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Westlake Legal Group > Food and Drug Administration

Science Under Attack: How Trump Is Sidelining Researchers and Their Work

WASHINGTON — In just three years, the Trump administration has diminished the role of science in federal policymaking while halting or disrupting research projects nationwide, marking a transformation of the federal government whose effects, experts say, could reverberate for years.

Political appointees have shut down government studies, reduced the influence of scientists over regulatory decisions and in some cases pressured researchers not to speak publicly. The administration has particularly challenged scientific findings related to the environment and public health opposed by industries such as oil drilling and coal mining. It has also impeded research around human-caused climate change, which President Trump has dismissed despite a global scientific consensus.

But the erosion of science reaches well beyond the environment and climate: In San Francisco, a study of the effects of chemicals on pregnant women has stalled after federal funding abruptly ended. In Washington, D.C., a scientific committee that provided expertise in defending against invasive insects has been disbanded. In Kansas City, Mo., the hasty relocation of two agricultural agencies that fund crop science and study the economics of farming has led to an exodus of employees and delayed hundreds of millions of dollars in research.

“The disregard for expertise in the federal government is worse than it’s ever been,” said Michael Gerrard, director of the Sabin Center for Climate Change Law at Columbia University, which has tracked more than 200 reports of Trump administration efforts to restrict or misuse science since 2017. “It’s pervasive.”

Hundreds of scientists, many of whom say they are dismayed at seeing their work undone, are departing.

Among them is Matthew Davis, a biologist whose research on the health risks of mercury to children underpinned the first rules cutting mercury emissions from coal power plants. But last year, with a new baby of his own, he was asked to help support a rollback of those same rules. “I am now part of defending this darker, dirtier future,” he said.

This year, after a decade at the Environmental Protection Agency, Mr. Davis left.

“Regulations come and go, but the thinning out of scientific capacity in the government will take a long time to get back,” said Joel Clement, a former top climate-policy expert at the Interior Department who quit in 2017 after being reassigned to a job collecting oil and gas royalties. He is now at the Union of Concerned Scientists, an advocacy group.

Mr. Trump has consistently said that government regulations have stifled businesses and thwarted some of the administration’s core goals, such as increasing fossil-fuel production. Many of the starkest confrontations with federal scientists have involved issues like environmental oversight and energy extraction — areas where industry groups have argued that regulators have gone too far in the past.

“Businesses are finally being freed of Washington’s overreach, and the American economy is flourishing as a result,” a White House statement said last year. Asked about the role of science in policymaking, officials from the White House declined to comment on the record.

The administration’s efforts to cut certain research projects also reflect a longstanding conservative position that some scientific work can be performed cost-effectively by the private sector, and taxpayers shouldn’t be asked to foot the bill. “Eliminating wasteful spending, some of which has nothing to do with studying the science at all, is smart management, not an attack on science,” two analysts at the conservative Heritage Foundation wrote in 2017 of the administration’s proposals to eliminate various climate change and clean energy programs.

ImageWestlake Legal Group 00CLI-SCIENCE-dorian-articleLarge Science Under Attack: How Trump Is Sidelining Researchers and Their Work United States Politics and Government Trump, Donald J Science and Technology Research Regulation and Deregulation of Industry national institutes of health National Academies of the United States Justice Department Interior Department Greenhouse Gas Emissions Government Employees Global Warming Food and Drug Administration Environmental Protection Agency environment Commerce Department

The president’s desk.Credit…Erin Schaff/The New York Times

Industry groups have expressed support for some of the moves, including a contentious E.P.A. proposal to put new constraints on the use of scientific studies in the name of transparency. The American Chemistry Council, a chemical trade group, praised the proposal by saying, “The goal of providing more transparency in government and using the best available science in the regulatory process should be ideals we all embrace.”

In some cases, the administration’s efforts to roll back government science have been thwarted. Each year, Mr. Trump has proposed sweeping budget cuts at a variety of federal agencies like the National Institutes of Health, the Department of Energy and the National Science Foundation. But Congress has the final say over budget levels and lawmakers from both sides of the aisle have rejected the cuts.

For instance, in supporting funding for the Department of Energy’s national laboratories, Senator Lamar Alexander, Republican of Tennessee, recently said, “it allows us to take advantage of the United States’ secret weapon, our extraordinary capacity for basic research.”

As a result, many science programs continue to thrive, including space exploration at NASA and medical research at the National Institutes of Health, where the budget has increased more than 12 percent since Mr. Trump took office and where researchers continue to make advances in areas like molecular biology and genetics.

Nevertheless, in other areas, the administration has managed to chip away at federal science.

At the E.P.A., for instance, staffing has fallen to its lowest levels in at least a decade. More than two-thirds of respondents to a survey of federal scientists across 16 agencies said that hiring freezes and departures made it harder to conduct scientific work. And in June, the White House ordered agencies to cut by one-third the number of federal advisory boards that provide technical advice.

The White House said it aimed to eliminate committees that were no longer necessary. Panels cut so far had focused on issues including invasive species and electric grid innovation.

At a time when the United States is pulling back from world leadership in other areas like human rights or diplomatic accords, experts warn that the retreat from science is no less significant. Many of the achievements of the past century that helped make the United States an envied global power, including gains in life expectancy, lowered air pollution and increased farm productivity are the result of the kinds of government research now under pressure.

“When we decapitate the government’s ability to use science in a professional way, that increases the risk that we start making bad decisions, that we start missing new public health risks,” said Wendy E. Wagner, a professor of law at the University of Texas at Austin who studies the use of science by policymakers.

Skirmishes over the use of science in making policy occur in all administrations: Industries routinely push back against health studies that could justify stricter pollution rules, for example. And scientists often gripe about inadequate budgets for their work. But many experts say that current efforts to challenge research findings go well beyond what has been done previously.

In an article published in the journal Science last year, Ms. Wagner wrote that some of the Trump administration’s moves, like a policy to restrict certain academics from the E.P.A.’s Science Advisory Board or the proposal to limit the types of research that can be considered by environmental regulators, “mark a sharp departure with the past.” Rather than isolated battles between political officials and career experts, she said, these moves are an attempt to legally constrain how federal agencies use science in the first place.

Some clashes with scientists have sparked public backlash, as when Trump officials pressured the nation’s weather forecasting agency to support the president’s erroneous assertion this year that Hurricane Dorian threatened Alabama.

But others have garnered little notice despite their significance.

This year, for instance, the National Park Service’s principle climate change scientist, Patrick Gonzalez, received a “cease and desist” letter from supervisors after testifying to Congress about the risks that global warming posed to national parks.

“I saw it as attempted intimidation,” said Dr. Gonzalez, who added that he was speaking in his capacity as an associate adjunct professor at the University California, Berkeley, a position he also holds. “It’s interference with science and hinders our work.”

Even though Congress hasn’t gone along with Mr. Trump’s proposals for budget cuts at scientific agencies, the administration has still found ways to advance its goals.

One strategy: eliminate individual research projects not explicitly protected by Congress.

For example, just months after Mr. Trump’s election, the Commerce Department disbanded a 15-person scientific committee that had explored how to make National Climate Assessments, the congressionally mandated studies of the risks of climate change, more useful to local officials. It also closed its Office of the Chief Economist, which for decades had conducted wide-ranging research on topics like the economic effects of natural disasters. Similarly, the Interior Department has withdrawn funding for its Landscape Conservation Cooperatives, 22 regional research centers that tackled issues like habitat loss and wildfire management. While California and Alaska used state money to keep their centers open, 16 of 22 remain in limbo.

A Commerce Department official said the climate committee it discontinued had not produced a report, and highlighted other efforts to promote science, such as a major upgrade of the nation’s weather models.

An Interior Department official said the agency’s decisions “are solely based on the facts and grounded in the law,” and that the agency would continue to pursue other partnerships to advance conservation science.

Research that potentially posed an obstacle to Mr. Trump’s promise to expand fossil-fuel production was halted, too. In 2017, Interior officials canceled a $1 million study by the National Academies of Sciences, Engineering, and Medicine on the health risks of “mountaintop removal” coal mining in places like West Virginia.

Mountaintop removal is as dramatic as it sounds — a hillside is blasted with explosives and the remains are excavated — but the health consequences still aren’t fully understood. The process can kick up coal dust and send heavy metals into waterways, and a number of studies have suggested links to health problems like kidney disease and birth defects.

“The industry was pushing back on these studies,” said Joseph Pizarchik, an Obama-era mining regulator who commissioned the now-defunct study. “We didn’t know what the answer would be,” he said, “but we needed to know: Was the government permitting coal mining that was poisoning people, or not?”

While coal mining has declined in recent years, satellite data shows that at least 60 square miles in Appalachia have been newly mined since 2016. “The study is still as important today as it was five years ago,” Mr. Pizarchik said.

The cuts can add up to significant research setbacks.

For years, the E.P.A. and the National Institute of Environmental Health Sciences had jointly funded 13 children’s health centers nationwide that studied, among other things, the effects of pollution on children’s development. This year, the E.P.A. ended its funding.

At the University of California, San Francisco, one such center has been studying how industrial chemicals such as flame retardants in furniture could affect placenta and fetal development. Key aspects of the research have now stopped.

“The longer we go without funding, the harder it is to start that research back up,” said Tracey Woodruff, who directs the center.

In a statement, the E.P.A. said it anticipated future opportunities to fund children’s health research.

At the Department of Agriculture, Secretary of Agriculture Sonny Perdue announced in June he would relocate two key research agencies to Kansas City from Washington: The National Institute of Food and Agriculture, a scientific agency that funds university research on topics like how to breed cattle and corn that can better tolerate drought conditions, and the Economic Research Service, whose economists produce studies for policymakers on farming trends, trade and rural America.

Nearly 600 employees had less than four months to decide whether to uproot and move. Most couldn’t or wouldn’t, and two-thirds of those facing transfer left their jobs.

In August, Mick Mulvaney, the acting White House chief of staff, appeared to celebrate the departures.

“It’s nearly impossible to fire a federal worker,” he said in videotaped remarks at a Republican Party gala in South Carolina. “But by simply saying to people, ‘You know what, we’re going to take you outside the bubble, outside the Beltway, outside this liberal haven of Washington, D.C., and move you out in the real part of the country,’ and they quit. What a wonderful way to sort of streamline government and do what we haven’t been able to do for a long time.”

The White House declined to comment on Mr. Mulvaney’s speech.

The exodus has led to upheaval.

At the Economic Research Service, dozens of planned studies into topics like dairy industry consolidation and pesticide use have been delayed or disrupted. “You can name any topic in agriculture and we’ve lost an expert,” said Laura Dodson, an economist and acting vice president of the union representing agency employees.

The National Institute of Food and Agriculture manages $1.7 billion in grants that fund research on issues like food safety or techniques that help farmers improve their productivity. The staff loss, employees say, has held up hundreds of millions of dollars in funding, such as planned research into pests and diseases afflicting grapes, sweet potatoes and fruit trees.

Former employees say they remain skeptical that the agencies could be repaired quickly. “It will take 5 to 10 years to rebuild,” said Sonny Ramaswamy, who until 2018 directed the National Institute of Food and Agriculture.

Mr. Perdue said the moves would save money and put the offices closer to farmers. “We did not undertake these relocations lightly,” he said in a statement. A Department of Agriculture official added that both agencies were pushing to continue their work, but acknowledged that some grants could be delayed by months.

In addition to shutting down some programs, there have been notable instances where the administration has challenged established scientific research. Early on, as it started rolling back regulations on industry, administration officials began questioning research findings underpinning those regulations.

In 2017, aides to Scott Pruitt, the E.P.A. administrator at the time, told the agency’s economists to redo an analysis of wetlands protections that had been used to help defend an Obama-era clean-water rule. Instead of concluding that the protections would provide more than $500 million in economic benefits, they were told to list the benefits as unquantifiable, according to Elizabeth Southerland, who retired in 2017 from a 30-year career at the E.P.A., finishing as a senior official in its water office.

“It’s not unusual for a new administration to come in and change policy direction,” Dr. Southerland said. “But typically you would look for new studies and carefully redo the analysis. Instead they were sending a message that all the economists, scientists, career staff in the agency were irrelevant.”

Internal documents show that political officials at the E.P.A. have overruled the agency’s career experts on several occasions, including in a move to regulate asbestos more lightly, in a decision not to ban the pesticide chlorpyrifos and in a determination that parts of Wisconsin were in compliance with smog standards. The Interior Department sidelined its own legal and environmental analyses in advancing a proposal to raise the Shasta Dam in California.

Michael Abboud, an E.P.A. spokesman, disputed Dr. Southerland’s account in an emailed response, saying “It is not true.”

The E.P.A. is now finalizing a narrower version of the Obama-era water rule, which in its earlier form had prompted outrage from thousands of farmers and ranchers across the country who saw it as overly restrictive.

“E.P.A. under President Trump has worked to put forward the strongest regulations to protect human health and the environment,” Mr. Abboud said, noting that several Obama administration rules had been held up in court and needed revision. “As required by law E.P.A. has always and will continue to use the best available science when developing rules, regardless of the claims of a few federal employees.”

Past administrations have, to varying degrees, disregarded scientific findings that conflicted with their priorities. In 2011, President Obama’s top health official overruled experts at the Food and Drug Administration who had concluded that over-the-counter emergency contraceptives were safe for minors.

But in the Trump administration, the scope is wider. Many top government positions, including at the E.P.A. and the Interior Department, are now occupied by former lobbyists connected to the industries that those agencies oversee.

Scientists and health experts have singled out two moves they find particularly concerning. Since 2017, the E.P.A. has moved to restrict certain academics from sitting on its Science Advisory Board, which provides scrutiny of agency science, and has instead increased the number of appointees connected with industry.

And, in a potentially far-reaching move, the E.P.A. has proposed a rule to limit regulators from using scientific research unless the underlying raw data can be made public. Industry groups like the Chamber of Commerce have argued that some agency rules are based on science that can’t be fully scrutinized by outsiders. But dozens of scientific organizations have warned that the proposal in its current form could prevent the E.P.A. from considering a vast array of research on issues like the dangers of air pollution if, for instance, they are based on confidential health data.

“The problem is that rather than allowing agency scientists to use their judgment and weigh the best available evidence, this could put political constraints on how science enters the decision-making process in the first place,” said Ms. Wagner, the University of Texas law professor.

The E.P.A. says its proposed rule is intended to make the science that underpins potentially costly regulations more transparent. “By requiring transparency,” said Mr. Abboud, the agency spokesman, “scientists will be required to publish hypothesis and experimental data for other scientists to review and discuss, requiring the science to withstand skepticism and peer review.”

“In the past, when we had an administration that was not very pro-environment, we could still just lay low and do our work,” said Betsy Smith, a climate scientist with more than 20 years of experience at the E.P.A. who in 2017 saw her long-running study of the effects of climate change on major ports get canceled.

“Now we feel like the E.P.A. is being run by the fossil fuel industry,” she said. “It feels like a wholesale attack.”

After her project was killed, Dr. Smith resigned.

The loss of experienced scientists can erase years or decades of “institutional memory,” said Robert J. Kavlock, a toxicologist who retired in October 2017 after working at the E.P.A. for 40 years, most recently as acting assistant administrator for the agency’s Office of Research and Development.

His former office, which researches topics like air pollution and chemical testing, has lost 250 scientists and technical staff members since Mr. Trump came to office, while hiring 124. Those who have remained in the office of roughly 1,500 people continue to do their work, Dr. Kavlock said, but are not going out of their way to promote findings on lightning-rod topics like climate change.

“You can see that they’re trying not to ruffle any feathers,” Dr. Kavlock said.

The same can’t be said of Patrick Gonzalez, the National Park Service’s principle climate change scientist, whose work involves helping national parks protect against damages from rising temperatures.

In February, Dr. Gonzalez testified before Congress about the risks of global warming, saying he was speaking in his capacity as an associate adjunct professor at the University of California, Berkeley. He is also using his Berkeley affiliation to participate as a co-author on a coming report by the Intergovernmental Panel on Climate Change, a United Nations body that synthesizes climate science for world leaders.

But in March, shortly after testifying, Dr. Gonzalez’s supervisor at the National Park Service sent the cease-and-desist letter warning him that his Berkeley affiliation was not separate from his government work and that his actions were violating agency policy. Dr. Gonzalez said he viewed the letter as an attempt to deter him from speaking out.

The Interior Department, asked to comment, said the letter did not indicate an intent to sanction Dr. Gonzalez and that he was free to speak as a private citizen.

Dr. Gonzalez, with the support of Berkeley, continues to warn about the dangers of climate change and work with the United Nations climate change panel using his vacation time, and he spoke again to Congress in June. “I’d like to provide a positive example for other scientists,” he said.

Still, he noted that not everyone may be in a position to be similarly outspoken. “How many others are not speaking up?” Dr. Gonzalez said.

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Juul Says Its Focus Was Smokers, but It Targeted Young Nonsmokers

SAN FRANCISCO — In the face of mounting investigations, subpoenas and lawsuits, Juul Labs has insisted that it never marketed or knowingly sold its trendy e-cigarettes and flavored nicotine pods to teenagers.

As youth vaping soared and “juuling” became a high school craze, the company’s top executives have stood firm in their assertion that Juul’s mission has always been to give adult smokers a safer alternative to cigarettes, which play a role in the deaths of 480,000 people in the United States each year.

“We never wanted any non-nicotine user and certainly nobody underage to ever use Juul products,” James Monsees, a co-founder of the company, testified at a congressional hearing in July.

But in reality, the company was never just about helping adult smokers, according to interviews with former executives, employees and investors, along with reviews of legal filings and social media archives.

Juul’s remarkable rise to resurrect and dominate the e-cigarette business came after it began targeting consumers in their 20s and early 30s, a generation with historically low smoking rates, in a furious effort to reward investors and capture market share before the government tightened regulations on vaping.

As recently as 2017, as evidence grew that high school students were flocking to its sleek devices and flavored nicotine pods, the company refused to sign a pledge not to market to teenagers as part of a lawsuit settlement. It wasn’t until the summer of 2018, when the Food and Drug Administration required it to do so, that the company put a nicotine warning label on its packaging.

Though some former employees recalled Mr. Monsees wearing a T-shirt at the office that used an expletive to refer to Big Tobacco, the start-up’s early pitches to potential investors listed selling the business to a big tobacco company as one of the potential ways to cash out.

These and other previously unreported decisions would plant the seeds for a public health crisis in which a new generation is becoming hooked on nicotine and that has raised questions about the future of e-cigarettes in the United States and Juul’s ability to stay in business.

In the fall of 2015, only a few months after the company’s newfangled vaping device, called the Juul, came on the market, investors, including the mutual fund giant Fidelity Investments, were already impatient for progress, according to former executives.

ImageWestlake Legal Group 00ECIGARETTES-founders-articleLarge Juul Says Its Focus Was Smokers, but It Targeted Young Nonsmokers Youth your-feed-healthcare Teenagers and Adolescence Smoking and Tobacco Nicotine Juul Labs Inc Japan Tobacco James Monsees Food and Drug Administration E-Cigarettes Centers for Disease Control and Prevention Altria Group Inc Advertising and Marketing Addiction (Psychology) Adam Bowen

Juul Labs’s co-founders, Adam Bowen, left, and James Monsees at the company’s headquarters in San Francisco in May 2018.Credit…Jason Henry for The New York Times

“They had yet to see the fruits of their investment, given what the opportunity was, and it was unclear for how long vaping was going to be lightly regulated,” said Scott Dunlap, the chief operating officer at the time. “They were excited and pushing hard.”

Fidelity declined to comment.

The Juul, which looked unlike any other e-cigarette and delivered a far more powerful nicotine punch, was supposed to be the hit product for the company, then named Pax Labs, but a few months in, it appeared to be a bust. Convenience stores and vape shops were not getting their orders because of supply chain problems. Manufacturing defects left some customers with bad batteries, or worse, a condition nicknamed JIM — juice in mouth — with no one at the company quite sure how much of the toxic nicotine substance could be safely ingested.

In a meeting in San Francisco in the fall of 2015, the board of directors decided to remove Mr. Monsees as chief executive, dismiss other senior leaders and effectively take over the company. It would be 10 months before they named another C.E.O.

“I was in that first meeting where you tell the board, ‘We aren’t going to hit the numbers. There are issues; there are problems in the supply chain.’ Not a lot of good news,” said Mr. Dunlap, who said he had advised the company to slow down and take the time needed to fix the problems. He was fired the next day.

The board meeting, which has not been previously reported, was a turning point for the company.

Over the next few years, the company — which became Juul Labs after splitting from Pax in 2017 — would reignite the stale e-cigarette business, grabbing more than 75 percent of the vaping market and tallying more than $1 billion in sales in 2018. At the end of last year, it was valued at $38 billion, more than the Ford Motor Company.

From 2016 to 2018, the years Juul’s growth became astronomical, the number of adult nonsmokers who began using e-cigarettes doubled in the United States, according to an analysis of federal survey data by researchers at the Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease. The study estimates that six million adults were introduced to nicotine via e-cigarettes.

During that time, millions of high school and middle school students began vaping, according to federal health surveys. More than five million youths — one in four American high school students and one in 10 middle school students — now vape, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint report this summer. Nicotine is a highly addictive drug that impedes the developing brain, and many teenagers have struggled to quit.

From the beginning, there was plenty of evidence of teenage use on social media that should have been apparent to a company that had made social media the core of its marketing strategy. A sampling of tweets from Juul’s first 18 months of sales showed that juuling had quickly become a fad among high school students, long before the company acknowledged that there was a problem.

“petition to make our school mascot a juul,” said one tweet in December 2015.

“horizon highschool, where every1 is juuling in the bathroom,” said another in January 2016.

“HAPPY 16th BIRTHDAY, LEXI T!!! I hope ur day is filled with juuling & just having the best day ever!” said a tweet in October 2016.

There was also evidence from employees’ own lives. In 2016, some salespeople inside Juul passed around a photo taken by a colleague’s teenage son of a picture of a Juul drawn on a bathroom stall at his high school with the word “Juul” scrawled beside it.

Juul declined to make Mr. Monsees — who stayed at the company after being removed from the C.E.O. job — or any other executives available for this article.

The company says it is refocusing on its core mission. It has recently taken steps to keep its products away from teenagers, including stopping sales of most of its flavors; halting all broadcast, print and digital advertising; and offering $100 million in incentives for retailers to adopt a new electronic age-verification system intended to curb illegal sales to minors. This month it announced it would discontinue its mint flavor, which a new study showed had become its most popular among teenagers.

“We fully understand the need to earn back the trust of regulators, policymakers, key stakeholders and society at large and reset our company and the vapor category,” said Joshua Raffel, a spokesman who joined Juul in October 2018 after working as a deputy communications director in the Trump White House.

The story of Juul began more than a decade ago when two smokers, Mr. Monsees and Adam Bowen, became friends over cigarette breaks as graduate students in design at Stanford. During those chats, they came up with an idea for their final thesis, a design for an e-cigarette that would give smokers the nicotine they craved but without the cancer-causing substances that come from burning tobacco. They called it Ploom, and two years later, in 2007, they started a company by the same name.

Ralph Eschenbach, an early investor through the firm Sand Hill Angels, recalled Ploom’s pitch as being fairly simple: “They said they wanted to build a cigarette that would be a lot less dangerous to smokers and could be enjoyable.”

But, Mr. Eschenbach said, there was a major hurdle in going after that demographic: F.D.A. restrictions prevented Ploom from claiming its product was safer than cigarettes.

So the company was eying another potential market as well, he said: young millennials who were occasional smokers and might be drawn to a luxe, sleekly-designed tech product that they could carry while bar hopping on a Saturday night.

Other investors jumped on board, most notably Nicholas J. Pritzker, a member of the wealthy Chicago family that once owned the chewing tobacco giant Conwood before it was sold to Reynolds American. Mr. Pritzker had focused on the family’s holdings in real estate and the Hyatt hotel chain. Calls and emails to Mr. Pritzker’s investment firm were not returned.

When it was released in 2010, the Ploom Model One Vaporizer was shaped like an oversize pen. After a couple of years, it became clear that it wasn’t going to catch on. The biggest complaint? Not enough nicotine.

Kurt Sonderegger, who was Ploom’s head of marketing, would tape two of the devices together to try to get a satisfying hit, he said, but “I still needed to go out and smoke a cigarette.”

In early 2015, the company sold the Ploom brand to the industry it had ostensibly been taking on. Japan Tobacco International, a cigarette company, had bought a minority stake in Ploom in 2011 with a plan to market the device abroad, and in early 2015, it acquired the rights to the brand. Ploom executives renamed their company Pax Labs, for the pricey Pax Vaporizer that they had introduced in 2012. That device was quickly gaining a following among cannabis users as more states legalized marijuana.

But the company wasn’t abandoning e-cigarettes. On the contrary, it had a breakthrough. It had discovered a way to substantially increase the nicotine levels in a new product, named Juul.

It was this breakthrough that would make the Juul so addictive to teenagers and people who had never smoked.

But just before the debut, in an interview published by The Verge in April 2015, Ari Atkins, an engineer who had worked on the team developing the Juul, said: “We don’t think a lot about addiction here because we’re not trying to design a cessation product at all.”

He added, according to the article, “Anything about health is not on our mind.” The article noted that his colleagues in the interview winced.

What made the Juul a game-changer in the e-cigarette industry was not just the cool design, which immediately drew comparisons to the iPhone. It was the power and smoothness of its nicotine hit.

In 2013, Chenyue Xing, a young chemical engineer, was working at MAP Pharmaceuticals in California developing medications that could be inhaled, when she got a call from a Pax recruiter. The idea of working on a project to reduce health risks to smokers appealed to her.

“I was working in products that were treatments for sickness and illnesses,” Dr. Xing said. “I was intrigued at the idea of working on the preventative side.”

Mr. Bowen, the co-founder, had sketched out the concept for a new formulation of the pods for the company’s e-cigarettes, one that would use nicotine salts.

Nicotine salts are not exactly like the crystalline salt in a shaker on the dinner table. In chemistry, a “salt” is the substance produced from the reaction of an acid with a base. Nicotine salts exist naturally in tobacco, which means they are in all cigarettes.

But e-cigarettes at the time were using freebase nicotine, which is extracted from tobacco. The problem with freebase nicotine liquid is that it has a high alkalinity, which makes it harsh for consumers. Many smokers who tried e-cigarettes wound up with sore throats or coughs.

For manufacturers, that harshness increased with higher nicotine levels, so most e-cigarettes had only 1 or 2 percent nicotine. A few came in at 3 percent.

Dr. Xing and other researchers at Pax were able to develop a formulation that allowed the company’s Juul pods to have a nicotine level of 5 percent, the equivalent of a pack of cigarettes. They had worked through different formulations before landing on one that combined freebase nicotine with benzoic acid (the patent covers a range of acids) that set off a chemical reaction, producing a nicotine salt liquid that reduced the harshness and allowed a higher rate of nicotine.

The result was “a much better experience for smokers” compared with earlier e-cigarettes, Dr. Xing said. “One that would make them more willing to switch over from smoking to e-cigarettes.”

Mr. Dunlap, the chief marketing officer at the time, saw the immense promise. “When I first tried the Juul prototype, the nicotine hit was immediate, within seconds. No e-cig had ever come close to this,” he said. “The design was also unique — the shape, the glowing light, the crackling sound, the thick vapor. It was a multisensory experience. This was the first vaping product that actually had a shot at switching an existing smoker.”

The high level of nicotine also appealed to skeptical retailers. In the summer of 2014, the year before Juul’s debut, the sales teams had run into resistance from stores who were stuck with other e-cigarette inventory that simply was not selling. But by focusing on the chemistry behind Juul, and its delivery of nicotine levels that were close to combustible cigarettes, two former sales executives said, they persuaded convenience store chains like 7-Eleven and Circle K to order the new product.

The nicotine experience was the key to attracting smokers to any e-cigarette, but mention of nicotine was only in tiny, hard-to-read letters in the print ads for Juul’s initial marketing campaign.

In June of 2015, the campaign, called Vaporized, introduced the Juul with glitzy parties and events that stretched from San Francisco to Miami and New York, and ads and social media posts featuring young women in midriff-baring tops holding the sleek metal device.

Even some employees were confused. Three members of the company’s sales force recalled being puzzled: If this was a product targeting smokers, why not market where the smokers were, say, NASCAR races, which had long been sponsored by tobacco companies? Why was the campaign so youthful?

The ads for Juul showed up in Vice magazine, at pop-up “Juul Bars” at concerts that offered free samples of the product, on a bright billboard display that loomed over Times Square, and in a social media blitz. A lawsuit filed this month by the state of California against the company said that Juul directed “brand ambassadors” to look for “people who fit the JUUL demographic” such as “smokers, cool kids, fun people, etc.”

The company began hiring consultants to identify social media influencers with large followings on Instagram and Twitter to promote Juul. It pushed hashtags like #juul and #vaporized that the influencers used while showing images of themselves or other young people doing tricks with the device.

Mr. Dunlap, the chief operating officer at the time, noticed strikingly young users right away, in the wave of social media posts that followed the marketing events.

“There were hundreds of activation events, and it was in seeing the photos and social usage that followed that I would catch myself saying, ‘Wow, they look really young’,” he said. “But you don’t really know. It’s social media after all, where everyone is their younger, idealized selves. All you know is that you are seeing the early signs of a viral brand taking off.”

Two former executives, one from marketing and one from sales, said in interviews that the thinking inside the company was that by showing young and hip people using Juul, they would also draw in older smokers who imagined themselves as, well, young and hip.

Bailey Legacki was one of the high school students drawn in by the Vaporized campaign and she is now weighing a lawsuit against Juul.

She began using Juul during the 2015-16 school year, she said, as a 15-year-old in South Florida. “It was everywhere,” she recalled. “Everyone had one.”

Ms. Legacki, now 18, said she was influenced by her friends but also by the ubiquitous advertisements and social media posts on Snapchat, Instagram, Twitter and Facebook.

“They were young people and it looked like they were having fun,” she said. “Or, it would just be the device that was shown, but not really explaining anything about it, just, ‘Try this.’”

She said she did not realize there was nicotine in the pods. Mr. Raffel, the Juul spokesman, confirmed that in the early days the packaging mentioned nicotine only in tiny type in the ingredients list and did not have the warning labels it does now.

Ms. Legacki said she has now scaled back her vaping but has not been able to quit. “If I knew it had nicotine at all, I wouldn’t have done it,” she said. “Now I’m so reliant on something I had no intention of doing. I knew what cigarettes do. This Juul was new and nobody knew what the Juul did.”

She is considering suing the company. Her lawyer, Jeffrey L. Haberman of Schlesinger Law Offices in Fort Lauderdale, Fla., said the case will claim that Juul was made “to create and sustain nicotine addiction.”

Juul declined to comment on her experience.

Employees were also noticing orders made with clearly fake IDs. In 2017, orders were coming in weekly that all used an Arizona driver’s license for a man from Phoenix named Jelani Sample, according to an employee brought in to upgrade the age verification system. (It was actually a sample of the new driver’s license the state had posted online.)

The flagged orders were not filled, the employee said. But they were a sign teenagers were trying to buy Juuls.

There were also orders coming in for 10 Juul starter kits at a time, a tip-off to some employees that Juuls were being purchased either for resale or to be given to youths.

But the company continued to push its presence on social media, and in 2017, with sales soaring, the company and Mr. Bowen, the co-founder, filed a patent for a vaping device with a feature that seemed aimed at younger users. It was a gaming mode, so people could play Simon Says or Cat and Mouse on the device. It also had a “party” mode with lights and music clips. (It was never made, however.)

That same year the company was in talks to settle a lawsuit brought by the Center for Environmental Health, a nonprofit in California. The group had tested e-cigarettes and nicotine liquids made by Juul and over a dozen other companies and found levels of formaldehyde, a carcinogen created when e-cigarettes containing certain chemicals are heated, that exceeded the California limit. The organization had sued the manufacturers to force them to lower formaldehyde levels, and to add a warning label noting the presence of a cancer-causing ingredient.

But in settling the cases, the environmental group saw an opportunity to do something more. “We wanted to go beyond just the cancer warning,” its lawyer, Mark Todzo, said. “At the time, there were reports coming out about the teen vaping rates that were just starting to be reported on.”

Mr. Todzo said the group added a provision into the settlement to require the e-cigarette companies to agree not to market to youths. Documents show that it was signed by EonSmoke, Vapor4Life, International Vapor Group and others — but not by Juul.

Juul declined to sign and opted instead to pay an additional penalty, based on its sales for 2015 — just $2,500.

Mr. Raffel, the Juul spokesman, did not dispute the account, but said the company had no further comment.

Finally, last month, Juul signed.

In the summer of 2018, a group of former attorneys general and public health experts got on a call with Juul executives, including then-chief executive Kevin Burns, to advise them how to stop teenagers from getting Juuls.

The call, which has not previously been reported, did not go well, especially when Grant Woods, the former attorney general for Arizona, who had worked on the master settlement with tobacco companies in the 1990s, told Mr. Burns to dump the company’s flavored nicotine pods because of their appeal to youths.

“They just refused to do it,” said Mr. Woods, who dropped out of the advisory group after the initial call, convinced that the company was insincere. “I said on the call, ‘I would sue you.’”

Mr. Woods said the Juul C.E.O., Mr. Burns, took the position “that they were not marketing to minors, and so the flavoring wasn’t an issue.” Mr. Burns declined to comment on the phone call.

Mr. Burn’s recalcitrance in the face of growing pressure would soon be on display again in the company’s weekly executive meeting in September 2018, after the F.D.A. seized thousands of pages of documents from the company’s San Francisco headquarters, a former executive said.

“Kevin Burns said, ‘Do not give me anything in writing if it is sensitive, anything the F.D.A. could get,’” recalled the former executive, who was at the meeting but asked not to be identified for fear of retribution. “He said, ‘Pick up the phone and call me if you have to.’”

In a statement emailed to The New York Times, Mr. Burns said, “That is a mischaracterization of a meeting where I was clear that our employees should fully cooperate with any regulatory authority and that I expected them to bring any concerns to me directly to make sure important issues were addressed promptly and with no room for misinterpretation.”

Now Juul is facing an ever growing pile of lawsuits from parents, school districts, counties and states, including two new ones filed this month by California and New York. In addition to the F.D.A., the Federal Trade Commission, the United States attorney’s office in Northern California and several states are investigating the company.

And it is still waiting for federal health officials to completely clear its devices and nicotine pods from the mysterious vaping-related illness that emerged this summer, making almost 2,300 people seriously ill and killing 47 others. Earlier this month, the Centers for Disease Control and Prevention said that the likely culprit is THC vaping liquids, which Juul does not sell, that include vitamin E acetate, but cautioned that health investigators had not exonerated nicotine products.

All of this means that the F.D.A. is likely to make it very challenging for Juul to obtain the necessary clearance to stay on the market, according to two former F.D.A. commissioners: David Kessler, who served in the George H.W. Bush and Clinton administrations; and Scott Gottlieb, who ran the agency for President Trump until resigning this spring.

Juul’s application is due in May, and the F.D.A. must decide whether the products are appropriate for the protection of public health. The agency will weigh the number of people likely to become addicted to nicotine via Juul, against the number who might use it to quit combustible cigarettes, and will also assess the safety of the products.

In early 2017, the tobacco giant Altria, maker of Marlboro cigarettes, reached out to Juul, and in the spring of that year the two began confidential discussions in earnest, according to documents obtained from Altria by Senator Richard Durbin, Democrat of Illinois.

It would take 20 months to work out, but on Dec. 20 of last year, Altria announced it would pay $12.8 billion in cash for a 35 percent stake in Juul. Filings with the Securities and Exchange Commission showed that the vast majority of the cash went into executives and investors’ pockets. Less than $1 billion was required to stay on the company’s books.

Under the terms of the deal, Altria said it would use its vast distribution channels to sell Juul products and, after four years, Altria would be allowed to make a takeover offer for Juul Labs.

Some employees were unsettled by the fact that they were now in business with Big Tobacco. And regulators? They were irate.

The F.D.A. was blindsided by Juul’s deal with Altria, and it further strained the relationship between the agency, including its commissioner, Dr. Gottlieb, and both companies.

The F.D.A. had initially been supportive of e-cigarettes, and Dr. Gottlieb had served on the board of Kure, a chain of vaping lounges, when he was tapped to run the agency. In July 2017, a few months after taking office, Dr. Gottlieb made a much criticized decision to push back by four years the deadline for Juul and other e-cigarette companies to submit applications to stay on the market.

Juul contended it had a virtuous health mission, but by fall of 2018, the F.D.A. was no longer buying it. In October, Altria had agreed to stop selling its own e-cigarette products, after acknowledging that they were driving the youth vaping problem. The notion that Altria would now help Juul expand its market infuriated Dr. Gottlieb.

He summoned executives from Juul and Altria to his office in March of this year, for what several people who were there (and not authorized to speak publicly on the matter) described as a tense, unpleasant meeting with him, his chief of staff, Lauren Silvis, and the head of the agency’s tobacco division, Mitchell Zeller. When news about their difficult meeting leaked out, Altria’s stock fell 2.5 percent.

According to several people present, Dr. Gottlieb condemned Juul’s lobbying of Congress and the White House. “We have taken your meetings, returned your calls and I had personally met with you more times than I met with any other regulated company, and yet you still tried to go around us to the Hill and White House and undermine our public health efforts,” he said angrily, according to three people who were there. “I was trying to curb the illegal use by kids of your product and you are fighting me on it.”

In September, Juul’s ties to Altria further strengthened when Mr. Burns resigned under pressure, and the board replaced him with an Altria executive, K.C. Crosthwaite. A former president and chief executive of Philip Morris USA, Mr. Crosthwaite has spent his entire career in the tobacco industry.

Juul’s future now rests with Big Tobacco, the industry its founders said they were trying to vanquish.

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Texas jury: Father can’t stop chemical castration, gender change of seven-year-old son

Westlake Legal Group facepalm-fb Texas jury: Father can’t stop chemical castration, gender change of seven-year-old son transgender The Blog sex change puberty gender identity Food and Drug Administration dysphoria custody

Most seven-year-olds have difficulty deciding on Christmas lists, let alone anything as permanent as gender choice. However, a jury in Texas has ruled against a father’s petition for sole custody of his twin seven-year-old boys as a means to protect one from undergoing hormonal gender-change therapy at the hands of his mother. A judge has yet to formally enter custody orders, but Jeffrey Younger will likely now be forced to refer to his son James as “Luna,” the identity his mother Ann Georgulas has used for him since enrolling him in kindergarten, and stand by as his son takes potentially dangerous medication despite not being physically ill at all:

Jeffrey Younger had petitioned a court in Texas to grant him sole custody of his twin sons, James and Jude, in part to avoid a plan to infuse James with female hormones. James, who would like to be called Luna, has been the center of controversy in the heated debate among his parents and others.

Anne Georgulas, the mother of the two boys, has advocated for James to transition into Luna and has strongly backed the idea of chemically castrating her son and beginning hormone replacement therapy. The ruling on Wednesday will prevent Jeffrey from having sole custody of his children and paves the way for Georgulas to proceed with the procedure.

The court has ruled that Georgulas will maintain sole custody of her two children and go forward with plans to give James life-altering medical procedures. Her original court filing had sought to limit her ex-husband’s visits with their children and require that he now refer to James as Luna. She further asked that Jeffrey not be exposed to any people who would not confirm his female identity.

Good luck with that. Unless Georgulas plans to home-school James/Luna, tThis child will be surrounded by other kids who will repeatedly refuse to confirm his female identity. That’s because James/Luna is a prepubescent biological male by medical definition and biological fact, at an age where sexual identity shouldn’t actually matter at all — until one draws undue attention to it, as is exactly what Georgulas has been doing.

LifeSite’s Madeleine Jacobs offered a video report yesterday after the verdict from the pro-life perspective:

Expert witnesses testified to a child’s inability to full comprehend the potential side effects of such therapy, such as permanent infertility, inability to ever naturally engage in sexual relations, and a decreased lifespan.

On Friday, protesters called on Texas lawmakers to pass legislation making it illegal for anyone under 18 years of age to begin a medical transition. They argued that children cannot fully understand the lifelong consequences of their decisions and parents should not be allowed to make this decision for their children.

Currently, there aren’t any U.S. laws that restrict the use of puberty blockers or cross-sex hormones or outline a minimum age of administration.

Four weeks ago, Jazz wrote about the destructive and dangerous side effects of these “puberty blocker” drugs. He notes that the most common of these, Lupron, has not been approved by the FDA for use as a long-term puberty blocker, but is approved for shorter-term use in delaying early-onset puberty. That makes sense, as precocious puberty has long-term health consequences of its own that are well documented. The risk of short-term use in these cases is calculated against a serious medical risk from non-treatment, and is used with the presumed consent of both parents.

The FDA hasn’t actually approved any such therapy for prepubescent children whose parents want to delay or prevent puberty for the desire of gender change. Nor is there any reason to assume the risk of Lupron or other drugs when gender dysphoria does not create a risk of physical damage, especially in seven-year-olds. If adults want to make a choice of gender transition, that’s one thing, but adults (and juries) imposing those kinds of long-term risks on children far below any rational age of consent for no good medical reason is simply insane. In what other contexts do courts allow the use of risky medication on children without any physical ailments, let alone mandate their use against the will of one of the custodial parents?

Where is the FDA on this anyway? Is this the same FDA that drags its heels on allowing experimental therapies for terminally ill adult patients with the full capacity for informed consent? This gap on puberty blockers suggests that political correctness plays more of a role than logic at the FDA.

Let’s hope that Younger gets the chance to appeal this decision to a court with more rational thinkers. James/Luna should get a chance to make it completely through his childhood before making these kinds of decisions — and more importantly, he should be making them for himself as an informed adult capable of actual consent.

The post Texas jury: Father can’t stop chemical castration, gender change of seven-year-old son appeared first on Hot Air.

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Johnson & Johnson Recalls Baby Powder Over Asbestos Worry

Westlake Legal Group merlin_148254753_920dc85e-393b-480e-8f1d-4ce778d1fde8-facebookJumbo Johnson & Johnson Recalls Baby Powder Over Asbestos Worry Shopping and Retail Recalls and Bans of Products Johnson&Johnson Food and Drug Administration Asbestos

Johnson & Johnson, which has spent years insisting that its baby powder is safe, recalled 33,000 bottles of the product on Friday after the Food and Drug Administration discovered evidence of asbestos, a known carcinogen, in one of the bottles.

The recall, the first time Johnson & Johnson has pulled baby powder from store shelves over asbestos concerns, could undercut its defense against a swarm of allegations that its talc-based products caused cancer. It comes as the company, which reaches into the lives of millions of people through brands such as Tylenol, Band-Aid and Rogaine and reported nearly $82 billion in sales last year, is entangled in numerous legal battles over the safety of its products.

The company has settled some claims — and is still fighting others — involving its role in the nationwide opioid crisis. On Thursday, Johnson & Johnson agreed to pay $117 million in a settlement over the deceptive marketing of transvaginal pelvic mesh implants, and a jury this month ordered it to pay $8 billion to a Maryland man who accused the company of playing down the risks associated with the antipsychotic drug Risperdal. In total, the company faces more than 100,000 lawsuits over its products.

More than 15,000 of those are from people who say baby powder and other talc-based products caused them to develop cancer. Some have mesothelioma, an aggressive cancer that is considered the signature disease of asbestos exposure, while others have ovarian cancer.

The decision to pull the baby powder, sourced from China and distributed last year, is a “whopper” for a company as dependent on consumer trust as Johnson & Johnson, said David Noll, a law professor at Rutgers University.

“I can’t imagine an attorney for Johnson & Johnson standing up in front of a jury now and saying with a straight face that the product is safe,” Mr. Noll said. He added that “if people come to associate the company’s signature product with deadly diseases, there will be huge spillover effects for its ability to market other products.”

The recall was prompted by the FD.A.’s discovery of trace levels of chrysotile asbestos in samples from a bottle of baby powder bought from an online retailer. The company said it was informed of the results on Thursday and recalled bottles from lot number 22318RB out of an “abundance of caution,” though the F.D.A. advised consumers with baby powder from the affected lot to “stop using it immediately.”

But Johnson & Johnson also repeated its longstanding defense against cancer claims, saying that “thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos.” The company appeared to question the testing process, saying in a statement that it is working with the F.D.A. to “determine the integrity of the tested sample and the validity of the test results.”

Dr. Susan Nicholson, Johnson & Johnson’s vice president of women’s health, said during a short conference call with investors on Friday that the F.D.A.’s report showed “an extremely unusual finding” that was “inconsistent with our testing to date.”

In response, an agency spokeswoman, Gloria Sánchez-Contreras, said, “The F.D.A. stands by the quality of its testing and results.”

Analysts estimate the baby powder lawsuits could cost Johnson & Johnson $5 billion to $10 billion. The recall could lead to the company’s having to pay more in damages or to settle cases, said Erik Gordon, a University of Michigan business professor who studies corporate governance. Shares of the company closed down more than 6 percent on Friday.

Plaintiffs in the talc cases have accused Johnson & Johnson of failing to warn customers of the risks of asbestos contamination, despite being aware of concerns for decades. A New York Times investigation last year found internal memos and reports made public during litigation that document executives’ concerns about potential contamination that date back 50 years.

[Read our investigation into claims about asbestos in baby powder.]

Johnson & Johnson disclosed this year that it was being investigated by the Justice Department and the Securities and Exchange Commission over concerns about possible asbestos contamination of its talc-based products.

Johnson & Johnson is awaiting a major decision that could tilt the talc litigation in its favor. As part of pretrial proceedings for thousands of talc lawsuits consolidated in New Jersey, a federal judge is mulling whether to block testimony from expert witnesses hired by plaintiffs, a move that could cause many talc cases to be dismissed or dropped.

[Thousands of people who trusted Johnson & Johnson’s baby powder for decades are suing the company after developing cancer. “The Weekly,” our new TV show, investigates their allegations.]

Baby powder represents a tiny fraction of Johnson & Johnson sales but an outsize threat to its reputation.

Johnson & Johnson’s name is “so synonymous with their line of baby products,” said Alla Valente, an analyst with Forrester. But recently, she said, the company has started a “damage control campaign” that casts it as bigger than its baby powder, focusing on its slate of other products.

“It’s about trust: If a mother could trust a Johnson & Johnson product for their children, then that product must be safe,” Ms. Valente said. “But now, the dam is finally breaking, where consumers are saying that enough is enough.”

Talc is a natural mineral, formed in underground deposits under the same geological conditions as asbestos. In mines, veins of asbestos can intermingle with talc, geologists say.

Johnson & Johnson officials emphasized on Friday that the level of asbestos detected was very low, just a fraction of 1 percent of the sample. United States health agencies, however, say there is no known safe level of exposure to asbestos.

While health risks increase with heavier and longer exposure to asbestos, the overall evidence suggests no level of asbestos exposure is safe, and disease has been found in people with only brief exposures, according to the National Cancer Institute.

Several earlier F.D.A. tests, including one in the past year and another about a decade ago, did not detect any asbestos in samples of baby powder.

The F.D.A. does not require safety testing for personal-care products and cosmetics before they are marketed, and tests products only occasionally, usually after complaints by consumers or advocacy groups.

The agency considered — and soon abandoned — a plan to monitor talcum products for asbestos in the 1970s, when concern about asbestos in household products captured the public’s attention. The F.D.A. commissioned tests of Johnson & Johnson powders back then, and the company successfully challenged their validity.

This year, after consumer tests found asbestos in makeup kits for children sold at Claire’s, the F.D.A. followed up with its own tests. It detected the carcinogen in half of 20 products, including Claire’s eye shadow and compact powder, JoJo Siwa makeup sold at Claire’s, and bronzers, blush and other makeup made by Beauty Plus Global City Color Cosmetics and sold in retail outlets. The products were eventually recalled.

The agency plans to test 30 more products containing talcum powder, including those popular on social media and others marketed to children, Ms. Sánchez-Contreras said. The products are a tiny percentage of the thousands of personal-care products available for sale.

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Johnson & Johnson Recalls Asbestos-Tainted Baby Powder

Westlake Legal Group merlin_148254753_920dc85e-393b-480e-8f1d-4ce778d1fde8-facebookJumbo Johnson & Johnson Recalls Asbestos-Tainted Baby Powder Shopping and Retail Recalls and Bans of Products Johnson&Johnson Food and Drug Administration Asbestos

Johnson & Johnson is recalling a shipment of baby powder after the Food and Drug Administration discovered evidence of asbestos in one of the bottles, the company said on Friday, a move that undercuts its defense in a growing number of claims that its talc-based products were contaminated with the potent carcinogen.

The regulator found trace levels of chrysotile asbestos in samples taken from a bottle of baby powder purchased from an online retailer, Johnson & Johnson said. The company has, for years, denied that the carcinogen is, or ever was, present in its talc-based products.

This is the first time Johnson & Johnson has ever pulled baby powder from the market over asbestos concerns, a spokesman for the company said, and comes as Johnson & Johnson is battling thousands of lawsuits brought by people who say that baby powder and other talc-based products caused them to develop cancer. Some have mesothelioma, an aggressive cancer that is considered the signature disease of asbestos exposure, while others have ovarian cancer, which has also been linked to asbestos.

The recall will undermine defense claims against those suits, and could lead to the company having to pay more or to settle cases, said Erik Gordon, a University of Michigan business professor who studies corporate governance. Shares of the company fell 5 percent in early afternoon trading on Friday.

But in announcing the recall, the company also repeated part of its long-running defense against cancer claims, saying that “thousands of tests over the past 40 years repeatedly confirm that our consumer talc products do not contain asbestos.” The company said it was recalling the shipment out of an “abundance of caution.”

Though Johnson & Johnson said it has started “a rigorous, thorough investigation into the matter” it also appeared to question the testing process, saying in a statement that it is working with the F.D.A. to “determine the integrity of the tested sample and the validity of the test results.”

The recalled baby powder was produced and shipped last year. The recalled lot, #22318RB, involves 33,000 bottles sold by a retailer, which sold products online but may have shipped powder to stores, the spokesman, Ernie Knewitz, said. The F.D.A. has not responded to questions about the identity of the retailer.

A New York Times investigation last year found that Johnson & Johnson executives were aware for decades of the risks of asbestos contamination in talc but did not warn consumers. Internal memos and reports made public during litigation against the company document executives’ concerns about potential contamination that date back 50 years.

Earlier this year, Johnson & Johnson disclosed that it is being investigated by the Justice Department and Securities and Exchange Commission over concerns about possible asbestos contamination of its talc-based products.

The company is now entangled in litigation on multiple fronts. On Thursday, it agreed to pay $117 million to settle claims that it deceptively marketed transvaginal pelvic mesh implants. Earlier this month, a jury in Philadelphia ordered Johnson & Johnson to pay $8 billion to a Maryland man who accused the company of downplaying the risks associated with the anti-psychotic drug Risperdal. The company has also agreed to settle claims involving its role in the nationwide opioid crisis.

Lee Hambright, an analyst with Bernstein, wrote in a note to clients last week that Johnson & Johnson could face $5 billion in legal liability over the talc litigation. Of the 15,500 talc lawsuits the company has disclosed, Mr. Hambright estimated that 1,000 involved mesothelioma cases.

[Read our investigation into claims about asbestos in baby powder.]

Talc is a natural mineral that is mined from underground deposits, but asbestos can form under the same geological conditions that form talc, and geologists say veins of asbestos can intermingle with talc in underground mines.

Johnson & Johnson officials emphasized that the level of asbestos detected was very low, the amount being “two ten-thousands of a percent” of the sample. U.S. health agencies, however, say there is no known safe level of exposure when it comes to asbestos.

While health risks increase with heavier and longer exposure times to asbestos, the overall evidence suggests no level of asbestos exposure is safe, and disease has been found in people with only brief exposures, according to the National Cancer Institute.

[Thousands of people who trusted Johnson & Johnson’s baby powder for decades are suing the company after developing cancer. “The Weekly,” our new TV show, investigates their allegations.]

This is a developing story that will be updated.

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Juul Replaces Its C.E.O. With a Tobacco Executive

The vaping powerhouse Juul Labs replaced its chief executive with a veteran of Big Tobacco on Wednesday, deepening the company’s turmoil and raising doubts about the very future of the e-cigarette industry.

The sudden announcement capped a relentless cascade of events that has called into question the safety of devices once billed as a promising alternative to cigarettes, one of the world’s leading preventable causes of death. Now, Juul is looking to that very industry for its survival as it faces a federal criminal inquiry, new bans on some of its products, and an onslaught of state and federal regulatory investigations into its marketing practices.

Early Wednesday morning, after frantic days of internal meetings, the company announced that its current chief executive, Kevin Burns, would resign as chief executive. His chosen replacement is K.C. Crosthwaite, a top official at Altria, the cigarette giant that bought a 35-percent share in Juul for $12.8 billion last December and has seen the company it invested in rocked by growing crisis.

In another sign of regulatory and business uncertainty, Altria and Philip Morris International said on Wednesday that they had ended talks to merge, dashing the chances of reuniting the two arms of what had once been the tobacco giant Philip Morris.

The e-cigarette industry — which Juul commands, with more than 70 percent of the market — is being threatened by twin public health crises: the rise of teenage vaping, which public health officials fear could create a new generation of nicotine addicts, and a surge of severe lung illnesses, including at least 11 deaths, linked to vaping.

Dr. David Kessler, a former commissioner of the Food and Drug Administration, said that in light of the epidemic of youth vaping, he doubted that any e-cigarette company could now prove that the benefits of its products outweighed the risks — a critical factor to win agency approval to stay on the market in the United States.

“In some ways the last several years has provided a record where it’s hard to see that these products could ever meet the ‘protection of public health standard,’” Dr. Kessler said. “And if they can’t meet that standard, they can’t be marketed.”

Testifying at a congressional hearing on Wednesday, the acting F.D.A. commissioner, Dr. Ned Sharpless, appeared to echo that sentiment, saying, “We really don’t think anyone should be using e-cigarettes, except perhaps a person who is using it instead of a combustible cigarette.”

Dr. Sharpless said the agency could have done more to keep the products away from teenagers. “In retrospect the F.D.A. should have acted sooner,” he said. “We’re going to catch up.”

In addition to the deaths, 530 cases of the lung sicknesses have been reported by the Centers for Disease Control and Prevention, causing public health agencies to warn most people to refrain from vaping any substance.

Many of the patients have said they had been vaping THC, the high-inducing ingredient in marijuana, when they became short of breath and grew sicker, officials have reported. But some said they were using just nicotine, or both.

Juul sells only nicotine products along with its sleek and popular vaping pens. Nevertheless, the company has become synonymous with vaping generally for much of the public.

“Juul is the face of the current public health crisis. Heads need to roll,” said Stefanie Miller, a co-founder of Sandhill Strategy, which consults with investment firms on regulatory policy, particularly tobacco-industry regulations. “To see the top head roll is a sign to public health, investors, to everyone that they know they need to make some changes.”

In announcing its change of leadership, Juul appeared to cave on issues that could be detrimental to its business. It said it would not fight a Trump administration proposal to ban most flavored e-cigarettes, which would slash its domestic sales. The company also said it would end one of its marketing campaigns, “Make the Switch,” which the F.D.A. warned could be construed as an illegal effort to portray its e-cigarettes as safer than traditional cigarettes.

A Juul employee said the company was also considering whether it should abandon its multimillion-dollar campaign on a ballot initiative to overturn an e-cigarette ban that is to take effect in San Francisco early next year.

ImageWestlake Legal Group merlin_161482992_d7bca353-1885-4105-bcb4-f2694ab1bfbf-articleLarge Juul Replaces Its C.E.O. With a Tobacco Executive Teenagers and Adolescence Smoking and Tobacco Respiratory Diseases Regulation and Deregulation of Industry Recalls and Bans of Products Philip Morris Companies Inc Mergers, Acquisitions and Divestitures Juul Labs Inc Food and Drug Administration E-Cigarettes Crosthwaite, K C Burns, Kevin R Appointments and Executive Changes Altria Group Inc

Kevin Burns, the outgoing Juul Labs C.E.O., in June.CreditLea Suzuki/San Francisco Chronicle, via Polaris

Within the last week alone, several television networks decided to stop broadcasting Juul’s ads; Massachusetts announced a four-month ban on the sale of all vaping products; Rhode Island announced a ban on flavors; Walmart said it would stop selling all e-cigarettes; and the F.D.A. announced it had opened a criminal inquiry into the supply chain of vaping products and devices. The Federal Trade Commission also has been investigating Juul’s marketing practices. And the United States attorney for Northern California opened a criminal investigation into the company, a development first reported by The Wall Street Journal.

On Sept. 10, President Trump met with Dr. Sharpless and Alex M. Azar II, the health and human services secretary. After informing the president of another spike in teenage vaping, the two officials said they would issue the proposed ban on most flavored e-cigarettes within several weeks.

That would include mint and menthol, they said, although some vaping industry leaders have vowed to contest the inclusion of those two items. Juul has said mint and menthol now account for about 80 percent of its products and a ban on those would severely hurt its domestic sales.

All of this foreshadows a regulatory showdown at the F.D.A. that is slated to begin in May next year when the agency will determine what, if any, e-cigarettes can remain on the domestic market.

“The United States is moving toward asking vaping companies for permission to sell any products,” Ms. Miller from Sandhill Strategy said. “The people they’re asking, the F.D.A., have shown these products are killing people.”

The turn in fortunes for Juul, and perhaps e-cigarettes generally, culminates one of the biggest disagreements in public health in recent years: whether e-cigarettes would prove a benefit to society. Supporters of e-cigarettes have argued that these devices have the potential to save millions of lives and billions of dollars by providing a safer alternative to the nation’s leading killer, traditional cigarettes.

Some investment advisers pointed to the disarray with e-cigarettes as a potential benefit to traditional smoking. “The recent media scrutiny on vaping will help overall cigarette consumption,” Nik Modi, a tobacco-industry analyst for RBC Capital Markets, wrote in a message to investors.

In recent weeks, as Juul sales have slowed, sales of cigarettes declined at a slower pace with each passing week, according to Nielsen, a market-research firm.

But skeptics have said all along that not enough is known about the long-term health effects of e-cigarettes and assert that they, and Juul, in particular, have spurred heavy experimentation by teenagers.

The upshot may drive the market for e-cigarettes overseas, a market that Juul’s new chief executive, Mr. Crosthwaite, highlighted to employees in an all-hands meeting at the company headquarters on Wednesday morning.

“International expansion continues to be a huge opportunity given the number of smokers around the world,” he told employees.

But the company’s initial foray in China this month failed almost immediately, and last week India also said it would ban the sale of e-cigarettes.

Mr. Crosthwaite, in coming from Altria, brings to Juul the experience of working for one of the most regulatory-savvy companies in the world; the tobacco industry has navigated perilous straits in keeping its product on shelves and pushing internationally, despite cigarettes being a proven, addictive killer.

In a speech to a tobacco industry gathering in Washington on Wednesday, Howard Willard III, chief executive of Altria, said Mr. Crosthwaite would help Juul “urgently control, confront and reduce youth vaping,” and deal with the company’s other problems.

“This is a pivotal moment,” he said. “Vaping is at an inflection point.”

Dr. Ned Sharpless, the F.D.A. acting commissioner, testified about the threats of e-cigarettes to the public before a House subcommittee on Wednesday.CreditPete Marovich for The New York Times

Despite the public concerns, Altria invested $12.8 billion in Juul in 2018 for a 35 percent stake, valuing Juul at about $38 billion. Mr. Crosthwaite became a board observer at Juul.

As for the decision to end the merger talks between Philip Morris and Altria, the two companies said they would instead focus on rolling out the IQOS heated tobacco product in the United States. They emphasized that IQOS, which Philip Morris International sells abroad and which has received F.D.A. approval for sale in the United States, is not “an e-vapor product.”

IQOS is a penlike electronic device with a battery pack that resembles a cigarette case. It features a heating blade that warms a tobacco stick and emits a vapor with the taste of tobacco, but with fewer noxious chemicals than cigarette smoke. The F.D.A. has approved it for sale in the United States and said the product could help people to quit smoking. The agency is still weighing whether to permit Altria to be marketed as a reduced-risk product.

Investors had appeared largely skeptical of the potential deal, despite the companies arguing that reuniting could revive their fortunes amid a decline in cigarette sales.

On Wall Street, analysts said they were not that surprised by the abrupt end to the merger talks, especially given the steady drumbeat of negative headlines around vaping and Juul’s products. The stock of Philip Morris International ended Wednesday up more than 5 percent at $75.28, while Altria’s stock ended essentially flat at $40.56.

But Altria is likely to face a bumpier future amid the uncertainty around Juul.

Analysts said it was increasingly likely that Altria might have to write down the value of its $12.8 billion investment in Juul, given the recent developments and uncertainty surrounding the company.

“When the Juul transaction was done, it valued the company at around $37 billion,” said Garrett Nelson, an analyst at CFRA Research. “Juul’s valuation today is probably a fraction of that.”

Meanwhile, Altria’s debt levels more than doubled as it borrowed to buy the Juul stake, he noted.

Tim Hubbard, an assistant professor of management in the University of Notre Dame’s Mendoza College of Business, said it was not surprising that Mr. Burns was stepping down from the company as it had struggled to adapt to the swift change of perceptions, from a company that was providing an alternative to smoking to one that had been vilified.

“When compared to traditional tobacco products — which have remained on the shelves for decades despite being proven dangerous — e-cigarette makers have failed spectacularly,” Mr. Hubbard said in an email. “Bringing in a traditional tobacco executive who knows how to market and manage government relationships with deadly products matches the firm’s needs.”

Michael J. de la Merced and Katie Thomas contributed reporting.

Earlier coverage

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Juul Replaces Its C.E.O. With a Tobacco Executive

The vaping powerhouse Juul Labs replaced its chief executive with a veteran of Big Tobacco on Wednesday, deepening the company’s turmoil and raising doubts about the very future of the e-cigarette industry.

The sudden announcement capped a relentless cascade of events that has called into question the safety of devices once billed as a promising alternative to cigarettes, one of the world’s leading preventable causes of death. Now, Juul is looking to that very industry for its survival as it faces a federal criminal inquiry, new bans on some of its products, and an onslaught of state and federal regulatory investigations into its marketing practices.

Early Wednesday morning, after frantic days of internal meetings, the company announced that its current chief executive, Kevin Burns, would resign as chief executive. His chosen replacement is K.C. Crosthwaite, a top official at Altria, the cigarette giant that bought a 35-percent share in Juul for $12.8 billion last December and has seen the company it invested in rocked by growing crisis.

In another sign of regulatory and business uncertainty, Altria and Philip Morris International said on Wednesday that they had ended talks to merge, dashing the chances of reuniting the two arms of what had once been the tobacco giant Philip Morris.

The e-cigarette industry — which Juul commands, with more than 70 percent of the market — is being threatened by twin public health crises: the rise of teenage vaping, which public health officials fear could create a new generation of nicotine addicts, and a surge of severe lung illnesses, including at least 11 deaths, linked to vaping.

Dr. David Kessler, a former commissioner of the Food and Drug Administration, said that in light of the epidemic of youth vaping, he doubted that any e-cigarette company could now prove that the benefits of its products outweighed the risks — a critical factor to win agency approval to stay on the market in the United States.

“In some ways the last several years has provided a record where it’s hard to see that these products could ever meet the ‘protection of public health standard,’” Dr. Kessler said. “And if they can’t meet that standard, they can’t be marketed.”

Testifying at a congressional hearing on Wednesday, the acting F.D.A. commissioner, Dr. Ned Sharpless, appeared to echo that sentiment, saying, “We really don’t think anyone should be using e-cigarettes, except perhaps a person who is using it instead of a combustible cigarette.”

Dr. Sharpless said the agency could have done more to keep the products away from teenagers. “In retrospect the F.D.A. should have acted sooner,” he said. “We’re going to catch up.”

In addition to the deaths, 530 cases of the lung sicknesses have been reported by the Centers for Disease Control and Prevention, causing public health agencies to warn most people to refrain from vaping any substance.

Many of the patients have said they had been vaping THC, the high-inducing ingredient in marijuana, when they became short of breath and grew sicker, officials have reported. But some said they were using just nicotine, or both.

Juul sells only nicotine products along with its sleek and popular vaping pens. Nevertheless, the company has become synonymous with vaping generally for much of the public.

“Juul is the face of the current public health crisis. Heads need to roll,” said Stefanie Miller, a co-founder of Sandhill Strategy, which consults with investment firms on regulatory policy, particularly tobacco-industry regulations. “To see the top head roll is a sign to public health, investors, to everyone that they know they need to make some changes.”

In announcing its change of leadership, Juul appeared to cave on issues that could be detrimental to its business. It said it would not fight a Trump administration proposal to ban most flavored e-cigarettes, which would slash its domestic sales. The company also said it would end one of its marketing campaigns, “Make the Switch,” which the F.D.A. warned could be construed as an illegal effort to portray its e-cigarettes as safer than traditional cigarettes.

A Juul employee said the company was also considering whether it should abandon its multimillion-dollar campaign on a ballot initiative to overturn an e-cigarette ban that is to take effect in San Francisco early next year.

ImageWestlake Legal Group merlin_161482992_d7bca353-1885-4105-bcb4-f2694ab1bfbf-articleLarge Juul Replaces Its C.E.O. With a Tobacco Executive Teenagers and Adolescence Smoking and Tobacco Respiratory Diseases Regulation and Deregulation of Industry Recalls and Bans of Products Philip Morris Companies Inc Mergers, Acquisitions and Divestitures Juul Labs Inc Food and Drug Administration E-Cigarettes Crosthwaite, K C Burns, Kevin R Appointments and Executive Changes Altria Group Inc

Kevin Burns, the outgoing Juul Labs C.E.O., in June.CreditLea Suzuki/San Francisco Chronicle, via Polaris

Within the last week alone, several television networks decided to stop broadcasting Juul’s ads; Massachusetts announced a four-month ban on the sale of all vaping products; Rhode Island announced a ban on flavors; Walmart said it would stop selling all e-cigarettes; and the F.D.A. announced it had opened a criminal inquiry into the supply chain of vaping products and devices. The Federal Trade Commission also has been investigating Juul’s marketing practices. And the United States attorney for Northern California opened a criminal investigation into the company, a development first reported by The Wall Street Journal.

On Sept. 10, President Trump met with Dr. Sharpless and Alex M. Azar II, the health and human services secretary. After informing the president of another spike in teenage vaping, the two officials said they would issue the proposed ban on most flavored e-cigarettes within several weeks.

That would include mint and menthol, they said, although some vaping industry leaders have vowed to contest the inclusion of those two items. Juul has said mint and menthol now account for about 80 percent of its products and a ban on those would severely hurt its domestic sales.

All of this foreshadows a regulatory showdown at the F.D.A. that is slated to begin in May next year when the agency will determine what, if any, e-cigarettes can remain on the domestic market.

“The United States is moving toward asking vaping companies for permission to sell any products,” Ms. Miller from Sandhill Strategy said. “The people they’re asking, the F.D.A., have shown these products are killing people.”

The turn in fortunes for Juul, and perhaps e-cigarettes generally, culminates one of the biggest disagreements in public health in recent years: whether e-cigarettes would prove a benefit to society. Supporters of e-cigarettes have argued that these devices have the potential to save millions of lives and billions of dollars by providing a safer alternative to the nation’s leading killer, traditional cigarettes.

Some investment advisers pointed to the disarray with e-cigarettes as a potential benefit to traditional smoking. “The recent media scrutiny on vaping will help overall cigarette consumption,” Nik Modi, a tobacco-industry analyst for RBC Capital Markets, wrote in a message to investors.

In recent weeks, as Juul sales have slowed, sales of cigarettes declined at a slower pace with each passing week, according to Nielsen, a market-research firm.

But skeptics have said all along that not enough is known about the long-term health effects of e-cigarettes and assert that they, and Juul, in particular, have spurred heavy experimentation by teenagers.

The upshot may drive the market for e-cigarettes overseas, a market that Juul’s new chief executive, Mr. Crosthwaite, highlighted to employees in an all-hands meeting at the company headquarters on Wednesday morning.

“International expansion continues to be a huge opportunity given the number of smokers around the world,” he told employees.

But the company’s initial foray in China this month failed almost immediately, and last week India also said it would ban the sale of e-cigarettes.

Mr. Crosthwaite, in coming from Altria, brings to Juul the experience of working for one of the most regulatory-savvy companies in the world; the tobacco industry has navigated perilous straits in keeping its product on shelves and pushing internationally, despite cigarettes being a proven, addictive killer.

In a speech to a tobacco industry gathering in Washington on Wednesday, Howard Willard III, chief executive of Altria, said Mr. Crosthwaite would help Juul “urgently control, confront and reduce youth vaping,” and deal with the company’s other problems.

“This is a pivotal moment,” he said. “Vaping is at an inflection point.”

Dr. Ned Sharpless, the F.D.A. acting commissioner, testified about the threats of e-cigarettes to the public before a House subcommittee on Wednesday.CreditPete Marovich for The New York Times

Despite the public concerns, Altria invested $12.8 billion in Juul in 2018 for a 35 percent stake, valuing Juul at about $38 billion. Mr. Crosthwaite became a board observer at Juul.

As for the decision to end the merger talks between Philip Morris and Altria, the two companies said they would instead focus on rolling out the IQOS heated tobacco product in the United States. They emphasized that IQOS, which Philip Morris International sells abroad and which has received F.D.A. approval for sale in the United States, is not “an e-vapor product.”

IQOS is a penlike electronic device with a battery pack that resembles a cigarette case. It features a heating blade that warms a tobacco stick and emits a vapor with the taste of tobacco, but with fewer noxious chemicals than cigarette smoke. The F.D.A. has approved it for sale in the United States and said the product could help people to quit smoking. The agency is still weighing whether to permit Altria to be marketed as a reduced-risk product.

Investors had appeared largely skeptical of the potential deal, despite the companies arguing that reuniting could revive their fortunes amid a decline in cigarette sales.

On Wall Street, analysts said they were not that surprised by the abrupt end to the merger talks, especially given the steady drumbeat of negative headlines around vaping and Juul’s products. The stock of Philip Morris International ended Wednesday up more than 5 percent at $75.28, while Altria’s stock ended essentially flat at $40.56.

But Altria is likely to face a bumpier future amid the uncertainty around Juul.

Analysts said it was increasingly likely that Altria might have to write down the value of its $12.8 billion investment in Juul, given the recent developments and uncertainty surrounding the company.

“When the Juul transaction was done, it valued the company at around $37 billion,” said Garrett Nelson, an analyst at CFRA Research. “Juul’s valuation today is probably a fraction of that.”

Meanwhile, Altria’s debt levels more than doubled as it borrowed to buy the Juul stake, he noted.

Tim Hubbard, an assistant professor of management in the University of Notre Dame’s Mendoza College of Business, said it was not surprising that Mr. Burns was stepping down from the company as it had struggled to adapt to the swift change of perceptions, from a company that was providing an alternative to smoking to one that had been vilified.

“When compared to traditional tobacco products — which have remained on the shelves for decades despite being proven dangerous — e-cigarette makers have failed spectacularly,” Mr. Hubbard said in an email. “Bringing in a traditional tobacco executive who knows how to market and manage government relationships with deadly products matches the firm’s needs.”

Michael J. de la Merced and Katie Thomas contributed reporting.

Earlier coverage

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Trump administration may ban flavored vaping products

Westlake Legal Group v Trump administration may ban flavored vaping products vape Trump tobacco The Blog Prohibition Fruit Food and Drug Administration e-cigarette administration

This feels like an especially strange edition of 2019 Mad Libs. “On Wednesday, the Trump administration announced it would [VERB] [PLURAL NOUN] in order to protect the health of America’s children.”

*Reaches into “verb” bag* “Ban.”

*Reaches into “plural noun” bag* …”E-cigarettes”? Not actual cigarettes? Or sugar? Or guns? Or, Trump being Trump, immigrants?

Not all e-cigarettes are on the chopping block, just the flavored ones that are more likely to attract younger customers. Last week the feds announced that no fewer than 450 cases of severe lung disease, six of which have resulted in death, may be linked to vaping. The inflammation looks like pneumonia on lung scans, the NYT notes, and the symptoms can include nausea, coughing, and fatigue — but there’s no underlying evidence of illness. Some patients say they used vape cartridges containing THC, leading scientists to suspects that cannabinoid oils caused the inflammation, but others claim they used regular ol’ nicotine cartridges. Researchers are in the dark, wondering if maybe some as yet unidentified combination of chemicals in certain vaping products is causing the reaction.

Until they figure it out, a (partial) ban is in the offing:

The Food and Drug Administration is currently finalizing its guidance to remove all non-tobacco flavors of e-cigarettes, including mint and menthol, from the market within 30 days. Companies might be able to reintroduce their flavors at a later date, so long as they submit a formal application and receive approval from the FDA.

Vaping companies like Juul have been criticized for hooking children on e-cigarettes with their fruity flavors like mango and creme. The surge in underaged vaping, which U.S. health officials have labeled as an “epidemic,” is one of the reasons why they plan to ban them — at least until the FDA can thoroughly review their safety, Azar said after meeting with President Donald Trump at the White House on the issue…

Azar said they want to keep tobacco-flavored e-cigarettes on the market for adults who may be using them to quit smoking. The FDA has embraced e-cigarettes as a less harmful way for smokers to satisfy their nicotine addiction than smoking cigarettes. Skyrocketing numbers of minors started using the products, forcing the FDA to reverse course.

A bad idea, for at least two reasons. One: Leaving tobacco-flavored e-cigs on the market risks funneling kids who currently get their nicotine fix from fruit-flavored candy-like products towards something that tastes much more like real cigarettes. If the fear with vaping is that it’s a gateway drug for tobacco products, why the hell would you want to condition children to crave nicotine that tastes like tobacco? (Azar said the FDA might extend the ban to tobacco-flavored e-cigarettes if demand for it begins to increase among kids.) Two, via Casey Given: Although scientists are unsure what’s causing the cases of lung disease, even critics of vaping like former FDA commissioner Scott Gottlieb suspect that black-market products are to blame. In which case the last thing the feds should want to do is … push demand for fruit flavors entirely onto the black market, right?

A recent study of vape-related lung cases in Illinois and Wisconsin found that 83 percent of patients admitted to using black-market products. Among those who were extensively interviewed, 80 percent admitted to using THC oil products. Vitamin E acetate oil has been found in other black-market products linked to lung patients. These people aren’t “vaping” so much as, uh, “oiling.” The feds might inadvertently be doing more harm than good here by pulling safer mainstream products off the shelves and leaving consumers to try their luck with the bootleg stuff.

As for whether vaping really is a gateway to smoking, the data is mixed. Gottlieb published a statement as FDA commissioner last November claiming that “The data show that kids using e-cigarettes are going to be more likely to try combustible cigarettes later,” but Tiana Lowe rightly notes that smoking rates in the U.S. are momentarily at an all-time low. At least one study has claimed that cigarette smokers who switch to vaping are 77 percent more likely to stay away from smokes for two years than non-vapers are.

In fact, last year a British parliamentary committee devoted to science and technology recommended deregulating vaping in order to encourage more of it. Sure, there are health risks, said the committee, but the choice for many isn’t whether to vape or not, it’s whether to smoke or vape. “Concerns that e-cigarettes could be a gateway to conventional smoking, including for young non-smokers, have not materialized,” said the committee’s chairman. “If used correctly, e-cigarettes could be a key weapon in the NHS’s (National Health Service) stop smoking arsenal.” On top of everything else, Lowe argues, the policy is regressive: If you’re working class and trying to quit smoking, that’s going to be harder with vape cartridges less available. Seems like we’re headed for another hard lesson on what happens when you try to prohibit a pleasurable product, except in this case public health arguably benefits on balance from that product’s availability.

Might help Trump with suburban women next year, though, no? There can’t be a lot of moms who are eager to see their teen vaping, even knowing that it beats them smoking.

By the way, and possibly related, this appeared on political Twitter this afternoon not long after the FDA announcement:

Is Yang maybe going to vape onstage and plead the case for e-cigarettes? That would be a crafty way to leverage the news cycle to get young voters’ attention.

The post Trump administration may ban flavored vaping products appeared first on Hot Air.

Westlake Legal Group v-300x153 Trump administration may ban flavored vaping products vape Trump tobacco The Blog Prohibition Fruit Food and Drug Administration e-cigarette administration   Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Trump administration may ban flavored vaping products

Westlake Legal Group v Trump administration may ban flavored vaping products vape Trump tobacco The Blog Prohibition Fruit Food and Drug Administration e-cigarette administration

This feels like an especially strange edition of 2019 Mad Libs. “On Wednesday, the Trump administration announced it would [VERB] [PLURAL NOUN] in order to protect the health of America’s children.”

*Reaches into “verb” bag* “Ban.”

*Reaches into “plural noun” bag* …”E-cigarettes”? Not actual cigarettes? Or sugar? Or guns? Or, Trump being Trump, immigrants?

Not all e-cigarettes are on the chopping block, just the flavored ones that are more likely to attract younger customers. Last week the feds announced that no fewer than 450 cases of severe lung disease, six of which have resulted in death, may be linked to vaping. The inflammation looks like pneumonia on lung scans, the NYT notes, and the symptoms can include nausea, coughing, and fatigue — but there’s no underlying evidence of illness. Some patients say they used vape cartridges containing THC, leading scientists to suspects that cannabinoid oils caused the inflammation, but others claim they used regular ol’ nicotine cartridges. Researchers are in the dark, wondering if maybe some as yet unidentified combination of chemicals in certain vaping products is causing the reaction.

Until they figure it out, a (partial) ban is in the offing:

The Food and Drug Administration is currently finalizing its guidance to remove all non-tobacco flavors of e-cigarettes, including mint and menthol, from the market within 30 days. Companies might be able to reintroduce their flavors at a later date, so long as they submit a formal application and receive approval from the FDA.

Vaping companies like Juul have been criticized for hooking children on e-cigarettes with their fruity flavors like mango and creme. The surge in underaged vaping, which U.S. health officials have labeled as an “epidemic,” is one of the reasons why they plan to ban them — at least until the FDA can thoroughly review their safety, Azar said after meeting with President Donald Trump at the White House on the issue…

Azar said they want to keep tobacco-flavored e-cigarettes on the market for adults who may be using them to quit smoking. The FDA has embraced e-cigarettes as a less harmful way for smokers to satisfy their nicotine addiction than smoking cigarettes. Skyrocketing numbers of minors started using the products, forcing the FDA to reverse course.

A bad idea, for at least two reasons. One: Leaving tobacco-flavored e-cigs on the market risks funneling kids who currently get their nicotine fix from fruit-flavored candy-like products towards something that tastes much more like real cigarettes. If the fear with vaping is that it’s a gateway drug for tobacco products, why the hell would you want to condition children to crave nicotine that tastes like tobacco? (Azar said the FDA might extend the ban to tobacco-flavored e-cigarettes if demand for it begins to increase among kids.) Two, via Casey Given: Although scientists are unsure what’s causing the cases of lung disease, even critics of vaping like former FDA commissioner Scott Gottlieb suspect that black-market products are to blame. In which case the last thing the feds should want to do is … push demand for fruit flavors entirely onto the black market, right?

A recent study of vape-related lung cases in Illinois and Wisconsin found that 83 percent of patients admitted to using black-market products. Among those who were extensively interviewed, 80 percent admitted to using THC oil products. Vitamin E acetate oil has been found in other black-market products linked to lung patients. These people aren’t “vaping” so much as, uh, “oiling.” The feds might inadvertently be doing more harm than good here by pulling safer mainstream products off the shelves and leaving consumers to try their luck with the bootleg stuff.

As for whether vaping really is a gateway to smoking, the data is mixed. Gottlieb published a statement as FDA commissioner last November claiming that “The data show that kids using e-cigarettes are going to be more likely to try combustible cigarettes later,” but Tiana Lowe rightly notes that smoking rates in the U.S. are momentarily at an all-time low. At least one study has claimed that cigarette smokers who switch to vaping are 77 percent more likely to stay away from smokes for two years than non-vapers are.

In fact, last year a British parliamentary committee devoted to science and technology recommended deregulating vaping in order to encourage more of it. Sure, there are health risks, said the committee, but the choice for many isn’t whether to vape or not, it’s whether to smoke or vape. “Concerns that e-cigarettes could be a gateway to conventional smoking, including for young non-smokers, have not materialized,” said the committee’s chairman. “If used correctly, e-cigarettes could be a key weapon in the NHS’s (National Health Service) stop smoking arsenal.” On top of everything else, Lowe argues, the policy is regressive: If you’re working class and trying to quit smoking, that’s going to be harder with vape cartridges less available. Seems like we’re headed for another hard lesson on what happens when you try to prohibit a pleasurable product, except in this case public health arguably benefits on balance from that product’s availability.

Might help Trump with suburban women next year, though, no? There can’t be a lot of moms who are eager to see their teen vaping, even knowing that it beats them smoking.

By the way, and possibly related, this appeared on political Twitter this afternoon not long after the FDA announcement:

Is Yang maybe going to vape onstage and plead the case for e-cigarettes? That would be a crafty way to leverage the news cycle to get young voters’ attention.

The post Trump administration may ban flavored vaping products appeared first on Hot Air.

Westlake Legal Group v-300x153 Trump administration may ban flavored vaping products vape Trump tobacco The Blog Prohibition Fruit Food and Drug Administration e-cigarette administration   Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Trump Administration Plans to Ban Flavored E-Cigarettes

WASHINGTON — Trump administration officials said on Wednesday they want to ban the sale of most flavored e-cigarettes, at a time when hundreds of people have been sickened by mysterious vaping-related illnesses.

Sitting in the Oval Office with Alex M. Azar II, the secretary of Health and Human Services, and Dr. Ned Sharpless, the acting Food and Drug Administration commissioner, President Trump acknowledged that there was a vaping problem, and said, “We’re going to have to do something about it.”

Mr. Azar said that the F.D.A. would outline a plan within the coming weeks for removing most flavored e-cigarettes from the market.

The move follows increasing pressure by lawmakers, parents and educators, who have been overwhelmed by the popularity of vaping among youths, and felt powerless to keep e-cigarettes out of their schools.

Details were sparse, but officials said the proposal may include a ban on menthol and mint flavored e-cigarettes, which have been the among the most popular flavors for the industry. Research has shown that these flavors are very appealing to youths and to nonsmokers, although some vaping advocates note that they hold great appeal for smokers who want to use e-cigarettes to quit.

The first lady, Melania Trump, also attended the White House meeting. “She’s got a son,” the president said of their teenage child, Barron. “She feels very strongly about it,” he said of Mrs. Trump’s interest in the vaping issue.

What You Need to Know About Vaping-Related Lung Illness
Coughing, fatigue and shortness of breath are warning signs for anyone who has vaped within the last 90 days.

Sept. 7, 2019

Westlake Legal Group merlin_160293528_5b0b0b27-3c5e-49cf-b7eb-bb1ddce4646d-threeByTwoSmallAt2X Trump Administration Plans to Ban Flavored E-Cigarettes your-feed-healthcare Trump, Donald J Smoking and Tobacco Sharpless, Norman E Recalls and Bans of Products Nicotine Marijuana Juul Labs Inc Food and Drug Administration E-Cigarettes

Just this week, Michigan became the first state to prohibit the sale of flavored e-cigarettes. New York Gov. Andrew Cuomo also called for a ban, and Massachusetts and California are considering similar measures. San Francisco approved an e-cigarette ban earlier this year, which Juul Labs, the dominant seller in the United States, is lobbying to reverse through a ballot initiative this November.

Last week, Senator Dick Durbin, Democrat of Illinois and a longtime opponent of tobacco and e-cigarettes, warned Dr. Ned Sharpless, the acting commissioner of the Food and Drug Administration, that if the agency failed to remove e-cigarette flavors from the market, he would call for the commissioner’s resignation. After Kansas reported a sixth vaping-related death on Tuesday , Senator Durbin again slammed the F.D.A. for failing to take decisive action to protect the public from e-cigarettes.

Pressure also began to mount as Michael R. Bloomberg, the former mayor of New York, decided to step in by announcing a $160 million push to ban flavored e-cigarettes. Long an opponent of traditional smoking, the former mayor said his organization, Bloomberg Philanthropies, would seek prohibitions of flavored e-cigarettes in at least 20 cities and states.

In New York, Governor Cuomo also directed state health officials to subpoena companies that market or sell so-called thickening agents, which are sometimes added to illicit vaping products. A state laboratory, which detected the agents in vaping products collected from New York’s patients, found that they were nearly pure vitamin E acetate oil, which officials have said is a potential cause of some of the illnesses.

Hospitals and health officials in nearly three dozen states have reported nearly 500 cases of vaping-related illnesses since the beginning of the summer. Doctors have said that many patients appear to have vaped some THC or cannabis-related products, although others have reported using e-cigarettes as well. No one has singled out a particular company, device or product as the possible culprit.

Deaths have been reported in Illinois, Kansas, California, Indiana, Minnesota and Oregon. The patients’ ages ranged from the 30s to middle-aged or older, and some had underlying lung or other chronic conditions, health officials said.

ImageWestlake Legal Group 11ECIGARETTES-articleLarge Trump Administration Plans to Ban Flavored E-Cigarettes your-feed-healthcare Trump, Donald J Smoking and Tobacco Sharpless, Norman E Recalls and Bans of Products Nicotine Marijuana Juul Labs Inc Food and Drug Administration E-Cigarettes

Various flavors of Juul e-cigarettes in a store in Manhattan.CreditJeenah Moon for The New York Times

Months ago, public and agency pressure forced Juul to yank its flavored pods — which were considered to appeal particularly to youths — from store shelves. The F.D.A. said at the time that it would seek to have retailers curb access to products to keep them away from minors.

Since Dr. Scott Gottlieb resigned as F.D.A. commissioner in April, the agency has appeared to be more sluggish in its efforts to control the epidemic of youth vaping. Although Dr. Sharpless had said he planned to continue the agency’s work to reduce both cigarette and e-cigarette use, not much moved forward. Dr. Gottlieb’s proposal to ban menthol in cigarettes, for example, has languished, as has his call for reducing nicotine in cigarettes to non-addictive amounts.

That appears to have changed this week. On Monday, the F.D.A. took action against Juul, sending a warning letter accusing the company of violating federal regulations by promoting its vaping products as a healthier option than cigarettes.

There is little conclusive research on the long-term safety of using Juul or other e-cigarettes. The company’s flavor pods have a higher level of nicotine than cigarettes do, which is of concern because of the impact nicotine can have on the still-developing teenage brain.

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Coverage of flavored e-cigarettes

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