Washington, DC—The U.S. Food and Drug Administration (FDA) is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter (OTC) monograph drug products for the temporary relief of nasal congestion. The proposal comes after an agency review of the available data determined that oral phenylephrine is not effective for this use.
FDA reported that, for now, companies can continue to market OTC monograph drug products containing oral phenylephrine as a nasal decongestant, since only a final order will affect what products can be marketed. FDA added that the proposed order is based on effectiveness concerns, not on safety concerns.
Nathan Jones, CEO of Xlear Inc., released a statement regarding the FDA’s proposal: “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 said. For people looking for help, Jones noted that the U.S. Centers for Disease Control (CDC) advises using saline nasal spray to feel better. (See CDC references 1,2)
“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,” Jones added. “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 that, 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 (3),” Jones explained. "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% above placebo (4)."
Jones added a comparison to further make the point: "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.”
References:
- https://www.cdc.gov/antibiotic-use/media/pdfs/HCP-Relief-Colds-Cough-85by11-P.pdf
- https://www.cdc.gov/sinus-infection/about/index.html
- 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.
- 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.
