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FDA investigating 127 reports of seizures, neurological symptoms related to vaping

The US Food and Drug Administration has received 127 reports of seizures or other neurological symptoms possibly related to e-cigarettes, the agency announced Wednesday. Investigators have yet to determine, however, whether vaping was directly linked to the cases.

“The FDA is continuing its scientific investigation to determine if there’s a direct relationship between the use of e-cigarettes and a risk of seizure or other neurological symptoms,” said Dr. Ned Sharpless, the acting FDA commissioner.

The FDA said the reported cases occurred between 2010 and 2019, and in addition to seizures, some people reported fainting or tremors. Sharpless said that “we still don’t have enough information to determine if e-cigarettes are causing these reported incidents” but called on the public to continue submitting reports.
Additional information “may help us identify common risk factors and determine whether any specific e-cigarette product attributes, such as nicotine content or formulation, may be more likely to contribute to seizures,” he said.

In April, the FDA announced that it had received 35 reports of seizures related to vaping, particularly among younger users. “Seizures or convulsions are known potential side effects of nicotine toxicity,” the agency said at the time.

There have been 92 new reports since then, but the FDA didn’t announce any clear pattern across the cases.
Cases were reported in both first-time and experienced e-cigarette users, and “seizures have been reported as occurring after a few puffs or up to one day after use,” the FDA said in April. Several people had previously had a seizure diagnosis, the agency said at the time, and a few had also been using other drugs such as marijuana.

“Additional reports or more detailed information about these incidents are vital to help inform our analysis,” Sharpless said Wednesday. Cases can be reported to the FDA online, the agency said, and submissions are most helpful when they specify the product involved and any underlying medical conditions.

“It is imperative that health care professionals, consumers, parents, teachers and other concerned adults, as well as youth and young adult users, report detailed information about any past or future incidents of seizures following e-cigarette use to the FDA,” Sharpless said.

“We’re committed to monitoring this issue closely and taking additional steps as necessary to protect the public, especially our nation’s youth, from the dangers of e-cigarettes and other tobacco products,” he added.

Embattled Juul seeks allies in Washington

Juul Labs is spending big on campaign donations and a massive lobbying blitz as the e-cigarette maker faces growing threats from lawmakers and regulators, and with few allies in Washington.

The company spent $1.95 million on lobbying in the first two quarters of 2019, surpassing its 2018 total of $1.64 million. And Juul’s PAC has given nearly $100,000 to lawmakers this year, a pace that will blow past the $225,000 the company spent in the entire 2018 cycle.

Those moves have rattled Juul’s critics, who fear the efforts could slow momentum to combat teen vaping, and question if the company is serious about addressing the problem.

“Juul’s increased spending on lobbying and political donations is the latest example that the company says one thing and does another,” said Vince Willmore, vice president of communications at the Campaign for Tobacco-Free Kids.

“Juul claims it doesn’t want kids to use its products, yet it is doing everything it can to fight strong policies to prevent youth use, such as effective FDA regulation and prohibitions on flavored e-cigarettes,” he added.

Juul insists it is working with policymakers to reduce teen vaping.

“We have grown our team to engage with lawmakers, regulators, public health officials and advocates to drive awareness that JUUL exists to help adult smokers switch from combustible cigarettes and is committed to keeping JUUL products out of the hands of underage people,” Juul spokesperson Ted Kwong told The Hill in a statement. “That is why we have taken the most aggressive actions of anyone in the industry to combat youth usage.”

But influence world watchers expect the lobbying work to also intensify amid scrutiny from both the Food and Drug Administration (FDA) and House Democrats, who say Juul targeted its products to teenagers, leading to a spike in youth vaping.

“I would be surprised if they weren’t ramping up even more,” said David Williams, president of the Taxpayers Protection Alliance, a nonprofit group. “I think you’re going to see a lot more questions about their products that they’re going to have to answer from Republicans and Democrats. This is probably just the beginning for Juul.”

Juul is facing scrutiny over its marketing practices on multiple fronts.

At hearings last month, House lawmakers accused the company of deliberately targeting teenagers. At the state level, the attorneys general of Connecticut and Massachusetts are investigating the company and Juul faces a lawsuit from North Carolina alleging it marketed its products to young people. The FDA is also weighing tougher rules on e-cigarette sales.

Juul says it is trying to lower youth vaping, including by stopping the retail sale of some products critics say appeal to young people, shutting down their Facebook and Instagram accounts and beefing up online age verification. The company also backs legislation to raise the smoking age to 21.

But those efforts haven’t stopped Juul from also seeking help in Washington.

Its PAC has donated $74,000 to Democrats and $22,500 to Republicans so far in 2019, according to Federal Election Commission figures.

Rep. Cedric Richmond (D-La.) was the top recipient with $7,500. Democratic Sens. Kyrsten Sinema (Ariz.) and Jeanne Shaheen (N.H.) received $5,000, with the Congressional Black Caucus (CBC) and the Congressional Hispanic Caucus’ political action committees receiving the same, The Associated Press reported.

The wooing of minority Democratic lawmakers has rankled some anti-tobacco advocates.

“Going after at-risk communities is core to [tobacco companies’] business plan and has been for a long time,” said Stanton Glantz, director of the Center for Tobacco Control Research and Education.

“The CBC has grave concerns about the staggering rise in youth vaping, especially its impact on Black youth,” Gabrielle Brown, CBC spokeswoman, told The Hill in response. “Several of our members … have been very aggressive in providing the needed oversight to better understand the business practices of companies like JUUL.”

Juul’s in-house team has also brought on former aides as lobbyists and consultants, including Benjamin Branch, former senior policy adviser to Rep. Gregory Meeks (D-N.Y.), currently the chairman of the House Financial Services Subcommittee on Consumer Protection and Financial Institutions, and Ted McCann, a former assistant to ex-Speaker Paul Ryan (R-Wis.).

And the company has turned to prominent K Street firms, including KDCR Partners, which has a $180,000 lobbying contract, and S-3 Group with a $160,000 contract. The S-3 team includes Mike Ference, former senior policy adviser to ex-House Majority Leader Eric Cantor (R-Va.) and Matthew Bravo, former director of floor operations for House Majority Whip Steve Scalise (R-La.). Last week, Juul added the Nickles Group to their lobbying team, including former Sen. Don Nickles (R-Okla.).

Bruce Mehlman, a partner at Mehlman Castagnetti Rosen & Thomas, said it was no surprise Juul was “in need of significant government relations” help.

“When an industry is threatened, a lot of money is poured into lobbying,” said Beth Leech, director of graduate studies at Rutgers University’s Department of Political Science.

All of those resources are being put to the test.

“It’s self-preservation for them,” Williams said.

The company is pushing ahead, announcing new plans this week for a product that would monitor users’ vaping and include facial recognition technology to prevent youth smoking. But that could also bring the company new regulatory questions.

Juul insists it is working with regulators. CEO Kevin Burns wrote an op-ed in March highlighting the company’s actions to limit e-cigarette sales to young people. He also called for regulators to help crack down on other e-cigarette products he said could be less safe.

“We also need government agencies to take their own actions against counterfeit, knockoff and other illegal vapor products, which are often made with unknown ingredients, with unknown quality standards, and with youth-appealing flavors and packaging,” he wrote.

The company’s critics, though, are skeptical as Juul devotes more resources to its lobbying campaign, which is likely to fuel the fight.

“The tobacco companies, which include Juul, have a long history of using campaign contributions and fancy lobbyists to deter effective public health measures,” Glantz said.

Critics are vowing to keep pressure on the company.

“Policymakers shouldn’t be fooled and must hold Juul accountable,” said Willmore.

Do Local Tobacco-21 Laws Reduce Smoking among 18 to 20 Year-Olds?

Abstract
Introduction
States and municipalities are increasingly restricting tobacco sales to those under age-21, in an effort to reduce youth and young adult smoking. However, the effectiveness of such policies remains unclear, particularly when implemented locally.

Methods
Analyses use 2011 – 2016 data from the Behavioral Risk Factor Surveillance System’s Selected Metropolitan/Micropolitan Area Risk Trends dataset. Difference-in-differences and triple-difference regressions estimate the relationship between local tobacco-21 policies and smoking among 18 to 20 year-olds living in MMSAs (metropolitan/micropolitan statistical areas).

Results
Current smoking rates fell from 16.5 percent in 2011 to 8.9 percent in 2016 among 18-20 year-olds in these data. Regressions indicate that a tobacco-21 policy covering one’s entire MMSA yields an approximately 3.1 percentage point reduction in 18 to 20 year-olds’ likelihoods of smoking [CI: -0.0548, -0.0063]. Accounting for partial policy exposure — tobacco-21 laws implemented in some but not all jurisdictions within an MMSA — this estimate implies that the average exposed 18 to 20 year-old experienced a 1.2 percentage point drop in their likelihood of being a smoker at interview relative to unexposed respondents of the same age, all else equal.

Conclusions
Local tobacco-21 policies yield a substantive reduction in smoking among 18 to 20 year-olds living in metropolitan and micropolitan statistical areas. This finding provides empirical support for efforts to raise the tobacco purchasing age to 21 as a means to reduce young adult smoking. Moreover, it suggests that state laws preempting local tobacco-21 policies may impede public health.

Implications
While states and municipalities are increasingly restricting tobacco sales to under-21-year-olds, such policies’ effectiveness remains unclear, particularly when implemented locally. Using quasi-experimental methods, this paper provides what may be the first evidence that sub-state tobacco-21 laws reduce smoking among 18 to 20 year-olds. Specifically, considering metropolitan and micropolitan areas from 2011 to 2016, the average 18 to 20 year-old who was exposed to these policies exhibited a 1.2 percentage point drop in their likelihood of being a current established smoker, relative to those who were unexposed. These findings validate local tobacco-21 laws as a means to reduce young adult smoking.

Tobacco‐21 laws reducing youth and young adult smoking

Abstract
Aims
To estimate the impact of tobacco‐21 laws on smoking among young adults who are likely to smoke, and consider potential social multiplier effects.

Design

Quasi‐experimental, observational study using new 2016–17 survey data.

Setting
United States.

Participants/cases
A total of 1869 18–22‐year‐olds who have tried a combustible or electronic cigarette.

Intervention and comparators
Tobacco‐21 laws raise the minimum legal sales age of cigarettes to 21 years. Logistic regressions compared the association between tobacco‐21 laws and smoking among 18–20‐year‐olds with that for 21–22‐year‐olds. The older age group served as a comparison group that was not bound by these restrictions, but could have been affected by correlated factors. Age 16 peer and parental tobacco use were considered as potential moderators.

Measurements
Self‐reported recent smoking (past 30‐day smoking) and current established smoking (recent smoking and life‐time consumption of at least 100 cigarettes).

Findings
Exposure to tobacco‐21 laws yielded a 39% reduction in the odds of both recent smoking [odds ratio (OR) = 0.61; 95% confidence interval (CI) = 0.42, 0.89] and current established smoking (OR = 0.61; 95% CI = 0.39, 0.97) among 18–20‐year‐olds who had ever tried cigarettes. This association exceeded the policy’s relationship with smoking among 21–22‐year‐olds. For current established smoking, the tobacco‐21 reduction was amplified among those whose closest friends at age 16 used cigarettes (OR = 0.50; 95% CI = 0.29, 0.87), consistent with peer effects moderating the policy’s impact on young adult smoking.

Conclusions
Tobacco‐21 laws appear to reduce smoking among 18–20‐year‐olds who have ever tried cigarettes.

New York State Raises Smoking Age From 18 To 21

ALBANY, N.Y. (CBSNewYork/AP) — New York will raise its smoking age from 18 to 21 under legislation signed into law Tuesday by Gov. Cuomo.

The change takes effect in 120 days, on Nov. 13, and will apply to the sales of traditional tobacco products as well as electronic cigarettes and vaping devices.

Gov. Cuomo said too many children and teens pick up smoking despite decades of efforts to snuff out the habit. The governor blamed part of that on marketing he says is aimed directly at young people.

“By raising the smoking age from 18 to 21, we can stop cigarettes and e-cigarettes from getting into the hands of young people in the first place and prevent an entire generation of New Yorkers from forming costly and potentially deadly addictions,” he said in a statement.

The governor’s office added that, according to the Surgeon General, 88 percent of adult smokers start using tobacco before age 18 and 90 percent of the people who buy cigarettes for underage children are between ages 18 and 20.

“Tobacco 21 is a no-brainer,” said Julie Hart, senior government relations director for the American Cancer Society Cancer Action Network of New York.

Sixteen states have approved raising the smoking age to 21, though the changes won’t take effect in some of those states until late 2019 or some time after.

In addition, hundreds of local communities around the nation have made the move to 21. In New York state they include New York City, Long Island, Albany and a dozen other counties.

“Tobacco use is harmful to New Yorkers and leads to cancer, major health problems, and death. Raising the age of purchase to 21 will help ensure fewer children start this deadly habit,” senate majority leader Andrea Stewart-Cousins added.