CVS removing decongestant from shelves after FDA panel says it's ineffective

The panel voted that phenylephrine works no better than a placebo.

October 20, 2023, 2:03 PM

CVS Health is planning to remove one type of a common decongestant from shelves after an advisory committee to the U.S. Food and Drug Administration said it was ineffective earlier this year.

The products contain the oral formulation of phenylephrine (PE), which is found in several over-the-counter (OTC) medications.

Although PE has been used as a decongestant for nearly a century, experts have been questioning its efficacy for years.

The FDA Nonprescription Drugs Advisory Committee unanimously voted in September that PE did not improve nasal congestion any more than a placebo at the dosage given for OTC use.

In response, CVS said it is removing products, in which PE is the only active ingredient, from store shelves. This means products like Dayquil, which uses a combination of active ingredients, will remain available for purchase.

Walgreens pharmacy, over-the-counter medicine, cough, cold and flu relief.
Jeff Greenberg/Universal Images/Getty Images

"We are aware of the FDA Advisory Committee's position on oral phenylephrine (PE) and will follow direction from the FDA to ensure products we sell comply with all laws and regulations," CVS Health said in a statement. "We are removing certain oral cough and cold products that contain phenylephrine as the only active ingredient from CVS Pharmacy stores. Other oral cough and cold products will continue to be offered to meet consumer needs."

CVS did not give specifies on brands that will be removed.

The FDA told ABC News it has not yet determined whether it no longer considers PE to be a safe and effective medication and has not ordered the product to be removed from shelves. CVS's move is voluntary.

"The FDA has no further information to provide at this time regarding the timing of any decision the agency may make following the advisory committee meeting," the federal health agency said.

The Consumer Healthcare Products Association told ABC News that the advisory committee's recommendation is a non-binding decision and not a change in regulation.

"FDA is currently in the process of reviewing the regulatory status of oral phenylephrine (PE) following September's advisory committee meeting," CHPA said in a statement. "Until FDA makes a determination on the committee's recommendation, oral PE remains a Category 1 OTC ingredient, which is generally recognized as safe and effective."

Concerns were first raised about PE in 2007. Since then, evidence has accumulated showing that the drug offers little to no relief for nasal congestion.

Experts believe this is because the body processes the drug before it reaches the nasal passages where it needs to work.

It's unclear if other major retail pharmacy chains will follow in CVS's footsteps.

Walgreens Boots Alliance would not disclose whether it is planning to remove products with PE from store shelves and said it would defer to the FDA.

"Walgreens follows FDA regulations. We are closely monitoring the situation and actively partnering with the Walgreens Office of Clinical Integrity and suppliers on appropriate next steps," a Walgreens spokesperson told ABC News.

Other major pharmacy chains including Albertsons, Costco and Kroger did immediately reply to ABC News' request for comment. Walmart did not have an answer immediately available.

ABC News' Sasha Pezenik and Sony Salzman contributed to this report.