The drug suzetrigine, known by its brand name Journavx, works by targeting pain signals before they reach the brain.

Its manufacturer Vertex Pharmaceuticals said this enables it to provide effective relief for moderate to severe pain without “the addictive potential of opioids”.

The US has been grappling with a painkiller-addiction crisis for years. In 2017 US President Trump called it a “national shame” and declared a public health emergency .

The FDA said clinical trials had showed that Jounavx reduced pain after surgery, and called its approval “an important public health milestone in acute pain management”.

Every year, tens of thousands of Americans die from opioid use, with 82,000 opioid-involved overdose deaths in 2022, according to the US Center for Disease Control and Prevention (CDC).

Now in his second term, President Trump has said he will hit imports from Canada and Mexico with 25% border taxes in part to address the large amounts of fentanyl – a powerful synthetic opioid – crossing into the country.

The president has also threatened to impose tariffs on China, citing the country’s fentanyl exports as a reason.

Opioids work by stimulating opioid receptors in the brain, blocking pain signals.

During the process, the brain also floods with the neurotransmitter dopamine, creating feelings of euphoria and activating the brain’s reward system.

This makes opioids highly addictive. Vertex estimates nearly 10% of acute pain patients treated initially with an opioid will go on to have prolonged opioid use.

But Journavx works in a different way,by blocking pain signals before they reach the brain.

Vertex says the drug is the first in a new class of pain medicine to be approved in more than 20 years.

Its chief executive Reshma Kewalramani called the approval an “historic milestone for the 80 million people in America who are prescribed a medicine for moderate-to-severe acute pain each year”.

Journavx will cost $15.50 (£12.50) per capsule, the company said, adding it is not yet known whether the drug “is safe and effective in children”.

Manufacturers will no longer be allowed to use the dye, called red No 3 or red dye 3, after studies linked it to cancer in male laboratory rats, the US Food and Drug Administration (FDA) announced on Wednesday.

While normal exposure to the dye is much lower in humans than in the rats in the studies, US law requires a ban if any link to cancer is found.

The dye is used primarily in candy, cakes, cookies, frozen desserts and frosting as well as some medicines, the agency said.

The ban is a result of a petition filed in 2022 by a number of groups, including the Center for Science in the Public Interest. They argued the dye should be barred due its links to cancer and its widespread use by US consumers, specifically children.

Red No 3 was banned in cosmetics 35 years ago by the FDA. California also banned the additive in food products in October 2023.

It’s restricted in countries outside the US, like Australia, New Zealand and the European Union.

The FDA’s ban is “long-delayed”, said the Center for Science in the Public Interest, a US-based a non-profit consumer advocacy group that has long pushed for the ban.

“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” said the group’s president, Dr Peter Lurie, in a statement on Wednesday.

Food manufacturers using red No 3 will have until January 2027 to reformulate their products, while drug manufacturers will have an extra year – until January 2028 – to adjust.

Food imported into the US also will have to comply with the new ban, the FDA said.

Red No 3, also known as erythrosine or red dye 3, has been used in a number of candies, baked goods, fruit products and beverages.

Coloured candies – like Pez – include the additive as an ingredient. It also has been used in toaster pastries, maraschino cherries, and some sodas and fruit-flavoured drinks.

The additive was used in cough syrups and gummy vitamins to give them a bright red colour.

Some manufacturers already have phased out using the dye in their products, like Dole, which eliminated it from its fruit bowls in 2023.

Instead of red dye 3, some companies have started using red dye 40, which is considered a healthier alternative, though one study linked it to an increase in bowel disorders in mice.

Another study by the UK’s Food Standards Agency linked red dye 40 to increased hyperactivity in children. The additive was banned in California schools as of last year.

On Saturday, The Associated Press news agency published a statement from a spokesperson for Robert F Kennedy Jr, whom Trump has nominated to lead the Health and Human Services Department.

In the statement, Kennedy’s camp attempted to distance the nominee from a New York Times report that his lawyer Aaron Siri had petitioned to suspend approval for the life-saving vaccine.

“Mr Kennedy believes the Polio Vaccine should be available to the public and thoroughly and properly studied,” Katie Miller, Kennedy’s spokesperson, said.

But The New York Times article has raised alarm about Kennedy’s nomination to Health and Human Services, a department whose mission is to enhance the “health and well-being of all Americans”.

Kennedy, like Siri, is a vocal vaccine sceptic. In 2020, at the height of the COVID-19 pandemic, Kennedy helped spread doubts about vaccines designed to protect against the deadly virus, calling them “shoddily tested” and potentially “deadly”.

And in 2019, when a measles outbreak killed more than 80 children in Samoa, Kennedy wrote to the Samoan prime minister implying that a “defective vaccine” could be to blame.

He has also pushed conspiracy theories that link vaccination to autism, a widely debunked belief.Kennedy has long denied being anti-vaccine, arguing instead that he simply wants to ensure vaccine safety. But members of his own family have spoken out against his track record of spreading vaccine misinformation.

In the 2024 presidential race, Kennedy ran on an independent ticket, before suspending his campaign in August and throwing his support behind Trump.

Afterwards, he became a prominent Trump surrogate, appearing numerous times on the campaign trail with the Republican leader.Trump, in turn, teased early on that he would nominate Kennedy to his administration.

“I’m going to let him go wild on health,” Trump said at an October campaign stop at Madison Square Garden in New York. “I’m going to let him go wild on the medicines.”

Trump’s decision to pick Kennedy to head Health and Human Services has raised concern in the medical community about the future of efforts to limit the spread of preventable illness.

Those concerns were amplified on Friday, with The New York Times report. The article resurfaced a 2022 petition Siri made to the Food and Drug Administration to rescind the polio vaccine’s approval, along with that of other vaccines.

Polio is a highly infectious disease, capable of causing paralysis and death. There is no cure once infected, but vaccines can prevent its spread.

Siri has enjoyed a close relationship with Kennedy. The two campaigned together during Kennedy’s bid for office, and NBC News reported that Kennedy mulled appointing Siri as his attorney general, had he succeeded in winning the White House.

The backlash to Friday’s report was swift, with bipartisan condemnation pouring in.

Senate Minority Leader Mitch McConnell, a Republican, issued a statement on Friday warning that any effort to discredit the polio vaccine could threaten the nominee’s Senate confirmation hearing.

He did not mention Kennedy by name, but McConnell, 82, is known to be a survivor of childhood polio, which left his left leg briefly paralysed.

“Efforts to undermine public confidence in proven cures are not just uninformed — they’re dangerous,” McConnell wrote.

“Anyone seeking the Senate’s consent to serve in the incoming administration would do well to steer clear of even the appearance of association with such efforts.”

Democrats likewise criticised Kennedy’s association with Siri.

“Say goodbye to your smile and say hello to polio,” Senator Elizabeth Warren said in a video posted to social media. “This is a man who wants to stop kids from getting their polio and measles shots.”

Another senator, Chuck Schumer, called on Kennedy to make his position on the polio vaccine clear.

“It’s outrageous and dangerous for people in the Trump Transition to try and get rid of the polio vaccine that has virtually eradicated polio in America and saved millions of lives,” Schumer, the Senate majority leader, wrote. “RFK Jr. must state his position on this.”

Hillary Clinton the 2016 Democratic nominee for the presidency and a longtime rival of Trump’s, posted her own rejoinder, with a screenshot of The New York Times article.

“I think Trump voters may be surprised to learn they voted to make polio great again,” she wrote, offering a riff on Trump’s slogan, “Make America Great Again”.