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FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes

As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products.
Products that would be “deemed” to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as electronic cigarettes (e-cigarettes), cigars, pipe tobacco, nicotine gels, water-pipe (or hookah) tobacco, and dissolvable not already under the FDA’s authority. The FDA currently regulates cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

“This proposed rule is the latest step in our efforts to make the next generation tobacco-free,” said HHS Secretary Kathleen Sebelius.

Consistent with currently regulated tobacco products, under the proposed rule, makers of newly deemed tobacco products would, among other requirements:

Register with the FDA and report product and ingredient listings;
Only market new tobacco products after FDA review;
Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole; and
Not distribute free samples.
In addition, under the proposed rule, the following provisions would apply to newly “deemed” tobacco products:
Minimum age and identification restrictions to prevent sales to underage youth;
Requirements to include health warnings; and
Prohibition of vending machine sales, unless in a facility that never admits youth.
“Tobacco remains the leading cause of death and disease in this country. This is an important moment for consumer protection and a significant proposal that if finalized as written would bring FDA oversight to many new tobacco products,” said FDA Commissioner Margaret A. Hamburg, M.D. “Science-based product regulation is a powerful form of consumer protection that can help reduce the public health burden of tobacco use on the American public, including youth.”
“Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims.”

The FDA proposes different compliance dates for various provisions so that all regulated entities, including small businesses, will have adequate time to comply with the requirements of the proposed rule.

Products that are marketed for therapeutic purposes will continue to be regulated as medical products under the FDA’s existing drug and device authorities in the Food, Drug &Cosmetic Act.

The proposed rule will be available for public comment for 75 days. While all comments, data, research, and other information submitted to the docket will be considered, the FDA is requesting comments in certain areas, including:

The FDA recognizes that different tobacco products may have the potential for varying effects on public health and is proposing two options for the categories of cigars that would be covered by this rule. The FDA specifically seeks comment on whether all cigars should be subject to deeming, and which other provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars.
The FDA seeks answers to the many public health questions posed by products, such as e-cigarettes, that do not involve the burning of tobacco and inhalation of its smoke, as the agency develops an appropriate level of regulatory oversight for these products. The FDA seeks comment in this proposed rule as to how such products should be regulated.
For more information:
Proposed rule: Tobacco Products Deemed to be Subject to the Food, Drug and Cosmetic Act (Deeming) disclaimer icon
FDA: Extending Authorities to Additional Tobacco Products
Consumer Update: Recognize Tobacco in Its Many Forms
FDA Voice Blog: Proposed Rule Would Expand FDA’s Tobacco Control Authority
En Espanol: La FDA propone ampliar su autoridad para regular otros productos de tabaco, incluyendo los cigarros electrónicos
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


The rise of the e-cigarette

Debating the safety and effectiveness of electronic cigarettes is not a debate confined just to the UK. In the USA, the number of cities banning the use of e-cigarettes, also known as vaping, in public places, such as bars, nightclubs and restaurants, and therefore treating them similarly to traditional cigarettes, is growing. Boston, Chicago and New York are among them, and Los Angeles is destined to join the list soon; the LA City Council has already voted to ban them, so passing the measure into law is just a matter of process.

In the UK, the stance on use in public places is still very much subjective. Pub chains Wetherspoons and the Slug & Lettuce have banned the use of them insider their establishments; McDonald’s too. Some train operators, including First Capital Connect, have imposed a complete ban on passengers using the devices.

In February, however, Boots announced their stores would be stocking e-cigarettes, making the brand, Puritane, available online as well as giving the product a presence in the high street. Under-18s are banned from buying electronic cigarettes though – and the UK government has also made it illegal for adults to buy traditional cigarettes for anyone under 18.

Depending on who you talk or listen to, e-cigarettes either offer the best hope yet of significantly reducing harmful smoking, or are a new way for tobacco companies to regain some control in the falling tobacco market. Though whether it actually matters if consumers are spending their money on a less harmful product instead, is another argument.

Critics also raise the concern that e-cigarettes can serve as a gateway for young adults and teens to experience a form of smoking before graduating to the real thing. The counter to that, surely, is that if habits are hardened in those early and impressionable years, the user may never be tempted to try old-style cigarettes.

In brief, e-cigarettes consist of a battery, a cartridge filled with nicotine, a solution of propylene glycol or glycerine mixed with water, and an atomiser to turn the solution into a vapour. When the user inhales, the solution is vaporised – hence the term vaping – and a nicotine hit to the lungs is delivered without tar and toxins. And this, insist e-cigarette users and supporters, is what makes the crucial difference and distinction between those and traditional cigarettes.

Author Matt Ridley, who appeared on News Night, is a well-known supporter of electronic cigarettes, having spoken about the subject in the House of Lords and written extensively on the subject. Ridley likens e-cigs to a product widely popular in Sweden. Snus, which is put under the top lip, provides the nicotine but not the tar. Sweden has the fewest smokers per head of population of all EU countries; lung cancer mortality in Swedish males over the age of 35 is less than half the British rate. “If snus can halve smoking and lung-cancer deaths, imagine what electronic cigarettes could do,” Ridley wrote. “These are objects that mimic the actions of smoking but are maybe 1,000 times safer.”

Speaking on Tonight, Professor Robert West from Cancer Research UK, suggested that e-cigarettes could potentially save millions of lives a year. Glenn Thomas, of the World Health Organisation, insisted that more research is required to establish what, if any, impact on health e-cigarettes has.

A poll conducted after an ITV debate in January illustrated a public divided: on the question of whether e-cigarettes set a bad example, showing people imitating smoking even in smoke free areas, there was an even split of 42 per cent each. Asked whether it was socially acceptable to regularly use an e-cigarette in public, 48 pre cent agreed it was; 33 per cent did not and 19 per cent were unsure. However, 45 per cent disagreed that e-cigarettes should be allowed in public, indoor places.

The benefits of electronic cigarettes may evoke debate, but the popularity of such devices cannot be disputed. The rise of the e-cigarette has been verging on the meteoric – in 2013, sales rose 340 per cent year on year, beating nicotine patches, lozenges and gum for the first time. While e-cigarettes are not necessarily pitched as aids to help smokers quit traditional tobacco, it’s clear they are being used as an alternative – sales totalled £193 million last year (up from £44 million in 2012). In comparison, collective sales of patches, lozenges and gum were £131 million, an increase of just 1.7 per cent.

In France, a country almost synonymous with the image of traditional cigarette smokers, e-cigarettes are hugely popular. A survey carried out by Ipsos in December 2013 revealed one in five French people – that is around 10 million – had tried an e-cigarette. At the same time, sales of traditional cigarettes dropped by just over 7 per cent in France.

There are estimated to be around 1.3 million e-cigarette users in the UK, and as the popularity of the devices grow, that figure is only going to increase. There is an extensive range of brands and styles, ranging from models which look very alike to real cigarettes in appearance, to those that resemble pens. Disposable, rechargeable and personal vaporizer versions are all readily available, as are e-juices to flavour the vapour. Conventional menthol flavours sit alongside apple, pineapple, kiwi and even bubblegum for the more adventurous e-pioneer.

Celebrity endorsement from rapper Snoop Dogg (now known as Snoop Lion), who has designed a vaporiser pen with a roadmap of Long Beach printed on it, and Leonardo DiCaprio have helped to cement the device’s status as a viable smoking alternative, rather than an awkward stopgap to quitting. A variety of novelty versions in the guise of lightsabres and Nintendo NES controllers, seem to promote them as a form of fashionable, ironic accessory.

Should the Welsh government succeed in banning e-cigarettes from public places, those forced to go outside may well go back to smoking the real deal. It’s difficult to see how an enforced ban may affect the e-cig industry, but it’s unlikely to go up in a puff of smoke any time soon.

Health and cigarettes

Despite the Alarming Studies, E-Cigarettes Are a Win for Public Health

There has been all sorts of bad news about e-cigarettes this month.

The electronic smoking alternatives — at least according to recent headlines —  may cause cancer, lead teenagers into a lifetime of nicotine addiction and don’t help smokers quit. Predictably, politicians are again demanding that something be done to protect the public from the proliferation of electronic cigarettes.

Sen. Dick Durbin (D-Ill.) and Rep. Henry Waxman (D-Calif.) announced on Monday that they want to restrict e-cigarette marketing and limit the flavors of nicotine e-liquid available to consumers. According to Durbin, the regulations are meant to discourage e-cigarette use among children because it is  “ … a candy-flavored addiction, which is dangerous to our young people … and sadly poses serious public health threats.”

E-cigarette critics have been making this assertion for nearly a decade. They were wrong then because we had no evidence one way or the other, and they’re wrong now because the evidence we’ve gathered contradicts their claims. Put simply, Durbin and Waxman with the help of the media are misleading the public about e-cigarettes, who’s using them and how safe they are.

E-cigarette use has exploded in recent years. As a result, so has the research investigating how the smoking alternatives affect human health. Going back to 2011, we’ve had clinical evidencethat smokers who switch to e-cigarettes are able to quit tobacco entirely, and do so with few or no side effects, and that’s very likely because the chemicals in e-cigarettes are not dangerous.

Today it’s the same story. A study published this month by researchers in England found that smoking cessation in the country has increased significantly right along with the growth of e-cigarette use. The result doesn’t necessarily prove that e-cigarettes caused the decline in smoking, but as the study’s authors concluded, the “Evidence conflicts with the view that electronic cigarettes are undermining tobacco control … and they may be contributing to a reduction in smoking prevalence through increased success at quitting smoking.”

Other studies from Europe have yielded even more impressive results, with one Frenchsurvey (English summary available here) finding that e-cigarettes may have helped 1% of the France’s population quit smoking.

These studies are important because they demonstrate the effectiveness of e-cigarettes. But they’re even more important because they provide solid evidence that smokers — people already addicted to nicotine — are using the devices to quit; children are not using e-cigarettes to develop a nicotine addiction. You may see contrary stories in the news, but the suggestion that kids are taking up e-cigarettes is based on nothing more than badlymisinterpreted CDC statistics, released in 2013. Moreover, a study published just a week after the CDC data found that e-cigarette use among teenagers is very low, and the teens who had tried e-cigarettes were already smokers.

Durbin, Waxman and other critics will undoubtedly continue to cry foul about advertising aimed at children, but the growing body of evidence about e-cigarette use renders their complaints moot. If e-cigarette manufacturers are marketing their products to kids, they sure suck at it, as the numbers above illustrate. But that’s assuming the manufacturers are targeting children, and several major e-cigarette brands have successfully argued in court that they are not. In response to these new proposed rules, six manufacturers also said they would favor a ban on selling e-cigarettes to minors.

That brings us to an important point: Nobody involved in this debate is against sensible regulations. It’s perfectly reasonable to put an age restriction on the sale of e-cigarettes, butmisrepresenting the evidence and demonizing a life-saving product in the process is not only unnecessary but shameful. As cigarette consumption both around the world and in the United States continues to drop, we should acknowledge that the growing popularity of e-cigarettes is a massive win for public health.