FDA Calls for Removal of Ineffective Oral Phenylephrine Nasal Decongestants from Stores

Following an extensive, year-long evaluation of the safety and effectiveness of the nasal decongestant phenylephrine, federal regulators have announced that they intend to remove all medications that contain the ingredient in an oral pill from store shelves in the U.S.

Phenylephrine is a widely used nasal decongestant, which can be found in versions of Sudafed, Benadryl, NyQuil, Mucinex, TheraFlu and other popular cold medicines. However, in September 2023, a panel of scientific FDA advisors determined that the nasal decongestant does not actually work when taken orally, despite decades of marketing claims by drug manufacturers.

In a proposed order (PDF) published this week in the Federal Register, the U.S. Food and Drug Administration (FDA) is now moving for a phenylephrine ban, which would remove versions of the oral nasal decongestants from store shelves.

The agency stresses that there are no safety risks associated with the medications, only concerns that they are ineffective. Therefore, the drugs will be allowed to remain on the market until the order for their removal is finalized.

Since concerns about the effectiveness of phenylephrine first emerged last year, dozens of nasal decongestant lawsuits have been filed by consumers throughout the federal court system, each raising similar allegations that pharmaceutical manufacturers sold the nasal decongestant for decades, even though it does not work or provide any established benefits.

Phenylephrine Ineffectiveness

Phenylephrine, which has been on the market for 30 years, is supposed to constrict blood vessels in the nasal passages to help relieve congestion. Between 2012 and 2021, nearly 20 billion units of phenylephrine were sold to consumers, who believed the ingredient was effective.

However, last year the FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously to inform the agency that phenylephrine is no more effective than a placebo. The advisory committee determined that only 1% of phenylephrine actually affects the body when taken orally. Previously, it was believed that the decongestant’s bioavailability was closer to about 38%, but the committee determined that estimate was made using outdated technology.

“It is the FDA’s role to ensure that drugs are safe and effective,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a press release issued this week. “Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant.”

Nasal sprays containing the ingredient are still considered effective, because they have a much larger bioavailability, when compared to pills or liquids. Therefore, these nasal decongestant sprays will remain on the market in the U.S.

The agency has been under pressure from both sides of the issue, with consumer protection groups like Public Citizen urging the FDA to remove the products as soon as possible, arguing that leaving them on store shelves allows drug manufacturers to fleece consumers for a product that doesn’t work. However, manufacturers, and some researchers, argue that a phenylephrine ban would lead to the removal of most multi-symptom products from U.S. shelves, affecting products with other ingredients that are effective against other cold symptoms.

Experts predict that the drug manufacturers will have to remove the products from store shelves or reformulate them with different nasal decongestant ingredients. That could take a significant amount of time.

The FDA is accepting electronic public comments on the proposed rule until May 7, 2025.

Nasal Decongestant Lawsuits

Since a number of class action lawsuits were filed by consumers in the wake of the revelations about phenylephrine’s ineffectiveness, all nasal decongestant lawsuits were consolidated in an MDL in December 2023, and the claims have been centralized before U.S. District Judge Brian M. Cogan in the Eastern District of New York for discovery and pretrial proceedings.

As part of the coordinated management of the nasal decongestant MDL, it is expected that Judge Cogan will establish a “bellwether” program, where a small group of representative cases are prepared for early trial dates, to help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout various cases in the litigation.

If no nasal decongestant settlement agreement or other resolution is reached during the MDL pretrial proceedings, each individual claim may later be remanded back to the U.S. District Court where it was originally filed for trial.