In an unannounced appearance at a New York psychedelic conference, the VA’s Dr. Shereef Elnahal said his agency was ready to start rolling out MDMA-assisted therapy for post-traumatic stress disorder as soon as regulators approved it.

“The VA has to be first, as we have been, with the mental health needs of our veterans,” Elnahal told attendees at the May meeting. He also highlighted the “awesome, groundbreaking” research on the drug by MAPS, or the Multidisciplinary Association for Psychedelic Studies, the leading nonprofit advocating for the medical and legal use of hallucinogenic drugs.

But expectations for MDMA’s first-of-a-kind approval quickly unraveled a few weeks later when Food and Drug Administration advisers voted overwhelmingly against the drug, citing flawed data, questionable research conduct, and potential safety and addiction risks. The panel’s recommendation isn’t binding, but the FDA is widely expected to delay or decline approval when it makes its decision by mid-August.

The potential rejection has sent shockwaves through the psychedelic community, including combat veterans who have spent years lobbying for the drug, which is also known as ecstasy or molly. The advocacy effort has long been intertwined with MAPS, which has funded or supported some of the most vocal veterans supporting psychedelic therapy.

Dr. Harold Kudler of Duke University met with veterans and MAPS leaders while serving as the VA’s top consultant on mental health services. He believes FDA’s experts are justifiably skeptical of the science behind the drug, which he says has been drowned out by messaging from MAPS and its leader, Rick Doblin, who began pursuing MDMA’s approval in the mid-1980s.

“Rick is the most persuasive advocate within the scientific community that I’ve ever seen. You want to believe him because he’s offering you something you sorely need — an effective treatment for PTSD,” Kudler said. “But I think the FDA committee caught a glimpse of how much of this is Rick’s zeal and how much is real.”

MAPS declined to make Doblin available for an interview. Instead the group pointed to a recent statement by two dozen scientists and pharmaceutical executives — many with backgrounds in psychedelic research — supporting MDMA’s approval.

Earlier this year, MAPS changed the name of its drug development arm to Lykos Therapeutics, allowing the new company to raise funds from outside investors.

In addition to shortcomings in Lykos’ studies, FDA panelists voiced concern about separate allegations that some MAPS-affiliated researchers suppressed negative study results or coached patients to inflate positive results. The FDA says it’s investigating those claims.

Casey Tylek, an Army veteran, says he didn’t experience any of that while participating in the study. When he asked researchers for guidance in evaluating the effect of the drug, Tylek says he was repeatedly rebuffed and told he had to rate the treatment without any outside influence.

Tylek says he was “pessimistic” going into the trial, but credits MDMA-assisted therapy with resolving anger, anxiety and trauma stemming from a rocket attack in Iraq.

“It basically rewrote that memory in my mind and how it functioned,” Tylek said. “I was able to just kind of let go of it and not be hung up on it.”

Kudler and other researchers say they want to see the MDMA results confirmed in larger studies that have no links to the psychedelic community.

That work would take years. Veterans who support the treatment say it would jeopardize patients suffering from PTSD who haven’t been helped by antidepressants and other existing therapies. The suicide rate among veterans is 70% higher than the general population, according to government figures, with 18 veteran suicides per day in 2021.

Jon Lubecky, who served in both the Marines and the Army, says he tried to kill himself five times after returning from deployment to Iraq in 2006. After years of struggling with PTSD he enrolled in a MAPS trial in 2014. He credits MDMA-assisted therapy with curing his condition.

Since then, Lubecky has told his story hundreds of times in media interviews, congressional hearings and private meetings with military officials and federal lawmakers, including conservatives like Sen. Rand Paul and Rep. Dan Crenshaw.

Lubecky worked as a consultant for MAPS for more than five years. But he rejects the idea that he was merely advancing the agenda of psychedelic boosters who want to see the drugs outright legalized.

“I’m not in this for ending the drug war or any of those other things,” he said. “I’m in it for my friends.”

Lubecky’s work helped secure $20 million in funding for the VA to conduct its own studies of psychedelics, including MDMA and ketamine.

Part of the rationale for that research: Many veterans now leave the U.S. to undergo psychedelic therapy at clinics in Mexico, Peru and other countries where it is more accessible.

A nonprofit group, Heroic Hearts Project, currently has a waiting list of over 1,000 veterans seeking financial and logistical support to travel abroad. A former Army Ranger, Jesse Gould, founded the group after returning from a weeklong retreat in Peru using ayahuasca, the psychedelic brew associated with indigenous cultures of the Amazon. After the experience, he said he was able to overcome anxiety, anger and depression that had burdened him after three deployments to Afghanistan.

Gould says MAPS deserves credit for kickstarting research that could eventually help thousands of veterans.

“I think MAPS has done more for the veteran community in this area than most politicians have done in the last 20 years,” said Gould, whose group has no financial ties to MAPS. “Time and time again our needs either go unheard or go to the back of the line.”

Heroic Hearts hosted an event on Capitol Hill earlier this month where several House lawmakers and veterans called for MDMA’s approval.

Gould doesn’t expect the FDA to flatly reject MDMA. Instead he and others say the agency may ask Lykos to perform additional studies.

Even if the company is unable to quickly conduct that research, experts say others could benefit by avoiding the pitfalls in Lykos’ MDMA application, including a small patient population with little diversity and a high potential for bias.

Dozens of other drugmakers are studying psilocybin, LSD and other psychedelics for depression, anxiety and addiction.

Dr. John Krystal, a Yale University psychiatry professor, said Lykos’ setback “will hopefully ensure that future studies are conducted in ways that give reviewers greater confidence about the effectiveness and the safety of these drugs.”

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

The Food and Drug Administration decision only applies to several tobacco-flavored versions of the reusable product, which takes cartridges filled with liquid nicotine. The FDA previously rejected Reynold’s application for its more popular menthol flavor, but the company is challenging that decision in court.

Last month, the FDA granted competitor Njoy the first authorization for a menthol-flavored e-cigarette. The vaping brand, which is not a big seller, is controlled by tobacco giant Altria, which also sells Marlboro cigarettes.

Thursday’s announcement is not an approval or endorsement, and the FDA reiterated that people who do not smoke should not use Vuse or any other e-cigarettes. The FDA determination indicates that smokers who switch completely to Vuse can reduce their exposure to deadly carcinogens and other chemicals found in traditional tobacco.

“All tobacco products are harmful and potentially addictive,” the FDA said in a statement. “Those who do not use tobacco products, especially young people, should not start.”

Like other tobacco companies, Reynolds makes most of its income from traditional cigarettes, including Camels and Newports.

Vuse made up 40% of U.S. vaping sales in the past year, according to retail data from Nielsen. Most company sales are for menthol products, which remain available under a court order while Reynold’s challenges the FDA’s negative ruling.

Juul Labs is now a distant second in the e-cigarettes market, accounting for less than a quarter of retail sales. The company was forced to drastically cut back its marketing and promotions following legal settlements with states, local governments and families that blamed the brand’s small, discreet e-cigarettes for hooking children on nicotine.

The FDA is wrapping up a sweeping regulatory review intended to clean up the multibillion-dollar vaping industry after years of delays.

Some brands like Vuse have been sold in the U.S. for years, awaiting FDA action on their scientific applications. The market also includes thousands of fruit- and candy-flavored products from China that are technically illegal but widely available in convenience stores and vape shops.

The FDA faced a self-imposed court deadline last month to wrap up its yearslong review of major vaping brands. Currently, Juul’s products remain under federal review, although FDA recently rescinded a 2022 order that would have forced the products off the market. That action never took effect because FDA regulators agreed to place it on hold following a legal challenge by Juul.

The agency has rejected more than 26 million applications for products it received from vaping companies hoping to stay on the market. Only a handful of products from major manufacturers have been authorized to help smokers

To win FDA authorization, companies generally must show that their e-cigarettes provide an overall health benefit for smokers, without significantly appealing to kids.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

WASHINGTON (AP) — The Food and Drug Administration on Friday authorized the first menthol-flavored electronic cigarettes for adult smokers, acknowledging that vaping flavors can reduce the harms of traditional tobacco smoking.

The FDA said it authorized four menthol e-cigarettes from Njoy, the vaping brand recently acquired by tobacco giant Altria, which also sells Marlboro cigarettes.

The decision lends new credibility to vaping companies’ longstanding claim that their products can help blunt the toll of smoking, which is blamed for 480,000 U.S. deaths annually due to cancer, lung disease and heart disease. E-cigarettes have been sold in the U.S. since 2007 but in recent years their potential benefits for smokers have been overshadowed by their use by adolescents and teens.

Parents and anti-tobacco groups immediately criticized the decision, which follows years of advocacy efforts to keep menthol and other flavors that can appeal to teens off the market.

“This decision could mean we’ll never be able to close the Pandora’s box of the youth vaping epidemic,” said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes. “FDA has once again failed American families by allowing a predatory industry to source its next generation of lifetime customers — America’s children.”

Youth vaping has declined from all-time highs in recent years, with about 10% of high schoolers reporting e-cigarette use last year. Of those who vaped, 90% used flavors, including menthol.

All the e-cigarettes previously authorized by the FDA have been tobacco, which isn’t widely used by young people who vape.

Njoy is one of only three companies that previously received FDA’s OK for vaping products. Like those products, two of the Njoy menthol varieties come as cartridges that plug into a reusable device that heats liquid nicotine, turning it into an inhalable aerosol. The other two Njoy menthol products are disposable e-cigarettes.

Njoy’s products accounted for less than 3% of U.S. e-cigarette sales in the past year, according to retail data from Nielsen. Vuse, owned by Reynolds American, and Juul control about 60% of the market, while hundreds of disposable brands account for the rest.

Most teens who vape use disposable e-cigarettes, including brands like Elf Bar, which come in flavors such as watermelon and blueberry ice.

Altria’s data showed Njoy e-cigarettes helped smokers reduce their exposure to the harmful chemicals in traditional cigarettes, the FDA said. The agency stressed the products are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.

Friday’s action is part of a sweeping FDA review intended to bring scientific scrutiny to the multibillion-dollar vaping market after years of regulatory delays. Currently the U.S. market includes thousands of fruit- and candy-flavored vapes that are technically illegal but are widely available in convenience stores, gas stations and vape shops.

The FDA faced a self-imposed court deadline at the end of this month to wrap up its yearslong review of major vaping brands, including Juul and Vuse.

Those brands have been sold in the U.S. for years, awaiting FDA action on their scientific applications. To stay on the market, companies must show that their e-cigarettes provide an overall health benefit for smokers, without significantly appealing to kids.

“Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth,” said Matthew Farrelly of FDA’s Center for Tobacco Products.

Richmond-based Altria previously took a $13 billion stake in Juul in 2018, when the brand controlled most of the U.S. vaping market. But Juul’s value plummeted after it was hit with lawsuits and investigations over its role in sparking a national spike in underage vaping.

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This story has been updated to correct that two of the four menthol e-cigarettes from Njoy are disposable products.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

The Food and Drug Administration issued the alert Friday on Crecelac Infant Powdered Goat Milk Infant Formula, after a sample collected from a Texas store tested positive for cronobacter, which can cause deadly infections in babies. The same bacteria sparked recalls and shortages of infant formula in 2022 after it was detected at a major U.S. formula factory.

The Crecelac formula was imported and distributed by Dairy Manufacturers Inc., of Prosper, Texas, according to the FDA. Press releases from the FDA and the company did not specify where the product was produced or how widely it was distributed in the U.S. Messages left for the company Friday were not immediately returned.

Last week, the company voluntarily recalled the Crecelac formula and another brand, Farmalac, because they had not received approval by the FDA for sale in the U.S. Infant formula distributors are required to submit data to FDA regulators showing their products meet U.S. food and nutritional standards.

The FDA said testing of the Farmalac product did not detect cronobacter, but parents and caregivers should still avoid using the formula.

Cronobacter can cause blood infections and other serious complications in infants, including meningitis and nervous system injuries. The bacteria are found naturally in the environment and also can make their way into infant formula after packages are opened.

In 2022, FDA investigators shutdown an Abbott formula plant in Sturgis, Michigan, after inspections sparked by four infant illnesses linked to cronobacter, including two deaths, showed widespread contamination at the site.

Amid the shortages caused by the shutdown, the FDA began allowing imports of infant formula produced by overseas manufacturers. Previously the agency restricted U.S. infant formula production to a handful of domestic manufacturers, including Abbott.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

WASHINGTON (AP) — President Joe Biden’s administration is indefinitely delaying a long-awaited menthol cigarette ban, a decision that infuriated anti-smoking advocates but could avoid a political backlash from Black voters in November.

In a statement Friday, Biden’s top health official gave no timeline for issuing the rule, saying only that the administration would take more time to consider feedback, including from civil rights groups.

“It’s clear that there are still more conversations to have, and that will take significantly more time,” Health and Human Services Secretary Xavier Becerra said in a statement.

The White House has held dozens of meetings in recent months with groups opposing the ban, including civil rights organizers, law enforcement officials and small business owners. Most of groups have financial ties to tobacco companies.

The announcement is another setback for Food and Drug Administration officials, who drafted the ban and predicted it would prevent hundreds of thousands of smoking-related deaths over 40 years. The agency has worked toward banning menthol across multiple administrations without ever finalizing a rule.

“This decision prioritizes politics over lives, especially Black lives,” said Yolonda Richardson of the Campaign for Tobacco-Free Kids, in an emailed statement. “It is especially disturbing to see the administration parrot the false claims of the tobacco industry about support from the civil rights community.”

Richardson noted that the ban is supported by groups including the NAACP and the Congressional Black Caucus.

Previous FDA efforts on menthol have been derailed by tobacco industry pushback or competing political priorities. With both Biden and former President Donald Trump vying for the support of Black voters, the ban’s potential impact has been scrutinized by Republicans and Democrats heading into the fall election.

Anti-smoking advocates have been pushing the FDA to eliminate the flavor since the agency gained authority to regulate certain tobacco ingredients in 2009. Menthol is the only cigarette flavor that wasn’t banned under that law, a carveout negotiated by industry allies in Congress. But the law instructed the FDA to continue studying the issue.

More than 11% of U.S. adults smoke, with rates roughly even between white and Black people. But about 80% of Black smokers smoke menthol, which the FDA says masks the harshness of smoking, making it easier to start and harder to quit. Also, most teenagers who smoke cigarettes prefer menthols.

The FDA released its draft of the proposed ban in 2022. Officials under Biden initially targeted last August to finalize the rule. Late last year, White House officials said they would take until March to review the measure. When that deadline passed last month, several anti-smoking groups filed a lawsuit to force its release.

“We are disappointed with the action of the Biden administration, which has caved in to the scare tactics of the tobacco industry,” said Dr. Mark Mitchell of the National Medical Association, an African American physician group that is suing the administration.

Separately, Rev. Al Sharpton and other civil rights leaders have warned that a menthol ban would create an illegal market for the cigarettes in Black communities and invite more confrontations with police.

The FDA and health advocates have long rejected such concerns, noting FDA’s enforcement of the rule would only apply to companies that make or sell cigarettes, not to individuals.

An FDA spokesperson said Friday the agency is still committed to banning menthol cigarettes.

“As we’ve made clear, these product standards remain at the top of our priorities,” Jim McKinney said in a statement.

Smoking can cause cancer, strokes and heart attacks and is blamed for 480,000 deaths each year in the U.S., including 45,000 among Black Americans.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Amylyx Pharmaceuticals announced it will voluntarily halt sales and marketing of the drug in the U.S. and Canada, where new patients will no longer be able to get a prescription.

“While this is a difficult moment for the ALS community, we reached this path forward in partnership with the stakeholders who will be impacted and in line with our steadfast commitment to people living with ALS,” company co-founders said in a statement. Patients already taking the therapy who wish to continue will be able to enroll in a program to receive it for free.

The Food and Drug Administration approved the much-debated drug, Relyvrio, in September 2022, following a years-long advocacy campaign by patients with amyotrophic lateral sclerosis, or ALS.

The drug’s failure is a bitter disappointment for patients and advocates, who have pressed the FDA and other federal agencies to fund and approve more experimental therapies for the fatal muscle-wasting disease.

Relyvrio’s withdrawal leaves just three ALS medicines available to U.S. patients, only one of which has been shown to extend survival by several months.

Cambridge, Massachusetts-based Amylyx also said Thursday it will lay off 70% of its more than 350 employees as part of a major restructuring effort. Company executives said they plan to continue studying Relyvrio and another experimental drug for several rare diseases, including Wolfram syndrome, which causes childhood diabetes and blindness.

Company shares climbed more than 7.5% in trading Thursday morning.

Amylyx said last month it was considering pulling its drug after a clinical trial in 600 patients failed to show any improvements in survival or other health measures, such as muscle strength or walking ability.

The company’s voluntary action resolves what could have been a major dilemma for the FDA. The agency’s regulators would not have had a clear path to quickly force the drug from the market if the company had refused to remove it. That’s because the FDA granted the drug full approval, despite the preliminary nature of the company’s data on effectiveness.

The 2022 approval was mainly based on results from one small, mid-stage study that was criticized by some of the agency’s own internal scientists. Normally the agency requires two large, late-stage studies that show a clear benefit before granting approval. But at the time FDA officials explained that “regulatory flexibility” was appropriate when reviewing Relyvrio, “given the serious and life-threatening nature of ALS and the substantial unmet need.”

The medication is part of a string of drugs for deadly, degenerative diseases that have won FDA approval in recent years despite questionable evidence they work.

ALS gradually destroys the nerve cells and connections needed to walk, talk, speak and breathe. Most patients die within three to five years of a diagnosis.

Relyvrio is a powder that combines two older drugs: a prescription medication for liver disorders and a dietary supplement associated with traditional Chinese medicine.

Amylyx faced criticism for pricing the drug at $158,000 for a year’s supply. Sales were disappointing, with some patients discontinuing the medicine after only a few months.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

The U.S. Supreme Court will take up a case Tuesday that could impact how women get access to mifepristone, one of the two pills used in the most common type of abortion in the nation.

The central dispute in the case is whether the Food and Drug Administration overlooked serious safety problems when it made mifepristone easier to obtain, including through mail-order pharmacies.

Legal briefs filed with the court describe the pill’s safety in vastly different terms: Medical professionals call it “among the safest medications” ever approved by the FDA, while the Christian conservative group suing the agency attributes “tens of thousands” of “emergency complications” to the drug.

Earlier this year, a medical journal retracted two studies that claimed to show the harms of mifepristone. The studies were cited in the pivotal Texas court ruling that brought the matter before the Supreme Court. The publisher cited conflicts of interest by the authors and flaws in their research, although the studies’ lead author called the retractions a baseless attack.

Here’s what to know about the safety of mifepristone, which is typically used with misoprostol in a medication abortion.

The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies.

There are rare occasions when mifepristone can cause dangerous, excessive bleeding that requires emergency care. Because of that, the FDA imposed strict safety limits on who could prescribe and distribute it — only specially certified physicians and only as part of three mandatory in-person appointments with the patient getting the drug.

The doctors also had to be capable of performing emergency surgery to stop excess bleeding and an abortion procedure if the drug didn’t end the pregnancy.

Over the years, the FDA reaffirmed mifepristone’s safety and repeatedly eased restrictions, culminating in a 2021 decision doing away with any in-person requirements and allowing the pill to be sent through the mail.

Abortion opponents say the more lax restrictions resulted in many more “emergency complications.” But that argument lumps together women experiencing a range of issues with mifepristone — from the drug not working to people who may simply have questions or concerns but don’t require medical care.

OB-GYNs say a tiny fraction of patients suffer “major” or “serious” adverse events after taking mifepristone.

A legal brief by a group of medical organizations including the American College of Obstetricians and Gynecologists says: “When used in medication abortion, major adverse events — significant infection, excessive blood loss, or hospitalization — occur in less than 0.32% of patients, according to a highly regarded study with more than 50,000 patients.”

The definition that scientists generally use for serious adverse events includes blood transfusions, major surgery, hospital admissions and death, said Ushma Upadhyay, one of the authors of that 2015 study. She added: “The hospital admission is a catch-all for the very serious but more rare events such as major infection.”

The prescribing information included in the packaging for mifepristone tablets lists slightly different statistics for what it calls “serious adverse reactions.” It cites ranges for how frequently various complications occur: 0.03% to 0.5% for transfusion; 0.2% for sepsis and 0.04% to 0.6% for hospitalization related to medication abortions. The ranges reflect findings across various relevant studies, experts said.

Mifepristone’s labeling also lists a complication that most medical groups don’t consider a serious or major adverse event: ER visits, which ranged from 2.9% to 4.6%. The current FDA label lists going to the ER as an option if patients experience prolonged heavy bleeding, severe abdominal pain or a sustained fever.

But ER visits don’t always reflect big problems, doctors told The Associated Press.

Some people may go there after a medication abortion because they want to be checked out or have questions but don’t have a doctor, said Upadhyay, a professor at the University of California, San Francisco. Others, she said, “don’t want to go to their primary care provider about their abortion” because of stigma.

A study she co-authored in 2018 found that slightly more than half of patients who visited the ER because of abortions received only observational care. Some, Upadhyay said, “don’t receive any treatment.”

Mifepristone results in a completed abortion 97.4% of the time, according to U.S. studies cited in the FDA label.

But in 2.6% of cases, a surgical intervention is needed. And 0.7% of the time, the pregnancy continues.

That’s compared to a procedural abortion in a clinic, where the chance of the procedure failing to end a pregnancy “is extremely, extremely low,” probably less than 0.1%, said Dr. Pratima Gupta, a board member for the American College of Obstetricians and Gynecologists.

“Any time a procedural abortion is done, the clinicians ensure that it was a complete abortion” by examining the tissue that is removed or performing an ultrasound during or after the procedure, she said.

Gupta, who has done abortion procedures for more than 20 years, said there are “very few complications from abortion — any kind of abortion, medication or procedural abortion.” A recent study suggests that’s just as true for medication abortions that happen in a clinic, a doctor’s office or at home with the help of telehealth.

The FDA makes drug approval decisions on a case-by-case basis, weighing effectiveness, safety and other factors.

No drug is 100% effective, and many common medications don’t work for a significant portion of patients.

Antidepressants typically help between 40% and 60% of people with depression. New antibiotics approved by the FDA often resolve about 70% of infections.

Since 2000, roughly 6 million patients have taken mifepristone, according to the FDA. A 2021 review of agency records looking for deaths that were likely related to the drug identified 13, or .00027% of patients.

Medical organizations supporting mifepristone’s availability say the drug’s safety — given the rate of deaths — compares to “ibuprofen, which more than 30 million Americans take in any given day.”

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

WASHINGTON (AP) — The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the manufacturer nearly $400 million.

Device maker Philips has recalled more than 5 million pressurized breathing machines due to risks that their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep.

The company first announced the problem in mid-2021, but efforts to repair or replace the machines have dragged on for years, frustrating patients in the U.S. and other countries.

The Dutch manufacturing giant said it has agreed to a consent decree with the Food and Drug Administration and the Department of Justice. The deal has not yet been finalized and will have to be approved by a U.S. judge. Philips executives disclosed the tentative agreement during a quarterly earnings update.

Under the agreement’s terms, Philips would continue servicing previously sold machines in the U.S., but couldn’t sell new ones until it meets corrective actions laid out by the FDA. Company executives said they have set aside $393 million for operational changes and upgrades needed to comply.

The company promised it would put “safety and quality at the center of everything we do with a greater level of accountability,” Philips CEO Roy Jakobs told analysts and investors.

The FDA’s website warns patients that the risks of ingesting the sound-dampening foam could include headache, asthma, allergic reactions and more serious problems. In November, the agency issued a new warning that the machines can overheat, in rare cases causing fires.

The agency said it cannot comment on Philips’ announcement until a final agreement is “signed and filed with the court.”

In 2022, the FDA took the rare step of ordering Philips to step up its outreach to customers about the recall including “clearer information about the health risks of its products.” At the time, the agency estimated only about half the people in the U.S. with affected machines knew they had been recalled.

Customers trying to obtain refunds or new or refurbished devices from the company have reported months of delays.

Most of the recalled devices are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep passageways open during sleep. The company has also recalled certain lines of ventilators and other breathing devices.

Untreated sleep apnea can cause people to stop breathing hundreds of times per night, leading to dangerous drowsiness and increased heart attack risk. The problem is more common in men than women, with estimates ranging from 10% to 30% of adults affected.

On Monday, Philips again pointed to company-commissioned studies suggesting that inhaling foam from its machines is “unlikely to result in appreciable harm” to patients. The company has discontinued several of the recalled models.

The latest announcement does not resolve 675 personal injury lawsuits filed against the company over the devices. Those cases have been consolidated in a federal court in Pennsylvania.

Philips faces similar legal challenges in Canada, Australia, Israel and Chile, according to the company’s update.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

WASHINGTON (AP) — The Food and Drug Administration on Friday cleared the way for Florida’s first-in-the-nation plan to import prescription drugs from Canada, a long-sought approach to accessing cheaper medications that follows decades of frustration with U.S. drug prices.

Republican Gov. Ron DeSantis signed the plan into law in 2019, but it required federal review and approval by the FDA, which controls prescription drug imports.

Democratic President Joe Biden has backed such programs as a way to lower prices, signing an executive order in 2021 that directed the FDA to work with states on imports.

The policy change represented a shift after years of successful lobbying by the pharmaceutical industry, which said imports would expose U.S. patients to risks of counterfeit or adulterated drugs. The FDA also previously warned of the difficulties of assuring the safety of drugs originating from outside the U.S.

But the politics surrounding the issue have shifted in recent years, with both parties — including former President Donald Trump — doubling down on the import approach.

The FDA said Florida’s program will be authorized for two years, though imports won’t begin immediately. Under federal requirements, state officials must first test the drugs to make sure they’re authentic and relabel them so that they comply with U.S. standards.

Florida’s health department must also provide a quarterly report to the FDA on the types of drugs imported, cost savings and any potential safety and quality issues.

“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Dr. Robert Califf said in a statement.

The FDA action was first reported by The New York Times.

DeSantis, who is battling Trump for the Republican presidential nomination, previously sued the Biden administration for allegedly delaying approval of the import program. Several other states are also awaiting federal approval.

The FDA is likely to face legal challenges over the decision, which the pharmaceutical industry’s trade group called “a serious danger to public health.”

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” the Pharmaceutical Research and Manufacturers of America said in a statement Friday.

Many people already buy at least some of their medicines from pharmacies in Canada or Mexico, although technically it’s illegal to import them.

Work on allowing state imports began under Trump, a relentless critic of industry pricing.

Under the current regulations, states can import certain medicines through pharmacies and wholesalers. DeSantis has previously estimated taxpayers could save up to $150 million annually under the program.

The state’s proposal includes a number of drug classes, including medications for asthma; chronic obstructive pulmonary disease, or COPD; diabetes; HIV and AIDS; and mental illness.

The medications would be only for certain people, including foster children, inmates, certain elderly patients and — eventually — Medicaid recipients.

The White House called Friday’s action “a step in the right direction,” and encouraged more states to apply for importation.

“For too long, Americans have been forced to pay the highest prescription drug prices of any developed nation,” White House spokesperson Kelly Scully said in a statement. “President Biden believes this is unacceptable and is laser-focused on actions to cut the cost of medicine families need.”

Like most developed nations, Canada sets limits on the prices drugmakers can charge if they wish to enter the market. Health officials there have suggested their country’s prescription drug market is too small to have any real impact on U.S. prices.

Until recently, the U.S. government had almost no leverage over the prices set by drugmakers. Only in 2022 did Congress pass a law allowing the federal government to negotiate prices for a small number of medications used by seniors in the Medicare program. The first such negotiations are set to take place later this year.

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Associated Press writer Zeke Miller contributed to this story

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

In a survey, 10% of high school students said they had used electronic cigarettes in the previous month, down from 14% last year.

Use of any tobacco product — including cigarettes and cigars — also fell among high schoolers, according to the Centers for Disease Control and Prevention report.

“A lot of good news, I’d say,” said Kenneth Michael Cummings, a University of South Carolina researcher who was not involved in the CDC study.

Among middle school students, about 5% said they used e-cigarettes. That did not significantly change from last year’s survey.

This year’s survey involved more than 22,000 students who filled out an online questionnaire last spring. The agency considers the annual survey to be its best measure of youth smoking trends.

Why the drop among high schoolers? Health officials believe a number of factors could be helping, including efforts to raise prices and limit sales to kids by raising the legal age to 21.

“It’s encouraging to see this substantial decrease in e-cigarette use among high schoolers within the past year, which is a win for public health,” said Brian King, the Food and Drug Administrations tobacco center director.

The FDA has authorized a few tobacco-flavored e-cigarettes intended to help adult smokers cut back but has struggled to stop sales of illegal products.

Other key findings in the report:

— Among students who currently use e-cigarettes, about a quarter said they use them every day.

— About 1 in 10 middle and high school students said they recently had used a tobacco product. That translates to 2.8 million U.S. kids.

— E-cigarettes were the most commonly used kind of tobacco product, and disposable ones were the most popular with teens.

— Nearly 90% of the students who vape used flavored products, with fruit and candy flavors topping the list.

In 2020, FDA regulators banned those teen-preferred flavors from reusable e-cigarettes like Juul and Vuse, which are now only sold in menthol and tobacco. But the flavor restriction didn’t apply to disposable products, and companies like Elf Bar and Esco Bar quickly stepped in to fill the gap.

The growing variety in flavors like gummy bear and watermelon has been almost entirely driven by cheap, disposable devices imported from China, which the FDA considers illegal. Those products now account for more than half of U.S. vaping sales, according to government figures.

In the latest survey, about 56% of teens who vape said they used Elf Bar, trailed by Esco Bar and Vuse, which is a reusable e-cigarette made by R.J. Reynolds. Juul, the brand widely blamed for sparking the recent spike in teen vaping, was the fourth most popular brand, used by 16% of teens.

The FDA tried to block imports of both Elf Bar and Esco Bar in May, but the products remain widely available. Elf Bar has thwarted customs officials by changing its brand name, among other steps designed to avoid detection

On Thursday, the FDA announced another round of fines against 20 stores selling Elf Bar products. The agency has sent more than 500 warning letters to retailers and manufacturers of unauthorized e-cigarettes over the past year, but those citations are not legally binding and are sometimes ignored.

In the latest report, the CDC highlighted one worrisome but puzzling finding. There was a slight increase in middle schools students who said they had used at least one tobacco product in the past month, while that rate fell among high school students. Usually those move in tandem, said Kurt Ribisl, a University of North Carolina researcher. He and Cummings cautioned against making too much of the finding, saying it might be a one-year blip.

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Perrone reported from Washington.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.