After FDA experts smack down ineffective decongestant, class-action lawsuits fly

Questions first circulated about decongestant pills containing phenylephrine in 2007. Sixteen years later, the products may be pulled from shelves nationwide as experts have concluded they don't work.

But when did the sellers of the cold and flu products know?

That’s the question before a U.S. federal court in Florida, where a plaintiff has filed a class-action lawsuit against Johnson & Johnson Consumer Inc. and Procter & Gamble. Steve Audelo claims that the companies knew that Sudafed PE, Vicks NyQuil and Benadryl Allergy Plus Congestion—all over-the-counter products containing phenylephrine—did not work as advertised.

“As a result of the defendants’ false and deceptive marketing, plaintiff and the class members suffered economic damages, including the cost of purchasing the product,” the lawsuit says.

After a recent spinoff, J&J's consumer division is now known as Kenvue, an independent and publicly traded company.

In a New Jersey federal court, Walgreens, Kenvue and Procter & Gamble were among the companies named in a separate filing.  

“There’s a serious problem when a ‘decongestant’ doesn’t ‘decongest,’ and the FDA’s recent findings are a prime example of how the pharmaceutical industry makes billions by knowingly selling questionable products to consumers who are suffering from specific ailments,” Adam Levitt, founding partner of DiCello Levitt, said in a statement.

The lawsuits come in response to an FDA advisory committee agreeing by a 16-0 vote on Tuesday that products containing phenylephrine are ineffective. The FDA will now decide whether to ban the products. Products that include the ingredient—some 242 of them—generated $1.76 billion in sales in 2022, the FDA said this week.

Data presented to the panel showed that phenylephrine performed no better than placebo in relieving congestion. Phenylephrine is designed to reduce the swelling of blood vessels, but the committee concluded that when the drug is taken orally, not enough reaches the nasal passages.

The FDA’s scrutiny of phenylephrine began in 2007, when the Nonprescription Drugs Advisory Committee came to a similar conclusion on its ineffectiveness. While four subsequent studies showed the ineffectiveness of phenylephrine when taken as a pill, there was enough variability in the results to raise questions about how the studies were conducted.

Editor's note: This story was corrected to remove references to branded pharmaceutical companies that have spun off their consumer divisions.