Elevated Lead Levels Found in Cinnamon Products, New Study Shows

Consumer Reports found lead in a variety of products, at a time when federal regulators are seeking authority from Congress to combat the problem of heavy metals in foods.One dozen of 36 cinnamon products tested by a consumer group contained elevated levels of lead, according to a study released on Thursday that reinforced concerns about metals in foods after tainted cinnamon applesauce poisoned dozens of children last year.The study, by Consumer Reports, documented levels that were far lower than the amounts discovered last year.The Consumer Reports team tested the spice and found high levels in lead in 12 items sold at discount stores and ethnic markets, with lead levels reaching 3.5 parts per million. New York, the only state with tough lead standards in spices, recalls spices — among them curry powder, chili powder, cumin and five-spice powder — with more than one part per million of lead. Consumer Reports advised that people throw out items with that amount.Badia, one common brand, sold cinnamon with one part per million of lead, according to the report. The company did not respond to a request for comment.While the levels in the cinnamon applesauce recalled last year were “astronomical,” those in the new report were still 1,000 times as high as the levels that concern lead-exposure experts who focus on children’s health, said Tomás R. Guilarte, a neuroscience and environmental health professor at Florida International University.“These are extremely high levels of lead,” he said. “Clearly they shouldn’t be used.”Earlier this year, the Food and Drug Administration urged a series of recalls of cinnamon products. The discoveries provided the impetus for consumer advocacy groups to generate greater public awareness of the dangers of lead and other metals, and for the agency to push Congress for tough limits on those heavy metals in food.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Mushroom-Laced Candy Recall Highlights F.D.A.’s Limited Safety Role

More than 150 people were sickened from products sold at smoke and vape shops, providing evidence of the lax regulation of new food items.Nearly 160 people have reportedly been sickened this summer by eating mushroom-laced candy and chocolate bars that are widely available at vape and smoke shops, underscoring the dangers of a sprawling market of psychoactive products that pop up on store shelves with no review or regulation across the United States.Two deaths now under investigation may be related to the candy, samples of which were found to contain an illegal form of psilocin, an ingredient in so-called magic mushrooms, according to federal health officials.More than a third of those who became ill required hospitalization, suffering symptoms ranging from vomiting to loss of consciousness, seizures and hallucinations.The illnesses were traced to Diamond Shruumz chocolates and gummies, which the company recalled on June 28, officials said. Since then, the Food and Drug Administration has said that it was aware that the candy continued to be sold, and the agency released a list of about 2,300 shops that it said carried the products.Those items and other snacks, supplements and teas promising a mind-altering experience often contain ingredients like synthetic Delta-8-THC, or kratom, a botanical, that the F.D.A. considers hazardous.They are commonly sold in stores and do not have to meet quality standards, nor do they carry restrictions on sales to minors.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Teenage E-Cigarette Use Continues to Decline

The percentage of middle and high school students reporting that they vaped tobacco products dropped to about a third of those students reporting use of e-cigarettes at a vaping peak in 2019, a new survey shows.The number of teenagers who reported using e-cigarettes in 2024 has tumbled from a worrisome peak reached five years ago, raising hopes among public health officials for a sustained reversal in vaping trends among teens.In an annual survey conducted from January through May in schools across the nation, fewer than 8 percent of high school students reported using e-cigarettes in the past month.That’s far lower than the apex, in 2019, when more than 27 percent of high school students who took the same survey reported that they vaped — and an estimated 500,000 fewer adolescents than last year.The data is from the National Youth Tobacco Survey, a questionnaire filled out by thousands of middle and high school students that is administered each year by the Food and Drug Administration and the Centers for Disease Control and Prevention. Overall, it found that just under 6 percent of middle and high school students reported vaping in the last month, down from nearly 8 percent among those surveyed last year. Use among high school students largely accounted for this year’s decline; middle school use stayed fairly steady.“I want to be unequivocally clear that this continued decline in e-cigarette use among our nation’s youth is a monumental public health win,” Brian King, the director of the F.D.A.’s tobacco division, said during a news briefing.Public health experts said the decline in teenage vaping may be due to several factors, including city and state flavored tobacco bans, a blitz of enforcement against sellers of flavored vapes and three public messaging campaigns aimed at young people about the dangers of vaping.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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He Regulated Medical Devices. She Represented Their Makers.

For 15 years, Dr. Jeffrey E. Shuren was the federal official charged with ensuring the safety of a vast array of medical devices including artificial knees, breast implants and Covid tests.When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms.Dr. Shuren signed ethics agreements obtained by The Times that were meant to wall him off from matters involving Arnold & Porter’s business. But it’s not clear how rigorously the ethics agreements were actually enforced. His wife’s law firm refused to provide a list of clients — and the agency had no legal authority to require it, said Michael Felberbaum, a spokesman for the F.D.A.In a review of thousands of pages of court documents and F.D.A. records and dozens of interviews with current and former agency staff members and advocates, The Times identified some clients and several instances in which the Shurens’ roles intersected.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Law Enforcement Unit Formed to Crack Down on Illegal E-Cigarettes

Agents from various federal agencies will focus on unauthorized candy-flavored and nicotine-laden vapes that have flooded the U.S. market from overseas.A multi-agency coalition of law enforcement agents will begin tackling the unruly market of illegal e-cigarettes, under pressure from antismoking groups, lawmakers and the tobacco industry urging federal authorities to stop the flood of vaping devices favored by adolescents.The Justice Department announced the new effort, which is expected to target fruit- and candy-flavored vapes containing high levels of addictive nicotine.The new coalition would include the Bureau of Alcohol, Tobacco, Firearms and Explosives; the U.S. Marshals Service; the Federal Trade Commission and the U.S. Postal Service, tapping into federal laws that could include significant fines and jail terms. “Unauthorized e-cigarettes and vaping products continue to jeopardize the health of Americans — particularly children and adolescents — across the country,” Benjamin C. Mizer, the acting associate attorney general, said.Until now, enforcement efforts have largely involved warning letters and limited penalties issued by the Food and Drug Administration to various vendors like gas station and convenience store owners, ordering them to stop selling the items.Those F.D.A. initiatives have been criticized as unsuccessful by congressional lawmakers and others, who have pushed the agency to do more to keep illegal e-cigarettes from entering the United States.Traditional tobacco companies, including Reynolds American, have also asked the F.D.A., which regulates tobacco, to banish the illicit products that are in competition with their own e-cigarettes. Their call for flavored vape enforcement, though, has ended at the U.S. border. British American Tobacco, Reynolds’ parent company, has said it marketed its Vuse Go vapes in flavors like Mango Ice and Blue Raspberry in 46 countries.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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Setback Deals Blow to Neuralink’s First Brain Implant Patient, but He Stays Upbeat

Elon Musk’s first human experiment with a computerized brain device developed significant flaws, but the subject, who is paralyzed, has few regrets.Just four months ago, Noland Arbaugh had a circle of bone removed from his skull and hair-thin sensor tentacles slipped into his brain. A computer about the size of a small stack of quarters was placed on top and the hole was sealed.Paralyzed below the neck, Mr. Arbaugh is the first patient to take part in the clinical trial of humans testing Elon Musk’s Neuralink device, and his early progress was greeted with excitement.Working with engineers, Mr. Arbaugh, 30, trained computer programs to translate the firing of neurons in his brain into the act of moving a cursor up, down and around. His command of the cursor was soon so agile that he could challenge his stepfather at Mario Kart and play an empire-building video game late into the night.But as weeks passed, about 85 percent of the device’s tendrils slipped out of his brain. Neuralink’s staff had to retool the system to allow him to regain command of the cursor. Though he needed to learn a new method to click on something, he can still skate the cursor across the screen.Neuralink advised him against a surgery to replace the threads, he said, adding that the situation had stabilized.The setback became public earlier this month. And although the diminished activity was initially difficult and disappointing, Mr. Arbaugh said it had been worth it for Neuralink to move forward in a tech-medical field aimed at helping people regain their speech, sight or movement.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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CPAP Lawsuits Settled for $1.1 Billion

Thousands of people with sleep apnea and other illnesses had sued the company, claiming flawed devices were harming them. Philips Respironics has reached a $1.1 billion settlement over claims that people who used their CPAP and other breathing devices were harmed by noxious gasses and flecks of foam that lodged in their airways, sometimes for years.Thousands of people contended in lawsuits that they had been injured by popular Philips DreamStation machines. The settlement affects CPAP, or continuous positive airway pressure, machines that people with sleep apnea or other respiratory difficulties use at night to improve their breathing, as well as other types of machines used at home and in hospitals.Philips did not admit any fault in the settlement, including whether the devices caused the injuries, according to a financial report issued Monday.The personal injury settlement follows a $479 million settlement reached in September over economic losses to the patients and medical equipment sales companies that financed replacement devices. Philips also agreed to a consent decree earlier this year that forced the company to halt U.S. sales of new devices until certain conditions are met.Monday’s agreement largely settles years of litigation over a problem that was deeply upsetting to patients and doctors, who had to weigh the risk of letting patients’ interrupted breathing go untreated against the use of a machine that might cause harm. Patients flooded lawmakers and the Food and Drug Administration with complaints about a chaotic recall and replacement effort that left many waiting for months or more than a year for an updated device.In a letter to Philips in May 2022, the F.D.A. noted that the company had received reports about the problem as early as 2015, but failed to evaluate the information and address the device’s problems.The recall started in the summer of 2021 amid concerns that the machines blew out potentially cancer-causing gases. The initial recall affected about 15 million breathing machines produced since 2006, though roughly five million were still in circulation in mid-2021.The F.D.A. reported earlier this year that since Philips first warned of the problems, officials had received 116,000 complaints, including 561 reports of deaths, that people or lawyers said were linked to the faulty foam in the device.The company has since tempered its warnings, saying that further testing showed that the gasses were not as toxic as initially believed.Investors recognized the resolution, as the company stock surged by about 33 percent Monday morning, to about $28 per share. The company said that part of the settlement would be covered by insurance.Plaintiffs’ lawyers welcomed the settlement.“Ultimately, these combined agreements accomplish what we sought to achieve when this litigation began — holding Philips accountable by obtaining care for those with physical injuries and compensation for those needing new respiratory devices,” Sandra L. Duggan, Kelly K. Iverson and Christopher A. Seeger, lawyers representing the plaintiffs, said in a statement.

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U.S. Scrutiny of Chinese Company Could Disrupt U.S. Supply Chain for Key Drugs

A Chinese company targeted by members of Congress over potential ties to the Chinese government makes blockbuster drugs for the American market that have been hailed as advances in the treatment of cancers, obesity and debilitating illnesses like cystic fibrosis.WuXi AppTec is one of several companies that lawmakers have identified as potential threats to the security of individual Americans’ genetic information and U.S. intellectual property. A Senate committee approved a bill in March that aides say is intended to push U.S. companies away from doing business with them.But lawmakers discussing the bill in the Senate and the House have said almost nothing in hearings about the vast scope work WuXi does for the U.S. biotech and pharmaceutical industries — and patients. A New York Times review of hundreds of pages of records worldwide shows that WuXi is heavily embedded in the U.S. medicine chest, making some or all of the main ingredients for multibillion-dollar therapies that are highly sought to treat cancers like some types of leukemia and lymphoma as well as obesity and H.I.V.The Congressional spotlight on the company has rattled the pharmaceutical industry, which is already struggling with widespread drug shortages now at a 20-year high. Some biotech executives have pushed back, trying to impress on Congress that a sudden decoupling could take some drugs out of the pipeline for years.WuXi AppTec and an affiliated company, WuXi Biologics grew rapidly, offering services to major U.S. drugmakers that were seeking to shed costs and had shifted most manufacturing overseas in the last several decades.WuXi companies developed a reputation for low-cost and reliable work by thousands of chemists who could create new molecules and operate complex equipment to make them in bulk. By one estimate, WuXi has been involved in developing one-fourth of the drugs used in the United States. WuXi AppTec reported earning about $3.6 billion in revenue for its U.S. work.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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National Academy Asks Court to Strip Sackler Name From Endowment

Millions in Sackler donations sat dormant, rising in value as the opioid epidemic raged and as other institutions distanced themselves from the makers of a notorious painkiller.The National Academy of Sciences is asking a court to allow it to repurpose about $30 million in donations from the wealthy Sackler family, who controlled the company at the center of the opioid epidemic, and to remove the family name from the endowment funds.The petition filed by the Academy in Superior Court in Washington, D.C., Thursday aims to modify the terms of the donations so the institution can use them for scientific studies, projects and educational activities.The move follows a report in The New York Times last year that examined donations from several Sackler members, including an executive of Purdue Pharma, which produced the painkiller OxyContin that has long been blamed for fueling the opioid crisis that has claimed thousands of lives.“The notoriety of the Sackler name has made it impossible for the Academy to carry out the purposes for which it originally accepted the funds,” Marcia McNutt, president of the National Academy of Sciences, said in a statement released on Thursday.Daniel S. Connolly, a spokesman for the Raymond Sackler family, said it supported the National Academies in “using the funds as they see fit” and would have supported the change.“We would have said yes if we’d been asked, just as we will still say yes despite this unnecessary court filing and false assertions about us,” Mr. Connolly said in a statement.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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FDA Issues Alert on Heart Pump Linked to Deaths

The agency faulted the device maker for delayed notice of mounting complications, citing increasing reports of how use of the device perforated the walls of the heart.A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert about the risk that it could puncture a wall of the heart.The tiny Impella pumps, about the width of a candy cane, are threaded through blood vessels to take over the work of the heart in patients who are undergoing complex procedures or have life-threatening conditions.The F.D.A. said the manufacturer of the device, Abiomed, should have notified the agency more than two years ago, when the company first posted an update on its website about the perforation risk. Such a notice, the F.D.A. added, would have led to a much broader official agency warning to hospitals and doctors.The alert is the latest of concerns raised in recent years about the deadly side effects of cardiac devices, especially those that take over the heart’s role in circulating blood. It is the third major F.D.A. action for an Impella device in a year.A series of studies suggested that the Impella heart devices heighten the risk of death in patients with unstable medical conditions. Meanwhile, the device maker has spent millions of dollars promoting the device and awarding consulting payments to cardiologists and grants to hospitals.Since Abiomed’s first notice about the Impella’s complications in October 2021, the F.D.A. received 21 additional reports of heart-wall tears linked to patient deaths, according to Audra Harrison, a spokeswoman for the agency.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

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