The FDA suggests stopping the use of decongestants found in many cold medications

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

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

Based on the data, “we are taking this next step in the process of proposing the removal of 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, in a 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 decision would force pharmacies to clear the shelves of hundreds of products containing oral forms of the ingredient, which is found in versions of drugs such as NyQuil, Benadryl, Sudafed and Mucinex.

Last year, CVS said it has already moved to withdraw certain drugs that contain oral phenylephrine.

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 struggle to find spray versions of the drug or other drugs with different ingredients, both of which are unaffected by the FDA’s decision.

Retail stores like CVS and Walgreens could also be hit: Those stores sold 242 million bottles of medicine containing phenylephrine in 2022, generating nearly $1.8 billion in sales, according to a presentation by FDA staff last year.

The FDA could specifically revoke the drug’s over-the-counter designation as “generally recognized as safe and effective.” The designation, typically used for older medications, allows drug manufacturers to include an ingredient in over-the-counter products without having to file 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 that showed they performed no better than placebo pills in cold and allergy patients overload.

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

However, FDA staff concluded in briefing documents released ahead of the panel meeting last year 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 actually reaches the nose to relieve congestion.

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

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

The group shared a study 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 main decongestant in over-the-counter cold and allergy medications in 2006 when sales of another decongestant, pseudoephedrine, were restricted in the US

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