The Food and Drug Administration's independent Nonprescription Drugs Advisory Committee unanimously voted 16-0, declaring oral phenylephrine ineffective as a decongestant. Some of the most common medications containing phenylephrine include Sudafed PE, DayQuil and NyQuil Severe Cold and Flu, Mucinex Cold and Flu, Tylenol Cold and Flu, Tylenol Sinus and Headache, Robitussin Cough and Allergy, Advil Cold and Flu and Benadryl Allergy Plus Congestion. According to the FDA stores sold roughly 242 million of OTC cold and allergy oral medications containing phenylephrine. These products make up the roughly $13 billion cough, cold and sore throat market, of which a large portion is taken by nasal congestion products. Products with formulations that contain phenylephrine, the drug FDA experts deemed ineffective, make up about four-fifths of that market.
One in two U.S. households used oral decongestants over the past year and consumers prefer oral to nasal decongestants 3 to 1, and expressed concerns alternative medications would not be easily available.
As a Company, Applied Biological Laboratories and its Co-Founder and Chief Scientific Officer, Dr Nazlie Latefi, have been rallying against ingredients like phenylephrine for over a decade. They cite a large body of third-party peer-reviewed evidence that question the safety and efficacy of commonly marketed products. Applied Bio’s first product, Biovanta is a testament to their beliefs as it is formulated to work in an entirely different way than anything else on the market. For one, it targets inflammation, the root cause of cold symptoms and supports the respiratory barrier.
The question remains, given our expansive scientific progress, why are consumers still beholden to ineffective OTC remedies that are proven not to perform better than placebo and that don’t address the root cause of the sickness? Phenylephrine is supposed to block nerve signals on blood vessels and an FDA advisory panel just concluded that it does not do that effectively when administered orally. But even if it did, that would do nothing to shorten the duration of the common cold because cold symptoms are caused by inflammation of the respiratory membranes.
Building on the pressing concerns surrounding common OTC ingredients, Dr. Nazlie Latefi's foundational understanding in molecular biology comes into sharp focus. While the majority of the industry remained complacent, relying on outdated and now proven ineffective solutions, Dr. Latefi’s scientific pursuits had always aligned with a deeper understanding of respiratory health at the cellular level. This knowledge bridged the gap between scientific progress and the stagnant state of over-the-counter offerings, illuminating the role of addressing inflammation, the root cause of many respiratory issues.
Instead of temporary symptom relief, the emphasis now leans heavily towards understanding and targeting root causes. Now more than ever, the call for innovation grounded in solid scientific understanding becomes paramount.