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Will FDA Regulation Preserve Or Destroy The E-Cigarette Industry?

The first time the Food and Drug Administration (FDA) moved to regulate electronic cigarettes, it tried to ban them. Last week it took a different approach that may ultimately have a similar effect. Much will depend on whether the FDA irrationally decides to treat e-cigarettes as a menace to public health or recognizes them as a lifesaving alternative to conventional cigarettes.

On the face of it, the proposed rule that the FDA published last week is much more accommodating than its 2009 attempt to ban e-cigarettes as unapproved “drug-device combination products,” which was blocked by the courts. This time the FDA is classifying e-cigarettes as “tobacco products.” That in itself is rather puzzling, since e-cigarettes do not contain any tobacco. They do, however, contain nicotine derived from tobacco, which is the court-endorsed legal pretext for FDA regulation.
By the same logic, nicotine gum, lozenges, patches, and inhalers are also tobacco products, except that the FDA already regulates them as pharmaceuticals. As tobacco products, e-cigarettes should have a much better chance of remaining on the market. After all, the FDA is not trying to ban conventional cigarettes, which are far more dangerous because they deliver nicotine in a cloud of tobacco combustion products rather than a propylene glycol aerosol.

But there’s a catch. All the familiar brands of conventional cigarettes were grandfathered by the Family Smoking Prevention and Tobacco Control Act, the 2009 law that gave the FDA authority over tobacco products. According to the FDA, so were e-cigarettes, as long as they were on the market as of February 15, 2007—the cutoff date set by the statute. Since the e-cigarette business was just getting started in the United States at that point, this grandfather clause does not cover much.

E-cigarette companies that did not exist in early 2007 can get permission to continue selling their products by demonstrating that they are “substantially equivalent” to the early models, which means they have “the same characteristics” or raise the same public health issues. Will they be able to meet this test? I asked three people who are familiar with the e-cigarette industry that question, and I got three different answers.

The most optimistic answer came from Chip Paul, founder of the Oklahoma-based e-cigarette franchise Palm Beach Vapors, which sells vaping equipment and store-blended fluids to go with them. “I think everybody will be able to make that argument, that they are just furthering the technology that existed in 2007,” Paul says. One major change has been the shift from disposable cartridges of e-cigarette fluid to refillable tanks, but the underlying technology remains the same. “We don’t think what’s on the market today is substantially different from what was on the market in 2007,” Paul says. “There have been improvements in the technology, and there have been some design changes, but the way the liquid is delivered to the user is fundamentally the same, and the liquid is fundamentally the same. I think everybody who is in business today will be able to [satisfy that test] and be OK.”

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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.
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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.