July 4, 2025 The Best Source of News, Culture, Lifestyle for Culver City, Mar Vista, Del Rey, Palms and West Los Angeles

FDA Panel Deems Popular Nasal Decongestant Ineffective, May Impact OTC Medication Market

Unanimous Decision Raises Questions About Phenylephrine’s Efficacy

By Dolores Quintana

A unanimous decision by a Food and Drug Administration (FDA) advisory panel on Tuesday has cast doubt on the effectiveness of phenylephrine, a key ingredient in numerous over-the-counter cold and allergy medications, in alleviating nasal congestion. This is a conclusion that many people who suffer from sinus issues came to long ago. Phenylephrine, used in Sudafed PE, was a substitute for Pseudoephedrine, which has a common illegal and alternative use as an ingredient in the production of methamphetamine. Medicines that contain Pseudoephedrine were removed from over-the-counter sales in 2006. 

The panel’s vote, which specifically addressed the ineffectiveness of oral formulations of phenylephrine, is poised to disrupt the market for over-the-counter (OTC) cold and allergy remedies. These remedies, which predominantly rely on pill forms, are preferred by consumers. Phenylephrine is a common component in medications such as Sudafed PE, Vicks Nyquil Sinex Nighttime Sinus Relief, and Benadryl Allergy Plus Congestion. It stands as the most widely used oral decongestant in the United States, generating nearly $1.8 billion in sales in the previous year, as reported by FDA officials on Monday.

The panel’s vote aligns with the FDA’s comprehensive findings, which indicated that when taken orally, only a minute amount of phenylephrine actually reaches the nasal area to provide congestion relief.

Susan Blalock, an advisory committee member and retired professor at the UNC Eshelman School of Pharmacy in North Carolina, stated, “The evidence is quite compelling that this medication is ineffective. I believe no further data are necessary to support this conclusion.” The FDA must now determine whether to withdraw phenylephrine’s over-the-counter designation as “generally recognized as safe and effective.” This designation typically applied to older drugs, permits the inclusion of an ingredient in OTC products without requiring an FDA application.

Should the designation be revoked, products containing phenylephrine may be removed from store shelves, or manufacturers may need to develop alternative formulations. An FDA spokesperson declined to specify when the agency will make a final decision, though historically, the FDA tends to align with its advisory committees.
Jennifer Schwartzott, a patient representative from New York, commented, “This drug and its oral form should have been removed from the market long ago. The patient community requires and deserves medications that safely and effectively address their symptoms, and I do not believe this medication fulfills that need.”

Related Posts

(Video) A visit to New York Bagel & Deli in Santa Monica

July 3, 2025

July 3, 2025

Authentic NY Style Bagels with Extra Creamy Cream Cheese and Multi-Cultural Desserts. Located at 2216 Wilshire Blvd. A visit to...

Hot Dogs & Rosé: Something About Her and The Culver Hotel Roll Out Summer Specials

July 2, 2025

July 2, 2025

Westside Venues to Serve Playful Bites and Seasonal Sips For the Holiday Weekend A bold new offering is making its...

NeueHouse Hosts Bold One-Night Dinner With Culinary Phenomenon Diego Argoti

July 2, 2025

July 2, 2025

Acclaimed Chef Brings Culinary Mischief With a Five-Course Tasting Experience. NeueHouse Hollywood will host an exclusive, one-night-only dining event on...

(Video) Legacy, Reimagined: Architecture, Design & Construction by Home Front Build Los Angeles

July 2, 2025

July 2, 2025

Go To Homefrontbuild.com For More Information @home_front_build Legacy, Reimagined: Architecture, Design & Construction by Home Front Build Los Angeles Go...

405 Crash Near the Getty Sends Three to Hospital: Two Seriously Hurt Near Site Where LAPD Sgt. Died

July 2, 2025

July 2, 2025

Early Morning Multi-Vehicle Collision Shut Down Lanes Near Brentwood Three men were injured and traffic was snarled for hours following...

(Video) Jikoni, the AfriCali PopUp from celebrated cookbook author Kiano Moju Has Been Extended Until July 3 at Citizen Public Market

July 1, 2025

July 1, 2025

Bold Flavors and Spice Merge with Crisp, Chewy Chapati. Delicious With a Caring Chef and Staff. Jikoni, the AfriCali PopUp...

Pentagon Orders Troop Drawdown in LA: 150 National Guard Members Reassigned to Wildfire Duty

July 1, 2025

July 1, 2025

Federal Forces Begin Partial Withdrawal From Protest Response as California Leaders Push Back U.S. Northern Command announced Tuesday that 150...

California Highway Patrol Deploys for Independence Day Enforcement Surge

July 1, 2025

July 1, 2025

All Available Officers to Hit California Highways for Holiday Weekend As Californians gear up for Fourth of July festivities, the...

Court Postpones Arraignment for Driver in Malibu Crash That Killed Four Students

July 1, 2025

July 1, 2025

Fraser Michael Bohm Faces Murder Charges in Fatal PCH Wreck  The arraignment for Fraser Michael Bohm, the 23-year-old man accused...

(Video) Los Angeles County Supervisor from the 2nd district, Holly J. Mitchel, Gives a Powerful Speech

June 30, 2025

June 30, 2025

Supervisor Mitchell Called on Residents to take action at the rally for Ambrocio “Enrique” Lozano in Culver City.

Top Military Commander Urges Return of Troops Deployed to ICE Protest Response

June 30, 2025

June 30, 2025

General Requests 200 National Guard Soldiers Be Returned to California Wildfire Unit The senior U.S. military officer overseeing federal forces...

Second Victim Killed Alongside LAPD Sergeant in Brentwood 405 Crash Identified

June 30, 2025

June 30, 2025

Authorities Confirm Garcia, 34, Died at the Scene, GoFundMe Launched  Authorities have identified the civilian who was killed alongside a...

The Westside Lights Up for July 4: Fireworks, Drone Shows, and Parades Return Across West Los Angeles

June 30, 2025

June 30, 2025

From Marina Del Rey’s Fireworks to Culver City’s 1980s-Themed Drone Show, Get Ready to Celebrate From fireworks over Marina del...

California Judge Rules FAIR Plan’s Smoke Damage Policy Unlawful

June 29, 2025

June 29, 2025

Court Says Wildfire Insurance Program Illegally Denied Claims Legal protections for California homeowners took a step forward this week after...

(Video) Culver City Residents and City and County Leaders Rally for Disappeared Ice Cream Man Ambrocio “Enrique” Lozano

June 29, 2025

June 29, 2025

US Representative for California’s 37th Congressional District, Sydney Kamlager-Dove Speaks About What is happening to the disappeared.