The National Legal and Policy Center, which is committed to promoting open, accountable and ethical practices related to health care policy, advised the U.S. Senate today that a bill to give the Food & Drug Administration regulatory authority over tobacco products would, as written, “limit consumer access to critical health information.”
29 October 2013
By Dick Puddlecote
A couple of weeks ago, this is what a government spokesman said of e-cigs following the very sensible rejection by the EU of medical licensing.
Earl Howe (Parliamentary Under Secretary of State (Quality), Health; Conservative)
My Lords, […] we are disappointed that the Commission’s proposal to regulate nicotine-containing products, including e-cigarettes, as medicines was not supported by the European Parliament. We believe that these products need to be regulated as medicines and we will continue to argue for this during further negotiations.
[…]
It is undoubtedly true that we can never do enough to raise our game on smoking cessation measures, one of them being nicotine-containing products.
[…]
My Lords, our position is clear: e-cigarettes should be regulated as medicines. These products need to be regulated for safety and quality, one of the reasons being that, as medicines, we can more effectively control their sale to children and the way that they are advertised and promoted.
[…]
My noble friend is right. E-cigarettes certainly have the potential for being a force for good in helping smokers to quit. At the same time, we do not want them to become a gateway into smoking.
Just as an aside, this is indeed the same Earl Howe who happily references tobacco control propaganda denying that a single pub has closed because of the smoking ban; who was in favour of plain packaging of tobacco by the end of 2011 with his puppet-master Debs Arnott viewing from the gallery; and who heldclandestine meetings with CRUK to discuss plain packs while the {cough} impartial consultation was still ongoing.
In short, he’s firmly in the pocket of pharma lobbyists.
Yesterday, new Under-Secretary of State Jane Ellison revealed a little more about the government’s approach to the Tobacco Products Directive (TPD) includingthis on e-cigs.
We are currently considering the detailed amendments that the European Parliament would like to make. We were disappointed that the Parliament did not support the regulation of nicotine-containing products as medicines. We believe that the medicines regulatory regime, applied with a light touch, is the best fit for these products. Although I cannot say too much more about that now, we recognise that there is a lively ongoing debate on that subject, and it is one that we are engaged in.
Indeed they are. Because, you see, they didn’t think the TPD was dictatorialenough!
We want member states to have the flexibility to make further progress on domestic tobacco control measures in certain key areas, potentially going beyond the new directive, and we have been helping to shape the final text of article 24 to try to achieve that as an objective.
Presumably this means striving to ensure that the MHRA – a body only last year described as “an organisation whose activities are entirely financed by a levy from the pharmaceutical industry” – are free to classify e-cigs as medicines regardless, and for the government to ignore half a million of its electorate (or 64% of those they consulted) by introducing evidence-free plain packaging.
Indeed, preserving this sovereign ‘freedom’ was precisely what motivated Ellison’s predecessor Anna Soubry to usurp democratic parliamentary process by voting on the TPD without consulting the EU Scrutiny Committee as she was supposed to do back in the summer.
It doesn’t seem to matter whether you’re a smoker or a vaper, Howe, Ellison and their Department of Health chums will do pharma-backed tobacco control’s bidding whatever you or the EU think.
It comes to something when our own government is more extreme, unaccountable and undemocratic than the EU, doesn’t it?
10/9/2013
“The European Parliament’s decision not to treat e-cigarettes like medical devices is a huge win for smokers trying to quit, and thus great news for public health. Such a move would have made e-cigarettes prohibitively expensive and would have sent the wrong message to cigarette smokers who would consider using e-cigarettes to quit cigarettes?
“Switching from burning tobacco to combustion-free e-cigarettes would yield significant health benefits both in the short and long terms.? Banning e-cigarette sales to minors, but keeping them accessible to adults, strikes the right balance.?
“But as usual, activists on the nanny state side want the government to get in the way of free-market approaches that work. That they didn’t succeed in Europe is a big win for (actual) public health, but a loss for ideologically driven activist groups. Now, attention shifts to the U.S., where FDA has promised a decision very soon. We can only hope that the FDA takes note of Europe’s rational approach.”?
Jeff Stier
Senior Fellow National Center for Public Policy Research
media@heartland.org
312/377-4000??
10/1/2013
http://heartland.org/policy-documents/research-commentary-age-restrictions-electronic-cigarettes
Age Restrictions for Electronic Cigarettes
Thousands of American smokers trying to quit have tried electronic cigarettes, or “e-cigarettes,” sales of which have doubled in recent years. These devices, designed as nicotine replacement products, have become key components in tobacco harm reduction strategies. As electronic cigarettes grow in popularity, state and local governments across the nation are initiating efforts to regulate and tax the products.
E-cigarettes simulate the physical and psychological act of smoking while eliminating the harmful chemicals and smoke found in conventional cigarettes. They work by vaporizing a solution of either propylene glycol or glycerin with a weak concentration of nicotine. This allows smokers to replace the nicotine in cigarettes in a controlled manner while reducing the harms involved.
Enforcing an age limit for those seeking to purchase e-cigarettes is common sense and fits with current laws regulating other products such as tobacco and alcohol. According to The Wall Street Journal, more than a dozen states, including Arkansas, Colorado, and Maryland, have banned e-cigarette sales to minors, and in the past year six additional states have proposed legislation that would prohibit sales to minors. These laws fine retailers who violate the age laws.
Prohibiting the sale of e-cigarettes to minors enjoys wide support, although opposition has arisen from some anti-smoking groups who oppose the restrictions and are pushing instead for a full ban on e-cigarette purchases.
Several studies have found e-cigarettes are an effective and viable option for smokers seeking a nicotine replacement therapy. A recent clinical trial in New Zealand showed e-cigarettes are as effective as nicotine patches in helping smokers quit. The American Association of Public Health Physicians has concluded e-cigarettes “could save the lives of 4 million of the 8 million current adult American smokers who will otherwise die of a tobacco-related illness over the next 20 years.”
Like many other legal nicotine products, e-cigarettes are not intended for use by minors. Expanding existing age restrictions to e-cigarettes is a logical step in protecting against abuse. However, legislators must avoid overregulating and overtaxing e-cigarettes, because that would disrupt an increasingly popular and successful method of helping Americans reduce smoking or quit altogether.
The following articles examine electronic cigarettes and efforts to regulate their sale and use from multiple perspectives.
Electronic Cigarette Legislation Prohibiting Sale to Minors in Other Stateshttp://heartland.org/policy-documents/electronic-cigarette-legislation-prohibiting-sale-minors-other-statesThis chart outlines the proposals considered in various states to prohibit the sale of electronic cigarettes to minors.?
Tobacco and Tobacco Products at a Crossroads in the 21st Centuryhttp://heartland.org/policy-documents/tobacco-and-tobacco-products-crossroads-21st-centuryTobacco and health policy consultant Scott D. Ballin outlines several considerations he says must be part of the debate if further improvement in harm reduction is to continue.?
The Clueless Crusade to Ban E-Cigaretteshttp://reason.com/archives/2013/08/28/the-clueless-crusade-to-ban-e-cigarettes#commentWriting for the Reason Foundation, Nick Gillespie discusses the effort to ban e-cigarettes and the motivation such bans.?
Regulatory Options for Electronic Cigaretteshttp://publichealthlawcenter.org/sites/default/files/pdf/tclc-fs-regulatory-options-e-cigarettes-2013.pdfThis fact sheet from the Tobacco Control Legal Consortium examines the perspective of e-cigarette opponents and provides a brief overview of e-cigarettes, their potential health risks, gaps in current federal and state regulation, and some approaches state and local governments might consider to regulate their use, pricing,sale, and marketing.?
Research & Commentary: Electronic Cigaretteshttp://heartland.org/policy-documents/research-commentary-electronic-cigarettesMatthew Glans of The Heartland Institute examines tobacco harm reduction and proposals to regulate e-cigarette use. Electronic cigarettes have quickly become one of the most popular nicotine replacement products and a key building block in tobacco harm reduction strategies.?
E-Cigarette Regulation: Take Sensible Approach to Help Smokers Quithttp://news.heartland.org/editorial/2013/08/19/e-cigarette-regulation-take-sensible-approach-help-smokers-quitJeff Stier of the National Center for Public Policy Research discusses the efforts to regulate e-cigarettes and why e-cigarettes have come under scrutiny. Stier argues nicotine’s bad reputation comes not from any inherent dangers with the chemical, but with the dangers from its most common delivery device, cigarettes. “Nicotine itself is about as dangerous as the caffeine in soda,” he writes. “Along the same lines, while too much soda can cause weight gain, nobody seriously suggests that caffeine causes obesity. Similarly, e-cigarettes provide the nicotine and the habitual activity of smoking, without the danger of burning tobacco.”?
The Case Against Smoking Banshttp://www.cato.org/pubs/regulation/regv29n4/v29n4-4.pdfThomas A. Lambert, an associate professor at the University of Missouri-Columbia School of Law, contends the market is the best place to make decisions regarding smoking. He writes, “a laissez-faire approach better accommodates heterogeneous preferences regarding public smoking.”?
Electronic Cigarettes as a Harm Reduction Strategy for Tobacco Control: A Step Forward or a Repeat of Past Mistakes?http://www.palgrave-journals.com/jphp/journal/v32/n1/abs/jphp201041a.htmlZachary Cahn and Michael Siegel review the existing evidence on the safety and efficacy of electronic cigarettes. They then revisit the tobacco harm reduction debate, with a focus on these novel products. Cahn and Siegel conclude electronic cigarettes show tremendous promise in the fight against tobacco-related morbidity and mortality. By dramatically expanding the potential for harm reduction strategies to achieve substantial health gains, they may fundamentally alter the tobacco harm reduction debate.?
Nothing in this Research & Commentary is intended to influence the passage of legislation, and it does not necessarily represent the views of The Heartland Institute. For further information on this and other topics, visit The Heartland Institute’s Web site at http://heartland.org, and PolicyBot, Heartland’s free online research database, at www.policybot.org.?
If you have any questions about this issue or The Heartland Institute, contact Heartland Legislative Specialist Matthew Glans at 312/377-4000 or mglans@heartland.org.
A Compilation of the Materials from the July 21-22, 2011, January 18-20, 2012 and March 1, 2012 meetings of the Tobacco Products Scientific Advisory Committee
March 28, 2012
Heartland Institute experts today praised a new report from the Food and Drug Administration that says dissolvable tobacco products are less harmful than smoking cigarettes.
The report, available online here? http://www.fda.gov/tobaccoproducts/? deals with finely milled tobacco products that dissolve in the user’s mouth. In addition to confirming that such products are less dangerous than cigarettes, the FDA report warns dissolvable products could increase the total number of tobacco users.
________________________________________
“Smokeless products are so much less harmful than cigarettes that even if there were more total tobacco users, the total amount of disease and death caused by tobacco use would decline dramatically because of the shift to far less risky products. Personally, I’d rather see more tobacco users and less illness. Yes, even if that meant more profits for tobacco companies. I doubt most anti-tobacco activists would be willing to agree.”
Jeff Stier
Senior Fellow
National Center for Public Policy Research
jeffstier@gmail.com
________________________________________
“For once, the FDA is showing it has some sense. Hardly anything works consistently to help people quit smoking. And, although no tobacco product is safe, some are safer than others. If people switch to other, safer tobacco products it could save lives.”
Eli Lehrer
Vice President, DC Operations
The Heartland Institute
elehrer@heartland.org
202/615-0586
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The Heartland Institute is a 28-year-old national nonprofit organization with offices in Chicago, Illinois and Washington, DC. Its mission is to discover, develop, and promote free-market solutions to social and economic problems. For more information, visit our Web site or call 312/377-4000.
EUDOXA BULLETIN BLOG
May 30, 2007
*** Institute on Medicine ***
*** Associated Content ***
*** International Harm Reduction Association ***
Jacob Sullum
?
??? WASHINGTON, Feb. 28, 2007 /PRNewswire-USNewswire/ — The National Legal and
Policy Center, which is committed to promoting open, accountable and
ethical practices related to health care policy, advised the U.S. Senate
today that a bill to give the Food & Drug Administration regulatory
authority over tobacco products would, as written, “limit consumer access
to critical health information.”
??? Testimony submitted to the Senate Committee on Health, Education,
Labor, and Pensions by NLPC Chairman Kenneth F. Boehm said the organization
“strongly questions the policies promoted by S.625, a bill that would
prohibit companies from educating consumers about the relative risk
associated with various forms of tobacco products.”
??? Boehm said the most dramatic example of relative risk is a comparison
of cigarettes with smokeless tobacco products. Britain’s Royal College of
Physicians reports that smokeless tobacco “is on the order of 10-1,000
times less hazardous than smoking, depending on the product.” They suggest
that producers of smokeless tobacco products might market them “as a ‘harm
reduction’ option for nicotine users.”
??? “That is but one element of a wide body of evidence and substantial
scientific consensus that the use of smokeless tobacco involves
significantly less risk than cigarette smoking,” Boehm said. The majority
of smokers are addicted to nicotine, a substance that is no more harmful
than caffeine, which is also addictive. Smokeless tobacco has been shown to
be 98 percent safer than cigarettes.
??? “Smokers should have ready access to the basic tobacco harm reduction
fact: smokeless tobacco can satisfy nicotine cravings while substantially
reducing health risk. Yet S.625 would prohibit dissemination of this
information by the manufacturers and marketers of tobacco products. Why?”
Boehm asks.
??? One reason, he told the Senate, may be the “anti-science attitude of
outright tobacco prohibitionists who are among the bill’s supporters, if
not designers.” Recently, the NLPC took to task the government’s National
Institute on Aging for misleading Americans on this issue. A second reason
for the bill’s dangerous restriction on relative risk communication may be
from the nation’s largest cigarette manufacturer and marketer, which could
gain a competitive advantage from these marketing restrictions.
??? “Whatever the reason, perpetuating the myth that all tobacco products
are equal in their health impact would be a serious error,” Boehm said.
??? A National Cancer Institute-funded study concluded: “[Smokeless]
products pose a substantially lower risk to the user than do conventional
cigarettes. This finding raises ethical questions concerning whether it is
inappropriate and misleading for government officials or public health
experts to characterize [smokeless] products as comparably dangerous with
cigarette smoking.”
??? Said Boehm, “As it is presently written, with a prohibition on
marketing claims that set forth truthful relative risk comparisons of
tobacco products, S.625 is a seriously flawed bill. We urge this committee
to amend the bill accordingly. The public health demands it.”
?
