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Impact of FDA Deeming Regulation on Public Health
FDLI Annual Conference
April 23, 2013
Washington, DC
Presentation by
Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com
I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to ban smoking in workplaces, reduce tobacco marketing to youth, hold cigarette companies accountable in civil litigation, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that smokefree tobacco/ nicotine products are far less hazardous alternatives to cigarettes, and ensure that smokefree alternatives remain legal and affordable to smokers. In 2007, I convinced Sen. Mike Enzi to amend to TCA to require graphic warnings on cigarette packs. In 2009, we urged FDA to keep electronic cigarettes legal, and in 2010 we filed an amicus brief with the DC Court of Appeals in support of njoy’s lawsuit against FDA’s unlawful e-cigarette import ban.
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 the CDC, daily cigarette smoking causes 438,000 deaths annually in the US. The 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 noncombustible tobacco/nicotine products are below 2.
In fact, e-cigarettes, dissolvables and smokeless tobacco products have very similar or superior health/safety risk/benefit profiles as FDA approved nicotine products.
Cigars are also far less hazardous than cigarettes because only a small percentage of cigar smokers inhale the smoke, and because only a small percentage smoke multiple cigars daily.
While 33 million daily cigarette smokers in America face enormous morbidity and mortality risks, tobacco use poses negligable disease risks for most of the nation’s nearly 70 million tobacco users (including 10M smokeless tobacco users, 14M cigar smokers, 12M non daily cigarette smokers, 1M pipe smokers and several M e-cigarette users).
Scientific evidence indicates that switching from cigarettes to smokefree tobacco products reduces a smoker’s disease risks nearly as much as quitting all tobacco and nicotine use. Survey and sales data indicate that more than a million smokers have quit smoking by switching to smokeless tobacco products, and that several million smokers have switched to e-cigarettes in just the past several years.
While cigarette smoking is the leading cause of disease and death, smoking is not considered a disease or disorder. Rather, the US Public Health Service and the FDA consider “tobacco dependence” (not smoking) to be a disorder that must be treated with FDA approved drugs.
These drugs include nicotine gums, lozenges and patches, which clinical trials have found to have a 95% failure rate for treating “tobacco dependence” and for “smoking cessation”. I’m not aware of any other FDA approved drug that has a 95% failure rate, and DHHS has refused our 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 resulted in 2,600 lawsuits filed against Pfizer for suicides, suicidal thoughts and depression. Yet, the FDA and drug industry funded groups 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 Americans smoked dried up tea leaves multiple times daily to obtain their caffeine, many would get lung cancer, emphysema and heart disease. But instead of condemning “caffeine dependence” and banning caffeine, public health officials would simply inform consumers they can sharply reduce their disease risks by consuming caffeine in coffee, tea and soft drinks instead of smoking it.
Although nicotine is demonized by many as toxic and lethal, there’s no evidence anyone has ever died from consuming nicotine.
The large and rapidly growing mountain of evidence has found that e-cigarettes:
- are >99% less hazardous than cigarettes,
- pose no risks to nonusers,
- have helped at least a millon smokers quit,
- have helped millions of other smokers sharply reduce cigarette consumption,
- may not be addictive as there’s no evidence they’ve ever addicted any nonsmoker or youth, and
- aren’t marketed to children.
But during the past 20 years, J & J, GSK, Pfizer and other drug companies have given several hundred million dollars to CTFK, ACS, AHA, ALA, AMA, Pinney Associates (which employed Mitch Zeller for the past decade) and others to promote FDA approved drugs as the only effective way to quit smoking, and to demonize and lobby for bans and unwarranted regulations on smokefree tobacco products and e-cigarettes.
The old anti smoking movement has split into two factions, public health advocates who want to reduce cigarette consumption and diseases, and the abstinence-only prohibitionists who are primarily funded by drug companies. But just as alcohol and ......... prohibition policies failed miserably, so will tobacco prohibition.
Early in 2009, Senator Frank Lautenberg and many drug industry funded front groups urged the FDA to ban e-cigarettes.
After unlawfully banning e-cigarette imports, Obama appointed FDA Deputy Commissioner and former Henry Waxman staffer Josh Sharfstein retaliated against two e-cigarette companies (SE/njoy) for suing the agency at a July 2009 press conference falsely claiming there was no evidence e-cigarettes helped smokers quit and that the products were target marketed to addict youth, and he misrepresented FDA’s laboratory test findings to scare the public to believe e-cigarettes were toxic and carcinogenic.
That event also turned e-cigarettes into a partisan crusade, as then CA AG Jerry Brown, then CT AG Richard Blumenthal and other Democrat State AGs also retaliated by suing the two e-cigarette companies that sued Obama’s FDA. Within a year, citing FDA’s fear mongering claims, liberal Democrat lawmakers in five states introduced bills to ban e-cigarette sales to adults, and John Corzine signed a bill banning the product’s use in NJ workplaces.
At the federal level, Senators Durbin, Lautenberg, Blumenthal and others have repeatedly urged FDA Commissioner Margaret Hamburg to issue the deeming regulation to apply Chapter IX of the TCA to e-cigarettes, cigars and dissolvables, and they’ve introduced bills (last session and this session) to unfairly tax e-cigarettes at the same rate as cigarettes.
Since 2011 when the FDA agreed to comply with Judge Richard Leon’s ruling prohibiting FDA from banning e-cigarettes, the FDA has refused to correct or clarify any of its false and misleading claims about e-cigarettes and companies.
After we presented and submitted lots of evidence to the FDA confirming that cigarettes are far more hazardous than smokefree tobacco and nicotine products (including e-cigarettes), the FDA created a webpage ironically called Health Fraud that claims in bold letters: “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products."
That statement is a blatant lie. And yet, the FDA still insists that its tobacco regulatory policies are based on scientific evidence. Many other FDA and DHHS websites also contain false and misleading fear mongering claims about e-cigarettes and other smokefree tobacco products.
The US military services have also misrepresented the risks and benefits of e-cigarettes, and restricted their use in recent years. In 2011, under pressure from Sen. Lautenberg, the US DOT proposed a regulation to ban e-cig use on airlines. A group of us submitted comments stating that the proposed regulation was unlawful, and US DOT hasn’t taken further action.
After decades of truthfully informing Americans that cigarette smoking is the leading cause of disease and death, Obama appointees at DHHS now deceptively claim its “tobacco use”.
Since urging enactment of the 1986 Comprehensive Smokeless Tobacco Education Act requiring intentionally deceptive fear mongering package warnings, DHHS has misled smokers to believe that smokeless tobacco is as hazardous as cigarettes, and the CDC has given Obama stimulus grants to state and local health departments to unlawfully lobby for laws seeking to ban the sale and/or use of e-cigarettes and other smokefree alternatives.
Despite this massive misinformation by the Obama admistration about the risk/benefit profile of e-cigarettes, and despite FDA’s unlawful ban on e-cigarettes from 2009 to 2011, e-cigarette sales in the US have skyrocketed, surpassing $500 million in sales last year, with a projected $1 billion in sales in 2013. In contrast, NRT sales have remained stagnant at $1 billion annually for more than a decade.
In recent weeks, three different Wall Street tobacco stock analysts have credited the rapid e-cigarette sales growth for the unexpected 4.5% decline in cigarette sales volume in the first quarter of 2013.
Smokers have a human right to truthful health information and legal access to less hazardous alternatives, and public health officials 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 scaring the public to believe that all tobacco products are as hazardous as cigarettes, the FDA and other DHHS agencies should collaborate with the public health community, consumers and industry to sharply reduce cigarette consumption.
FDA Deeming Regulation
Section 901(b) of the FSPTCA states: “This chapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this chapter.“
Since April 25, 2011 when the FDA conceded to comply with Judge Leon’s ruling, the agency has repeatedly stated its intent to propose a “deeming” regulation to apply Chapter IX of the FSPTCA to e-cigarettes, large cigars, little cigars, pipe tobacco, hookah/shisha, dissolvables and other unregulated tobacco products.
The TCA states that the FDA may impose new regulations on tobacco products “if the Secretary of DHHS determines that such regulation would be appropriate for the protection of public health. The finding as to whether such regulation would be appropriate for the protection of public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product.”
A proposed "deeming" regulation could be just a page or two long, and would include definitions for all categories of newly regulated products, including e-cigarette products.
But Sections 905(j) and 910 would ban all e-cigarettes that weren’t on the market before February 15, 2007 because FDA set May 2011 as the deadline to file SE applications for tobacco products already on the market, and because e-cigarette products now on the market are far superior to the ones marketed in 2007 (and as such, wouldn’t be considered “substantially equivalent” by the FDA).
To avoid losing another lawsuit, FDA might exempt e-cigarettes from the 2007 grandfather date. But even if FDA changed the grandfather date to 2103 for newly regulated products, all new e-cigarette products would be banned unless approved by FDA, which has yet to approve any "substantial equivalent" applications.
While Judge Leon’s ruling and the free market have enabled e-cigarette products to significantly improve over the past several years and save many smokers lives, the FDA deeming regulation would not only halt, but would reverse all that progress.
The TCA requires the FDA to consider the potential impact of black markets before approving new tobacco product regulations. Since FDA’s 2009 e-cigarette import ban created a thriving and rapidly growing black market for e-cigarettes, an FDA “deeming” regulation would create a far larger black market, which could threaten public health since there would be less incentive for black marketers to ensure quality control.
Unless the FDA exempts e-cigarettes from Section 911, manufacturers and importers would be prohibited from truthfully informing smokers that their products are less hazardous than cigarettes. Just to submit an MRTP application, manufacturers would have to spend tens of millions of dollars on unnecessary research.
Unless the FDA extends the smokeless tobacco exemption in 911(b)(2)(C) to e-cigarettes, manufacturers couldn’t even truthfully claim that e-cigarettes are "smoke free" or emit "no smoke".
Section 900 defines "Tobacco Product Manufacturer" as "any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a tobacco product" and anyone who "imports a finished tobacco product for sale or distribution in the US". This and other provisions in Chapter IX would increase prices, and destroy or drive underground hundreds of small e-cigarette companies. And if FDA exempts e-cigarettes from the worst provisions of Chapter IX, the deeming regulation would establish an oligopoly, basically giving the e-cigarette industry to Big Tobacco.
Title 1, Section 101 defines a "Tobacco Product" as "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product." Thus, FDA "deeming" regulation could result in FDA regulations on e-cigarette hardware, cartridges, batteries and rechargers.
Potential Additional FDA Regulations for E-cigarettes
A deeming regulation would just require e-cigarettes to comply with Chapter IX provisions that pertain to “tobacco products”, and FDA would have to propose/approve additional regulations to specifically regulate e-cigarettes and other currently unregulated products.
Since the FDA falsely accused e-cigarette companies of target marketing to youth, additional regulations would likely include a sales ban to minors. Although there’s no evidence the products are marketed to youth, e-cigarette companies and consumers groups have supported state laws banning their sale to minor, while drug industry funded e-cigarette prohibitionists have opposed these laws.
New FDA regulations may restrict e-cigarette advertising, promotions and sponsorships, which would further protect cigarettes from market competition by e-cigarettes.
Despite no evidence that nicotine consumption is hazardous, and despite no nicotine restrictions on cigarettes, the FDA might propose a regulation to limit nicotine levels in the products. If similar to the EU Tobacco Products Directive, all e-cigarettes would be banned except no-nicotine e-cigarettes, which account for only about 5% of the e-cigarette market.
Although there’s no evidence e-cigarettes have ever created nicotine addiction in a nonsmoker, the FDA might propose a mandatory package warning stating the product is addictive.
Since the FDA has falsely claimed that flavored e-cigarettes are target marketed to children, the FDA may propose a regulation to ban some/most/all flavorings in e-cigarette products. While the TCA banned cigarette flavorings that never accounted for more than one tenth of one percent of the cigarette market share, a flavoring ban would have far greater impact on market shares of e-cigarettes, cigars and smokeless tobacco. There’s NO evidence, but lots of false accusations by drug industry funded groups, that flavored tobacco products are target marketed to youth.
In sum, a deeming regulation for e-cigarettes would threaten the lives of cigarette smokers and e-cigarette consumers, and would only protect existing cigarette and drug industry markets. FDA’s actions on e-cigarettes since 2009 have been unethical public health malpractice. The FDA should begin to truthfully inform smokers that e-cigarettes and other smokefree tobacco products are far less hazardous alternatives to cigarettes. States should and have been banning sales to minors, but there’s no public health justification for federal regulations for these life saving products.
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.
Thank you,
FDLI Annual Conference
April 23, 2013
Washington, DC
Presentation by
Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
smokefree@compuserve.com
I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to ban smoking in workplaces, reduce tobacco marketing to youth, hold cigarette companies accountable in civil litigation, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that smokefree tobacco/ nicotine products are far less hazardous alternatives to cigarettes, and ensure that smokefree alternatives remain legal and affordable to smokers. In 2007, I convinced Sen. Mike Enzi to amend to TCA to require graphic warnings on cigarette packs. In 2009, we urged FDA to keep electronic cigarettes legal, and in 2010 we filed an amicus brief with the DC Court of Appeals in support of njoy’s lawsuit against FDA’s unlawful e-cigarette import ban.
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 the CDC, daily cigarette smoking causes 438,000 deaths annually in the US. The 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 noncombustible tobacco/nicotine products are below 2.
In fact, e-cigarettes, dissolvables and smokeless tobacco products have very similar or superior health/safety risk/benefit profiles as FDA approved nicotine products.
Cigars are also far less hazardous than cigarettes because only a small percentage of cigar smokers inhale the smoke, and because only a small percentage smoke multiple cigars daily.
While 33 million daily cigarette smokers in America face enormous morbidity and mortality risks, tobacco use poses negligable disease risks for most of the nation’s nearly 70 million tobacco users (including 10M smokeless tobacco users, 14M cigar smokers, 12M non daily cigarette smokers, 1M pipe smokers and several M e-cigarette users).
Scientific evidence indicates that switching from cigarettes to smokefree tobacco products reduces a smoker’s disease risks nearly as much as quitting all tobacco and nicotine use. Survey and sales data indicate that more than a million smokers have quit smoking by switching to smokeless tobacco products, and that several million smokers have switched to e-cigarettes in just the past several years.
While cigarette smoking is the leading cause of disease and death, smoking is not considered a disease or disorder. Rather, the US Public Health Service and the FDA consider “tobacco dependence” (not smoking) to be a disorder that must be treated with FDA approved drugs.
These drugs include nicotine gums, lozenges and patches, which clinical trials have found to have a 95% failure rate for treating “tobacco dependence” and for “smoking cessation”. I’m not aware of any other FDA approved drug that has a 95% failure rate, and DHHS has refused our 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 resulted in 2,600 lawsuits filed against Pfizer for suicides, suicidal thoughts and depression. Yet, the FDA and drug industry funded groups 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 Americans smoked dried up tea leaves multiple times daily to obtain their caffeine, many would get lung cancer, emphysema and heart disease. But instead of condemning “caffeine dependence” and banning caffeine, public health officials would simply inform consumers they can sharply reduce their disease risks by consuming caffeine in coffee, tea and soft drinks instead of smoking it.
Although nicotine is demonized by many as toxic and lethal, there’s no evidence anyone has ever died from consuming nicotine.
The large and rapidly growing mountain of evidence has found that e-cigarettes:
- are >99% less hazardous than cigarettes,
- pose no risks to nonusers,
- have helped at least a millon smokers quit,
- have helped millions of other smokers sharply reduce cigarette consumption,
- may not be addictive as there’s no evidence they’ve ever addicted any nonsmoker or youth, and
- aren’t marketed to children.
But during the past 20 years, J & J, GSK, Pfizer and other drug companies have given several hundred million dollars to CTFK, ACS, AHA, ALA, AMA, Pinney Associates (which employed Mitch Zeller for the past decade) and others to promote FDA approved drugs as the only effective way to quit smoking, and to demonize and lobby for bans and unwarranted regulations on smokefree tobacco products and e-cigarettes.
The old anti smoking movement has split into two factions, public health advocates who want to reduce cigarette consumption and diseases, and the abstinence-only prohibitionists who are primarily funded by drug companies. But just as alcohol and ......... prohibition policies failed miserably, so will tobacco prohibition.
Early in 2009, Senator Frank Lautenberg and many drug industry funded front groups urged the FDA to ban e-cigarettes.
After unlawfully banning e-cigarette imports, Obama appointed FDA Deputy Commissioner and former Henry Waxman staffer Josh Sharfstein retaliated against two e-cigarette companies (SE/njoy) for suing the agency at a July 2009 press conference falsely claiming there was no evidence e-cigarettes helped smokers quit and that the products were target marketed to addict youth, and he misrepresented FDA’s laboratory test findings to scare the public to believe e-cigarettes were toxic and carcinogenic.
That event also turned e-cigarettes into a partisan crusade, as then CA AG Jerry Brown, then CT AG Richard Blumenthal and other Democrat State AGs also retaliated by suing the two e-cigarette companies that sued Obama’s FDA. Within a year, citing FDA’s fear mongering claims, liberal Democrat lawmakers in five states introduced bills to ban e-cigarette sales to adults, and John Corzine signed a bill banning the product’s use in NJ workplaces.
At the federal level, Senators Durbin, Lautenberg, Blumenthal and others have repeatedly urged FDA Commissioner Margaret Hamburg to issue the deeming regulation to apply Chapter IX of the TCA to e-cigarettes, cigars and dissolvables, and they’ve introduced bills (last session and this session) to unfairly tax e-cigarettes at the same rate as cigarettes.
Since 2011 when the FDA agreed to comply with Judge Richard Leon’s ruling prohibiting FDA from banning e-cigarettes, the FDA has refused to correct or clarify any of its false and misleading claims about e-cigarettes and companies.
After we presented and submitted lots of evidence to the FDA confirming that cigarettes are far more hazardous than smokefree tobacco and nicotine products (including e-cigarettes), the FDA created a webpage ironically called Health Fraud that claims in bold letters: “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products."
That statement is a blatant lie. And yet, the FDA still insists that its tobacco regulatory policies are based on scientific evidence. Many other FDA and DHHS websites also contain false and misleading fear mongering claims about e-cigarettes and other smokefree tobacco products.
The US military services have also misrepresented the risks and benefits of e-cigarettes, and restricted their use in recent years. In 2011, under pressure from Sen. Lautenberg, the US DOT proposed a regulation to ban e-cig use on airlines. A group of us submitted comments stating that the proposed regulation was unlawful, and US DOT hasn’t taken further action.
After decades of truthfully informing Americans that cigarette smoking is the leading cause of disease and death, Obama appointees at DHHS now deceptively claim its “tobacco use”.
Since urging enactment of the 1986 Comprehensive Smokeless Tobacco Education Act requiring intentionally deceptive fear mongering package warnings, DHHS has misled smokers to believe that smokeless tobacco is as hazardous as cigarettes, and the CDC has given Obama stimulus grants to state and local health departments to unlawfully lobby for laws seeking to ban the sale and/or use of e-cigarettes and other smokefree alternatives.
Despite this massive misinformation by the Obama admistration about the risk/benefit profile of e-cigarettes, and despite FDA’s unlawful ban on e-cigarettes from 2009 to 2011, e-cigarette sales in the US have skyrocketed, surpassing $500 million in sales last year, with a projected $1 billion in sales in 2013. In contrast, NRT sales have remained stagnant at $1 billion annually for more than a decade.
In recent weeks, three different Wall Street tobacco stock analysts have credited the rapid e-cigarette sales growth for the unexpected 4.5% decline in cigarette sales volume in the first quarter of 2013.
Smokers have a human right to truthful health information and legal access to less hazardous alternatives, and public health officials 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 scaring the public to believe that all tobacco products are as hazardous as cigarettes, the FDA and other DHHS agencies should collaborate with the public health community, consumers and industry to sharply reduce cigarette consumption.
FDA Deeming Regulation
Section 901(b) of the FSPTCA states: “This chapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this chapter.“
Since April 25, 2011 when the FDA conceded to comply with Judge Leon’s ruling, the agency has repeatedly stated its intent to propose a “deeming” regulation to apply Chapter IX of the FSPTCA to e-cigarettes, large cigars, little cigars, pipe tobacco, hookah/shisha, dissolvables and other unregulated tobacco products.
The TCA states that the FDA may impose new regulations on tobacco products “if the Secretary of DHHS determines that such regulation would be appropriate for the protection of public health. The finding as to whether such regulation would be appropriate for the protection of public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product.”
A proposed "deeming" regulation could be just a page or two long, and would include definitions for all categories of newly regulated products, including e-cigarette products.
But Sections 905(j) and 910 would ban all e-cigarettes that weren’t on the market before February 15, 2007 because FDA set May 2011 as the deadline to file SE applications for tobacco products already on the market, and because e-cigarette products now on the market are far superior to the ones marketed in 2007 (and as such, wouldn’t be considered “substantially equivalent” by the FDA).
To avoid losing another lawsuit, FDA might exempt e-cigarettes from the 2007 grandfather date. But even if FDA changed the grandfather date to 2103 for newly regulated products, all new e-cigarette products would be banned unless approved by FDA, which has yet to approve any "substantial equivalent" applications.
While Judge Leon’s ruling and the free market have enabled e-cigarette products to significantly improve over the past several years and save many smokers lives, the FDA deeming regulation would not only halt, but would reverse all that progress.
The TCA requires the FDA to consider the potential impact of black markets before approving new tobacco product regulations. Since FDA’s 2009 e-cigarette import ban created a thriving and rapidly growing black market for e-cigarettes, an FDA “deeming” regulation would create a far larger black market, which could threaten public health since there would be less incentive for black marketers to ensure quality control.
Unless the FDA exempts e-cigarettes from Section 911, manufacturers and importers would be prohibited from truthfully informing smokers that their products are less hazardous than cigarettes. Just to submit an MRTP application, manufacturers would have to spend tens of millions of dollars on unnecessary research.
Unless the FDA extends the smokeless tobacco exemption in 911(b)(2)(C) to e-cigarettes, manufacturers couldn’t even truthfully claim that e-cigarettes are "smoke free" or emit "no smoke".
Section 900 defines "Tobacco Product Manufacturer" as "any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a tobacco product" and anyone who "imports a finished tobacco product for sale or distribution in the US". This and other provisions in Chapter IX would increase prices, and destroy or drive underground hundreds of small e-cigarette companies. And if FDA exempts e-cigarettes from the worst provisions of Chapter IX, the deeming regulation would establish an oligopoly, basically giving the e-cigarette industry to Big Tobacco.
Title 1, Section 101 defines a "Tobacco Product" as "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product." Thus, FDA "deeming" regulation could result in FDA regulations on e-cigarette hardware, cartridges, batteries and rechargers.
Potential Additional FDA Regulations for E-cigarettes
A deeming regulation would just require e-cigarettes to comply with Chapter IX provisions that pertain to “tobacco products”, and FDA would have to propose/approve additional regulations to specifically regulate e-cigarettes and other currently unregulated products.
Since the FDA falsely accused e-cigarette companies of target marketing to youth, additional regulations would likely include a sales ban to minors. Although there’s no evidence the products are marketed to youth, e-cigarette companies and consumers groups have supported state laws banning their sale to minor, while drug industry funded e-cigarette prohibitionists have opposed these laws.
New FDA regulations may restrict e-cigarette advertising, promotions and sponsorships, which would further protect cigarettes from market competition by e-cigarettes.
Despite no evidence that nicotine consumption is hazardous, and despite no nicotine restrictions on cigarettes, the FDA might propose a regulation to limit nicotine levels in the products. If similar to the EU Tobacco Products Directive, all e-cigarettes would be banned except no-nicotine e-cigarettes, which account for only about 5% of the e-cigarette market.
Although there’s no evidence e-cigarettes have ever created nicotine addiction in a nonsmoker, the FDA might propose a mandatory package warning stating the product is addictive.
Since the FDA has falsely claimed that flavored e-cigarettes are target marketed to children, the FDA may propose a regulation to ban some/most/all flavorings in e-cigarette products. While the TCA banned cigarette flavorings that never accounted for more than one tenth of one percent of the cigarette market share, a flavoring ban would have far greater impact on market shares of e-cigarettes, cigars and smokeless tobacco. There’s NO evidence, but lots of false accusations by drug industry funded groups, that flavored tobacco products are target marketed to youth.
In sum, a deeming regulation for e-cigarettes would threaten the lives of cigarette smokers and e-cigarette consumers, and would only protect existing cigarette and drug industry markets. FDA’s actions on e-cigarettes since 2009 have been unethical public health malpractice. The FDA should begin to truthfully inform smokers that e-cigarettes and other smokefree tobacco products are far less hazardous alternatives to cigarettes. States should and have been banning sales to minors, but there’s no public health justification for federal regulations for these life saving products.
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.
Thank you,
Last edited:
Bravo Bill
