E-cigarettes in regulatory doldrums

The phenomenon of e-cigarette has caught regulators flat footed. The devices vaporise a solution, allowing vapers to inhale nicotine. Their popularity has surged and regulators are running to catch up. However, around the world countries are adopting different approaches as people begin to get into the vaping habit. What is certain is that they are proving controversial. And they have split tobacco-control community. Some see them as life savers, others as a pathway to normalisation and more tobacco use.

The kinds of products on sale also vary widely; users inhale mostly propylene glycol, but there is not long-term data on its effects. Many products contain flavourings, but again little is known about inhaling these chemicals. The situation is complicated by big tobacco moving into the area and buying up e-cigarette companies. “We need to make sure the research we do is focused and is not led by the tobacco industry,” says Deborah Arnott of the UK NGO Action on Smoking and Health (ASH).

The trouble is that the urge to make regulatory decisions concerning e-cigs—classified as medical device—has arisen at a time when there is not a lot of evidence available. The approach to measuring risk will be critical in e-cigarettes, according to Thomas Hartung, director of the Centre for Alternatives to Animal Testing (CAAT) at Johns Hopkins University, Baltimore, Maryland, USA. He also believes applying strict old-fashioned toxicological tests to these new products is a mistake. “If you want to hinder these products getting to market then you do extensive testing as you do for drugs and other types of products. These methods are meant to exclude risk and we already know these products include risk,” he says.

Risks versus benefits

Still, many scientist view Europe as taking a hard line on a technology that could save millions of lives, while at the same time not taking a sensible approach to research needed to fill in the gaps. “Regulators are primarily focusing on risks, and most of these risks are very hypothetical,” says Peter Hajek, tobacco researcher at Queen Mary University of London, UK. “They are ignoring the potential benefits.”

Eagerness to bridge the regulatory vacuum around this issue could have some unintended repercussions. “Responsible regulators need to weigh the benefits and risks of restrictive regulation,” Hajek adds. He points to the European Union’s Tobacco Products Directive, which he says will regulate e-cigarettes more strictly than conventional cigarettes. The Commission notes that a concern for public health is that e-cigarettes will be increasingly be used by young people and non-smokers, the so-called gateway effect.

Riccardo Polosa, director of the Centre for Tobacco Research (CPCT) at the University of Catania, Italy, denounces, in an interview with the EuroScientist webzine, a lack of transparency around the Tobacco Directive, with closed door discussions by the Commission, Parliament and European Council. He believes the directive aims to bloc innovation and use of e-cigarettes, the most promising approach to getting smokers to quit their deadly habit.

Even the World Health Organisation has taken what many consider a tough line on e-cigarettes. It called for strict regulation and bans on indoor use, as well as a ban on flavourings.

Evidence gap

 Despite their potential benefits, many believe an evidence-based approach is needed. “We need tremendous amounts of research to understand how e-cigarettes are used by the public, whether they will be a replacement and meaningfully reduce the rates of tobacco use, or will serve as a crutch to keep people hooked,” says deputy director of the National Institute on Drug Abuse in Bethesda, Maryland, USA, Wilson Compton, who is driving a programme of research to probe related questions. While there is a remarkable lack of information on e-cigarettes, Compton believes, the public is marching ahead of scientists and policy makers.

However, Europe is underperforming in seeking evidence. “I look to America and the amount of money going into research in this area with an enormous amount of jealousy,” says Arnott. “And research here is much less coordinated, a real problem in a rapidly expanding area.”

Some see an obvious source for funding needed research. “The source of funding for tobacco research out of the [US Food and Drug Administration (FDA)] is the tobacco industry itself,” says Compton. “These are user fees levied against the tobacco industry but administered by neutral parties, and that is the model we are using and I think others could consider a similar model,” Compton told his European audience this summer at the ESOF meeting in June 2014, in Copenhagen, Denmark

EU Regulation puzzle

Moves to regulate e-cigarettes have not been uniform across territories. The US FDA, for example, has been given authority over the manufacture and marketing of tobacco produces. It is now undertaking a research programme on e-cigarettes, working with the National Institute of Health (NIH) and the Centre for Diseases Control (CDC) among others. The US top-down approach needs to be distinguished from the European bottom-up approach, according to CAAT’s Hartung, who trained as a scientist in Germany.

He argues that Europe does not even have the structures to figure out how best to regulate e-cigarettes because of the lack of European-wide mechanism available to studying them. “In the US, there is very much a drop-down research, which is led by agencies, which are heavily engaged in revamping science and finding new ways of regulating. We don’t have an equivalent in EU institutions, where the EU agencies are essentially executive,” Hartung complains. “They are not promoting novel science and where research into new aspects is only funded in a bottom-up approach, by giving money to researchers. Here in the tobacco area this is extremely poor and there is not much being done [in Europe].”

Italy’s Polosa, however, warns that such an approach brings a risk of scientific evidence overload, which could paralyse the regulatory process. Then, there is a risk that regulating e-cigarettes would be akin to merely identifying which research aligns with the political agenda.

Outside Europe, countries are already regulating or introducing rules for e-cigarettes, some aimed at dissuading people from using them. “It’s a confusing mess, really,” says Arnott. Countries such as Brazil, Hong Kong and Singapore are banning the products completely. In Canada, they are illegal to sell, but are sold widely. In South Korea, they are on sale but heavily taxed.

So what’s next?

Hajek is clear that the evidence so far points to positives for public health. “The effects of e-cigarettes on standard cigarette use, that is about the only thing that matters. There is clear data that as e-cigarettes become more popular, standard cigarette use is declining and smoking prevalence is going down. That is about the strongest evidence you can have for beneficial effects, and that is what we are seeing in the UK, the US [and] even France and Italy.”

But most proponents say it is vital that research tracks use trends and gathers more evidence on who is using tobacco and why – to quit a deadly habit, supplement a habit or as a gateway to traditional tobacco. The answers will be of great import to public health policy.

Featured image credit: CC BY-SA 2.0 by Michael Dorausch

Anthony King

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One thought on “E-cigarettes in regulatory doldrums”

  1. The growing mountain of scientific and empirical evidence consistently finds e-cigarettes (aka vapor products):
    – are 99% (+/-1%) less hazardous than cigarettes,
    – have never been known to cause any disease or death,
    -are nearly all (i.e. >99%) consumed by smokers and by exsmokers who switched to vaping,
    – have replaced more than 2 Billion packs of cigarettes worldwide in the past five years,
    – have helped more than a million smokers quit smoking and have helped millions more significantly reduce their cigarette consumption,
    – are more effective than FDA/MHRA approved nicotine gums, lozenges, patches and inhalers for smoking cessation (which have a 95% failure rate),
    – pose fewer risks than FDA/MHRA approved Verenicline (Chantix/Champix),
    – have never been found to create nicotine dependence in any nonsmoker (youth or adult),
    – have never been known to precede cigarette smoking in any daily smoker,
    – emit trace levels of nontoxic aerosol that poses no harm to nonusers,
    – have never poisoned any human, and
    – have further denormalized cigarette smoking (as youth and adult smoking rates and cigarette consumption have declined every year since 2007 when vapor sales began to skyrocket).

    But in April 2009, Obama’s FDA revealed its unscientific, unethical and inhumane policy to deceive Americans about e-cigs and defend the FDA’s unlawful e-cig ban: “We don’t want the public to perceive them as a safer alternative to cigarettes.”

    In July 2009, Obama appointee (and former Henry Waxman staffer) FDA Deputy Commissioner Josh Sharfstein held a press conference (along with CDC OSH Director Matt McKenna and Big Pharma funded AAP’s Jonathan Winickoff) to defend the agency’s unlawful and unwarranted e-cig ban from lawsuits by two companies (whose products were among nearly 1,000 seized by US Customs Agents) where FDA’s e-cig lab findings were deceitfully misrepresented to scare the public to believe e-cigarette are carcinogenic and toxic, where e-cig companies were falsely accused of target marketing to youth, and where it was falsely alleged (without any evidence provided) that e-cigs are addicting children, can be gateways to cigarettes, can renormalize smoking, and don’t help smokers quit.

    Thankfully for the rule of law, public health, civil liberties, market competition and common sense, all 12 federal appeals court judges upheld Judge Richard Leon’s Janaury 15, 2010 ruling striking down FDA’s e-cig ban as unlawful.

    But instead of ethically clarifying or correcting any of the many false and misleading fear mongering claims it made about e-cigs (when attempting to win the e-cig litigation), Obama’s DHHS has not only continued to repeat those same false claims about e-cigs, but it has doubled down by making and repeating many more false claims many more times.

    The recently proposed FDA e-cig regulation (as well as the recently announced UK MHRA e-cig regulation) would protect cigarettes by banning >99.9 of e-cig products now on the market and by giving the e-cig industry to Big Tobacco companies.

    Meanwhile, the FDA has also given hundreds of millions of dollars to so-called researchers to study e-cigs, but most of the funding recipients are e-cigarette prohibitionists and propagandists who will spend the money generating more false and misleading fear mongering claims about e-cigs.

    Even worse, the US CDC has given several hundred million dollars to state and local health agencies to lie about e-cigs, and to lobby to ban or severely restrict their sales, marketing and use, and to tax them.

    While the FDA and CDC claim that all of their policies are based upon scientific evidence, their e-cigarette prohibition and propanda policies have never been based upon scientific evidence, which they continue to deny, ignore or misrepresent.

    Smokefree Pennsylvania’s 110 page comment exposing these ugly facts and urging the FDA to kill its proposed Deeming Regulation is at: http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-80846

    Bill Godshall
    Executive Director
    Smokefree Pennsylvania
    1926 Monongahela Avenue
    Pittsburgh, PA 15218