WASHINGTON — The US Food and Drug Administration has announced a proposal to remove oral phenylephrine — a common ingredient in many popular over-the-counter decongestants — from the market, citing evidence that it doesn’t work.

Phenylephrine, found in products such as Sudafed PE, Vicks DayQuil, and Mucinex Sinus-Max, has been widely used as a nasal decongestant for decades. The FDA proposal is not an immediate order; is launching a six-month public comment period, after which the agency will make a final decision on whether to pull it off the shelves.

In a preemptive move, CVS stopped selling phenylephrine products last year after an FDA advisory panel said it was ineffective. Other major drugstores, including Walgreens and Rite Aid, still stock products containing the drug for now.

Although phenylephrine received FDA approval for over-the-counter use in the 1970s, its popularity increased in 2005 after legislation moved products that use a similar decongestant, pseudoephedrine — which, in large quantities, can also be used to make methamphetamine – behind pharmacy counters. .

The safety of phenylephrine is not a concern, but its effectiveness has been debated for years. In 2007, an FDA advisory panel that reviewed the available studies found that phenylephrine “may be effective” as a decongestant, although it recommended further research.

Since then, several large clinical trials have shown that the drug is ineffective when taken orally. In September 2023, an FDA advisory committee concluded that the evidence was clear that phenylephrine is ineffective at its typical oral dose.

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If the FDA ultimately decides to ban the ingredient, it will give manufacturers time to “either reformulate or remove drug products containing oral phenylephrine from the market,” Dr. Theresa Michele, director of the FDA’s Office of Nonprescription Drugs.

Phenylephrine is also used in nasal sprays to relieve congestion, but Michele noted that the FDA proposal only targets oral forms of the drug.

The Consumer Healthcare Products Association, which represents over-the-counter drug makers, said it was disappointed by the FDA’s move.

“CHPA maintains its position that no change to the GRASE (generally recognized as safe and effective) status of oral PE for nasal decongestant is warranted based on the data made available since the previous review in 2007. … PE is the only decongestant orally OTC. available without purchase restrictions and is included in many OTC cough and cold medicines labeled with a decongestant claim,” the association said in a statement.

“Consumers need options for self-care, and freedom of choice for self-care is a core attribute of our nation’s health care system. PE should remain an available option for consumers because Americans deserve the option to choose the safe and effective OTC medications available to them. prefer and rely on.”

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