The latest survey numbers show the teen vaping rate fell to under 6% this year, down from 7.7% in 2023. More than 1.6 million students reported vaping in the previous month — about one-third the number in 2019, when underage vaping peaked with the use of discrete, high-nicotine e-cigarettes like Juul.

This year’s decline was mainly driven by a half-million fewer high school students who reported using e-cigarettes in the past month, officials said. Vaping was unchanged among middle schoolers, but remains less common in that group, at 3.5% of students.

“This is a monumental public health win,” FDA’s tobacco director Brian King told reporters. “But we can’t rest on our laurels. There’s clearly more work to do to further reduce youth use.”

King and other officials noted that the drop in vaping didn’t coincide with a rise in other tobacco industry products, such as nicotine pouches.

Sales of small, flavored pouches like Zyn have surged among adults. The subject of viral videos on social media platforms, the pouches come in flavors like mint and cinnamon and slowly release nicotine when placed along the gumline. This year’s U.S. survey shows 1.8% of teens are using them, largely unchanged from last year.

“Our guard is up,” King said. “We’re aware of the reported growing sales trends and we’re closely monitoring the evolving tobacco product landscape.”

The federal survey involved more than 29,000 students in grades 6 through 12 who filled out an online questionnaire in the spring. Health officials consider the survey to be their best measure of youth tobacco and nicotine trends. Thursday’s update focused on vaping products and nicotine pouches, but the full publication will eventually include rates of cigarette and cigar smoking, which have also hit historic lows in recent years.

Officials from the FDA and Centers for Disease Control and Prevention attributed the big drop in vaping to recent age restrictions and more aggressive enforcement against retailers and manufacturers, including Chinese vaping companies who have sold their e-cigarettes illegally in the U.S. for years.

Use of the most popular e-cigarette among teens, Elf Bar, fell 36% in the wake of FDA warning letters to stores and distributors selling the brightly colored vapes, which come in flavors like watermelon ice and peach mango. The brand is part of a wave of cheap, disposable e-cigarettes from China that have taken over a large portion of the U.S. vaping market. The FDA has tried to block such imports, although Elf Bar and other brands have tried to find workarounds by changing their names, addresses and logos.

Teen use of major American e-cigarettes like Vuse and Juul remained significant, with about 12% of teens who vape reporting use of those those brands.

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

Other key findings in the report:

— Among students who current use e-cigarettes, about 26% said they vape daily.

— Nearly 90% of the students who vape used flavored products, with fruit flavors as the overwhelming favorite.

— Zyn is the most common nicotine pouch among teens who use the products.

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.

An AP analysis of Food and Drug Administration data shows that agency staffers have not returned to roughly 2,000 pharmaceutical manufacturing firms to conduct surveillance inspections since before the pandemic, raising the risks of contamination and other issues in drugs used by millions of Americans.

The firms that are overdue for safety and quality inspections represent about 42% of the 4,700 plants that are currently registered to produce drugs for the U.S. and previously underwent FDA review before May 2019, the AP found. The plants make hundreds of critical medicines, including antibiotics, blood thinners and cancer therapies.

Under FDA’s own guidelines, factories that haven’t been inspected in five or more years are considered a significant risk and are supposed to be prioritized for “mandatory” inspections. Most of the overdue plants are in the U.S., but more than 340 are in India and China, countries that together make up the largest source of drug ingredients used in low-cost U.S. prescriptions.

“Generic drugmakers are under intense pressure to cut their costs and some will do that by cutting quality,” said David Ridley of Duke University, who studies the pharmaceutical industry. “If they’re not inspected, then we won’t know about it until — in a few tragic cases — it’s too late.”

Last year, tainted eyedrops from an Indian factory led to an outbreak of antibiotic-resistant bacteria that sickened more than 80 Americans, killing four of them and blinding more than a dozen others. The plant never registered with the FDA.

Prior to COVID-19, dozens of common medications made at FDA-regulated plants were recalled due to traces of cancer-causing contaminants. The FDA didn’t open its first overseas outposts until 2008, after dozens of U.S. deaths were linked to a contaminated blood thinner imported from a Chinese plant that hadn’t been inspected.

“The U.S. drug supply is the safest on the planet and no other regulator conducts more inspections than the FDA,” said FDA Associate Commissioner Michael Rogers, noting that the agency has increased drug inspections each year since 2021 while prioritizing foreign factories.

But last year’s inspection numbers were still down almost 40% from the pre-pandemic period, when the FDA averaged around 4,300 annual inspections. Rogers offered no date for when the backlog of uninspected plants might be cleared.

The agency’s work has been hampered by a wave of staff departures, he said, including longtime inspectors who have found new jobs that often allow them to work from home.

“There’s a significant cost to the agency associated with the loss through attrition of an experienced investigator,” Rogers said. “We need to retain these people, and we are.”

The FDA halted all but the most “mission critical” inspections in March 2020. It gradually restarted prioritized inspections later that year, but regular international visits did not resume until 2022.

In a statement, the FDA said that it receives inspection details from international partners, including European regulators, which help the agency decide whether a visit is necessary. The agency also began using video and other online tools to evaluate plants remotely during COVID-19, although those aren’t equivalent to physical inspections.

The FDA’s struggles overseeing the global pharmaceutical supply have been documented by the Government Accountability Office, which has flagged the area as a “high risk” issue every year since 2009.

Beginning in the 1990s, drugmakers began shifting manufacturing overseas, first to Puerto Rico, and then to Asia in search of cheaper labor and materials. The FDA has largely been playing catch-up ever since.

“We have to recognize that this is the world we live in and we have to adapt to it,” said Dr. Stephen Ostroff, FDA’s former chief scientist. “That has to include being able to get into these facilities and take a look at what they’re doing, particularly in India and China.”

“Cascade of failure”

The FDA keeps a confidential list of drug facilities to inspect, prioritizing them based on potential risks.

The AP created its own list by compiling public records of FDA inspections from before COVID-19 and tracking which firms haven’t received a follow-up within five years. The data accounts for the vast majority of inspections, but has some omissions, including visits required for new drug approvals and those that are part of ongoing government investigations.

The AP’s tally of overdue plants also doesn’t include any of the new facilities that have registered with the agency since COVID-19 but haven’t yet had an initial inspection. FDA’s internal list of sites for inspection has increased 14% over the past five years, the agency noted last year.

The FDA said in a statement that it “must be judicious and apply a risk-based approach,” due to the “enormity” of its workload and limited budget.

“We prioritize the inspections that pose the greatest risk to public health,” the agency said.

On a global basis, FDA says only 6% of sites inspected last year had serious problems. But rates are higher in India, where 11% of plants were cited for violations, the most of any country.

Nearly 90% of FDA’s foreign inspections in fiscal 2023 were announced in advance, according to FDA correspondence with Congress obtained via public records requests. The GAO and other government watchdogs have long raised concerns about the practice, which typically gives companies up to 12 weeks to correct or conceal potential problems.

Even with the advanced warnings, the FDA has found egregious violations in overseas factories.

When agency staffers visited Intas Pharmaceuticals’ plant in northwest India for the first time in nearly three years they found what they called a “cascade of failure.” Among the violations, inspectors saw an employee “pouring acetic acid in a trash bin” to destroy company documents used for drug testing. Elsewhere inspectors found “plastic bags filled with torn and discarded” documents relating to quality control measures.

“This kind of behavior has been pointed out to the FDA time and time again by people like me for the last 10 years,” said Dinesh Thakur, a former pharmaceutical industry executive who became a whistleblower for the U.S. government. In 2013, his work led to a $500 million settlement with Indian drugmaker Ranbaxy for falsifying generic drug data.

“If you do not prosecute people who do this kind of wrongdoing, it gives the implicit signal that the FDA will give companies a pass,” Thakur said.

In the case of Intas, FDA issued a warning letter — which has no legal repercussions — and blocked some of the company’s exports to the U.S., while attempting to maintain shipments of the critical chemotherapy drug cisplatin. That strategy backfired in June 2023 when Intas abruptly shuttered the plant, triggering a nationwide shortage of cisplatin, which is used in more than a half-dozen cancers.

FDA inspections in India have been accelerating, but 160 plants are overdue, including some which haven’t been inspected since 2015 yet continue shipping pain pills, antibiotics and other medications to the U.S., according to AP’s analysis.

Mexico, France and Spain also have over 100 overdue firms between them.

In China, political tensions have made inspections even more challenging. Just two fulltime FDA inspectors are based in the country, where about 185 factories are overdue. Former FDA officials say the Chinese government has withheld visas from inspectors unless the U.S. reciprocates for Chinese nationals seeking to enter the U.S.

FDA Commissioner Robert Califf has acknowledged his discomfort with the current situation.

“Even if we do periodic inspections, it’s not the same as a society where you have more freedom of information,” Califf told lawmakers at a hearing last year. “I am very concerned about it.”

Help wanted

The FDA could seemingly address its inspection backlog by hiring more investigators or assigning extra work to current staffers. But the agency is struggling to hold onto inspectors who can often earn far more working for the companies they now regulate.

On a call with FDA stakeholders in May, Rogers warned that “our attrition rates and our inability to retain our staff” would soon impact the agency’s ability to oversee drugs and other medical supplies.

The FDA currently has 225 vacancies on its inspection workforce, nearly four times as many as before COVID-19, according to agency records.

New inspectors generally start at an annual salary of about $40,000 and can eventually rise to over $100,000. Job postings alert applicants they may have to travel “up to 50% of the time.”

In 30 years as an FDA inspector, Jose Hernandez experienced firsthand the grueling pace and pressures of the job.

When he began doing international inspections in the mid-1990s, it was on a volunteer basis and employees spent no more than six weeks per year outside the U.S. By the end of his government career, Hernandez was traveling overseas more than four months per year, making multiple trips to Asia.

For each one-week inspection, he said he might need another week or more to write up his report, particularly if he found serious violations. Hernandez says that extra time and attention to detail wasn’t always appreciated by his managers.

“They just wanted people who are like bean counters: walk in, walk out and find nothing so that they can get this report through the system and make their numbers,” he said.

Hernandez retired from the FDA in 2014, earning just over $100,000 in his final year. Today he is a private consultant and says former FDA inspectors can easily earn more than $250,000 working for industry.

“Now I fly business class, I stay in nice hotels, I rest when I get there and nobody tells me what to do,” Hernandez said. “I made the right decision.”

FDA says it’s exploring ways to make the jobs more attractive, including extra pay for experienced staffers and offering more flexible, comfortable travel arrangements.

Testing for quality

The slowdown in inspections has attracted scrutiny from lawmakers and raised new questions about whether FDA’s decades-old approach is working.

House Republicans have peppered the agency with dozens of inquiries about the program since 2023. In their most recent letter, members of the Energy and Commerce Committee ask regulators to explain why FDA staffers making high-priority inspections in Asia are reporting less than half as many violations today compared with pre-COVID-19.

“The committee is concerned that FDA’s fear of triggering additional drug shortages is driving the decreased rate that FDA issues warning letters,” states the June letter.

FDA’s Rogers rejected the argument, saying inspectors follow strict guidelines when conducting inspections and that decisions about managing drug shortages are handled separately by other parts of the agency.

A pilot program requested by the U.S. Defense Department takes an alternative approach to monitoring the drug supply. The Pentagon is collaborating with a private laboratory, Valisure, to evaluate 40 prescription drugs critical to military personnel, testing them for contaminants, dosing and other issues. Initial findings from the two-year program found serious flaws in about 10% of a subset of drugs tested, according to results shared with the AP.

Laboratory testing of imported drugs has long been standard practice in Europe, where more than 70 private labs operate alongside government regulators.

The testing approach has attracted interest from experts concerned that FDA’s method — rooted in physical inspections and reviewing paperwork — may not be up to the task of uncovering manufacturing problems on the other side of the world.

Stanford University’s Dr. Kevin Schulman says one solution would be to incentivize U.S. pharmacy chains and drug distributors to only purchase drugs from high-quality manufacturers.

Currently, U.S. companies decide which generic drugs to buy based on whichever company has the lowest price, Schulman said. “Purchasers say, ‘Well, it’s the FDA’s job to worry about quality, not ours,’” he said.

Even as the FDA struggles to recover from COVID-19 and reinspect plants worldwide, Schulman sees a potential upside.

“Maybe this is the straw that breaks the camel’s back,” he said. “That, in fact, we should just admit that one U.S. agency can’t regulate the entire global manufacturing for this critically important market.”

___

Forster reported from New York. Follow Matthew Perrone on X: @AP_FDAwriter

___

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.

Drugmaker Lykos Therapeutics said the FDA notified the company that its drug “could not be approved based on data submitted to date,” and requested an additional late-stage study. Such studies generally takes several years and millions of dollars to conduct. The company said it plans to ask the agency to reconsider.

Lykos and other psychedelic companies had hoped that MDMA would be approved and pave the way for other hallucinogenic drugs to enter the medical mainstream. If the FDA had granted the request, MDMA, also known as ecstasy or molly, would have become the first illegal psychedelic to become a federally approved medicine.

The FDA’s decision was expected after a panel of government advisors voted overwhelmingly against the drug’s use for post-traumatic stress disorder in June. The negative vote came after an all-day meeting in which experts scrutinized Lykos’ study data, research methods and possible risks of the drug, including heart problems, injury and abuse.

FDA said Friday the MDMA application had “significant limitations” that “prevent the agency from concluding that the drug is safe and effective for the proposed indication.” The agency said it will continue encouraging “innovation for psychedelic treatments and other therapies to address these medical needs.”

Lykos said the issues FDA raised in what’s called a complete response letter echoed the concerns during the June meeting.

“The FDA request for another study is deeply disappointing,” Lykos CEO Amy Emerson said Friday in a statement. “Our heart breaks for the millions of military veterans, first responders, victims of sexual and domestic abuse and countless others suffering from PTSD who may now face more years without access to new treatment options.”

Lykos is essentially a corporate spinoff of the nation’s leading psychedelic advocacy group, the Multidisciplinary Association for Psychedelic Studies, or MAPS, which funded the initial studies of MDMA by raising millions of dollars from wealthy backers.

The group has been a pioneer in researching the medical use of psychedelics, which major pharmaceutical companies have been unwilling to fund. Two small studies submitted to the FDA suggested combining MDMA with talk therapy led to significant easing of PTSD symptoms.

Antidepressants are now the only FDA-approved drugs for PTSD, which is closely linked to depression, anxiety and suicidal thinking and is more prevalent among women and veterans.

In recent years, MDMA research has been widely publicized by combat veterans, who say the lack of treatments options for the condition has contributed to higher rates of suicide among military personnel. Last month, veterans supporting psychedelic therapy rallied on Capitol Hill in support of the drug. And more than 80 House and Senate lawmakers have signed letters to the FDA in recent weeks urging MDMA’s approval.

But FDA’s review brought new scrutiny to the research. The vast majority of patients in Lykos’ studies correctly guessed whether they had received MDMA or a dummy pill, making it “nearly impossible” to maintain the “blinding” which is considered essential for medical research, according to FDA internal staffers.

In recent months, separate allegations of misconduct have emerged, including that some researchers involved in the studies coached patients to suppress negative results or inflate positive ones.

Despite the setback, many experts say other psychedelics may fare better before the agency.

MDMA is the first in a series of psychedelics that are expected to be reviewed by the FDA in coming years as part of a resurgence of interesting into their therapeutic potential.

The idea of using psychedelics to enhance psychotherapy is not new. A handful of therapists in California used MDMA during the 1970s and 1980s — when it was still legal — to facilitate couples therapy sessions. MAPS was founded in 1986 to oppose a federal decision placing MDMA in the same ultra-restrictive drug category as heroin, LSD and other illegal psychedelics.

MAPS’ studies of MDMA began more than a decade ago. Since then, dozens of small, startup drugmakers have entered the field, studying other substances like psilocybin and LSD for conditions including depression, addiction and anxiety. Those studies are generally larger and more rigorous than the MDMA studies submitted to the FDA.

Two drug developers, Compass Pathways and Usona Institute, are conducting late-stage studies of psilocybin — the active ingredient in magic mushrooms — for severe depression.

___

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 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.”

___

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.

___

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.

___

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

___

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.

___

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.

___

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.

___

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.”

___

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.