Bests & Worsts Reviews from Amazon

There are always risks and benefits in using any product, as nothing is 100% safe, so let’s take a hard look at those and make an informed decision (TLDR at the end). If you doubt that harmful products are allowed to be sold, then look up “argyria,” Rosemary Jacobs, promise yourself that you won’t rely on manufacturers to put out safe products and come back here. Please note that the lack of clinical data on this product means that the best any of us can do is to look for evidence, and this is all tentative. We have two questions to organize our thoughts: Is this product safe? Is it effective? I point you to sources of information throughout, and there is a TLDR at the end. At first I had 10 pages, so this was way longer, ha ha! Pros: ✔This antiseptic does kill bacteria, viruses and fungi ✔ Doesn't burn. "Comforting" is a stretch, though. ✔ From the seller’s company website: "NanoBio® Protect was tested against COVID-19 by mixing the virus with the product and checking viral counts (More details on their site). The results were conclusive – NanoBio® Protect killed the COVID-19 virus at every time point. Any remaining virus was below the level of detection in all samples, representing more than 99.99% killing and demonstrating how effective NanoBio® Protect is at inactivating COVID-19." I could not find anything published in the scientific literature on this, and that is not unusual because it takes time to publish. We can give this the benefit of the doubt for now. If we reach 2021 without seeing published data, then I would begin to question that. ✔ It IS being manufactured in an FDA registered facility: Apex International MFG, Inc, 10000 Valley View Road, Eden Prairie, Minnesota (MN) 55344, United States (USA), FDA Establishment Identifier 3010471640, DUNS 079110793, responsible for analysis, label, manufacture, pack. Expires 12/31/2020. Beyond this date, look this up yourself in the FDA database. It is a law; they had to register. Cons: ✘Expiry date and lot # could not be seen in normal lighting (black on dark blue); they could do better. ✘Essential information is lost if you throw out the box. They could do better and put all info on the bottle, like other antiseptic products. ✘ Being manufactured in that facility is being touted by seller as some indication of quality. This is what the FDA actually says: “Registration of a drug establishment or drug wholesaler, or assignment of a registration number, or assignment of a NDC number does not in any way denote approval of the company or its products. Any representation that creates an impression of official approval because of registration or possession of registration number or NDC number is misleading and constitutes misbranding under the federal Food, Drug, and Cosmetic Act.” ✘NSF International independently registers manufacturers that meet GMP requirements. Registration services are available for manufacturers…that want to demonstrate a commitment to public safety. Apex International has not registered or certified. They may still be following CGMP, we wouldn’t know, as consumers. ✘The testing for effectiveness with COVID-19 was done in vitro (think petri dishes), and we do not have data on the safety and efficacy when used on a human as directed, much less on a daily basis. You may want to wait on this until they can demonstrate that NanoBio Protect works to at least prevent the common cold; clinical trials are possible on that and would be a good start. ✘We require data showing that this product is more effective than iodine, saline, soapy water, or alcohol-based solutions. These are cost-effective, and may be safer. The FDA would like to know this, too, and they said so! Read about soap and COVID-19 in the March 2020 article on the CNN website called, “Why soap, sanitizer and warm water work against Covid-19 and other viruses.” ✘The manufacturer claims that this works for 4 – 8 hours. What is that based on? As far as I could tell from their own website, it is that the chemical was still found in/on skin cells 4 hours after application. Does that mean that the virus cannot infect and reproduce in those cells? That’s a good question! I am skeptical re: 8 hrs, until that is demonstrated. ✘The seller has posted claims on here that their product is FDA approved. Did you know that you can check that out? I did, and it looks to me that this may be a FALSE claim. The FDA website has a search feature for FDA-approved drugs. I searched for benzalkonium chloride (and under the other names for it- Alkylbenzyldimethylammonium chloride, BZK, BAC, Zephiran, CureChrome, HandClens, Merthiolate, Neosporin Wound Cleanser, Antimicrobial Cleanser, and NanoBio Protect). None of these are included in the database, data current to 08/17/2020 and updated daily. I also looked under Code of Federal Regulations Title 21, Part 333, which regulates topical antimicrobials. Products that meet ALL of the conditions are considered generally regarded as safe. Benzalkonium chloride is NOT on that approved list. (Data current to August 14, 2020). Let’s go through what I DID find! ✘ Benzalkonium chloride (BAC) was classed as a Category IIISE antiseptic active ingredient by the US FDA for its use as both a health care antiseptic and consumer antiseptic product. Category “III” denotes a classification that the available data are insufficient to classify the active ingredient as GRAS/GRAE. “S” denotes safety data needed. “E” denotes effectiveness data needed. Reference: 1. Food and Drug Administration. 42912 Federal Register/Vol. 81, No. 126/Thrsday, June 30, 2016/Proposed Rules. You can find more information by searching for Antiseptic FDA letters on the fda.gov website. ✘2017 Health Care Antiseptic Final Monograph (December 20, 2017, 82 FR 60474) We issued a final rule finding that certain active ingredients used in OTC healthcare antiseptic products are not GRAS/GRAE. We deferred further rulemaking on six specific active ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol, ethyl alcohol, isopropyl alcohol and povidone iodine) used in OTC healthcare antiseptic products to allow for the development and submission of new safety and effectiveness data to the record for those ingredients. As of this writing (Aug 2020), this guidance is still current. ✘According to the article, “ FDA Bans Antibacterial Chemicals in Soaps” on the livescience website, the FDA informed manufacturers back in 2013 that they required more research. Instead of doing that, manufacturers started removing the disinfectants from their products. So here we are, it is 7 years later, and in that time that work could not have been accomplished? Why not? I suspect that some of them may have tried and it failed to reach the bar, but I couldn’t tell you. ✘A potential hazard is for antibiotic resistance to develop. Pseudomonas aeruginosa is a bacterium that can cause pneumonia and sepsis. It is common and found in soil and water, and sometimes growing on skin in moist parts of their body (like your nose)! In laboratory tests, exposing this bacterium to benzalkonium chloride caused it to develop antibiotic resistance to ciprofloxacin, penicillin G, and tetracycline, even without being exposed to those antibiotics. Now that is some scary stuff! Will it work in our nasal passages the way it did in the petri dishes? We don’t know for sure; we do not have that data. For those who wish to read more on this, here are 3 references: 1) P. H. Mc Cay, A. A. Ocampo-Sosa, G. T. A. Fleming, 'Effect of subinhibitory concentrations of benzalkonium chloride on the competitiveness of Pseudomonas aeruginosa grown in continuous culture', Microbiology Jan. 2010, 30-38; doi 10.1099/mic.0.029751-0. 2) Long-term exposure to benzalkonium chloride disinfectants results in change of microbial community structure and increased antimicrobial resistance. Environ Sci Technol 47: 9730 – 9738. doi: 10.1021/es401507k. 3) Kim M, Weigand MR, Oh S, et al. Widely Used Benzalkonium Chloride Disinfectants Can Promote Antibiotic Resistance. Appl Environ Microbiol. 2018;84(17):e01201-18. Published 2018 Aug 17. doi:10.1128/AEM.01201-18 ✘I couldn’t find any third-party testing on this product. I ALWAYS look for that! I posted the question here, and seller didn’t answer (yet). This is especially important because the FDA does not require topical antiseptics to be manufactured in a sterile environment. This product can't kill absolutely everything: Intrinsic Resistance of Burkholderia cepacia Complex to Benzalkonium Chloride Youngbeom A, Jeong Myeong K, Ohgew K, et al., mBio Nov 2016, 7 (6) e01716-16; DOI: 10.1128/mBio.01716-16 ✘According to the NIH DailyMed website, this product should be stored at 20°-25°C (68° -77°F). Look closely at that info, there, that is a tight range. You need A/C, and can’t use the refrigerator for it. Remember that in transit it may sit in a truck in the sun, or freeze in the winter. ✘It is true that the active ingredient is widely used, but that could be worse. It is possible that your systemic exposure could be far greater than you realize, and perhaps higher than you are comfortable with or is safe. The list of products was too long to include, here. ✘If you are using other nasal or sinus products that contain corticosteroids, then there is risk of an interaction with this product: “Therefore, we suggest that long-term use of intranasal corticosteroids with benzalkonium chloride can lead to high-grade dysplasia in the nasal mucosa.” Tamer F, Koc E, Gun T, Ergin C. Nasal Mucosal Dysplasia Induced by Topical Corticosteroids with Benzalkonium Chloride. Indian Dermatology Online Journal. 2018 Mar-Apr;9(2):126-127. DOI: 10.4103/idoj.idoj_53_17. ✘ This product is stronger than recommended limits by two authorities: 1) Benzalkonium Chloride is listed in the Cosmetics Directive of the European Union in Annex III and in Annex VI. It is authorized for use at maximum concentrations of 3% in rinse-off hair care products and 0.1% in other products, and must be labeled with conditions of use and warnings. 2) The Food and Drug Administration (FDA) permits Benzalkonium Chloride to be used in Over-the-Counter (OTC) first aid antiseptic drug products. The safety of Benzalkonium Chloride has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated scientific data and concluded that Benzalkonium Chloride, at concentrations up to 0.1% free, active ingredient, was safe as a cosmetic ingredient. The Cosmetic Ingredient Review report summarizes data from a tumorigenicity study in mice and rabbits in which ulceration and inflammation, but no tumors, were observed. It was a skin and ocular irritant at concentrations greater than 0.1%. ✘ After 28 days of use, benzalkonium chloride spray alone induced an increase in nasal mucosal swelling....which explains why the presence of this preservative in a decongestant spray aggravates rhinitis medicamentosa. Graf P, Hallén H. Laryngoscope. 1996 May;106(5 Pt 1):605-9. doi: 10.1097/00005537-199605000-00016. PMID: 8628089 Clinical Trial. While this product isn’t a spray, we are applying it to the nose and then breathing past it. IDK about doing that every day! ✘ Per Drugs dot com, benzalkonium chloride topical has 3 moderate drug interactions, with: hyaluronan, hylan g-f 20, sodium hyaluronate . TLDR: this is an unproven product that might work and might not, yet might also risk antibiotic resistant infection, skin irritation, interactions with steroids, aggravation of rhinitis medicamentosa, and nasal mucosal swelling. There is not enough data to determine safety or efficacy per the FDA, and by saying that it is FDA approved the seller might be misleading and misbranding under the federal Food, Drug, and Cosmetic Act. It may be just as effective to swab a little soap. Nobody knows. Seller’s promotion of daily use is viewed as ill-advised by this writer. I can’t tell you whether this product is right for you. If I encountered someone clearly ill or had a known exposure to COVID-19, I would use it. Once! Otherwise, no. If you do have adverse reactions, report to the FDA- it will help with data. This product gets 1* for making unproven claims and false statements. I hope that this review is helpful to you in making your decision a bit more informed. Do let me know, and happy shopping!