FDA Finally Bans Controversial Ingredient in Popular Decongestants: ScienceAlert

Sudafed, Mucinex, Benadryl, Advil, Tylenol, Vicks and Dimetapp.

These popular brand names appear on oral decongestants that are staples in American drugstores for colds and flu, and yet many contain an ingredient that doesn’t work as promised.

The U.S. Food and Drug Administration (FDA) has now proposed an order to remove oral phenylephrine from every single cold, cough, allergy, bronchodilator and anti-asthma medication available today, about four-fifths of all oral ones decongestants.

The proposal is now open for public comment, and if the ruling is final, it would dramatically change the drug formulations contained in hundreds of over-the-counter oral decongestants available in the country – a market share of about $1.76 billion in 2022.

Popular products affected by the proposal include Advil Sinus Congestion & Pain, Sudafed PE Nasal Decongestant, Vicks DayQuil and NyQuil, and Tylenol Cold & Flu Severe, to name a few.

The proposed regulation comes a year after an independent FDA advisory panel unanimously concluded that while oral phenylephrine was safe, it was no better than a placebo for clearing a stuffy nose.

For nearly two decades, some scientists have called for the removal of oral phenylephrine from the market. However, the last time the FDA reviewed the drug, it kept the drug on the shelves.

“It is the FDA’s job to ensure that drugs are safe and effective,” said Patrizia Cavazzoni, director of the agency’s Center for Drug Evaluation and Research (CDER).

“Based on our review of the available data and consistent with the advice of the Advisory Committee, we are taking this next step in the process and proposing the removal of oral phenylephrine because it is not effective as a nasal decongestant.”

To understand how such a large portion of the drug market came to be dominated by a useless decongestant, one must look back at the history of cold and flu medications.

Phenylephrine was first approved by the FDA in 1976 as a safe and effective decongestant, based on largely industry-funded studies whose methodology has since been criticized.

Before 2006, pseudoephedrine was the main ingredient in over-the-counter decongestants. In the early 2000s, a federal law required states to adopt comprehensive measures to control sales of the drug because of concerns that it was being used in the production of methamphetamine.

Since then, local laws either require a prescription for medications containing pseudoephedrine or impose limited quantities that can be sold over the counter.

Following this ruling, pseudoephedrine was replaced by phenylephrine in over-the-counter decongestants in drugstores, grocery stores, and convenience stores across the country.

In 2005, some scientists reviewed existing evidence that showed that phenylephrine did not clear nasal congestion when taken orally at the recommended dosage.

In 2007, a citizen petition asked the FDA to require better evidence of effectiveness. At the time, however, administration officials called for more research into higher doses.

As of 2015, clinical trials attempted to quadruple the dosage of oral phenylephrine, but the drug still proved useless as a decongestant, prompting another citizen to petition to remove these products from the market.

Now, after years of debate, the agency is convinced by overwhelming evidence. Last year, the FDA committee analyzed three large clinical trials that showed oral phenylephrine is not effective at any dosage.

Studies show that even when taking higher doses, almost no drug gets into the nasal passages. Most of the breakdown takes place in the intestines.

The proposed order to remove phenylephrine from oral decongestants does not apply to nasal sprays or eye drops. These products deliver the same medication in a way that is more effective than an oral tablet.

But most consumers are unaware of these differences. In 2022, more than 242 million cold medicines containing phenylephrine were sold in the United States – more than four times as many as pseudoephedrine.

Because this is a proposed regulation, the FDA is not requiring companies to do anything yet. However, they will be informed of further measures that will soon result in them withdrawing from the market products that contain phenylephrine as the only active ingredient.

A list of oral decongestants containing phenylephrine can be found here.