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, doesn’t actually relieve nasal congestion. It comes more than a year after advisors to the FDA 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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a release.
The FDA said the proposed order is not based on safety concerns and not final yet, which means companies can still market over-the-counter drugs containing oral phenylephrine for now. But a final decision would force pharmacies to clear 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 pull certain medicines containing oral phenylephrine.
A final order would also require drugmakers such as Procter & Gamble, Bayer, 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 scramble to seek out spray versions of the drug, or other medications with different ingredients, both of which the FDA’s decision does not affect.
Retail stores such as CVS and Walgreens could also take a hit: Those stores sold 242 million bottles of drugs containing phenylephrine in 2022, which generated 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 medicines, allows drugmakers to include an ingredient in over-the-counter products without the need to file an FDA application.
The meeting of FDA advisors last year was prompted by researchers at the University of Florida, who petitioned the agency to remove phenylephrine products from the market based on studies showing they failed to outperform placebo pills in patients with cold and allergy congestion.
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 documents posted ahead of the panel meeting last year, concluded that oral formulations of phenylephrine don’t work at standard or even higher doses. The staff said only a very small amount of phenylephrine actually reaches the nose to relieve congestion.
Representatives for the Consumer Healthcare Products Association, a group that represents over-the-counter drug manufacturers, did not offer any new evidence to counter the FDA staff’s conclusion about phenylephrine during the meeting last year.
But the group argued that pulling oral phenylephrine from the market would be a significant burden to consumers.
The group shared a survey that found 1 in 2 households in the U.S. used an oral decongestant over the last year. It also found people prefer oral decongestants over nasal spray by a 3-to-1 margin.
Phenylephrine became the main decongestant in over-the-counter cold and allergy medicines in 2006, when sales of another decongestant, pseudoephedrine, were restricted in the U.S.
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.