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Westlake Legal Group > Smoking and Tobacco

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

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

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

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

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

Is It Time to Quit Vaping?

Public health officials have long been wary of e-cigarettes, also known as vape pens. But after an outbreak of serious lung illnesses this summer, those concerns became much more urgent.

Last week, federal health officials announced that e-cigarettes — which people can use to vaporize and inhale liquids containing nicotine or T.H.C., the high-inducing chemical in marijuana — could be behind at least 450 cases of severe lung disease in 33 states. The number of reported deaths reached six on Tuesday.

Most scientists and doctors think e-cigarettes are probably safer than regular cigarettes, though some states and cities have started to limit their use. It remains unclear just how much safer they are, especially given the recent spate of illnesses. And on Wednesday, Trump administration officials said they would move toward a ban on the sale of most flavored e-cigarettes.

Public health officials are still trying to figure out why so many people have gotten sick, and have recommended that people cut back on vaping in the meantime.

Here’s what we know so far.

The lung illness associated with vaping starts with symptoms that can include nausea, vomiting, fatigue, coughing and fever, escalating to shortness of breath that can become so extreme as to require hospitalization. Some patients have needed supplementary oxygen.

On lung scans, the illness looks like bacterial or viral pneumonia, but no infection has been found in testing.

The Centers for Disease Control and Prevention released an official health advisory regarding the illness last month. It said people concerned about the disease should “consider refraining from using e-cigarette products.”

ImageWestlake Legal Group 30VAPING1-articleLarge Is It Time to Quit Vaping? United States Smoking and Tobacco Regulation and Deregulation of Industry Marijuana Lungs Juul Labs Inc Hazardous and Toxic Substances Food and Drug Administration E-Cigarettes Deaths (Fatalities) Centers for Disease Control and Prevention

An X-ray of a patient with a vaping habit shows whitish, cloud-like areas typically associated with some pneumonias, fluid in the lungs or inflammation.CreditIntermountain Healthcare

Read more about the sickness and its symptoms.
What You Need to Know About Vaping-Related Lung Illness

Sept. 7, 2019

There are also broader concerns about the safety of e-cigarettes.

Although e-cigarettes do not contain the tar and other carcinogens of traditional tobacco products, questions remain about the effects nicotine may have — especially on young people. Some experts say that nicotine may have harmful effects on a developing teenager’s brain, and some research has suggested that ingesting nicotine can affect the heart and arteries.

There are also reports of e-cigarettes causing fires and explosions, often because of malfunctioning lithium batteries. Explosions have killed at least two vape pen users in recent years.

Vaping gained popularity in recent years as an alternative to tobacco cigarettes. According to a history compiled by the Consumer Advocates for Smoke Free Alternatives Association, modern e-cigarettes did not make their way to the United States until 2006.

By 2014, “vape” was the Oxford Word of the Year.

Read more about the long-running debates around vaping
Safer to Puff, E-Cigarettes Can’t Shake Their Reputation as a Menace

Nov. 1, 2016

As vaping became popular, mounting evidence suggested that it was far less dangerous than smoking. E-cigarette users can inhale nicotine without the deadly tar found in tobacco products, and many smokers use vape pens as a quitting aid.

But some American public health experts, led by the C.D.C., have been suspicious of e-cigarettes. And regulations have largely banned vaping product companies from making broad claims about health and harm as compared with tobacco products — at least not without extensive data.

Skeptics of the devices have warned about the potential for unknown risks, as well as the dangers of opening a new door to addiction for children and teenagers. Flavored products were considered especially worrisome, especially when it became clear that vaping products were popular with minors.

Read more about allegations that the vaping products company Juul Labs was purposely targeting teenagers.
Juul Targeted Schools and Youth Camps, House Panel on Vaping Claims

July 25, 2019

The Food and Drug Administration gained jurisdiction over e-cigarettes in 2016. Two years later, the agency mounted an aggressive campaign against the major manufacturers of vaping products that appeal to young people, focusing on Juul, a popular brand of e-cigarette vape pods. Juul stopped selling most of its popular flavored nicotine pods in stores last fall, but some look-alikes have since popped up.

On Monday, amid heightened concerns about the proliferation of lung illnesses, the F.D.A. said Juul had violated regulations by touting its vaping products as safer than traditional tobacco cigarettes.

San Francisco became the first city to ban e-cigarettes in June, and other communities have similar measures in the works. Last week, Michigan said it would ban all flavored e-cigarettes, becoming the first state to do so. Several state attorneys general have called for the federal government to ban flavored e-cigarettes, and bills to stop sales of flavored vaping products have been introduced in California and Massachusetts.

It’s still unclear what caused the illnesses this summer.

Some people who were sickened said they had vaped with oil containing T.H.C., and some doctors reported that cannabinoid oils vaporized in cartridges may have caused some of the lung inflammation.

The F.D.A. said that a significant subset of samples of vaping fluid used by sick patients included T.H.C., and also contained a compound called vitamin E acetate, which has been a subject of further investigation.

Read more about the people who have suffered from lung illnesses in recent months.
The Mysterious Vaping Illness That’s ‘Becoming an Epidemic’

Aug. 31, 2019

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Trump Administration Weighs Ban on Flavored E-Cigarettes

WASHINGTON — Trump administration officials said on Wednesday they would move toward a ban on 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 that are not tobacco products 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.

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 Weighs Ban on 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 11ECIGARETTES2-articleLarge Trump Administration Weighs Ban on 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

From left, Dr. Norman Sharpless, the acting F.D.A. commissioner, Melania Trump, President Trump and Alex M. Azar II, the health and human services secretary, discussing flavored e-cigarettes in the Oval Office on Wednesday.CreditKevin Lamarque/Reuters

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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‘Juul-alikes’ Are Filling Shelves With Sweet, Teen-Friendly Nicotine Flavors

The purveyors of Strawberry Milk, Peach Madness and Froopy (tastes like Froot Loops) e-cigarette pods are having a very good year.

After Juul Labs, under pressure from the Food and Drug Administration, stopped selling most of its hugely popular flavored nicotine pods in stores last fall, upstart competitors swooped in to grab the shelf space. Trumpeting their own fruity and candy-flavored pods as compatible with Juul devices, they have seen their sales soar.

The proliferation of “Juul-alikes” is not only complicating Juul’s efforts to clean up its tarnished image, but also shows just how entrenched the youth vaping problem has become and that voluntary measures are unlikely to solve it.

When Juul agreed to discontinue store sales of its fruit and dessert flavors, it said it would continue selling them online and strengthen the age verification process on its website.

“If Juul’s voluntary actions were working, youths would not still be using their products at epidemic rates,” said Chris Bostic, deputy director for policy of Action on Smoking & Health. “We can’t rely on the companies alone to self-regulate. That’s where the government needs to step in.”

Exactly how willing the Trump administration is to step in is up in the air. In the last few weeks of his tenure at the F.D.A., the former commissioner Scott Gottlieb issued a proposal requiring that stores sequester flavored e-cigarettes, except menthol, mint and tobacco, to areas off limits to minors. Retailers, among them convenience stores and gas stations, would be expected to verify the age of their customers.

But the details of the proposal were vague, and with Dr. Gottlieb’s departure, it’s unclear how federal policy might change, although Acting Commissioner Norman E. Sharpless has said he is working on finalizing the plan and supported Dr. Gottlieb’s e-cigarette crackdown.

Juul has filed numerous lawsuits, and complaints with the International Trade Commission, seeking to beat back the cheaper copycat devices and pods.

“If the box isn’t around, the parent would say it’s a Juul pod, but it’s not us,” said Matthew Hult, a Juul lawyer. “It injects confusion and tarnishes the Juul brand.”

The company is also targeting sellers of counterfeit vaping devices and pods sold under the Juul name, and training federal customs officials to catch them at ports of entry.

Juul said its concern was less about losing market share than about further damaging its reputation at a time when the company is trying to convince the public that it really does not want minors to vape, and that it is working to prevent them from doing so.

ImageWestlake Legal Group merlin_158446533_b8978d6d-6696-403b-84de-fa08b9c1f798-articleLarge ‘Juul-alikes’ Are Filling Shelves With Sweet, Teen-Friendly Nicotine Flavors Ziip Youth Vapor4Life United States International Trade Commission Teenagers and Adolescence Smoking and Tobacco Shopping and Retail Nicotine Juul Labs Inc Inventions and Patents Healey, Maura (1971- ) Eonsmoke E-Cigarettes Counterfeit Merchandise

James Monsees, a Juul co-founder and chief product officer, testifying before a House subcommittee last month.CreditSusan Walsh/Associated Press

In the past few months, Juul has spent millions of dollars to run numerous full-page advertisements in newspapers — including The New York Times, The Washington Post and The Wall Street Journal — and digital news organizations like Politico and Axios. The somber black and white, text-only displays blast messages like, “IT’S TIME TO RAISE THE LEGAL AGE TO PURCHASE TOBACCO PRODUCTS, INCLUDING VAPOR, FROM 18 TO 21.”

But as the company pushes back against other companies’ flavor pods, Juul says it still has the legal right, under F.D.A. rules, to bring back dozens of its own sweet flavors that it once sold in very limited release. They include varieties of watermelon, strawberry and melon, which competitors are already selling, as well as specially designed concoctions: Coconut Bourbon, Elderflower Fizz, Mimosa and Thai Tea, and others.

In April, Juul told Congress it had no intention of bringing those flavors back in the United States.

Juul’s vaping products have been on the market only since 2015, but the sleek devices, sometimes called “the iPhones of e-cigarettes,” have become so popular, particularly with young people, that the company now has more than 70 percent of the e-cigarette market. Many public health and school officials believe Juul’s early marketing campaigns, which highlighted the “coolness” of the devices, helped make them fashionable with teenagers and led to rising nicotine addiction among young people who had never smoked. The F.D.A. and some state attorneys general are investigating the company’s marketing practices.

The company has filed patent infringement claims against 21 manufacturers and sellers of copycat devices and pods.

Most of those companies agreed to stop selling their similar products, but three did not, according to Juul: Eonsmoke, based in New Jersey, which uses factories in China; Ziip, based in China; which makes many different brands of nicotine pods and devices; and Vapor4Life, an Illinois-based seller of pods, devices and other goods.

“We are taking aggressive actions against counterfeit and compatible products because they are a direct threat to our plan to combat youth usage,” said Joshua Raffel, a Juul spokesman.

Mr. Raffel said that Juul had participated in raids on factories making counterfeit Juul products. He said United States Customs had made 37 seizures of counterfeit Juul products that they are aware of, so far this year.

He also said that Juul had sent 278 cease-and-desist letters related to counterfeit or illegal products.

Eonsmoke is one of Juul’s growing rivals. Juul’s removal of its creme, cucumber, fruit and mango flavors from stores gave Eonsmoke’s fortunes a big boost. In 2018, Eonsmoke generated an estimated $5.3 million in revenue based on sales tracked by Information Resources Inc., which analyzes retail spending. This year, the company’s business has soared, with an estimated $43.6 million in tracked sales as of mid-July.

Stephen Lobbin, an Eonsmoke lawyer, said the company’s nicotine pods are designed for adults, and that people under 18 are not permitted to buy them in stores or online.

“There are things that may harm you and we allow that in our society, because we favor personal responsibility over the nanny state,” he added.

Ziip and Eeonsmoke products in a Manhattan vape shop.CreditBrittainy Newman/The New York Times

But teenagers are still getting their hands on them.

Phillip Fuhrman, a 16-year-old New Yorker whose mother is a co-founder of Parents Against Vaping e-cigarettes, said Eonsmoke’s wide range of flavors was a big draw for minors.

“A lot of my friends use the blueberry,” Phillip said in an interview. “People use the mango because it’s somewhat similar to the Juul mango.”

Aside from being cheaper than Juul’s products and available in more flavors, Eonsmoke also offers another attraction, Phillip said — some of the company’s pods come with levels of nicotine higher than any Juul sells.

“Some of my friends use Eon pods because they have a higher nicotine percentage, because they want a bigger head rush,” Phillip said. “If you’re Juuling every single day, you aren’t going to get as much of a head rush.”

Eonsmoke is under investigation by both the F.D.A. and the attorney general of Massachusetts.

In May, the Massachusetts attorney general, Maura Healey, filed suit against Eonsmoke, accusing it of targeting its vaping products to young people through marketing and advertising intended to appeal to youth. The state also alleged that Eonsmoke failed to verify the ages of its online buyers. As a result of a cease-and-desist letter sent in September 2018, Eonsmoke no longer sells its products online to Massachusetts residents.

Eonsmoke and the other companies deny targeting minors.

Eonsmoke argues that Juul’s patents are invalid. “Juul has tweaked some very simple standard ways to basically heat up and vaporize a liquid and puff on it,” Mr. Lobbin said. “They haven’t figured out a way to get to Mars.”

Ziip, which designs and manufactures dozens of different flavor pods and devices is also under investigation by the F.D.A., which said that it, like Eonsmoke, might have products on the market illegally.

Like Eonsmoke, Ziip claims that Juul’s technology is either the same or very close to what was previously invented, invalidating its patents.

“Juul is trying to gain a virtual monopoly over the e-cigarette industry in the United States,” said Steven Susser, a lawyer for Ziip. He also blamed Juul’s marketing practices for putting the industry under a microscope.

“All Ziip wants to do is to offer a less expensive, and what it believes to be a better quality, alternative,” he said. Ziip sells dozens of Juul-compatible flavors including Froopy, Iced Pina Colada, Cinnamon Roll and Strawberry Lemonade.

In documents filed with the trade commission, Juul called its vaping system “a runaway success” and said that the devices and nicotine pods manufactured and sold by the accused companies were based on stolen intellectual property. Juul also raised questions about its competitors’ quality control, although in an interview it did not give any specific examples of problems.

Melanie Milin, co-founder of Vapor4Life, said her company had always told prospective customers not to start vaping if they don’t already smoke. The company offers products in a range of nicotine levels to encourage people who vape to taper off and quit.

The showdown has stirred up mixed feelings among the tobacco-control crowd.

“It is hard to root for Juul in a corporate fight about who profits from nicotine addiction,” Mr. Bostic said. “But from a purely public health perspective, an I.T.C. decision in their favor would at least get some products aimed at children off the market. All of these should be banned, and a growing number of jurisdictions are doing just that.”

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F.D.A. Permits the Sale of IQOS, a New Tobacco Device

WASHINGTON — The Food and Drug Administration said Tuesday that it would permit the sale of IQOS, a “heat not burn” tobacco device made by Philip Morris International, in the United States.

While the agency stopped short of declaring that the device was safer than traditional cigarettes, the F.D.A. did say the heated tobacco-stick system could help people to quit smoking.

Philip Morris has waited two years for the agency to clear IQOS (pronounced EYE-kose), a penlike electronic device that comes with a sleek battery pack resembling a cigarette case. The product includes an electronically controlled heating blade that warms a tobacco stick and releases a vapor with the taste of tobacco but fewer harmful chemicals than cigarette smoke.

It differs from e-cigarettes already on the market because it contains tobacco rather than liquid nicotine. But IQOS still delivers an amount of nicotine that’s similar to traditional cigarettes.

“The F.D.A.’s decision to authorize IQOS in the U.S. is an important step forward for the approximately 40 million American men and women who smoke,” said André Calantzopoulos, the chief executive of Philip Morris International. “Some will quit. Most won’t, and for them IQOS offers a smoke-free alternative to continued smoking.”

Howard A. Willard III, chief executive of Altria, which will distribute the product in this country, said the company planned to begin sales of IQOS in Atlanta.

A few years ago, the F.D.A.’s decision would have been a clear win for both Philip Morris and Altria. But IQOS products will now have to compete with the extremely popular devices sold by the vaping giant Juul Labs, in which Altria has a 35 percent stake.

Altria officials say the products will appeal to different consumers. But the Philip Morris team had chafed at their product’s being kept off the shelves while Juul gobbled up market share, and was unhappy with Altria’s $12.8 billion investment in the San Francisco start-up.

Juul now commands more than 70 percent of the e-cigarette market in this country. But in the last year, it has been sharply criticized, largely blamed for the soaring increase in teenage vaping. Under pressure from the F.D.A. and a public backlash over marketing tactics that appeared to target youths, the company stopped supplying most of its flavored pods to retail stores around the country and curtailed its social media promotions.

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The device warms a tobacco stick and releases a vapor with the taste of tobacco but fewer harmful chemicals than cigarette smoke.CreditIssei Kato/Reuters

The F.D.A. said it did not appear that the IQOS devices, which will be sold with Marlboro-branded regular and menthol sticks, would appeal to younger people. In Japan and Italy, the devices haven’t attracted use among teenagers, and the product isn’t sold in flavors except for menthol, the F.D.A. noted in its report.

But in an effort to prevent sales of IQOS to minors, the agency said the company would have to submit advertising and marketing plans for review.

The F.D.A. said it still considered IQOS to be a type of cigarette, even though it releases fewer toxic chemicals. That designation means that IQOS must adhere to the same advertising and other federal restrictions. In addition, Philip Morris must include a label warning that nicotine is addictive.

Most public health groups criticized the F.D.A.’s decision. Erika Sward, an assistant vice president of the American Lung Association, said: “Inhaling chemicals and toxins into one’s lungs always poses risks. Lungs are on the front line — and have been showing immediate results of being exposed to chemicals — whether in the workplace, using tobacco products or outdoor air pollution.”

Philip Morris International introduced IQOS in test cities in late 2014. It became nationally available in Japan in the spring of 2016 and quickly became popular. It is now sold in 47 countries.

Philip Morris had hoped to become the first company in the United States permitted to claim that it was selling a new tobacco product that would be considered less harmful than other products, like traditional cigarettes. But the agency is still reviewing its application, first submitted in December 2016, to sell the device under such a label.

The company’s share price rose 2 percent by the close of trading on Tuesday.

During the review process, Philip Morris, like other major tobacco companies, faced lingering skepticism and distrust from the public health community for the industry’s decades-long history of concealing evidence that cigarettes caused cancer. In January 2018, a federal advisory panel questioned the quality of the company’s safety studies and its claim that IQOS would not appeal to youths.

The F.D.A.’s tobacco control policy under Dr. Scott Gottlieb, its commissioner until a month ago, centered on offering smokers a variety of reduced-risk alternatives to cigarettes. But Dr. Gottlieb’s early support of e-cigarettes shifted as evidence piled up that teenage vaping had grown. The ensuing F.D.A. crackdown on e-cigarettes and sales to minors has drawn opposition from vaping shops and manufacturers, who argue that the agency is making it tough for smokers to gain access to safer alternatives.

Although smoking rates have declined, cigarettes still kill about 480,000 people every year. Dr. Ned Sharpless, the acting F.D.A. commissioner, said he intended to continue Dr. Gottlieb’s effort to curb youth vaping.

The agency warned Philip Morris that it would be subject to scrutiny even though it had received clearance to sell the devices.

“We’ll be keeping a close watch on the marketplace,” said Mitch Zeller, director of the agency’s tobacco control unit.

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F.D.A. Approves IQOS, a New Tobacco Device

Westlake Legal Group IQOS-facebookJumbo F.D.A. Approves IQOS, a New Tobacco Device your-feed-healthcare Smoking and Tobacco Philip Morris Companies Inc Juul Labs Inc IQOS Food and Drug Administration Altria Group Inc

WASHINGTON — The Food and Drug Administration on Tuesday said that it would permit the sale of IQOS, a “heat-not-burn” tobacco device made by Philip Morris International, in the United States.

IQOS is a penlike electronic device that comes with a sleek battery pack resembling a cigarette case. An electronically controlled heating blade in the apparatus warms a tobacco stick, which releases a vapor with the taste of tobacco but fewer harmful chemicals than cigarette smoke.

The agency said the decision did not mean that it was pronouncing the products “safe,” and that they still met the definition of cigarettes even though they released fewer toxins than traditional cigarettes.

But the devices, the agency said, deliver “nicotine in levels close to combustible cigarettes suggesting a likelihood that IQOS users may be able to completely transition away from combustible cigarettes and use IQOS exclusively.” The agency said data provided by Philip Morris indicated that it appeared unlikely that non-tobacco users, including youths, would take up an IQOS device.

It also said it would require the company to attach additional labeling stressing the addictiveness of nicotine.

The F.D.A. has been reviewing IQOS since December 2016. Initially, IQOS seemed to be a sure bet — an example of the kind of innovative alternative to combustible cigarettes that the agency wanted to promote. But the public backlash that followed Juul’s unexpected popularity among teenagers made the F.D.A. more cautious about letting another electronic nicotine delivery system onto the market.

Philip Morris International launched IQOS in test cities in late 2014. It became nationally available in Japan in the spring of 2016 and quickly became popular. It is now sold in 44 countries. The company touts IQOS as a more natural smoking experience than e-cigarettes like Juul, its main rival for those seeking alternatives to traditional cigarettes. Altria will distribute IQOS in the United States.

Philip Morris International had hoped to become the first company in the United States permitted to claim that it was selling a new tobacco product that would be considered less harmful than other products, like traditional cigarettes. But the agency is still reviewing its application to sell the device under such a label.

IQOS will be sold with Marlboro regular and menthol flavored heat sticks. The agency wants adult smokers to be able to choose from a range of reduced risk alternatives to cigarettes. Although smoking rates have declined, cigarettes still kill about 480,000 people every year.

Philip Morris International, like most of the tobacco industry, hid evidence for decades that cigarettes cause cancer and mistrust of the industry lingers today. In January 2018, a federal advisory panel raised questions about the quality of the company’s safety studies, and its claim that IQOS would not appeal to youths.

At one time, the approval of IQOS would have been a clear win for Altria. But IQOS is a competitor to Juul, the vaping giant in which Altria now has a 35 percent stake. So any customers IQOS steals from Juul may hurt Altria more than help it, depending on the precise terms of the distribution deal.

Altria officials say that IQOS and Juul will appeal to different consumers. But the Philip Morris team had chafed at being kept off the market while Juul gobbled up market share, and were not pleased with Altria’s $12.8 billion investment.

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In Washington, Juul Vows to Curb Youth Vaping. Its Lobbying in States Runs Counter to That Pledge.

COLUMBIA, S.C. — For months, Juul Labs has had a clear, unwavering message for officials in Washington: The e-cigarette giant is committed to doing all it can to keep its hugely popular vaping products away from teenagers.

But here in Columbia, the South Carolina capital, and in statehouses and city halls across the country, a vast, new army of Juul lobbyists is aggressively pushing measures that undermine that pledge.

The company’s 80-plus lobbyists in 50 states are fighting proposals to ban flavored e-cigarette pods, which are big draws for teenagers; pushing legislation that includes provisions denying local governments the right to adopt strict vaping controls; and working to make sure that bills to discourage youth vaping do not have stringent enforcement measures.

Though Juul supports numerous state bills that would raise the legal age for buying vaping and tobacco products to 21, some of those bills contain minimal sanctions for retailers. Others fine only the clerks and not the owners for violations.

“Juul is attempting to rehabilitate its public image by posing as a public health advocate while working behind the scenes to weaken or defeat tobacco control proposals and prevent communities from even considering policies to curb tobacco use,” said Nancy Brown, chief executive of the American Heart Association, whose network of lobbyists has parried with e-cigarette and tobacco industries in many states this year.

In a statement, Juul said, “We are as committed as ever to combating youth usage but don’t take our word for it — look at our actions.”

The company cited its action plan, unveiled in November, which included shutting down its social media accounts, discontinuing sales of many flavored pods in retail stores and strengthening its online age verification systems.

E-cigarettes allow smokers to inhale the nicotine they crave without the toxins that come from burning tobacco. But Juul’s sleek devices, which resemble a flashdrive, became immensely popular with teenagers, stoking worries that the devices were creating a new generation of nicotine addicts among people who have never smoked.

ImageWestlake Legal Group merlin_153448086_ddc4b7a2-69e3-4e8a-8ca7-de6cd873b60e-articleLarge In Washington, Juul Vows to Curb Youth Vaping. Its Lobbying in States Runs Counter to That Pledge. Teenagers and Adolescence States (US) State Legislatures south carolina Smoking and Tobacco Local government Lobbying and Lobbyists Law and Legislation Juul Labs Inc E-Cigarettes

Marlon Kimpson, a state senator in South Carolina, put a legislative block on a bill that would bar communities from restricting sales of vaping products.CreditSean Rayford for The New York Times

Juul denies marketing to young people, and it has revamped its website to focus on adult smokers. But as it faces serious regulatory threats from the Trump administration, as well as targeting by state and city lawmakers, the company has quickly built an enormous lobbying machine to protect its turf as best it can. With the recent departure of Scott Gottlieb, a vociferous critic of Juul, from the post of F.D.A. commissioner, the company’s more urgent battles, for now, are in the states.

Most of Juul’s state lobbyists work for well-connected firms run by ex-governors, former state lawmakers and big political donors, public records show. Some are in-house, based in the growing number of offices the company is opening around the country. The company’s latest star hire is Martha Coakley, the former attorney general of Massachusetts. (The state’s current attorney general, Maura Healey, is investigating whether Juul intentionally targeted its vaping products to minors.)

In a series of interviews, Lindsay Andrews, a spokeswoman for Juul, said the lobbyists were primarily focused on raising the minimum age for buying e-cigarette and traditional tobacco products to 21 from 18, or in a few states, 19. More than 400 local governments and 14 states have already done so, eight of the states this year.

But in numerous states, the proposals that Juul publicly supports, known as Tobacco 21, or T21, contain measures that public health experts consider poison pills.

Juul says it prefers that T21 legislation does not have added provisions. But it worked to help pass a T21 law in the Arkansas Legislature, for example, that would also block local governments from enacting new rules regarding the manufacture, sale, storage or distribution of tobacco and vaping products — including restrictions on flavored products.

For related reasons, public health advocates have opposed Juul-backed T21 bills in Arizona, Florida, Iowa, Louisiana, Pennsylvania, Utah, Virginia and West Virginia. The tobacco industry supported the T21 bills.

In some states Juul’s advocacy is public, and in others the company is barely visible, working only through the Vapor Technology Association, or by relying on Altria, the tobacco company that late last year paid Juul $12.8 billion for a 35 percent stake.

In South Carolina, for example, Juul has not taken a public position on a contentious proposal to pre-empt local governments from banning flavored e-cigarettes or otherwise regulating any tobacco product. But at a hearing on the bill last month, Brian Flynn, one of Juul’s three lobbyists with McGuireWoods Consulting, a firm run by the former governor James H. Hodges, testified in favor of the pre-emption plan.

At the hearing, Mr. Flynn introduced himself as a lobbyist for both Juul and the South Carolina Association of Convenience Stores. He noted that on the matter of pre-emption, he spoke only for the retailers.

State Representative Beth Bernstein wrote legislation in South Carolina that would bar people under age 18 from going into vape shops without an adult, and also prohibit vaping on school property.CreditSean Rayford for The New York Times

Critics did not see much of a distinction.

“This is too cute by half,” said Pamela Gilbert, a lawyer and a former executive director of the Consumer Product Safety Commission. “Juul must know their lobbyist is lobbying for the pre-emption bill, and Juul must have approved that. If Juul really didn’t want to be connected to the support for that bill, Juul should hire another lobbyist.”

Some of the so-called pre-emption measures around the country were written using model language from the Vapor Technology Association, according to Kinn Elliott, a V.T.A. lobbyist who recently joined the association from Juul. Other pre-emption bills, in whole or in part, have been drafted with language from lobbyists for Altria and the R. J. Reynolds Tobacco Company.

Altria, maker of Marlboro cigarettes, has a potent lobbying network in Washington and around the country. Asked if Altria was advising Juul’s state lobbying efforts, or if the two related businesses were working together, an Altria spokesman, David Sutton, replied that there was no contractual service agreement by which Altria would assist Juul’s government affairs. He added that he did not know what informal conversations on state lobbying issues might have taken place.

“I just don’t know, I’m not on the ground,” Mr. Sutton said. “Is there a conversation between the Altria government affairs people and the Juul government affairs people on the ground? I don’t know.”

He declined to provide access to Altria employees who could answer the question. Juul also declined to answer the question.

But Vince Willmore, a spokesman for the Campaign for Tobacco-Free Kids, which has been involved in many of these state battles, said, “It’s hard to say where Altria ends and Juul begins.”

So far, Juul’s state and local efforts have had mixed success. In Sacramento, Juul tried to head off a proposal to ban the sale of all flavored e-cigarettes and tobacco products in the city, as San Francisco did last year.

Steve Hansen, the councilman who wrote the bill, met with two Juul lobbyists in early March to hear their alternative plan. They were pushing a plan that would ban only flavors that are “knowingly attractive to minors.” The City Council rejected Juul’s proposal and on April 16 passed Mr. Hansen’s plan.

Mr. Hansen said he was surprised by the intensity of the lobbying effort.

“In my six years on the City Council I’ve never seen the number of money, lobbyists and Astroturfing we’ve seen here on anything else,” he said.

The South Carolina Statehouse, the scene of intensive lobbying on bills involving e-cigarettes and vaping.CreditSean Rayford for The New York Times

“In our studies of thousands of Juul users, people who exclusively used nontobacco flavors were 30 percent more likely to switch than those who use tobacco flavors,” she said. “While we do not and will not sell flavors which are clearly targeted to youth, we also understand that flavors that drive adults from cigarettes have the potential to appeal to youth.”

One afternoon last month, Mr. Flynn and another Juul lobbyist, Darrell Campbell, milled about under the South Carolina Statehouse dome, awaiting the fate of a bill that would restrict youths’ access to vape shops.

That legislation, written by State Representative Beth Bernstein, a Democrat, bars anyone under age 18 from going into vape shops without an adult. It also prohibits vaping on school property. But at Juul’s request, Ms. Bernstein took out a provision that would have required an adult to sign for online deliveries of any e-cigarette products ordered online.

In an interview, Ms. Bernstein said that Mr. Flynn and Mr. Campbell were helpful in providing input for the bill, as was Juul’s in-house lobbyist, Jennifer Cunningham.

“They had a little heartburn with it because they felt they were already employing a robust process for verification,” she said. “Juul came to me and said, ‘We already employ a very robust measure to make sure the person purchasing online is over 18.’”

The bill passed, and Gov. Henry McMaster, a Republican, is expected to sign it.

The American Cancer Society Cancer Action Network opposed the legislation, saying it did not go far enough.

“This bill is like putting lipstick on a pig,” said Cathy Callaway, state and local campaign director for the American Cancer Society Cancer Action Network. “We don’t need cosmetic fixes, we need proven policies and strong tobacco retailer enforcement to prevent illegal sales to kids.”

Katrina F. Shealy, a Republican senator who supported the bill, said: “I have talked to the people from Juul. They want this.”

Ms. Shealy also said that Juul had spoken to her about bringing a manufacturing plant to her district. “They are looking at locations and one of them is in my district; 825 jobs,” she said. “That’s a lot of jobs.”

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com 

In Washington, Juul Vows to Curb Youth Vaping. Its Lobbying in States Runs Counter to That Pledge.

COLUMBIA, S.C. — For months, Juul Labs has had a clear, unwavering message for officials in Washington: The e-cigarette giant is committed to doing all it can to keep its hugely popular vaping products away from teenagers.

But here in Columbia, the South Carolina capital, and in statehouses and city halls across the country, a vast, new army of Juul lobbyists is aggressively pushing measures that undermine that pledge.

The company’s 80-plus lobbyists in 50 states are fighting proposals to ban flavored e-cigarette pods, which are big draws for teenagers; pushing legislation that includes provisions denying local governments the right to adopt strict vaping controls; and working to make sure that bills to discourage youth vaping do not have stringent enforcement measures.

Though Juul supports numerous state bills that would raise the legal age for buying vaping and tobacco products to 21, some of those bills contain minimal sanctions for retailers. Others fine only the clerks and not the owners for violations.

“Juul is attempting to rehabilitate its public image by posing as a public health advocate while working behind the scenes to weaken or defeat tobacco control proposals and prevent communities from even considering policies to curb tobacco use,” said Nancy Brown, chief executive of the American Heart Association, whose network of lobbyists has parried with e-cigarette and tobacco industries in many states this year.

In a statement, Juul said, “We are as committed as ever to combating youth usage but don’t take our word for it — look at our actions.”

The company cited its action plan, unveiled in November, which included shutting down its social media accounts, discontinuing sales of many flavored pods in retail stores and strengthening its online age verification systems.

E-cigarettes allow smokers to inhale the nicotine they crave without the toxins that come from burning tobacco. But Juul’s sleek devices, which resemble a flashdrive, became immensely popular with teenagers, stoking worries that the devices were creating a new generation of nicotine addicts among people who have never smoked.

ImageWestlake Legal Group merlin_153448086_ddc4b7a2-69e3-4e8a-8ca7-de6cd873b60e-articleLarge In Washington, Juul Vows to Curb Youth Vaping. Its Lobbying in States Runs Counter to That Pledge. Teenagers and Adolescence States (US) State Legislatures south carolina Smoking and Tobacco Local government Lobbying and Lobbyists Law and Legislation Juul Labs Inc E-Cigarettes

Marlon Kimpson, a state senator in South Carolina, put a legislative block on a bill that would bar communities from restricting sales of vaping products.CreditSean Rayford for The New York Times

Juul denies marketing to young people, and it has revamped its website to focus on adult smokers. But as it faces serious regulatory threats from the Trump administration, as well as targeting by state and city lawmakers, the company has quickly built an enormous lobbying machine to protect its turf as best it can. With the recent departure of Scott Gottlieb, a vociferous critic of Juul, from the post of F.D.A. commissioner, the company’s more urgent battles, for now, are in the states.

Most of Juul’s state lobbyists work for well-connected firms run by ex-governors, former state lawmakers and big political donors, public records show. Some are in-house, based in the growing number of offices the company is opening around the country. The company’s latest star hire is Martha Coakley, the former attorney general of Massachusetts. (The state’s current attorney general, Maura Healey, is investigating whether Juul intentionally targeted its vaping products to minors.)

In a series of interviews, Lindsay Andrews, a spokeswoman for Juul, said the lobbyists were primarily focused on raising the minimum age for buying e-cigarette and traditional tobacco products to 21 from 18, or in a few states, 19. More than 400 local governments and 14 states have already done so, eight of the states this year.

But in numerous states, the proposals that Juul publicly supports, known as Tobacco 21, or T21, contain measures that public health experts consider poison pills.

Juul says it prefers that T21 legislation does not have added provisions. But it worked to help pass a T21 law in the Arkansas Legislature, for example, that would also block local governments from enacting new rules regarding the manufacture, sale, storage or distribution of tobacco and vaping products — including restrictions on flavored products.

For related reasons, public health advocates have opposed Juul-backed T21 bills in Arizona, Florida, Iowa, Louisiana, Pennsylvania, Utah, Virginia and West Virginia. The tobacco industry supported the T21 bills.

In some states Juul’s advocacy is public, and in others the company is barely visible, working only through the Vapor Technology Association, or by relying on Altria, the tobacco company that late last year paid Juul $12.8 billion for a 35 percent stake.

In South Carolina, for example, Juul has not taken a public position on a contentious proposal to pre-empt local governments from banning flavored e-cigarettes or otherwise regulating any tobacco product. But at a hearing on the bill last month, Brian Flynn, one of Juul’s three lobbyists with McGuireWoods Consulting, a firm run by the former governor James H. Hodges, testified in favor of the pre-emption plan.

At the hearing, Mr. Flynn introduced himself as a lobbyist for both Juul and the South Carolina Association of Convenience Stores. He noted that on the matter of pre-emption, he spoke only for the retailers.

State Representative Beth Bernstein wrote legislation in South Carolina that would bar people under age 18 from going into vape shops without an adult, and also prohibit vaping on school property.CreditSean Rayford for The New York Times

Critics did not see much of a distinction.

“This is too cute by half,” said Pamela Gilbert, a lawyer and a former executive director of the Consumer Product Safety Commission. “Juul must know their lobbyist is lobbying for the pre-emption bill, and Juul must have approved that. If Juul really didn’t want to be connected to the support for that bill, Juul should hire another lobbyist.”

Some of the so-called pre-emption measures around the country were written using model language from the Vapor Technology Association, according to Kinn Elliott, a V.T.A. lobbyist who recently joined the association from Juul. Other pre-emption bills, in whole or in part, have been drafted with language from lobbyists for Altria and the R. J. Reynolds Tobacco Company.

Altria, maker of Marlboro cigarettes, has a potent lobbying network in Washington and around the country. Asked if Altria was advising Juul’s state lobbying efforts, or if the two related businesses were working together, an Altria spokesman, David Sutton, replied that there was no contractual service agreement by which Altria would assist Juul’s government affairs. He added that he did not know what informal conversations on state lobbying issues might have taken place.

“I just don’t know, I’m not on the ground,” Mr. Sutton said. “Is there a conversation between the Altria government affairs people and the Juul government affairs people on the ground? I don’t know.”

He declined to provide access to Altria employees who could answer the question. Juul also declined to answer the question.

But Vince Willmore, a spokesman for the Campaign for Tobacco-Free Kids, which has been involved in many of these state battles, said, “It’s hard to say where Altria ends and Juul begins.”

So far, Juul’s state and local efforts have had mixed success. In Sacramento, Juul tried to head off a proposal to ban the sale of all flavored e-cigarettes and tobacco products in the city, as San Francisco did last year.

Steve Hansen, the councilman who wrote the bill, met with two Juul lobbyists in early March to hear their alternative plan. They were pushing a plan that would ban only flavors that are “knowingly attractive to minors.” The City Council rejected Juul’s proposal and on April 16 passed Mr. Hansen’s plan.

Mr. Hansen said he was surprised by the intensity of the lobbying effort.

“In my six years on the City Council I’ve never seen the number of money, lobbyists and Astroturfing we’ve seen here on anything else,” he said.

The South Carolina Statehouse, the scene of intensive lobbying on bills involving e-cigarettes and vaping.CreditSean Rayford for The New York Times

“In our studies of thousands of Juul users, people who exclusively used nontobacco flavors were 30 percent more likely to switch than those who use tobacco flavors,” she said. “While we do not and will not sell flavors which are clearly targeted to youth, we also understand that flavors that drive adults from cigarettes have the potential to appeal to youth.”

One afternoon last month, Mr. Flynn and another Juul lobbyist, Darrell Campbell, milled about under the South Carolina Statehouse dome, awaiting the fate of a bill that would restrict youths’ access to vape shops.

That legislation, written by State Representative Beth Bernstein, a Democrat, bars anyone under age 18 from going into vape shops without an adult. It also prohibits vaping on school property. But at Juul’s request, Ms. Bernstein took out a provision that would have required an adult to sign for online deliveries of any e-cigarette products ordered online.

In an interview, Ms. Bernstein said that Mr. Flynn and Mr. Campbell were helpful in providing input for the bill, as was Juul’s in-house lobbyist, Jennifer Cunningham.

“They had a little heartburn with it because they felt they were already employing a robust process for verification,” she said. “Juul came to me and said, ‘We already employ a very robust measure to make sure the person purchasing online is over 18.’”

The bill passed, and Gov. Henry McMaster, a Republican, is expected to sign it.

The American Cancer Society Cancer Action Network opposed the legislation, saying it did not go far enough.

“This bill is like putting lipstick on a pig,” said Cathy Callaway, state and local campaign director for the American Cancer Society Cancer Action Network. “We don’t need cosmetic fixes, we need proven policies and strong tobacco retailer enforcement to prevent illegal sales to kids.”

Katrina F. Shealy, a Republican senator who supported the bill, said: “I have talked to the people from Juul. They want this.”

Ms. Shealy also said that Juul had spoken to her about bringing a manufacturing plant to her district. “They are looking at locations and one of them is in my district; 825 jobs,” she said. “That’s a lot of jobs.”

Real Estate, and Personal Injury Lawyers. Contact us at: https://westlakelegal.com