Finally! FDA Targets Useless Ingredient in Decongestants

For years, popular over-the-counter decongestants like Sudafed, Mucinex, and NyQuil have promised to relieve stuffy noses using phenylephrine.

Phenylephrine is an active ingredient that, as it turns out, does very little to help.

After nearly two decades of back-and-forth, the FDA has FINALLY taken a significant step toward removing this ineffective drug from our cold and flu options.

The FDA’s proposed order targets phenylephrine, which can be found in around 80% of oral decongestants on store shelves today.

After reviewing extensive evidence, FDA experts agree: phenylephrine in tablet form is essentially no more effective than a sugar pill when it comes to clearing up nasal congestion.

Phenylephrine first entered the market in the 1970s, but since then, independent studies have shown it can’t do what it claims.

It’s mostly broken down in the gut before it ever reaches the nasal passages, rendering it practically useless for relieving stuffiness. In recent trials, even quadrupling the dosage didn’t make a difference in effectiveness.

This move may be long overdue, but it addresses a deeper issue: when pseudoephedrine (the more effective ingredient) became restricted in the early 2000s, drug companies scrambled to find an alternative, pushing phenylephrine to the forefront of the market.

The result? Billions of dollars spent by consumers on products that don’t truly work.

Phenylephrine is only effective when applied directly to the nasal passages or eyes, so nasal sprays and eye drops are still valid options.

But for oral tablets? It’s all but proven to be a dud.

The FDA’s proposal has been put out for public comment, so manufacturers aren’t required to pull products just yet.

But companies are on notice, and we’re likely to see an overhaul of the cold and flu aisle soon. The market share for these products was worth a staggering $1.76 billion in 2022 alone, so there’s little doubt that manufacturers will need to either reformulate or make their case for a new solution.

For consumers looking for real relief this cold and flu season, consider some natural or alternative methods in the meantime:

• Humidifiers can keep nasal passages moist, helping relieve stuffiness naturally.
• Eucalyptus oil in a diffuser can also open up nasal passages.
• Hydration and warm liquids like herbal teas or soups can soothe and support a healthy respiratory system.

It’s a relief to see the FDA finally stepping up for consumers. While Big Pharma has long profited from an ineffective solution, we may soon see a shift in the types of products available to help us fight cold and flu symptoms.

For now, keep an eye out for natural options and keep your nose open to effective alternatives!

If you’ve been buying oral decongestants with phenylephrine, it might be time to rethink your options this season.

To effective solutions,

Rachel Mace
Managing Editorial Director, e-Alert
with contributions from the research team

P.S. Click here for an all-natural trick to survive this cold and flu season…

Sources:

Cassella, C. (2024, November 11). FDA to Finally Ban Controversial Ingredient in Popular Decongestants. ScienceAlert. https://www.sciencealert.com/fda-to-finally-ban-controversial-ingredient-in-popular-decongestants