Latest posts by Jeff Stier (see all)
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- FDA Creates Cigarette Confusion – Calls for Science to Back up Policy - March 17, 2018
Examples of lower risk products include smokeless tobacco such as swedish style snus, increasingly popular e-cigarettes, and next generation products such as Philip Morris International’s HeatStick, (which heats but does not burn tobacco), due out in cities in Japan and Italy later this year. British American Tobacco is engaged with regulatory agencies around the world as they prepare to roll out a variety of lower-risk products. And small innovators around the world are developing better e-cigarettes, almost daily. Each of these products come with some degree of risk, but those risks pale in comparison to the well-established and overwhelming harm that comes from smoking cigarettes.
United States law allows companies selling lower risk products to point to that difference in risk. Those wishing to make the claim must first prove to the Food and Drug Administration (FDA) that the product is not only less harmful to the individual user, but to the population as a whole. At the heart of this regulatory approach is adherence to rigorous science. This approach promises to significantly reduce the harm from tobacco by giving consumers accurate information that could prompt them to switch to lower risk products, even if they don’t (or can’t) follow the best advice: quit all forms of tobacco.
Yet regulators in much of the rest of the world eschew the scientifically rigorous approach in favor of grandstanding, anti-business rhetoric, and bizarre theories that seek to punish tobacco companies rather than help smokers.
The harm reduction model works in Sweden, the only European country where snus is legal and widely used by men instead of cigarettes. Not coincidentally, Swedish men have strikingly lower rates of tobacco-related disease than other Europeans.
Last month, Swedish Match applied to the FDA for permission to tell users that it’s snus isn’t as harmful as smoking. The proposed language would accurately and simply state, “no tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.“
The company backed up the “modified risk tobacco product” claim with some 120,000 pages packed with the very type of peer-reviewed research the law requires and that the FDA requested. That’s approximately 119,999 pages more than necessary to prove that cigarettes are more dangerous than a non-combustible product like snus.
A positive decision from the FDA would open the door to similar claims from other companies and spur investment in new lower-risk alternatives to smoking. This would be a win for public health. And by “public health,” I mean the health of the people we should be trying to help, not the activists who have co-opted the term and regularly oppose tobacco harm reduction.
Yet sadly, regulatory bodies in much the rest of the world are rushing to cut off long-existing products like snus, new products like e-cigarettes, and future products that are being developed using cutting edge science meant to deliver more satisfaction and less harm. Activist opposition to these newest products makes it evident that their problem isn’t with the harm, it’s with the satisfaction. If that’s the case, they aren’t advancing public health, they are advancing a form of public puratinism.
In the EU, with the exception of Sweden, snus is already banned as part of the Tobacco Product Directive. Now, according to reporting by the Financial Times, elements within the World Health Organization are trying to classify e-cigarettes as “tobacco: under the Framework Convention on Tobacco control (FCTC), which has 168 signatories. E-cigarettes contain nicotine derived from tobacco, but do not contain tobacco. Such a move would mean that the same strict advertising restrictions, public use bans, and possibly even sin taxes that apply to cigarettes, would automatically be applied to less harmful products, without any review of the scientific justifications or consideration of the unintended consequences of such rules.
Why would regulators treat dramatically less-harmful e-cigarettes the same way they treat actual cigarettes? They are reportedly concerned that the use of e-cigarettes will “normalise” smoking, according to published reports?
E-cigarettes “could result in a new wave of tobacco epidemic,” said top FCTC official Dr. Haik Nikogosian, in a meeting to set the agenda for a full FCTC gathering in Moscow in the fall. Dr. Nikogosian subscribes to the bizarre and undocumented theory that non-smokers will see former smokers now using e-cigarettes, and as a result from seeing it, decide themselves not only to start using e-cigarettes, but to start smoking cigarettes. This type of twisted thinking, if it finds its way into policy, is sure to inhibit smokers from switching to e-cigarettes, ironically doing the opposite of what countries who signed the FCTC wanted to accomplish, which was reduce smoking rates.
In fact, there’s a growing body of evidence that shows that e-cigarettes are helping smokers quit. In a study published this spring in the journal, Addiction, Professor Robert West found that e-cigarettes are 60 percent more effective than nicotine replacement therapies at helping smokers achieve their goal of quitting. Perhaps the FCTC should encourage more private sector investment in harm-reduction products. It could do so, in part, by establishing rules, much like those in place in the U.S. (not a party to the FCTC), where innovators know what scientific standards they’ll be held to.
The WHO approach is facing stiff opposition from scientists. In May, 53 leading researchers urged the WHO to think twice (or even once) about the wisdom of it’s ant-harm reduction approach. They wrote that “The 1.3 billion people who currently smoke could do much less harm to their health if they consumed nicotine in low-risk non-combustible form.”
They added that “we have known for years that people ‘smoke for the nicotine but die from the smoke…There are now rapid developments in nicotine-based products that can effectivelysubstitute for cigarettes but with very low risks.”
The EU, the WHO, and other bodies would serve the public well if they could garner the fortitude to put aside any preconceived notions about products of the private sector, and simply follow only the science.
The FDA should follow that science and apply already existing common sense regulations by swiftly approving Swedish Match’s application. Doing so would not only encourage smokers to quit, but it would give industry enough confidence in the regulatory system so that the private sector will continue to invest in other harm reduction approaches. As far as public health is concerned, the more non-cigarette options available, the better.
[Originally published at Pundicity]