Category: News This Week

The US Food and Drug Administration (FDA) has been told that it should refrain from a crackdown across the vaping category but act decisively against its ‘bad actors’.

Jeff Stier, senior fellow at the Consumer Choice Center, offered this advice as the FDA prepares its new action plan on electronic cigarettes.

Stier put forward some ‘simple steps’ for the FDA to follow if it wanted to adhere to common ground.

“We should all be able to agree that e-cigarettes are not entirely safe and should not be used by kids,” said Stier.

“At the same time, as Public Health England has been saying for more than three years, e-cigarettes are around 95 percent less harmful than combustible cigarettes and can help smokers quit. To maximize protection to Americans of all ages, the FDA must finally formulate sensible, science-based policies to achieve two key goals:

• “Prevent youth from initiating the use of any nicotine-containing product, including e-cigarettes.
• “Foster switching by adult smokers who have been unable to quit by other means.”

Stier said the FDA was threatening that, because of ‘news reports,’ public opinion and data about youth use that the agency hadn’t released, it might soon remove many e-cigarettes from the market, including most flavors, as well as the pods they come in, until a manufacturer applies for and receives approval for each product.

The agency was warning also that it might ban sales everywhere except in vape shops.

“But it’s not too late,” said Stier. “In its new plan, the FDA should implement the legitimate common ground by taking the following three steps:

1: “Focus on the bad-actors. The FDA should act swiftly and forcefully, as it has the authority to do, against any retailer caught selling an e-cigarette to a minor.

2: “The FDA must work constructively with the industry it regulates.

3: “Make good on the promise to change misconceptions about nicotine, which, while addictive, is not the major cause of tobacco-related disease.”

Stier then moved on to what he believed the FDA should not do:

1: “Remove e-cigarettes from all stores except vape shops.

2: “Allow either side to erode common ground. Just as the FDA shouldn’t be lenient with those who sell or give e-cigarettes to kids, it shouldn’t allow false assertions about the risks of e-cigarettes to stand unchallenged.

3: “Fall prey to the notion that the FDA has in its power the ability to prevent every last youth from ever trying an e-cigarette.”

Stier said that when it gave the FDA authority to regulate recreational lower-risk nicotine products, Congress believed the FDA could be sophisticated enough to prevent youth use while helping adults quit smoking.

“Sadly, to date, the FDA has accomplished little on either front,” he said. “These failures don’t justify a misplaced ‘crackdown’ on e-cigarettes. They require an intensive focus on stopping the bad actors.

“If the FDA doesn’t get it right – this month – President Trump should ask, in an exit interview, why FDA leadership couldn’t achieve a central promise of the administration: improving our lives not with more regulation, but with less of it, wisely implemented.”

It’s a power move. Colorado’s Governor John Hickenlooper signed an executive order on Friday targeting vape shop owners selling to minors. One of its actions is to require the Colorado Department of Revenue to double its number of compliance checks on vape shops, convenience stores and other retail locations.

Hickenlooper’s order also asked Colorado’s congress to increase the legal age to purchase vaping and tobacco products from 18 to 21. He asked for swift action, wanting a law to go into effect by Jan. 2019. The Colorado Department of Public Health and Environment (CDPHE) recently announced that Colorado teens have the highest incidence of vaping in the country, according to press note on the Hickenlooper’s state governor’s website.

The move was also in response to U.S. Food and Drug Administration (FDA) chief Scott Gottlieb calling the current rise in teen vaping an epidemic. “To lead the nation in youth vaping is intolerable,” stated Hickenlooper through a press note on the state’s governor’s website. “Collectively, we can help ensure families better understand the lifetime health impact of vaping at a young age and work to decrease the number of youths turning to this popular, yet problematic form of nicotine.”

The order takes several concrete steps that are within the governor’s existing authority, such as extending “the current prohibition on smoking in state buildings to e-cigarettes and vaping and extending prohibitions on smoking and vaping to the grounds of state buildings, not just the buildings themselves (i.e. it creates smoke free campuses).”

It also directs CDPHE to “issue a health advisory on e-cigarettes and vaping, and to investigate the association between vaping and other risky behavior (e.g. binge drinking and substance use) and identify programs to prevent these behaviors.”

The executive order is supported by members of the Colorado medical community, including the University of Colorado Cancer Center and the Children’s Hospital Colorado. “Vaping can lead to nicotine addiction, and can be associated with other risky behaviors that can affect a teen’s health,” said Tista Ghosh, interim Chief Medical Officer for CDPHE. “Our state data shows that teens who vape are more likely to use alcohol, drugs and engage in risky sexual behaviors.”

Additionally, while at a news conference held at Children’s Hospital Colorado, the governor signed a proclamation recognizing this month as Vape-Free November across Colorado.

The U.S, Food and Drug Administration (FDA) has announced a public hearing, to be held Dec. 5, to discuss its efforts to eliminate youth e-cigarette use. In a statement posted on the FDA website, FDA Commissioner Scott Gottlieb wrote that the meeting will have “a focus on the potential role of drug therapies to support cessation among youth, and the issues impacting the development of such therapies for children. This hearing will also give us an opportunity to discuss the need for drug therapies to support youth cessation of other tobacco products, including combustible products, such as cigarettes or cigars, or smokeless tobacco products. All of these tobacco products pose serious dangers to teens’ and adolescents’ health.”

Gottlieb also announced that research on youth nicotine cessation is limited and is mostly for combustible cigarettes, so the FDA is offering new funding opportunities to address the issue.

He also stated that the FDA would announce additional actions in the coming months to address youth vapor and other tobacco products.

A group of academics and tobacco control and public health experts is trying to convince the US Food and Drug Administration to slow down and consider the risks of hasty regulation, according to a piece by Jim McDonald at Vaping360.

The National Tobacco Reform Initiative (NTRI) is said to have sent a letter to Dr. Scott Gottlieb, calling on the FDA commissioner to hold a summit of stakeholders to discuss the FDA’s policy on vapor products and vaping.

In introducing his piece, McDonald said the FDA seemed dead set on restricting the vapor industry very soon. The agency had given JUUL Labs and the four major tobacco companies that also sell vapor products 60 days to submit plans to eliminate sales to teenagers. That 60-day deadline expired soon after next week’s elections.

Meanwhile, McDonald said that NTRI co-ordinator Allan Erickson had written to Gottlieb saying that to address the situation fully would require the involvement and support of not only the FDA, but other stakeholders as well. Erickson, a former American Cancer Society vice president, believes that e-cigarettes can play a part in tobacco control efforts to reduce smoking.

‘We therefore wish to recommend that the FDA/CTP [the FDA’s Center for Tobacco Products] sponsor a national dialogue related to youth use of tobacco and nicotine products as well as the need to provide the 30 million adult smokers in this country with lower risk alternative tobacco and nicotine products, to be held sometime in early 2019,’ he said in his letter.

The NTRI leadership includes David Abrams and Ray Niaura of New York University (both formerly with the Truth Initiative), former American Heart Association vice president Scott Ballin, and former American Cancer Society president John Seffrin. The organization’s advisory group includes Clive Bates and Iowa Attorney General Tom Miller. Miller was one of the state attorneys general who sued the tobacco companies, leading to the 1998 Master Settlement Agreement. He was the chair of the Truth Initiative board last year.

McDonald’s piece says, however, that the NTRI letter may be too late to affect Gottlieb’s thinking.

‘He’s shown no signs of cooling his reckless “epidemic” rhetoric,’ McDonald said. ‘There’s nothing the FDA commissioner needs more now than wisdom from clear-headed and open-minded veterans of the tobacco wars. But he appears less and less likely to listen.’

Electronic cigarettes are starting to attract the attention of people concerned about littering, according to a story by Mari A. Schaefer at www2.philly.com (Philadelphia).

While single-use plastic straws, bags, and coffee pods had already captured the attention of the public and legislatures looking to ban products that wind up littering the landscape, Schaefer said, e-cigarettes had begun to show up on streets and shores, catching officials off-guard and presenting the challenge of how to deal with litter that was part recyclable and part hazardous.

“We started seeing them a number of years ago,” said Cindy Zipf, executive director of Clean Ocean Action, a non-profit organization that compiles biannual beach clean-up reports from the New Jersey Shore. “Most of us didn’t even know what they were,” she said.

Schaefer said that each e-cigarette had five components – residual nicotine, plastic, lithium batteries, aluminium, and fabric – each of which had to be disassembled and recycled separately. The products came in various shapes and sizes, from large, refillable tank devices to rechargeable devices that incorporated single-use plastic pods that looked like USB flash drives.

Meanwhile, Philadelphia’s environmental planning director, Scott McGrath, said the city currently was investigating how to recycle e-cigarette waste.

The city had contacted its third-party electronic- and hazardous-waste vendors for guidance because the e-cigarettes fell into both categories. Of particular concern, he said, were the lithium batteries used in some products, which were water-reactive and which could start fires if not disposed of properly.

In a piece published at reason.com, Jacob Sullum makes the point that it is impossible for the public to evaluate the ‘epidemic’ of vaping among young people in the US because the relevant figures have not been made available.

Sullum, who is a senior editor at Reason magazine and a nationally syndicated columnist, said that when the commissioner of the Food and Drug Administration, Scott Gottlieb, threatened last month to crack down on vaping products in response to ‘an epidemic of e-cigarette use among teenagers,’ he alluded to ‘preliminary data’ showing that ‘youth use of e-cigs is rising very sharply’.

‘Although we still have not seen those numbers, that has not stopped Gottlieb from making policy decisions based on them, including changes that could limit the appeal and availability of products he concedes have enormous potential to reduce the harm caused by smoking,’ Sullum said.

Later in his piece, Sullum said that it was hard to be sanguine about Gottlieb’s use of this secret information after watching a CNBC interview, which he describes in his piece. In that interview, Gottlieb had talked about banning online sales of e-cigarettes, for example, even though online vendors such as Juul used age verification systems and the vast majority of illegal sales to minors occurred in brick-and-mortar stores, as Gottlieb conceded.

“We recognize [e-cigarettes] as a viable alternative for adult smokers who want to get access to satisfying levels of nicotine without all the harmful effects of combustion,” Gottlieb was quoted as saying. “If we could switch every adult smoker to an e-cigarette, it would have a profound public health impact.”

Yet, Sullum said, Gottlieb was ready to discourage that switch by making e-cigarettes less appealing (by restricting flavors, for example) and harder to get (by banning sales outside of adults-only vape shops, another idea he floated), all based on an ‘epidemic’ that was impossible to evaluate without the data he was not letting most people see.

South Australia is taking anti-vaping policy to a new level, according to a note posted on the website of the Australian Tobacco Harm Reduction Association.

The Tobacco Products Regulation (E-cigarettes and Review) Amendment Bill 2018 currently passing through parliament (the bill has been passed by the lower and upper houses and is back in the lower house for a final vote next month) is set to be the harshest in Australia.

Under the proposed law, which would ban in-store vaping and taste-testing, South Australia would become the first jurisdiction in Australia to ban the sale of vaping products online, by mail, phone, email or fax.

The Association points out that the proposed laws protect the tobacco industry from competition and make it even harder for smokers to transition to vaping, a much less harmful alternative.

‘Smokers in South Australia are already struggling to quit,’ the note says. ‘Smoking rates have not changed since 2012 when 16.7 percent of SA adults smoked, according to the South Australian Health and Medical Research Institute. ‘In fact, adult smoking rates increased … from 14.9 percent to 16.5 percent from 2016 to 2017.’

Given these figures, the Parliament might be expected to be doing everything it could to help smokers quit.

‘Instead, SA is attempting to destroy the vaping industry and make it harder for smokers to access safer products,’ the note said.

‘Two thirds of industry sales within South Australia are online according to Australia’s vape advocacy peak body, Australian Vaping Advocacy, Trade and Research (AVATAR). More than half of all vendors based in South Australia do not operate a physical retail store and rely entirely on online sales.

‘It is hard to see how this could have any possible benefit for public health.’

MarkTen products will stop selling all flavors except for tobacco, menthol and mint. This includes all other flavored variants of both MarkTen and Green Smoke cigalike products. During NuMark, maker of MarkTen products, parent, Altria’s, third-quarter earnings call this morning, the company announced it would pull from market all of its pod-based vapor products, such as the MarkTen Elite and MarkTen Apex, until the problem of youth use is addressed.

This is in response to the U.S. Food and Drug Administration’s (FDA) demand that four major tobacco companies and Juul manufacturer, Juul Labs, address the rising “epidemic” of youth vapor use.

A Q&A with Altria Chairman and CEO Howard Willard posted on the tobacco manufacturer’s website today stated the following:

Q: What have you announced?
Today, we announced actions we are taking to address what FDA has called an epidemic of underage use of e-vapor products. We are removing our pod-based products from the market and all flavored e-vapor products except for tobacco, menthol and mint. We are taking these actions until we receive FDA’s authorization to market the products or the youth issue is addressed.

We also announced our support for federal legislation to raise the minimum age to 21 – not just for e-vapor but for all tobacco products.

Q: Why are you removing your pod-based products?
Based on publicly-available information from FDA and others, we believe pod-based products significantly contribute to the rise in youth use of e-vapor products. We don’t believe our products are the issue, but we don’t want to risk contributing to the problem.

Q: Why are you supporting an increase in the minimum age to 21?
We believe now is the time. FDA is calling underage e-vapor use an epidemic. Today, the number one way kids get tobacco products is through social access, meaning the purchase of tobacco products by someone of legal age for use by minors. Raising the minimum age nationally to 21 should go a long way to solving that problem. Addressing the alarming rise in youth use of e-vapor is important if we want policy makers to more fully support the idea of giving adults greater access to and information about less harmful products.​ ​

Q: Why are you removing some flavors?
FDA has raised concerns about non-traditional flavors and how they are marketed. We strongly believe that flavors play an important role in helping to convert adult smokers from cigarettes to satisfying non-combustible products and intend to offer flavor options to adults through FDA’s authorization process or when the youth issue is addressed. ​

A recent report by Nicotine & Tobacco Research urges lawmakers not to treat electronic cigarettes and vaping devices in the same way as combustible cigarettes are treated, according to a story by Lindsey Stroud at heartland.org.

The report said that such a distinction was important because the more research treated e-cigarettes as equivalent to cigarettes, the more likely the research was to err in its conclusions about ‘these unique devices’.

The lead author, Matthew Olonoff, a PhD student at Northwestern University’s Feinberg School of Medicine, was quoted as saying that before ‘making policy changes, such as controlling nicotine or flavor options in e-cigarettes, [there is a] need to better understand what role these unique characteristics have’.

Stroud reported that the authors had used articles and studies to compare the differences between combustible cigarettes and vaping devices and noted key differences between the two, as well as differences between electronic cigarette devices.

‘These differences include the variety of nicotine levels in electronic cigarettes, vaping versus combustion, variability in nicotine dosing, the role of marketing and technology in attracting users to e-cigarettes, and the ability to use vaping devices in places where combustible cigarettes are banned,’ she said.

‘Increasingly, research indicates that the smoke in cigarettes causes the most harm, and tobacco harm reduction products, including e-cigarettes as well as smokeless tobacco, have proven to effectively deliver nicotine in a manner much less harmful than combustible cigarettes.’

The first electronic cigarette to receive UL 8139 certification, a safety standard that evaluates the electrical and battery systems of vaping devices, will go on sale in Canada next week, according to a story by Herb Weisbaum at nbcnews.com.

But it won’t be available in the US.

Weisbaum said the vaping industry blamed the US Food and Drug Administration, which regulates tobacco products, including ‘deemed’ tobacco products such as e-cigarettes, for preventing US citizens from buying safety-enhanced devices.

“They have locked us into antiquated technologies,” Tony Abboud, executive director of the Vapor Technology Association, was quoted as saying. “The US Government is suppressing innovation in a way that can only harm consumers going forward.”

As reported here on October 16, UL, the global safety company that tests and certifies tens of thousands of consumer products each year, now has a safety standard for electronic cigarettes: ANSI/CAN/UL 8139, Electrical Systems of Electronic Cigarettes and Vaping Devices. This standard has been recognized by the American National Standards Institute (ANSI) and the Standards Council of Canada (SCC), covering the electrical, heating, battery and charging systems of these products.

But when Joyetech’s eGo A10 vapor pen, the first UL-certified vaping device, hits the market this month it will be sold in Canada but not the US.

Joshua Church, Joyetech’s chief regulatory and compliance officer, was quoted by Weisbaum as saying safety was important to his company. “We did this [UL certification] to protect American consumers, but we can’t sell directly to them,” Church said in an exclusive interview from Shenzhen, China.

The problem is, as Weisbaum goes to some length to explain, that the FDA prohibits the sale of any new or modified e-cigarettes that were not sold in the US prior to August 8, 2016, without pre-market approval; for which it is only now developing guidelines.