Many popular over-the-counter cold and flu remedies face being pulled from shelves in the United States after the drug regulator deemed a key ingredient ineffective.

On Thursday, the Food and Drug Administration (FDA) said oral phenylephrine is not an effective nasal decongestant.

Phenylephrine is the main decongestant ingredient in soluble and tablet cold and flu medications such as Lemsip, Beechams and Sudafed.

It is believed to work by reducing the swelling of blood vessels in the nasal passages.

Other ingredients, like paracetamol, help lower temperatures and relieve aches.

The FDA said it reached its conclusion after a “thorough review of available data.”

The decision does not affect medicines available in the UK, with Dr Alison Cave, head of safety at the Medicines and Healthcare products Regulatory Agency (MHRA), saying there is “no safety issue” regarding phenylephrine products and that “people can continue to use them as directed.”

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A panel of FDA advisers concluded it was ineffective a year ago after research at the University of Florida showed phenylephrine products were no more effective than placebo pills for relieve symptoms.

Dr. Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research, said, “We are taking this next step in the process by proposing to phase out oral phenylephrine because it is not effective as a nasal decongestant. »

The decision is not final, he adds, meaning U.S. retailers can still stock drugs containing the drug.

But if it becomes permanent, U.S. stores and websites would be banned from selling drugs containing phenylephrine and drug companies would be forced to produce nasal decongestants instead — or find a different ingredient for oral remedies.

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US industry body the Consumer Healthcare Products Association said banning oral phenylephrine would have a negative impact on consumers.

Michelle Riddalls, chief executive of the UK’s Consumer Healthcare Association, which represents UK drugmakers, told Sky News: “We understand that consumers may be concerned or confused by the news about phenylephrine (PE) and what this could mean for them and their families. , especially this time of year, with cough, cold and flu season upon us.

“Consumer safety is paramount to our members, including those who manufacture products containing phenylephrine. We want to reassure consumers that the FDA consultation is not related to a safety issue.

“Healthcare professionals and consumers have trusted nasal decongestants containing PE for decades and are still available to help treat the symptoms of common respiratory infections, such as coughs, colds and flu.”

Sky News has contacted Lemsip, Beechams and Sudafed for comment.