Public Citizen Calls for Ban of “Ineffective” Nasal Decongestant in Sudafed, Tylenol and Other Popular Cold Medications

Researchers say it would be a “disservice” to consumers if the FDA leaves the ineffective nasal decongestant on the market, indicating widespread cold medication recalls are necessary

A prominent consumer watchdog group wants federal drug regulators to ban the nasal decongestant used in Sudafed, Tylenol and other popular over-the-counter cold medications, following a determination by a panel of scientists that it does not work.

Last week, the U.S. Food and Drug Administration (FDA) Nonprescription Drugs Advisory Committee (NDAC) unanimously determined that the nasal decongestant phenylephrine is ineffective when taking orally through pills, tablets or liquids, despite being sold on the market in expensive cold medications for decades.

As a result, the group Public Citizen issued a press release on September 15, calling for the agency to remove the decongestant from the market. If the FDA decides on a phenylephrine ban, it could lead to recalls impacting more than 250 cold and flu drugs, including brand-name and generic versions of products like NyQuil, Tylenol, Mucinex, Theraflu and Benadryl.

While the FDA is not required to follow the recommendations made by its advisory committees, the agency usually does.

Public Citizen Testimony Highlighted Nasal Decongestant’s Ineffectiveness

During the advisory committee hearing held earlier this month, Public Citizen’s Health Research Group submitted testimony calling for a vote against phenylephrine’s continued use on the market. The testimony noted that the bioavailability of the decongestant was less than 1% when taken orally, because the body breaks the drug down during absorption, making it less effective than nasal sprays and other forms of delivery.

“That this placebo-like, decades’ old drug remains on pharmacy shelves is a disservice to the millions of Americans who bought this drug in 2022 alone and many others who will likely purchase it in the coming weeks and months,” said Dr. Azza AbuDagga, a health services researcher with Public Citizen. “We now urge the FDA to prioritize prompt removal of all oral phenylephrine-containing products from the U.S. market – a process that must include a robust educational campaign about the inefficacy of these products and the availability of several effective treatment alternatives, including nasal phenylephrine.”

Nasal sprays containing the ingredient are still considered effective because they have a much larger bioavailability when compared to pills or liquids. They would likely continue to be sold on the market regardless of the FDA’s decision regarding cold and flu tablets and other oral medications.

The alternative is pseudoephedrine, which is used for hay fever or allergic rhinitis. However, sales are restricted, and it is placed behind the counter and in locked cabinets because it is frequently used as an ingredient in illegal methamphetamines, known more commonly as meth.

The number of pseudoephedrine tablets that can be purchased at one time is capped, and consumers must be 18 years or older and show ID. It is known to raise blood pressure and cause jitters and wakefulness.

Cold medication manufacturers now face the prospect of having to reformulate hundreds of products if phenylephrine is banned, which they warn could raise cold medication prices and affect product availability. In addition, they also face a growing number of nasal decongestant class action lawsuits by consumers who say they paid premium cold medication prices for decades for a drug that did not work.