A Senate homeland security committee examined growing health care shortages amid reports of rationing within hospitals.An increase in shortages of inexpensive yet critical medications is forcing hospitals to make “horrible” choices and is amounting to a national security threat, according to a report and testimony at a Senate homeland security hearing on Wednesday.A report prepared for the hearing found that drug shortages increased by nearly 30 percent last year compared with 2021, with an average shortage lasting 18 months and some spanning 15 years. They include common antibiotics, anesthetics and sterile fluids used to keep intravenous drug tubes clean.The problems were pegged to economic drivers, an opaque supply chain and the fact that as much as 80 to 90 percent of certain products are made overseas, said Senator Gary Peters, a Democrat of Michigan and chairman of the Senate Committee on Homeland Security and Government Affairs.“Taken together, these underlying causes not only present serious concerns about providing adequate care to patients, they also represent serious national security threats,” Mr. Peters said.Dr. Andrew Shuman, a cancer surgeon in Michigan, told senators at the hearing that shortages in his field have come to “represent a tragedy that’s happening in slow motion.”Dr. Shuman, who holds leadership roles at the University of Michigan hospital system and the Veterans Affairs Ann Arbor Healthcare System, said one cheap and established cancer drug called etoposide was recently in scarce supply. He had to weigh which patients, young and old, with lung, brain and testicular cancer, should receive the limited number of doses.“As a doctor who has devoted my life to fighting cancer, it’s hard to express how horrible that is,” Dr. Shuman said.The hospital pharmacist managed to stretch the supply on hand, but “our pharmacists should not be desperately trying to squeeze out a few last drops when a life may be on the line,” Dr. Shuman said.One expert outlined the efforts of the U.S. Pharmacopeia, a nonprofit focused on a safe drug supply, to map the dynamics and causes of shortages. That group found that there is a higher risk of shortages for drugs with a low price, complex manufacturing process or quality problems marked by a history of recalls, said Vimala Raghavendran, vice president of informatics product development for the U.S.P.Those factors can add up in interesting ways: Many of the cheapest products tend to be manufactured in regions of India and China where they are inexpensive to produce, but the concentration of facilities creates an extra layer of vulnerability to problems such as natural disasters or political unrest.Ms. Raghavendran said efforts to diversify the locations for production were important, but warned that bringing the manufacturing to the United States would not be the only way to fix the issue. She noted the recent bankruptcy of a U.S. generic drugmaker. The abrupt closure of Akorn Pharmaceuticals last month has been linked to the worsening of an albuterol shortage.Witnesses also emphasized the need for more transparency into drug supplies. Policymakers are “flying blind” when it comes to the sources of critical ingredients, often referred to as A.P.I., or active pharmaceutical ingredients, Ms. Raghavendran said.While the Food and Drug Administration gets some data on those active ingredients, the agency acknowledged to Senate staff that the data was not kept in a usable format, but rather “buried in PDFs within individual drug applications,” the Senate report says.Erin Fox, an expert at the University of Utah who tracks drug shortages, said another gap in information was critical, as well: There is no data on drugmaker quality. Such information might be used to reward the most scrupulous suppliers and help them expand production. Yet while the F.D.A. “sees really clear quality differences between products and manufacturing sites,” the information is confidential and not available to drug buyers.“There’s really no incentive for one company to do a better job,” Dr. Fox said. “If one company did do a better job, we have no way of knowing that.”The matter deserves attention, she said: “Unlike other products, people’s lives are at stake.”Dr. Shuman, the cancer surgeon, cited other troubling shortages, including of eye drops that “literally keep people from going blind that cost a few dollars a month.” He said patients with glaucoma who do not get the drops could be faced with surgery instead.Those critical but cheap treatments in short supply point to a need for incentives or subsidies to companies that make them, Dr. Shuman said, given that “drug pricing structures are not always reflective of their value to patients.”

Pfizer’s treatment applies an approach that is different from some other products, which doctors say may make it safer for people at risk of heart attacks or stroke.The Food and Drug Administration has approved a Pfizer nasal spray for treatment of migraines that uses a different therapy from other nasal products on the market for severe headache pain, the company said on Friday.The fast-acting treatment, which is called zavegepant and will be sold as Zavzpret, performed better than a placebo in relieving pain and patients’ most bothersome symptoms, according to clinical trial results published in the journal Lancet Neurology. Participants in the trial who took the medication were more likely to report returning to normal function 30 minutes to two hours after taking it.The gains, though, were not significant for every patient. A study tracked the experience of 1,269 patients — half on the drug and half on a placebo — focusing on how they reported feeling two hours after using either substance. About 24 percent on the medication reported freedom from pain, compared to about 15 percent who took a placebo, according to the study.Dr. Timothy A. Collins, chief of the headache division at Duke University Medical Center’s neurology department, said the product gave doctors a new option in a nasal spray format that patients with migraines tended to appreciate. He said the condition often comes with nausea, so swallowing a pill can be unpleasant. He also said the drug presented few side effects, like drowsiness, that had been reported with other products.“We’ve been waiting for this medication to come out,” Dr. Collins said. “It’s a really helpful addition to migraine management.”One additional upside of the medication is that it’s safe for patients who have had a heart attack or a stroke, he added.Pfizer said the medication would be available in pharmacies in July, but did not disclose the estimated price of the new spray. The company estimated that nearly 40 million people in the United States suffered from migraines each year.Calling the F.D.A.’s approval a “significant breakthrough,” Pfizer described the medication as the first and only nasal spray for migraines using a migraine inhibitor that attempts to block the release of proteins called calcitonin gene-related peptides, which studies have shown are present in greater volume during an attack and that can cause inflammation and pain. Some other nasal products use triptans, which are a class of drugs aimed at serotonin receptors but are generally not recommended for people with vascular diseases.Dr. Rashmi Halker Singh, an associate professor of neurology at the Mayo Clinic who cares for patients with migraines, said the new medication built on a discovery about the role of calcitonin gene-related peptides that was decades in the making.“And I think that discovery has been really groundbreaking in helping us to better understand what happens when someone is having a migraine attack,” she said.While medications in the class exist in pill form, nasal sprays are absorbed more quickly, another benefit of Pfizer’s new treatment.“Hopefully this will help us help more people,” Dr. Halker Singh said. “That’s the bottom line, right?”The major study of the drug also measured the trial participants’ freedom from their most bothersome symptoms two hours after taking the medicine. Forty percent of those taking it reported an improvement. Among those on a placebo, the result was 31 percent.Some side effects were reported by trial participants. About one-fifth of those who took the medication reported an altered sense of taste. Others experienced nasal discomfort and nausea.The authors concluded that “additional trials are needed to establish the long-term safety and consistency of effect across attacks.”

The F.D.A. seemed poised to rescind approval of Makena, after studies over time indicated the treatment did not halt early childbirth for many women.The company that makes Makena, the only drug aimed at preventing preterm birth, announced on Tuesday that it was voluntarily pulling the medication off the market after advisers for the Food and Drug Administration concluded that the treatment did not help pregnant women at all.Makena’s drugmaker, the Covis Pharma Group, said its decision had been made in deference to an F.D.A. advisory committee that agreed unanimously in October that a large study had showed that the drug offered no benefit to newborns.Makena had been cited by critics as a flawed example of the F.D.A.’s accelerated drug approval program because the agency’s original green light for sale was based on indications that the drug would be effective. But a succession of manufacturers could not provide convincing proof after years of study that the drug halted sometimes dangerous preterm births.Makena is now owned by Covis Pharma Group, a private-equity-backed company based in Switzerland.“While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the F.D.A. to effectuate an orderly wind-down,” Raghav Chari, chief innovation officer at Covis, said.The drug’s removal means that many women who have had an early birth will have no evidence-backed therapy to use during another pregnancy. While the drug was criticized for giving women false hope, patients and doctors who favored further study in the highest-risk populations spoke up in its defense at recent agency meetings.Despite dismal study results of late, Makena was the only resort for a health risk that disproportionately affects Black women and children who have higher risks of disability or death with premature birth. The initial study of the drug that led to its accelerated approval in 2011 showed signs of promise, but a far larger trial that concluded in 2019 showed no benefit for mothers or babies.The road to removing the drug from the market has been lengthy. The F.D.A. first proposed taking the drug off the market in October 2020. The drug’s sponsor appealed the decision, setting up a lengthy process leading to a hearing last fall.By October of last year, 15 F.D.A. advisers voted unanimously that the lengthy so-called confirmatory study had showed no benefit to babies. All but one agreed that the drug should be withdrawn from the market.Covis’s decision on Tuesday followed the recommendation made this past January by Dr. Celia Witten, an agency official and the presiding officer at the October hearing, that the drug be removed from the market. Still, Dr. Witten said she agreed with an advisory panel member who had acknowledged that officials could feel an imperative to “do something” when faced with a patient in need.“I think that when we leave something on the market that hasn’t been shown to be effective, we lose out on other investigations that might be pursued,” Dr. Anjali Kaimal, an obstetrician and administrator at the University of South Florida, said during the October hearing. “And the last thing I would say is that, again, faced with that powerless feeling: Is false hope really any hope at all?”In its news release on Tuesday, Covis said it had outlined a plan for voluntary withdrawal that included a wind-down period allowing patients using the medication to complete their courses and for the company to use its remaining inventory.But the F.D.A. “was not in agreement with the proposal,” Covis said, and let the process advance to Dr. Witten’s recommendation.The F.D.A.’s “accelerated approval” program is intended to grant rapid approval to a drug targeted at a serious, unmet medical need if it shows promise in delivering a benefit to patients. The program has sped about 300 drugs to the market in 30 years. It drew fierce criticism over the approval of the Alzheimer’s drug Aduhelm, an expensive drug that many experts criticized as risky and ineffective.Congressional efforts to alter the accelerated approval process culminated last year with minor changes, including the speeding up of follow-up studies to confirm whether a drug benefits patients.The F.D.A. should seek even more authority to improve the program, said Dr. Michael Carome, director of health research at Public Citizen, a consumer advocacy group. He said the agency advisers should be reviewing a drug seeking fast-tracked approval before an initial OK is granted. The F.D.A. should also seek authority to pull a drug from the market rapidly when the follow-up study shows no benefit, Dr. Carome said.“Makena is a classic example,” he said, “where the clock has dragged out too long.”

The shots, if approved by the agency, would be the first vaccines publicly available against a respiratory virus that kills thousands a year. Some advisers did cite a small but identifiable health risk.After hours of deliberation over safety concerns, a Food and Drug Administration advisory panel on Wednesday recommended approval of a second vaccine for the respiratory syncytial virus in older adults, advancing the first shots against an illness that can be deadly for the very young and the very old.Over two days this week, the panel debated and then voted in favor of two vaccines, one by Pfizer and one by GSK (GlaxoSmithKline), that would become available for adults 60 and older.The panels made their recommendations to the agency, which typically abides by advisory committee decisions and could grant formal approval within months.The F.D.A. estimates that R.S.V. is associated with 6,000 to 10,000 deaths each year in adults 65 and older and at least 60,000 hospitalizations in that group. It is a leading killer of children worldwide. This winter, R.S.V. contributed to the tripledemic also involving flu and Covid cases that swamped children’s hospitals and some I.C.U. wards. The caseloads have eased off recently.In addition to the vaccine candidates reviewed by the panel this week, AstraZeneca and Sanofi are seeking F.D.A. approval of a monoclonal antibody treatment aimed at protecting infants and toddlers up to 2 years old from R.S.V. infections. The companies reported findings from a major study indicating that the therapy reduced “medically attended” illnesses by 75 percent after one infusion, according to AstraZeneca.Pfizer is seeking separate approval for an R.S.V. vaccine given in the later stages of pregnancy to protect the youngest. It was 82 percent effective in keeping infants from developing severe R.S.V. in the first 90 days after they were born, the company said, though the effect fell to 69 percent by the time the infants were six months old.During two days of meetings this week, the F.D.A. advisers examining data on the proposed vaccines for older adults were not viewing the process as a simple pathway to approval. They debated the benefits of a vaccine for R.S.V. patients who overwhelmingly avoided hospitalization against the very few, but concerning, reports of autoimmune conditions like Guillain-Barré syndrome that emerged shortly after the shots were administered.On Tuesday, the panel voted in favor of the Pfizer vaccine by 7 to 4, with one abstention, on its safety and efficacy. On Wednesday, it voted 10 to 2 in favor of the GSK vaccine’s safety and unanimously on the shot’s efficacy.About 34,000 patients were studied in Pfizer’s trial, with half getting a placebo, according to an F.D.A. summary of the data. The vaccine was deemed nearly 67 percent effective in preventing R.S.V.-related lower respiratory tract illness, which can lead to pneumonia. That vaccine was nearly 86 percent effective in treating the disease with three or more symptoms, according to the data.The GSK vaccine was nearly 83 percent effective in lower respiratory tract illness in a study of about 25,000 patients — half on the vaccine and half on a placebo, according to data the company provided to the F.D.A. No R.S.V. deaths were reported among the patients in the GSK or Pfizer studies.Several panel members expressed concerns about side effects reported with each vaccine. After seven days, one patient who received the Pfizer vaccine developed Guillain-Barré syndrome, a condition where the immune system attacks the nervous system (but not the spine or brain). The case was considered life-threatening, F.D.A. records show, though a “potentially confounding factor” was that the patient had suffered a heart attack the day before the condition developed.Another Pfizer vaccine recipient developed Miller Fisher syndrome, which is considered to be a type of Guillain-Barré, eight days after getting the shot. That patient, from Japan, reported double vision and a tingling or burning feeling in her palms and the soles of her feet. Her symptoms were mostly resolved within 41 days, the F.D.A. records said.The two cases in the Pfizer study put the rate of the condition at about one in 9,000, even though it is typically about one in 100,000, according to Dr. Hana El Sahly, chairwoman of the vaccine advisory committee and a professor of virology at Baylor College of Medicine. “So this is major,” Dr. El Sahly said.Dr. Marie Griffin, a health policy professor at Vanderbilt University, said the Pfizer vaccine was difficult to evaluate given the low incidence of severe infections among those in the trial.“I think the benefit for relatively healthy, older people — you have to consider that — is not that great,” Dr. Griffin said. “Compared to a possible high risk of a very severe outcome.”One recipient of the GSK vaccine, who was 78 and from Japan, also developed Guillain-Barré nine days after getting the vaccine; she went on to spend six months in a rehabilitation hospital. The company and the F.D.A. considered the case to be related to the vaccine.Two recipients of the GSK vaccine, both 71 and from South Africa, developed acute disseminated encephalomyelitis, a neurological disorder with symptoms including weakness and loss of vision. One case resulted in death. The company and the F.D.A. considered the cases “possibly related” to the vaccine, noting that both patients also received a flu vaccine at the same time as the R.S.V. shot.Watching the safety of the vaccines after they are approved will be important, said Dr. Henry Bernstein of the Zucker School of Medicine at Hofstra University, and should be considered against the background that the effort to create an R.S.V. vaccine has gone on for years.“I don’t know that there’s a rush to get this to market if we’re going to take two steps forward, and three steps back as far as public health and optimizing vaccination rates,” Dr. Bernstein said.Pfizer and GSK said they would conduct continuing safety monitoring of the vaccines if they were approved by the F.D.A.Moderna is developing an mRNA-based vaccine for R.S.V. in older people, and said it plans to submit favorable data from a major trial to the F.D.A. for approval in the first half of this year. Janssen and Bavarian Nordic have also announced studies that are underway for their R.S.V. vaccines.Vaccine experts from the Centers for Disease Control and Prevention examined the Pfizer and GSK study data and determined that in one year, more than 21,000 people 65 and older would need to take the GSK vaccine to prevent one R.S.V. death; the number was nearly 25,000 for the Pfizer shot. They concluded that the data supported use of the vaccines for patients in that age group (but not in patients 60 and older).A C.D.C. survey of nearly 600 people who were 60 and older reported that 68 percent would “definitely” or “probably” get an R.S.V. vaccine if an option approved by the F.D.A. were available. Nearly 10 percent more said they would get the shot if a health care provider recommended it.

The problem begins at the farm where plants draw toxins from the soil. There’s no washing them away.The Food and Drug Administration’s new plan to keep high levels of lead out of baby foods like mashed sweet potatoes, apple sauce and dry cereal is part of a larger effort to eliminate heavy metals from the foods the youngest children eat.The push follows years of studies by public health, consumer and government experts revealing concerning levels of arsenic in rice cereal and other items fed to infants, including big-name brands like Gerber and organic staples like Earth’s Best.This problem is not confined to baby-food factories, though. Metals like cadmium and mercury often get into crops as the plants burrow into the ground, drawing in nutrients from contaminated soil — or from naturally occurring compounds. Here are some possible answers to how these heavy metals get into food, what growers can do to keep it out — and how parents of the tiniest diners can steer clear of tainted food.How do heavy metals get into foods in the first place?Rain washes pollutants from factories, landfills, animal feed lots or from roadway auto emissions into lakes, rivers and streams. These pollutants can travel through groundwater or irrigation streams and contaminate crops or soil, according to Laurie Beyranevand, director of the Center for Agriculture and Food Systems at Vermont Law and Graduate School.Some of the metals occur naturally in the soil. Others can get added by certain fertilizers and insecticides, said Arthur Villordon, a professor at Louisiana State University who specializes in sweet potato farming.As plants grow, some, like leafy greens, are particularly efficient at drawing in heavy metals and storing them in their leaves, roots or fruit.Why do these metals get into baby foods?Beyond contamination because of absorption from the soil, heavy metals can also find their way into baby food through additives like fortified vitamin mixes, said Evelyn Rusli, co-chief executive of Yumi, a baby food company that does extensive testing of its ingredients and finished products.Why is that a particular concern for babies?Heavy metals are not healthy for adults, but they are particularly bad for babies. Infants and toddlers grow rapidly, developing key body systems and laying the foundation for lifelong cardiovascular, immune and brain health. Because they are far smaller than adults, a small dose of any toxin can be harmful. They may also be less efficient at metabolizing toxins than adults. Small amounts of lead, for instance, have been found to affect behavior, I.Q. and academic achievement, according to the American Academy of Pediatrics.What products should I avoid if I’m feeding a baby?Rice, used in baby cereal and snack puffs, is consistently identified in studies as the food with the highest levels of arsenic, which is associated with cancer. The problem is believed to stem from rice farming in fields that are flooded year after year with water that can contaminate the soil. (Scientists are working on ways to minimize the problem.)Dry rice cereal is often one of the first foods parents are urged to mix with breast milk or formula when a baby begins the transition from a liquid diet to solid food. Dry oatmeal cereal is a better alternative, according to a report by Healthy Babies Bright Futures, an advocacy group.Other foods found to have the lowest levels of heavy metals include peas, green beans, butternut squash and bananas. Beans, eggs and soft meat in traditional baby food or prepared at home are low-metal forms of protein, the report says. Serving a wide variety of fruits and vegetables — instead of relying heavily on carrots and sweet potatoes — can help reduce overall exposure to heavy metals.Why aren’t the foods tested before they get on the market?While some food companies monitor toxin levels, they are not required to report the results to the public or to list them on product labels. The F.D.A. has broad mandates that food makers ensure their products are safe, but there are few actual limits for specific toxins. The F.D.A. has set an “action limit” for inorganic arsenic in rice cereal marketed for babies and has proposed one for lead in juice.These limits — like those proposed for lead in baby food — do not set a strict bar. Rather, they create guidelines for food makers to voluntarily follow. If the F.D.A. finds that a company exceeds the levels, it can pursue enforcement action, which can lead to a product recall, seizure or a recommendation for criminal prosecution.What can be done to remove metals from foods?Washing produce will not help. But there are agricultural techniques that can reduce the levels seeping into crops. Farmers can test soil and use contaminated fields for crops that do not tend to pick up the metals, like beans. They can also use fields with suboptimal soil to grow lavender or other crops that might not be eaten, Ms. Beyranevand, of Vermont Law, said. Farmers are also trying to reduce toxins by growing crops — such as sunflowers and poplar trees — that are efficient at drawing impurities out of the soil and then disposing of the plants.Agriculture experts are studying hundreds of varieties of plants that people eat to determine which are the least likely to harbor heavy metals, according to the Healthy Babies Bright Futures report.What can food companies do?Ms. Rusli, of Yumi, said her company reviewed soil content data from the Environmental Protection Agency to buy produce for its baby food from regions with lower levels of contamination. It also conducts testing before entering into contracts with farmers and tests finished products to ensure that metals aren’t added during processing.

The agency estimated that the guidelines could reduce young children’s dietary exposure to lead by about 25 percent.The Food and Drug Administration on Tuesday proposed maximum limits for the amount of lead in baby foods like mashed fruits and vegetables and dry cereals, after years of studies revealed that many processed products contained levels known to pose a risk of neurological and developmental impairment.The agency issued draft guidance, which would not be mandatory for food manufacturers to abide by. The guidelines, if adopted, would allow the agency to take enforcement action against companies that produced foods that exceeded the new limits.“This is really important progress for babies,” said Scott Faber, vice president of public affairs for the Environmental Working Group, a nonprofit organization that had urged the agency to take action to remove metals from foods. “We were grateful that F.D.A. has and the Biden administration has made reducing toxic metals in baby food a priority.”The new limits, aimed at foods for children under 2, do not address grain-based snacks that have also been found to contain high levels of heavy metals. And they do not limit other metals, like cadmium, that the agency and many consumer groups have detected in infant foods in previous years.Jane Houlihan, research director for Healthy Babies Bright Futures, a nonprofit, called the guidelines disappointing. “It doesn’t go far enough to protect babies from neurodevelopmental damage from lead exposures,” she said. “Lead is in almost every baby food we’ve tested, and the action levels that F.D.A. has set will influence almost none of that food.”She said the limits would address some of the highest levels they had found but more broadly appeared to “codify the status quo.”The Centers for Disease Control and Prevention has said there is no safe level of lead for children, who more readily absorb the heavy metal. The F.D.A. proposed setting a lead level lower than10 parts per billion in yogurts, fruits or vegetables and no more than 20 parts per billion in root vegetables and in dry infant cereals.The limits “would result in significant reductions in exposures to lead from food while ensuring availability of nutritious foods,” according to an F.D.A. news release. The move is part of the agency’s Closer to Zero initiative, which is aimed at reducing the exposure of young children to toxins such as lead, arsenic, cadmium and mercury.The changes “will result in long-term, meaningful and sustainable reductions in the exposure to this contaminant from foods,” said Dr. Robert M. Califf, the commissioner of the F.D.A. The guideline would allow the agency to identify foods as “adulterated” if they contained levels beyond the limits, and to then seek a recall, seize products or recommend a criminal prosecution.The agency estimated that the proposed levels could reduce the dietary exposure to lead for some young children by about 25 percent. According to the F.D.A., low levels of lead exposure in children can lead to “learning disabilities, behavior difficulties and lowered I.Q.” as well as immunological and cardiovascular effects.In 2020, the F.D.A. set limits for inorganic arsenic in rice cereal for infants and in April of last year, it proposed maximum levels for lead in juice.In comments submitted to the F.D.A. on its broader plan, Gerber wrote in 2021 that reducing toxins was difficult because plants absorbed them from the soil as they grew.“Actions that result in removing baby foods from the diet, whether intentional or not, do not change exposure if these foods are replaced with other sources of the same fruits, vegetables and grains that are prone to having heavy metals,” the company wrote.A Gerber spokeswoman said on Tuesday that the company was reviewing the F.D.A.’s proposal, and planned to work with the agency “to advance this important effort to continue to reduce the levels of heavy metals in infant and toddler foods.”Walmart and Hain Celestial, which produces Earth’s Best Organic foods, did not respond to requests for comment on the proposal. Beech-Nut Nutrition Company said in a statement that it was reviewing the guidance and would work with the F.D.A. on “the establishment of science-based regulatory” limits for “naturally occurring heavy metals.”Attorneys general from New York, Illinois, Pennsylvania, Michigan and other states had weighed in on the overall plan, urging the F.D.A. to post the results of its tests for multiple metals in baby food on its website.Lead is ubiquitous in the environment from decades of unregulated use in gasoline for cars, farm machinery, aircraft and paint, said Tracey Woodruff, a scientist at the University of California, San Francisco, who studies exposure to toxins.She applauded the F.D.A.’s goals, but said a strict limit would be more effective because the voluntary guideline would require monitoring for possible enforcement.“Corporations are innovative and know how to tweak what they need to do to meet legal standards and make a profit,” she said.Representative Raja Krishnamoorthi, Democrat of Illinois, has been a leading voice calling for reductions of heavy metals in baby foods. He and other lawmakers issued a report in 2021 showing that baby foods like carrots and sweet potatoes were contaminated with heavy metals.On Tuesday, Representative Krishnamoorthi said in a statement that he has been pressing the F.D.A. to ensure baby food is safe. He said he remained concerned that the “lead levels announced today are considerably more lenient than those specified in” legislation that he and other lawmakers introduced in March 2021.Months later, Consumer Reports released tests showing that arsenic remained present in rice cereal meant for babies even after the limit was issued. The group advised parents to favor dry oatmeal as a safer alternative.Mr. Faber, of the Environmental Working Group, said the new guideline would prompt food companies to encourage suppliers to alter their farming practices to reduce the lead levels in food.“I think that past history has shown that farmers and food companies are very quickly able to change how they grow and process these ingredients to meet tougher standards,” he said.

Abbott shut down production at the plant last year amid “shocking” sanitation lapses, touching off a disruptive infant supply formula shortage.The U.S. Department of Justice has opened an investigation into operations at the Abbott Nutrition infant formula plant in Michigan that shut down over sanitation problems early last year, causing a lengthy and widespread infant formula shortage.The company confirmed the investigation in an email but offered no further details, other than that it was “cooperating fully,” according to an Abbott spokesman.The plant, in Sturgis, Mich., came to national attention in 2022 after the Food and Drug Administration, while fielding reports of infants sickened by formula produced there, found strikingly unsanitary conditions, including puddles of water on the floor near production lines. In February, the agency urged the company to recall Similac and other widely used infant formulas, F.D.A. records show. Abbott voluntarily ceased production at the plant for several months.Baby formula was already somewhat scarce because of pandemic-related supply chain issues, but the Abbott recall made the situation much worse. Stunned parents reported hunting for hours to find formula needed to feed their infants. By May, President Biden was deploying military planes to airlift infant formula into the United States.The investigation was previously reported by The Wall Street Journal. The Department of Justice declined to comment.Four infants in three states — Minnesota, Ohio and Texas — fell ill with the dangerous Cronobactor sakazakii bacteria starting in September 2021, and two of them died. Though F.D.A. inspectors who swabbed the area near production lines at the Sturgis plant found samples of the bacteria, F.D.A. records show, no strain associated with an infant was directly linked to the facility.Lawmakers held hearings about the crisis, discussing the F.D.A.’s fumbling of a whistle-blower complaint from an Abbott insider who asserted that the plant did not destroy a batch of formula found to include micro-organisms because “senior management was under significant pressure to meet its ‘numbers.’”In one House hearing in May, Dr. Robert Califf, the F.D.A. commissioner, acknowledged that the agency moved too slowly to address the supply chain crisis and made “decisions that were suboptimal along the way.”He also described “shocking” and “egregiously unsanitary” conditions at the Sturgis plant, including a leaking roof and pooled water near production areas.The F.D.A. released a review of its response in September, noting that the agency needs better information technology and visibility into the supply chain, even as formula supply remained low. Dr. Califf commissioned a more sweeping review of the F.D.A. food division, released last month, which called for a stronger new leadership structure.Glenn Thrush

The proposed deal would resolve thousands of lawsuits in multidistrict litigation based in Northern California.Juul Labs has agreed to pay $1.7 billion to settle more than 5,000 lawsuits by school districts, local governments and individuals who claimed that its e-cigarettes were more addictive than advertised, according to people with knowledge of the deal.The amount for the deal, which involves a consolidation of cases centered in Northern California, is more than three times the sum reported for other Juul settlements in other state and local cases thus far.The settlement amount was reported earlier by The Wall Street Journal.In September, the company agreed to pay $438.5 million to settle a multistate investigation into whether the company had targeted young people. States investigating the company bristled at ads featuring young models and fruit and dessert flavors that appealed to adolescents. The resulting settlement restricted Juul from aiming marketing of its products at young people.Full terms of the settlement, reached earlier this week, have not been disclosed. But Juul has repeatedly denied targeting minors and has not admitted wrongdoing in reaching other agreements with plaintiffs.Juul continues to sell its products in the United States while awaiting a decision by the Food and Drug Administration, which regulates e-cigarettes. In June, the agency denied the company’s application to allow its vapes and pods to remain on the market. Juul went to court and received a temporary reprieve; the F.D.A. then put its decision on hold for further review, which is continuing.The new settlement does not put an end to claims against Altria, which owned a 35 percent stake in Juul, according to lawyers for the plaintiffs. The agreement does not offer funds immediately, but will open up a claims process for the 10,000 plaintiffs to apply for distribution of the funds.

The deal is the latest in the company’s efforts to resolve litigation over its marketing of products that some contend fueled the teenage vaping crisis.Juul Labs announced on Tuesday that it had agreed to settle about 5,000 lawsuits in a Northern California court case for an undisclosed sum, resolving one more legal battle over its sale and marketing of e-cigarettes blamed for the teenage vaping crisis.The proposed agreement on the multidistrict litigation would wrap up personal injury, consumer class action, government and Native American tribe cases in a deal that the company said it had secured an investment to fund.“These settlements represent a major step toward strengthening Juul Labs’ operations and securing the company’s path forward to fulfill its mission to transition adult smokers away from combustible cigarettes while combating underage use,” a company spokesman said in a statement.In September, the company settled an investigation by three dozen states for $438.5 million. That investigation focused on the company’s early marketing of its products, including the use of young models and the sale of flavors like mango and crème brûlée that many contended were deliberately aimed at underage youths. That settlement set terms for Juul’s marketing that prohibited the company from targeting young people.Juul has repeatedly denied targeting minors, and in other rounds of settlements the company has not admitted wrongdoing in reaching agreements with the plaintiffs. The latest settlement does not end claims against Altria, which owned a 35 percent stake in Juul, according to lawyers for the plaintiffs. The agreement does not offer funds immediately but will open up a claims process.“The scope of these suits is enormous,” Sarah R. London, a co-lead counsel for the plaintiffs, said in a statement. “These settlements will put meaningful compensation in hands of victims and their families, get real funds to schools for abatement programs, and help government and tribal entities prevent youth use of e-cigarettes across the U.S.”The company is still awaiting a decision by the Food and Drug Administration over permanent authorization for sale of its vaping devices and pods. In June, the agency denied the company’s application to allow its e-cigarettes to remain on the market. Juul received a temporary court reprieve, and then the F.D.A. put its decision on hold for further review, which is continuing.Juul said the agreement reached on Tuesday involved about 10,000 plaintiffs, many of whom claimed they had not been aware that the product could be more addictive than cigarettes. The plaintiffs, which included school districts, also argued that the e-cigarettes were unreasonably dangerous because of their attractiveness to young people. They made a wide range of claims, from racketeering to fraud and unjust enrichment.Meredith Berkman, a co-founder of Parents Against Vaping E-Cigarettes, said she hoped the settlement was large enough “to compensate millions of American families whose lives have been upended by the youth vaping epidemic created by Juul.” The group is not a plaintiff in this multidistrict litigation.She said she was troubled by the lack of details initially released by Juul and hoped the judge overseeing the litigation would require Juul to produce documents showing whether the company had deliberately targeted adolescents.

Spurred by the infant formula crisis, a panel found that the agency shied away from tough decisions, sometimes fearing confrontations with industry over enforcement of critical public health issues.The Food and Drug Administration’s food division has no clear leadership, avoids bold policy or enforcement actions, and fosters a culture that doesn’t adequately protect public health, according to a report issued on Tuesday by an agency-related group.Experts with the group, the Reagan-Udall Foundation, which was asked to examine the food division after widespread criticism stemming from the infant formula crisis, concluded in the report that the division’s management structure and mission should be overhauled.Dr. Robert Califf, the agency commissioner, released a statement Tuesday saying he would form a group to advise him on the findings and on how to put the recommendations in place. The infant formula crisis was the first major challenge that Dr. Califf confronted this year as commissioner, although the agency has also faced criticism over the regulation of vaping and tobacco products, which prompted a similar review of its tobacco division.“I expect this leadership group to be bold and focused on the transformative opportunities ahead for the F.D.A.’s food program,” Dr. Califf said. “I will be fully engaged to ensure that the program comes out of this transition with the resources, tools and visibility it warrants given how critical its work is to every American.”Congressional lawmakers and others have long called for strengthening the authority and influence of the agency’s food division, given the effects of foods like added sugar and salt on deadly chronic diseases and the toll of food-borne illnesses that account for an estimated 128,000 U.S. hospitalizations and 3,000 deaths each year.The report followed years of complaints that the food unit was toothless, a criticism that was amplified by what critics viewed as the agency’s plodding and disorganized response to reports of infant illness and death and unsanitary conditions at the Abbott Nutrition infant formula plant in Michigan. The agency’s shutdown of the factory in February aggravated an infant formula shortage that left parents scrambling to feed their babies for months earlier this year.A New York Times review found that the F.D.A. had fielded a complaint in September 2021 about a Minnesota infant hospitalized with the deadly Cronobactor sakazakii bacteria, reportedly after consuming formula from the plant. Yet even though agency inspectors inspected the plant in Sturgis, Mich., at the time, it was not until February that the authorities swabbed the plant and discovered the bacteria near production areas. Abbott has said that genetic sequencing did not connect bacteria found in the plant to the deaths of infants infected with Cronobactor.Representative Rosa DeLauro, Democrat of Connecticut and chairwoman of the House Appropriations Committee, which oversees the agency, said in a statement that she was “pleasantly surprised by the formal acknowledgment of the issues that plague the F.D.A. foods program.”“I look forward to working with the F.D.A. on how they intend to implement the positive reforms in this report,” Ms. DeLauro said.Food safety advocates who have been harsh critics of the agency said the report appeared detailed and strong enough to pave the way for needed change.“It’s very significant and encouraging from that standpoint, because for them to outline the findings that they did is important, because it’s a critical acknowledgment that things definitely need to change,” Brian Ronholm, director of food policy for Consumer Reports, said. “Now it comes down to: How does F.D.A. process this report and the information contained in it, and how does that translate to meaningful reform?”Some critics, however, pointed to the relationship the report’s authors have with the agency. The Reagan-Udall Foundation is funded by the F.D.A. and major corporations like Pfizer, AbbVie and Nestle USA, which makes infant formula. The foundation sought the views of food safety and nutrition experts and collated the comments of agency staff members, but has since removed the feedback from its website.The staff comments, reviewed by The Times, showed some discontent with how the division was run. Some employees repeatedly complained that division managers stopped short of enforcing food-safety laws out of fear of complaints or lawsuits. Others said that input from industry consultants and special advisers from industry added little value. And some others chafed about a lack of clear priorities, or personality politics and favoritism that trumped a focus on protecting the nation’s food supply.Four former F.D.A. food center directors submitted a statement calling for the division to be better protected from budget cuts and for giving its officials more control over food facility inspections.The report underscores that concern about lack of leadership, noting that three food division officials have competing levels of authority. The report recommends a structural change, laying out several options that would make leadership more centralized. It also recommended more funding to enhance the division’s operations, although congressional approval for budgetary increases might prove difficult now that inflation and the economy may force cutbacks.