FDA advisers say phenylephrine doesn't work — so why do DayQuil, Theraflu and other popular decongestants still include it?

With cold and flu season about to kick into high gear, it’s time to restock our medicine cabinets. But you may want to reconsider buying one longtime favorite, which is still available at some stores.

It’s been one year since advisers to the Food and Drug Administration unanimously concluded that phenylephrine — a decongestant found in products by familiar brands including Sudafed PE, Vicks DayQuil and Theraflu — is not actually effective.

So why are you still seeing medications with phenylephrine on pharmacy store shelves? Yahoo Life spoke with the FDA and top pharmacies to get the latest on where things stand.

Here's a recap of what happened

In September 2023, an FDA advisory committee of 16 experts held a two-day meeting, which culminated with the announcement that oral phenylephrine is not effective, and works no better than a placebo pill at relieving congestion.

As Yahoo Life reported last year, when taken in oral form, phenylephrine is metabolized so quickly that the amount absorbed into the bloodstream ends up being less than 1% of what was originally ingested, which experts concluded is not enough to be effective.

It’s important to note that the FDA advisory committee didn’t review nasal sprays or drops containing phenylephrine, so the announcement didn’t affect those forms of medications. The panel also didn’t find any safety concerns about oral phenylephrine, so if you’ve taken it in the past, you don’t need to worry.

The advisory panel’s conclusion wasn’t a surprise to many experts in the field, who had been flagging efficacy concerns about phenylephrine for years.

Brigid Groves, the American Pharmacists Association (APhA) vice president of professional and regulatory affairs, tells Yahoo Life that the APhA had submitted comments in support of removing oral phenylephrine from nasal decongestant products before the advisory committee meeting began.

“Pharmacists are aware of the lack of efficacy of oral phenylephrine because they see it firsthand,” Groves says.

If phenylephrine doesn't work, why are you still seeing it on store shelves?

The FDA advisory committee’s decision is nonbinding — meaning the FDA itself makes the final decision on whether oral phenylephrine is considered effective. So far, the FDA hasn’t put in a final order that would require manufacturers to reformulate or discontinue products containing oral phenylephrine.

“At this time, the status of phenylephrine as generally recognized as safe and effective (GRASE) has not changed,” an FDA spokesperson tells Yahoo Life. “However, the FDA’s advisory committee provided advice and recommendations on the information currently before the agency that could inform future agency action.”

Until the FDA says otherwise, Groves says it’s still up to individual pharmacies and businesses whether they want to continue selling oral phenylephrine products.

Last October, a few weeks after the FDA advisory committee’s conclusion, CVS Health announced that the pharmacy chain would be removing certain phenylephrine products from stores. In a statement to Yahoo Life, CVS confirmed that they have “removed oral decongestant products that contained phenylephrine as the only active ingredient from CVS Pharmacy stores … but continue to offer many other oral cough and cold products to meet consumer needs.”

When Yahoo Life asked rival pharmacy chain Walgreens if they have chosen to remove oral phenylephrine products from store shelves, a spokesperson said: “We work with our suppliers to follow FDA regulations and guidelines.”

Will phenylephrine ever disappear entirely? What are next steps?

The FDA’s September 2023 annual forecast — a nonbinding list, issued each year, of planned activities that the FDA intends to initiate over the next three years — indicated the agency’s intention to issue a proposed order on over-the-counter (OTC) oral phenylephrine.

An FDA spokesperson explains to Yahoo Life that if the agency decides that oral phenylephrine is no longer considered “generally recognized as safe and effective” (or GRASE) as an over-the-counter nasal decongestant, the agency would initiate a multistep process involving a proposed order, a 180-day comment period and then a final order. The public would have the opportunity to comment on the proposed order and to provide any additional data for the FDA to consider. Only after the FDA issues a final order would manufacturers be required to reformulate or remove over-the-counter oral phenylephrine products.

But that process could take a while — and the FDA doesn’t have a track record of moving swiftly when it comes to phenylephrine.

“This concern is not new,” Dr. Gailen Marshall, president of the American College of Allergy, Asthma and Immunology, tells Yahoo Life. “FDA first expressed concern about oral phenylephrine effectiveness in 2007 and it did not convene the advisory panel to consider this product’s lack of effectiveness until April 2023.”

What should you use instead?

If you’re congested, there are plenty of effective alternatives to oral phenylephrine.

“There’s so many other products out there that really do work,” Dr. James Tracy, vice president of the American College of Allergy, Asthma and Immunology, previously told Yahoo Life. “Almost all the nasal sprays, like nasal antihistamine sprays, they all work and they are also over-the-counter, but they don’t say ‘decongestant.’”

In addition to steroid nasal sprays and antihistamine sprays, Tracy says phenylephrine is still considered effective in nasal spray form — though Tracy warns it can be “habit-forming” if used regularly.

The most common oral decongestant that experts recommend is pseudoephedrine, though you’ll likely need to ask a pharmacist for help accessing it behind the counter.