Xlear Statement on FDA Decongestant Decision
Today, Nathan Jones, CEO of Xlear Inc., a consumer hygiene products company, released this statement regarding the FDA’s proposal to remove popular over-the-counter decongestants, which contain the drug phenylephrine, from the market:
“With the FDA concluding that this common decongestant isn’t effective, as we enter cold and flu season, and as families prepare to celebrate the holidays, many Americans need a new answer for the discomfort of sinus congestion,” Jones noted. “For people looking for help, the U.S. Centers for Disease Control (CDC) Guidance, ‘Relief for Symptoms of Colds and Coughs’, ‘instructions’ say to ‘use saline nasal spray to relieve congestion.’i Similarly, CDC’s ‘Sinus Infection Basics’ say ‘How to Feel Better’ ‘use a . . . saline nasal spray,’”ii he pointed out.
“You experience congestion because there is an irritant or pathogen in your upper airway that your body is trying to trap and wash away—your runny nose is your body flushing it out. Saline-based nasal sprays can help speed up that flushing, reduce pathogen load, and make it more effective. It’s commonsense: The faster the bad stuff is gone, the faster you feel better,” Jones added.
“For congestion caused by pathogens—like colds and flus—people can enhance that effect by using a nasal spray that contains xylitol. A series of studies show xylitol (a natural sugar) deactivates and/or blocks the adhesion of many types of viruses and bacteria, to your airway cells,”iii Jones continued. Adhesion is the process by which a pathogen attaches to your tissue to initiate infection. Using a nasal spray with xylitol helps block adhesion of these pathogens. For example, a Randomized Controlled (clinical) Trial published in 2022, determined that a saline-nasal spray containing xylitol and other ingredients reduced the rate of COVID-19 infections by 62 percent above placebo.iv
“Using a basic saline would be comparable to rinsing your hands with water; using a nasal spray with xylitol, like Xlear, would be comparable to washing your hands with soap. Expect more from your nasal hygiene products. Make sure they have xylitol so you can better and faster clean out the bad stuff while alleviating the congestion,” Jones added.
Xlear nasal spray is a saline-based nasal spray containing xylitol. Xlear 12 Hour Nasal Decongestant is a saline-based nasal spray containing xylitol and the decongestant Oxymetazoline HCL.
For more information on Xlear please visit www.xlear.com.
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https://www.cdc.gov/antibiotic-use/media/pdfs/HCP-Relief-Colds-Cough-85by11-P.pdf |
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For example: T Kontiokari, M Uhari, M Koskela, Antiadhesive effects of xylitol on otopathogenic bacteria., Journal of Antimicrobial Chemotherapy, Volume 41, Issue 5, May 1998, Pages 563–565, https://academic.oup.com/jac/article-abstract/41/5/563/652694?redirectedFrom=fulltext - google_vignette; Kontiokari, T., Uhari, M., & Koskela, M. (1998). Antiadhesive effects of xylitol on otopathogenic bacteria. The Journal of Antimicrobial Chemotherapy, 41(5), 563–565, https://academic.oup.com/jac/article-abstract/41/5/563/652694?redirectedFrom=fulltext&login=false; Jung, Kie Hoon. (2021). Antiviral Efficacy Against Virus Infections in Human-Derived Tracheal/Bronchial Epithelial Cells. Utah State University, https://xlrtmp.com/wp-content/uploads/2023/05/Antiviral-efficacy_USU2021.pdf; Vega, J. C., et al., (2020). Iota carrageenan and xylitol inhibit SARS-CoV-2 in Vero cell culture. BioRxiv, https://professionals.xlear.com/portfolio/anti-adherence-of-viruses/; Ruiz, V., Rodríguez-Cerrato, V., Huelves, L. et al. Adherence of Streptococcus pneumoniae to Polystyrene Plates and Epithelial Cells and the Antiadhesive Potential of Albumin and Xylitol. Pediatr Res 69, 23–27, https://www.nature.com/articles/pr920116 - citeas. |
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Damian Balmforth, et al., Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial., Journal of Clinical Virology, 155; 2022, https://www.sciencedirect.com/science/article/pii/S1386653222001809. |
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Guillermo Meneses
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gm@nuciglo.com
