E-cigarettes could become ‘medicines’ available on nhs

E cigarettes could be available on the NHS by the end of the year with at least two companies one a subsidiary of British American Tobacco having already embarked on the process of obtaining licences from the medicines regulator.

The UK company Nicolites said its application was «well advanced» while BAT’s Nicoventures has also started the process, although decisions on whether their products are prescribed on the NHS will be made by local commissioning groups.

The status of «medicines» will give the companies commercial advantage and allow the e cigarette makers to market their product internationally, including in sponsorship deals, a move that will be banned for competitors not in the same bracket.

The news came to light as ministers in England prepare to ban the sale of e cigarettes to under 18s Wales and Scotland are likely to follow suit.

The Committees of Advertising Practice are also about to launch a consultation on new rules to cover e cigarettes, used by 1.3 million people in Britain last year. It will start later this month, with the framework likely to be in place by autumn, nearly two years after the first TV adverts for such products.

The applications to the Medicines and Healthcare Regulatory Authority are a victory for the regulator’s determination to persuade manufacturers and importers to apply voluntarily for a licence and meet specific rules including on the amount of nicotine provided. They are continuing the process even though the European parliament defeated UK attempts to make medicinal licensing compulsory for e cigarettes last autumn,.

Existing anti smoking therapies such as gums, patches, an inhaler, and a mouthspray already have medicine licences and have been endorsed by the National Institute for Health and Clinical Excellence, which advises on good practice and value for money. Nearly 1.4m prescriptions for them were issued in England in 2012, but licensed e cigarettes would not need a separate Nice assessment.

Nikhil Nathwani, managing director of Nicolites, said the company was «well advanced in the product’s licencing» and hoped to achieve marketing authorisation some time this year. It was working closely with the government, the regulator and Nice. «This will be continued even after marketing authorisation has been achieved», he said. Nicoventures has also made a licence application for a nicotine inhalation device to the MHRA.

A spokesman for BAT, which already has a standard e cigarette brand, Vype, on sale in Britain, said the company would like to see «a regulatory approach that puts consumer safety and product quality first, while allowing the appropriate level of innovation, marketing and distribution freedoms to allow this important new product category to grow.»

A spokesperson for Njoy, a big US cigarette company, which has also endorsed MHRA regulation, could not say whether an application was in progress, when contacted.

The readiness of big e cigarette players to go down the voluntary route for the expensive process of medicines approval is in sharp contrast to the position of the UK trade body for e cigarettes, Ecita, which has railed against the over regulation it claims will be introduced EU wide.

E cigarettes classed only as consumer products from 2016 will have to carry health warnings that nicotine is highly addictive. The draft EU directive, which has still to complete its legislative process in the coming months also contains new curbs on tobacco including health warnings covering nearly two thirds of cigarette packs.

This article was amended on 3 February 2014 because it is the Committees of Advertising Practice who are launching a consultation on new rules to cover advertising e cigarettes, not the Advertising Standards Agency as the original said.

The anti-e-cigarette conspiracy

Many experts in tobacco control believe e cigs present the best hope of improving the unacceptably low rate of successful quitting among addicted smokers. Yet, in a perverse inversion of public health policy, these devices face relentless opposition and not from Big Tobacco, whose interests seemingly are most threatened by the switch from cigarettes to e cigarettes. Rather, it is the official public health agencies, such as the CDC and the FDA, and the big health nonprofits, such as the American Cancer Society and the American Lung Association, that are fighting this public health miracle. Even worse, they are using tactics akin to the deceptions and manipulations we recall from the cigarette makers of the 20th century. One of their more egregious tactics is simply redefining the words tobacco and smoke to include e cigs, which are linked to neither. The question is Why? One thing is certain Their antipathy is not based on science or the good of public health.

Our nation is home to over 40 million smokers, among whom about 480,000 die from their habit each year. Over half of the 40 million will die prematurely because of cigarette smoke. While the percentage of American adults who smoke has been in gradual decline since the groundbreaking 1964 surgeon general s report, the total number has hardly changed.

Most smokers desire to quit, understandably, but the addiction to smoking is extremely powerful, largely (though not solely) because of nicotine s power. Unfortunately, it is often believed by smokers, and even by some doctors, that it s the nicotine that is toxic and lethal. This is a dangerous myth. It is a proven aphorism that Smokers smoke for the nicotine but they die from the smoke. But it s not only the nicotine that is addictive There are many psychoactive chemicals in smoke these, along with the behavioral rituals and the nicotine, are what wrap the addicted smoker in a death grip.

E cigarettes provide not only a sufficiently potent dose of nicotine to satisfy a smoker s craving (unlike the ineffective patches and gums), but also the comforting rituals of inhaling and exhaling a smoke like mist, which is actually composed almost entirely of water. They use a battery to vaporize water and nicotine, which the user (called a vaper ) inhales, along with vegetable glycerin and/or propylene glycol and flavoring. They often have a cigarette like LED tip that glows red or some other color if preferred but without tobacco, without combustion, without smoke. The ingredients are generally recognized as safe by regulatory agencies, and have been in common use for decades although no long term health studies have been done on their safety in inhalational use. Such studies are being done, even now.

Sales of e cigarettes have doubled in each of the past few years, to the extent that a recent survey found that an astounding one fifth of smokers had tried them millions of smokers, now ex smoking vapers. At the same time, cigarette sales have shown a historic decline in this same period (a reliable analyst predicts that e cig sales may well overtake cigarette sales within a decade if regulators and health nonprofits get out of the way). While gold standard studies showing the markedly reduced health risk from e cigs haven t yet been completed, simple common sense would tell us that inhaling their ingredients, as compared to inhaling the thousands of chemicals from tobacco combustion (the smoke), is highly likely to be less harmful.

Despite the complete absence of any evidence or even report of harm from vaping, a bizarre trend seems to be sweeping the land, wherein towns, cities, and states are enacting measures to ban, restrict, or tax e cigs as if they were actually cigarettes. The rationales for such misguided, harmful regulation vary from locale to locale, politician to politician. But the fount of all these measures is unquestionably the federal agencies charged with the custodianship of our public health. The FDA initially tried to bar e cigs from even entering the country in 2009, but it was slapped down by a federal judge who accurately pointed out that nothing in the new law that gave tobacco oversight to the agency addressed e cigs. Perhaps out of spite, the FDA has continued to warn smokers not to even try vaping as a cessation method. The FDA s partner in such malfeasance, the CDC, has stooped to manipulating youth tobacco survey data to promote the anti e cig agenda, loudly alerting concerned parents that e cig use among teens had doubled between 2011 and 2012. The head of the CDC, Tom Frieden, conveniently neglected to note that almost all the young people who had experimented with e cigs were previously tobacco users. Even more revelatory, the official announcement lacked the key datum that during this ostensible epidemic of teen nicotine addiction, smoking rates among teens fell significantly, even more than they had fallen over the previous few years.

Other excuses for attacking e cigs range from We just don t know what will happen to vapers over the next five or ten years to We don t know what s in them. But we surely do know what will happen to many smokers over the next decade if they don t quit, and we surely do know what s in e cigs Their vapor has been extensively analyzed in objective academic labs, and nothing of concern to health has been detected as would be expected, based on their chemical constituents. Concerns about attracting and addicting young people to nicotine via e cigs have not been supported by valid evidence, despite a nearly hysterical response by the media to an outrageously deceptive study published last week by the formerly esteemed JAMA Pediatrics.

These days, when one reads about regulating e cigs, the real goal is usually to regulate them right off the market. Responsible scientists and the outnumbered members of the tobacco control movement who espouse reasonable regulation also want this groundbreaking technology regulated Age limits for sales and marketing good manufacturing practices, as with any consumer product accurate ingredient labeling childproof packaging these should all be mandatory. More stringent regulation is neither necessary nor desirable.

The unanswered question is this Why do all these public health groups and agencies abdicate their responsibilities in favor of deceiving smokers about the facts regarding e cigarettes? Can the leaders of these health bodies be so ignorant? Or are there darker forces at work Are the CDC and the FDA, perhaps, concerned more with abetting the collection of cigarette taxes than with saving smokers? Does the impressively generous funding support from Big Pharma to the nonprofit health groups generate influence, either overtly or more subtly? I cannot say. A particularly galling irony is that almost all the pompous hype calling for ever tighter restrictions and even outright bans emanates from the liberal Democratic camp, which has over the years been sympathetic to other forms of harm reduction, such as condoms for HIV positives and clean needles for addicts. But it s nicotine abstinence only for smokers Quit or die, they say.

The World Health Organization predicts that 1 billion lives will be lost to cigarettes this century, if current trends go unchanged. Everyone concerned with tobacco and health has been on tenterhooks since last November, awaiting the FDA s long overdue ruling on how it plans to regulate e cigarettes. The agency has the power to be flexible and maintain the current vibrant, innovative market or it could deem e cigs to be tobacco products, effectively banning them, which would be a catastrophe. One thing is certain This misguided, harmful crusade against e cigarettes is clearly detrimental to America s public health. While long term randomized clinical trials are desirable, the matter is too urgent and important to require these lengthy and expensive studies prior to market approval. In fact, those who demand a priori evidence before approval should be made aware that the effects of this type of regulation would be doubly
destructive Smokers would lose access for years to their best hope of quitting, and Big Tobacco will be the sole survivor after years of trials prove what we can plainly see now. E cigarettes have the potential to save millions of lives, and those who would impede smokers access to them or to truthful information about them are, in fact, killing smokers.

Gilbert Ross, M.D., is medical director of the American Council on Science and Health.