Electronic Cigarettes Protect Consumer and Public Health
November 26, 2013
Ottawa, Canada
Presentation by
Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com
Good morning,
For disclosure, neither I nor Smokefree Pennsylvania have ever received any funding from any tobacco, drug or electronic cigarette company or trade association.
More than 99% of all tobacco attributable morbidity, mortality and health care costs in the US are caused by daily inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco and nicotine products. Epidemiological evidence indicates that cigarettes are at least 100 times more hazardous than smokefree nicotine and tobacco products marketed in the US, including smokeless tobacco, e-cigarettes and NRT products.
According to CDC and ACS data, daily cigarette smoking causes 438,000 deaths annually in the US. In contrast, scientific evidence indicates that smokeless tobacco causes several dozen oral cancer deaths annually, and there’s no evidence e-cigarettes have ever killed anyone. On a continuum of risk from 1 to 100 on which FDA approved NRT products are 1 and cigarettes are 100, all other noncombustible tobacco/nicotine products are below 2.
E-cigarettes and other smokefree tobacco products have very similar or superior health and safety risk/benefit profiles as FDA approved nicotine products.
While 33 million daily cigarette smokers in America face huge morbidity and mortality risks, tobacco use poses negligible if any disease risks for another 36 million tobacco users in the US (including 10M smokeless tobacco users, 13M cigar smokers, 12M non daily cigarette smokers, and 1-2M e-cigarette users).
Although cigarette smoking is clearly harmful, isn’t considered a disease or disorder. Rather, the US Public Health Service and the FDA consider “tobacco dependence” (not smoking) to be a disorder that should be treated with FDA approved drugs.
These drugs include NRT gums, lozenges and patches, which have a 95% failure rate for treating “tobacco dependence” and for “smoking cessation”. Unfortunately, DHHS and other NRT promoters have refused our many requests to inform smokers of NRT’s dismal success rate.
Another FDA approved drug for treating “tobacco dependence” is Chantix, which increases heart attack risks, and has resulted in 2,600 lawsuits filed against Pfizer for suicides, suicidal thoughts and depression. But public health officials, drug companies and many of their funding recipients continue claiming that all FDA approved drugs are “safe and effective”, and are the most effective ways to quit smoking.
Nicotine is very similar to caffeine, as both can cause daily dependence, and cause temporary increases in blood pressure and heart rate. If millions of North Americans smoked dried up tea leaves many times daily to obtain their caffeine, many would get lung cancer, emphysema and heart disease. But instead of demonizing “caffeine dependence” and banning caffeine, public health officials would truthfully inform consumers they can sharply reduce their disease risks by consuming caffeine in coffee, tea and soft drinks instead of smoking it.
Although nicotine has been condemned by many as toxic poison, there’s no evidence that that consuming even 250 mg of nicotine is fatal.
The large and rapidly growing mountain of evidence has found that e-cigarettes are 99% (+/-1%) less hazardous than cigarettes, have never been found to create nicotine dependence in any nonsmoker, and have never been found to precede cigarette smoking in any daily smoker.
E-cigs emit similar trace levels of constituents as FDA approved nicotine inhalers, posing no risks to nonusers, are consumed almost exclusively (i.e. 99%) by smokers and former smokers who quit by switching to e-cigs, and are not marketed to children.
E-cigs have helped several million smokers quit and/or sharply reduce cigarette consumption, have replaced (reduced consumption of) nearly 1 Billion packs of cigarettes in the US in the past five years, are more effective than FDA approved nicotine gums, lozenges, patches and inhalers for smoking cessation and reducing cigarette consumption, and pose fewer risks than FDA approved Verenicline (Champix).
The US CDC recently released select survey data finding that e-cig use by teens doubled from 1% to 2% from 2011 to 2012. But far more importantly, that CDC survey found teen smokers were >20 times more likely than nonsmokers to report e-cig use in both years, which is evidence that e-cigs are a gateway away from (not towards) cigarette smoking.
Unfortunately, the CDC has refused to acknowledge this extremely important finding, and instead has repeatedly claimed that e-cigs are addicting teens, are gateways to cigarettes, and that nicotine is very dangerous to lobby for FDA e-cigarette regulations.
Another recent survey found that teen smokers in NY and CT high schools were 55 times more likely than nonsmokers to have reported e-cig use, while a new US survey of adults found that smokers were 156 times more likely than never smokers to report e-cig use.
Unfortunately, since 2009, many drug industry funded health and medical groups have also made false and misleading fear mongering claims about e-cigs to lobby FDA to unlawfully ban e-cigs in 2009 and to lobby for FDA e-cig regulations as tobacco products since 2011.
Due to sharp differences over smokeless tobacco and now e-cigs, the old anti smoking movement has split into two opposing factions, tobacco harm reduction public health advocates whose goal is to reduce cigarette deaths, diseases and consumption versus abstinence-only prohibitionists who demonize all things tobacco.
But those just as abstinence-only alcohol, ......... and birth control prohibition and propaganda failed miserably, so will anti tobacco moralism. Please remember that the “perfect is the enemy of the good”.
After banning e-cigarette imports in 2009, Obama appointed FDA Deputy Commissioner Josh Sharfstein retaliated against two e-cigarette companies (SE/NJOY) for suing the agency by holding a press conference falsely claiming e-cigs were target marketed to kids and that there was no evidence e-cigarettes helped smokers quit. Sharfstein also misled the public to believe e-cigs were toxic and caused cancer even though FDA’s lab report found similar nitrosamine levels in e-cigs as are in FDA approved NRT, and even though the one so-called toxin found in just one of 20 e-cig samples was at a nontoxic level.
The FDA’s ban also turned e-cigs into a partisan political issue, as several Democrat State AGs retaliated by suing the two e-cigarette companies that sued the FDA after their e-cig shipments were confiscated. And in the past four years, 95% of state and local legislation to ban e-cig sales and ban e-cig use where smoking is banned were sponsored by liberal Democrats.
At the federal level, after 13 federal judges unanimously struck down FDA’s e-cig import ban as unlawful, in 2011 the FDA stated its intent to regulate e-cigs as tobacco products under Chapter IX of the TCA. Since 2011, liberal Congressional Democrats have repeatedly urged the FDA to impose the deeming regulation and additional regulations for e-cigarettes, cigars and dissolvables, and they’ve introduced bills to unfairly tax e-cigarettes at the same rate as cigarettes.
And after four decades of truthfully informing Americans that cigarette smoking is the leading cause of disease and death, Obama appointees at DHHS have deceptively claimed the leading cause of death is “tobacco use” instead of cigarette smoking.
Despite all of these actions against e-cigs, e-cigarette sales in the US have continued to skyrocket, surpassing $500 million in sales last year, with a projected $2 billion in sales in 2013. In contrast, NRT sales have remained stagnant at $1 billion annually for the past decade.
Wall Street tobacco stock analysts credit the rapid e-cigarette sales growth for the 4.5% decline in cigarette sales volume this year, the largest decline since 2009 when the largest federal cigarette tax in history occurred.
The TCA states that the FDA may deem other tobacco products under Chapter IX regulations, and may impose new regulations on products “if the Secretary of DHHS determines that such regulation would be appropriate for the protection of public health.” To date, FDA hasn’t provided any evidence that e-cig regulations would protect public health, and no evidence appears to exist.
A proposed "deeming" regulation could be just several pages, and would include definitions for all categories of newly regulated products, including e-cigarette products.
But Sections 905(j) and 910 of the TCA would ban all e-cigarettes currently on the market, and would require FDA to approve all e-cig products before they can be introduced to the market.
To avoid losing another lawsuit, FDA may exempt e-cigs from the outright ban. But even if that occurs, the FDA deeming regulation would halt product development by requiring FDA approval to market new e-cig products, and would require all e-cigs to be approved by the FDA to remain on the market within several years.
Since FDA’s 2009 e-cigarette import ban created a rapidly growing black market for e-cigarettes, and since the TCA requires FDA to consider the impact of black markets in promulgating new regulations, new FDA regs could prompt another lawsuit against the agency.
Besides the deeming regulation, the FDA would have to impose additional regulations to restrict e-cig marketing, nicotine levels, and/or flavorings.
Since the FDA and CDC have falsely accused e-cigarette companies of target marketing to youth, FDA regs almost certainly would ban e-cig sales to minors, and are likely to apply many cigarette marketing restrictions to e-cigs. But 25 of the 50 US states have already banned e-cig sales to minors, and the remaining states could do so by next year. In contrast, two years are likely to pass before any proposed FDA e-cig regulations become law.
Despite no evidence that nicotine levels in e-cigs are hazardous, and despite no nicotine restrictions on cigarettes, the FDA may propose a regulation to limit nicotine levels in e-cigs. Nicotine restrictions in the EU Tobacco Products Directive that was rejected by the EU Parliament in October would have banned all e-cigs now on the market, while the newly proposed EU directive would ban 99% of all e-cigs on the market.
Since the FDA has falsely claimed that flavored e-cigarettes are target marketed to children, the FDA may propose a regulation to ban most/all flavorings in e-cigarette products. While the TCA banned so-called candy flavored cigarettes, those banned products never accounted for more than one tenth of one percent of the cigarette market. In contrast, a flavoring ban on e-cigs would ban the vast majority of e-cig products on the market.
In sum, the deeming regulation for e-cigarettes and other FDA regs would ban all or virtually all e-cig products and e-cig companies, would give the entire e-cig industry to Big Tobacco, would almost certainly create totally unregulated black markets, and would threaten the lives of vapers and smokers. That’s also why Altria has been lobbying for FDA to regulat e-cigs.
Smokers have a human right to truthful health information and legal access to less hazardous alternatives, and public health officials and other public health professionals have an ethical duty to inform smokers that all smokefree tobacco and nicotine products are far less hazardous alternatives to cigarettes, and to keep all less hazardous alternatives legal and affordable for smokers.
Instead of wasting public dollars lying about e-cigs and imposing unwarranted bans and regulations, public health officials and advocates should begin to study the impact of e-cigs on users, and should support e-cig industry efforts to further reduce cigarette consumption.
In February, more than 28,000 e-cigarette consumers signed a White House Petition urging the administration to not let the FDA ban or restrict e-cigarettes. We’re still waiting for the White House to respond.
While not understanding Canadian law, I urge Health Canada to rescind its stated e-cig sales ban ASAP, and to truthfully inform smokers that e-cigs are far less hazardous alternatives to cigarettes. Its also important to not ban e-cig advertising or product displays at retail stores because they inform smokers that e-cigs are available and help inform smokers about the new alternatives.
Banning e-cig sales to minors and banning e-cig use at K-12 schools is appropriate, but there’s no public health justification for laws banning e-cig use at other workplaces or public places, or to tax e-cigs.
Thank you.
