer® is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as both a consumer and a health care topical antiseptic drug.

Examples of claims observed on the Nozin® Nasal Sanitizer® labeling from your website and the social media websites listed above that provide evidence of the intended use (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:
“Nozin Nasal Sanitizer is an antiseptic that is used to kill pathogenic bacteria that are carried in the anterior nares (nasal vestibule). The vestibule is the single most abundant reservoir of antibiotic resistant and susceptible Staph aureus (MRSA & MSSA) on the body and also harbors other microbial pathogens. The use of the Nasal Sanitizer® antiseptic also contributes to good nasal hygiene.” [from your website under Consumer FAQs https://www.nozin.com/consumer-faq/]

“Nozin® Nasal Sanitizer® Nozaseptin® formula combines ethanol with antioxidant rich natural emollients. This provides a highly effective antiseptic for the nose in a pleasant and moisturizing application. No prescription needed.” “Helps reduce risk of infection.” [from your website under Buy Nozin https://www.nozin.com/product/nozin-nasal-sanitizer-12ml-bottle/]

“…Universal sustained nasal decolonization is now possible without some of the familiar constraints of antibiotics and iodine. Nozin® Infection Prevention Program helps safeguard your most vulnerable patients from the risks of MRSA colonization.” [from your website under product comparison https://www.nozin.com/nozin-nasal-sanitizer/]

“Nozin® Nasal Sanitizer® is specially formulated to effectively address nasal carriage of bacteria:
Effective - kills 99.99% of germs and is clinically proven to decrease nasal bacteria carriage Safe, fast acting - the active ingredient is ethyl alcohol, a well-established, trusted, broad spectrum antiseptic 12-hour duration - soothing solution is well tolerated, safe for regular use and Nasal Sanitizer® effect lasts 12 hours” [from your website under How It Works https://www.nozin.com/how-it-works/]

“The staff were very open to the idea of using Nozin, it meant we could quit using Mupirocin ointment. Patients could get swabbed for MRSA and did not have to stay a couple of hours for the MRSA results.” [from a testimonial on your website https://www.nozin.com/customer-testimonials/]

“We began the Nozin program right before COVID hit, it has been a game changer for us on saving on PPE, availability of patient rooms, and the patients have been better satisfied as they are not in isolation” [from a testimonial on your website https://www.nozin.com/customer-testimonials/]

“Now is the time to keep abreast of innovations in patient care to ensue optimal reduction of not only COVID-19 risk, but also HAI risk. With the support of hospital leadership, IP departments have long been early adopter of innovative products and practices in the interest of patient safety. Universal nasal and skin decolonization is an innovative approach with many advantages designed to reduce the transmission of MRSA and MSSA and associated infection risk in the interest of patient safety and cost containment.” [from a White Paper downloaded from your website under Healthcare Pros https://www.nozin.com/: “Increased Risk of HAIs and the Case for Patient Decolonization in the COVID-19 Era for Healthcare Professionals”]

“Independently conducted research studies of programs using Nozin Nasal Sanitizer antiseptic for nasal decolonization” led to a “100% reduction in total hip and total knee surgical site infections.” [from a post on your Facebook webpage, dated 9/02/2020, at https://www.facebook.com/NozinNasalSanitizer/wall/]

“Road trip time. Consider packing Nozin Nasal Sanitizer antiseptic, #1 hospital-trusted product for daily nasal decolonization, contains alcohol which kills 99.99% of germs and keeps working for up to 12 hours.” [from a repost by you on your X (formerly Twitter) webpage, dated 7/29/2020, at https://twitter.com/nozin]

Based on the above labeling claims, Nozin® Nasal Sanitizer® is intended for use as a consumer and a health care topical antiseptic product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless it is lawfully marketed under section 505G of the FD&C Act or under other exceptions not applicable here. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for this drug product identified above.¹

We note that OTC topical antiseptic products had been the subject of a rulemaking under the Agency’s OTC Drug Review. In particular, consumer topical antiseptics were addressed in a tentative final monograph (TFM) entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (1994 TFM), as further amended by “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 81 FR 42912 (June 30, 2016) (Consumer Antiseptic Rubs Proposed Rule). Over the course of these rulemakings, three active ingredients (benzalkonium chloride, ethyl alcohol (ethanol), and isopropyl alcohol) were classified as Category III for use in consumer antiseptic rub products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a consumer antiseptic rub. Health care topical antiseptics were addressed in the 1994 TFM, as further amended by “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 80 FR 25166 (May 1, 2015) (Health Care Antiseptics Proposed Rule), and “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” Final Rule, 82 FR 60474 (December 20, 2017) (Health Care Antiseptics Final Rule). Over the course of these rulemakings, six active ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol, ethyl alcohol, isopropyl alcohol, and povidone-iodine) were classified as Category III for use in health care antiseptic products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as health care antiseptics, including patient antiseptic skin preparations.

Section 505G of the FD&C Act addresses nonprescription drugs marketed without an approved application. Under section 505G(a)(3) of the FD&C Act, drugs that were classified as Category III for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330 – and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM and comply with all other applicable requirements.

However, your Nozin® Nasal Sanitizer® product does not conform to the 1994 TFM, nor any other TFM, 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.

Specifically, your labeling claims, suggesting that Nozin® Nasal Sanitizer® is effective in preventing infection or disease from the novel coronavirus that causes COVID-19 and other pathogenic organisms, such as Staphylococcus aureus that is either Methicillin-resistant (MRSA) or Methicillin-susceptible (MSSA), go beyond merely describing the general intended use of an antiseptic as set forth in the 1994 TFM.² In addition, your labeling claims, suggesting that Nozin® Nasal Sanitizer® provides up to 12 hours of efficacy against serious-disease related pathogens, are not permitted under the 1994 TFM or any of the amendments to the TFM, as discussed above. Time-specific extended efficacy claims, especially when related to serious-disease related pathogens, 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. This labeled intended use goes beyond merely describing the general intended use of topical antiseptics as set forth in the 1994 TFM and the amendments to the TFM, as discussed above.

In addition, according to the product labeling, Nozin® Nasal Sanitizer® is intended to be applied inside the nostrils. 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.³

Misbranded Drug Violations

Nozin® Nasal Sanitizer® is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in legal action including, without limitation, seizure and injunction.

This letter notifies you of our concerns and provides you an opportunity to address them. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to [email protected] and include your firm name in the subject line of your email.

Sincerely,
/S/

CAPT Tina Smith
Office Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

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1 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that your Nozin® Nasal Sanitizer® drug product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.

2 The 1994 TFM covers health care antiseptics that are indicated for use to help reduce bacteria that can potentially cause disease and health care and consumer antiseptics that are indicated to decrease bacteria on the skin. 59 FR at 31443.

3 The 2016 Consumer Antiseptic Rubs Proposed Rule covered consumer antiseptic products intended for use without water. Under the 1994 TFM, as amended by the 2016 Consumer Antiseptic Rubs Proposed Rule, only consumer topical antiseptic products intended for use on the hands without water are permitted. Products intended for other areas of the body such as inside the nose are not permitted. Under the 1994 TFM, as amended by the 2015 Health Care Antiseptics Proposed Rule and 2017 Health Care Antiseptics Final Rule, certain health care topical antiseptic products intended for use without water, including patient antiseptic skin preparations, are permitted. Health care antiseptic products intended for use inside the nose are not permitted because the inside of the nose is a mucous membrane.