The FDA is proposing to end the use of the decongestant found in many cold medicines

The Food and Drug Administration on Thursday proposed ending the use of a common ingredient found in many popular over-the-counter cold and allergy medications.

The agency said an extensive review of available data determined that the ingredient, oral phenylephrine, does not relieve nasal congestion. It comes more than a year after FDA advisers unanimously reached the same conclusion.

Based on the data, “we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. release

The FDA said the proposed order is not based on safety concerns and is not yet final, meaning companies can still market over-the-counter drugs containing oral phenylephrine for now. But a final ruling would force pharmacies to clear shelves of hundreds of products containing oral forms of the ingredient, which is found in drug versions such as NyQuil, Benadryl, Sudafed and Mucinex.

last year, CVS said it has already moved to withdraw some oral phenylephrine-containing drugs.

A final order would also require drug manufacturers such as Procter & GambleBayer, and Johnson & Johnson spinoff Kenvue to reformulate many of their oral cold and allergy products.

Phenylephrine is thought to relieve congestion by reducing the swelling of blood vessels in the nasal passages. Without oral phenylephrine on the market, patients will likely seek spray versions of the drug, or other medications with different ingredients, both of which are unaffected by the FDA’s decision.

Retail stores like CVS and Walgreens may also take a hit: Those stores sold 242 million bottles of phenylephrine-containing drugs in 2022, which generated nearly $1.8 billion in sales, according to a presentation by FDA staff last year.

The FDA can specifically revoke the designation of an over-the-counter drug as “generally recognized as safe and effective.” The designation, typically used for older drugs, allows drug manufacturers to include an ingredient in over-the-counter products without having to submit an FDA application.

The meeting of FDA advisers last year was prompted by researchers at the University of Florida, who asked the agency to remove phenylephrine products from the market based on studies showing they failed to outperform placebo tablets in patients with congestion. cold and allergies.

The same researchers also challenged the drug’s effectiveness in 2007, but the FDA allowed the products to remain on the market pending additional research.

However, FDA staff, in briefing papers posted before the panel’s meeting last year, concluded that oral formulations of phenylephrine do not work at standard or even higher doses. The staff said that only a very small amount of phenylephrine reaches the nose to relieve congestion.

Representatives of the Consumer Healthcare Products Association, a group that represents over-the-counter drug manufacturers, did not offer any new evidence to dispute the FDA staff’s conclusion on phenylephrine during last year’s meeting.

But the group argued that pulling oral phenylephrine from the market would be a significant burden on consumers.

The group shared a survey that found 1 in 2 US households used an oral decongestant in the past year. It also found that people prefer oral decongestants to nasal sprays by a 3-to-1 margin.

Phenylephrine became the leading decongestant in over-the-counter cold and allergy medicines in 2006, when sales of another decongestant, pseudoephedrine, were restricted in the US.

Pseudoephedrine was moved behind the pharmacy counter because it can be misused to make methamphetamine, a highly addictive stimulant drug that affects the central nervous system.