- Apr 2, 2009
- 5,171
- 13,288
- 66
Food and Drug Administration Center for tobacco Products
(Docket No. FDA-2014-N-0189,RIN 0910-AG38)
Deeming tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
August 8, 2014
Comments
Executive Summary
The growing mountain of scientific and empirical evidence (detailed in these comments) consistently indicates that electronic cigarettes (e-cigs):
- are 99% (+/-1%) less hazardous than cigarettes,
- are consumed almost exclusively (i.e. >99%) by smokers and exsmokers who quit by switching to e-cigs,
- have helped several million smokers quit and/or sharply reduce cigarette consumption,
- have replaced about 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,
- pose fewer risks than FDA approved Verenicline (Chantix),
- have not been found to cause any disease or death in users,
- pose no risks to nonusers,
- have further denormalized cigarette smoking,
- have never been found to create nicotine dependence in any nonsmoker, and
- have never been found to precede cigarette smoking in any daily smoker.
Accordingly, the FDA should never issue a Final Rule for its recently proposed Deeming Regulation because it would protect cigarette markets, threaten the lives of millions of vapers and tens of millions of smokers, and give the entrepreneurial e-cig industry to Big Tobacco companies by banning >99% of vapor products now on the market, including all of the products that have proven most effective for smoking cessation and reducing cigarette consumption.
Instead, the Obama administrations FDA (and all other DHHS agencies) should correct, clarify and apologize to vapers, smokers and the public for knowingly and intentionally misrepresenting the scientific and empirical evidence on e-cigs since 2009, for continuously confusing and scaring the public about e-cigs, for unlawfully banning e-cigs in 2009, for funding and encouraging others to demonize and ban vaping, for misrepresenting the public health impact of the Deeming Regulation, and for aggressively campaigning to impose the deadly Deeming Regulation.
According to the US Surgeon General, daily cigarette smoking causes 480,000 deaths annually in the US. In sharp contrast, the scientific and empirical evidence indicate that cigar smoking causes no more than several hundred deaths annually, smokeless tobacco causes no more than several dozen deaths annually, pipe smoking causes no more than several deaths annually, theres no evidence that e-cigs or dissolvables have ever caused any disease or death.
More than 99% of all tobacco attributable morbidity, mortality and health care costs in the US are caused by daily cigarette smoking, while <1% are caused by the use of smokeless tobacco, cigars, pipe tobacco, e-cigs and dissolvables all COMBINED.
But five years ago, FDA spokesperson Rita Chappelle revealed the agencys unscientific, unethical and inhumane policy to deceive Americans about e-cigs to defend the FDAs unlawful e-cig ban We dont want the public to perceive them as a safer alternative to cigarettes.
Unfortunately for smokers and public health, this is still an underlying policy of Obamas DHHS, which also has deceitfully and repeatedly claimed that tobacco use (instead of cigarette smoking) is the nations leading cause of disease and death. Just as it would be public health malpractice for DHHS to repeatedly claim insect bites (instead of mosquito bites) are the leading cause of malaria to confuse and scare the public, it is egregious public health malpractice for DHHS (or any other public health agency or official) to falsely claim that tobacco use is the leading cause of disease and death.
For nearly thirty years, Congressionally mandated warnings on smokeless tobacco products and the DHHS have deceitfully claimed that smokeless tobacco is NOT a safe alternative to cigarettes despite consistent epidemiologic evidence that smokeless tobacco is 99% less hazardous than cigarettes and despite survey evidence that many smokers have quit smoking by switching to smokeless tobacco.
Obama appointed federal health officials (and their staff and funding recipients) have been maliciously deceiving smokers and the public to believe that all tobacco/nicotine products are as addictive and hazardous as cigarettes (except for the tobacco derived nicotine products marketed by drug companies, which DHHS continues to deceptively tout as most effective for quitting smoking even though gums, lozenges and patches have a 95% failure rate as smoking cessation aids).
Since e-cigs have already helped more than a million cigarette smokers quit smoking and since e-cigs appear to be 99% less hazardous than cigarettes, the only way public health could be negatively impacted by e-cigs is if 100 million nonsmokers begin vaping and no more smokers do so, which isnt going to happen. The same is true for smokeless tobacco products, which the FDA and other DHHS agencies have denied for the past three decades.
Although there is no evidence that public health would benefit if FDA imposes the Deeming Regulation, the FDA and other DHHS agencies (and many of their funding recipients) have falsely claimed otherwise since 2011. To achieve its regulatory agenda, the FDA has been falsely claiming that its regulations are based upon scientific evidence.
The FDA did remove one false statement (after two years of criticism) from one of its many misleading websites stating: 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." But DHHS has never corrected or clarified its hundreds of other false and misleading claims about e-cigs, smokeless tobacco or cigars.
So what would be the impact of the deeming regulation?
Sections 905(j) and 910 would ban ALL e-cigs (and most cigars, pipe tobacco and dissolvable products) not on the market prior to February 15, 2007 because the manufacturers didnt file Substantial Equivalence (SE) reports with FDA before the May 2011 deadline, and because no e-cig products on the market today are Substantially Equivalent to a product on the market before February 15, 2007.
Under the proposed deeming regulation, ALL e-cig products would be banned two years after the Final Rule is issued unless a manufacturer submits a New Tobacco Product application to the FDA (that would cost millions of dollars for each application), and the FDA approves the application.
While Judge Richard Leons 2010 ruling overturning the FDAs unlawful 2009 e-cig ban and the largely free market have enabled vapor products to significantly benefit the health of more than a million smokers during the past several years, the FDA Deeming Regulation would not only halt, but would reverse, all that progress because many vapers would return to cigarettes or resort to buying e-cigs from a newly created black market. The Deeming Regulation also would deny tens of millions of cigarette smokers legal access to the most effective smoking cessation products ever invented, and would halt further improvements in e-cig product development.
The FDA has not yet approved any Premarket Tobacco Applications or any MRTP applications for any products currently regulated by Chapter IX of the FSPTCA, and it would cost e-cig manufacturers several million dollars to file each New Tobacco Product application. Recently the FDA announced that it has refused to accept four Premarket Tobacco Applications for currently regulated tobacco products, as well as six MRTP applications, with just one recently submitted MRTP application that is more than 100,000 pages in length.
Meanwhile, the FDA still hasnt taken action on more than 3,000 SE reports filed for products back in 2011, and still hasnt proposed new color graphic warnings for cigarettes packs (after a federal court struck down the agencys previously approved warnings as unconstitutional), which were required by Congress in the FSPTCA.
The TCA requires the FDA to consider the potential impact of black markets before approving new tobacco product regulations. Since FDAs 2009 e-cigarette import ban created a thriving and rapidly growing black market for e-cigarettes, and since black markets have been created by every country that has banned e-cigs, the FDAs proposed Deeming Regulation would almost certainly create a huge black market (perhaps surpassing $1 Billion annually) due to explosive sales growth in recent years. While the TCA requires FDA to consider the black market potential of all new regulations, the FDAs proposed Deeming Regulation failed to do so.
Section 911 of the TCA also would ban truthful claims that e-cigs are less hazardous than cigarettes by the several e-cig manufacturers (primarily Big Tobacco companies) whose cigalike e-cig products would be approved by the FDA. Meanwhile, unless the FDA extends the current smokeless tobacco exemption in Section 911(b)(2)(C) to e-cigs, those manufacturers could be banned from truthfully claiming that e-cigs are "smokefree" or emit "no smoke".
Since the proposed Deeming Regulation would apply to all of the tens of thousands of different e-liquid products containing nicotine, and to all parts and components of e-cigs, the Deeming Regulation also would authorize the FDA ban all e-cig hardware, cartridges, batteries and rechargers unless and until the FDA approves New Tobacco Product applications for each of those products, which would cost millions of dollars for manufacturers to submit each application.
According to the FDAs estimates, the Deeming Regulation would reduce the number of legal e-cig products from tens of thousands (perhaps 100,000) to less than a half dozen, and would reduce the number of legal e-cig manufacturers from several thousand to fewer than a dozen. In sum, the deeming regulation would decimate the e-cig industry and give it to Altria, Reynolds, Imperial Tobacco, British American Tobacco, Philip Morris International, Japan Tobacco and perhaps one or two of the largest e-cig companies.
Although the cigalike products made by the largest e-cig companies are excellent starter products for smokers, they are far less effective for smoking cessation than are the rapidly expanding billion dollar plus market segment of tanks/mods/premium vaporizers and e-liquid products (all of which would be banned). The proposed Deeming Regulation also would further protect cigarette markets by increasing the price of the several e-cig products that are approved by the FDA.
During the past 20 years, Johnson & Johnson, GlaxoSmithKline, Pfizer and other drug companies have given several hundred million dollars to the Campaign for Tobacco Free Kids, American Cancer Society, American Heart Association, American Lung Association, American Medical Association, American Academy of Pediatrics, Pinney Associates (which employed Mitch Zeller as a lobbyist/consultant for most of 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/or unwarranted regulations on smokeless tobacco products, dissolvables, and e-cigs.
Forty states have now banned the sale of e-cigs to minors, and many more would have done so by now had it not been for opposition lobbying by CTFK, ACS, AHA, ALA, which (after falsely accusing e-cig companies of target marketing to youth) have been hypocrticially opposing state bills to ban e-cig sales to minors as a tactic to lobby for the FDA deeming regulation (so they can continue claiming the Deeming Regulation is necessary since some states still havent banned e-cig sales to minors).
Please note that the US DOT still hasnt issued a Final Rule on the airline vaping ban it proposed back in 2011, which DOT first attempted to unlawfully impose by fiat.
Cigarette smokers have a human right to truthful health information and legal access to less hazardous alternatives. Consistently, public health officials and agencies 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 as long as highly addictive and lethal cigarettes remain on the legal market.
The actions and misleading claims by DHHS on smokeless tobacco and e-cigs are probably the most egregious public health malpractice ever committed by the US government, as the several million vapers and 45 million smokers whose lives DHHS is threatening far exceed the number of victims of the US Public Health Services infamous Tuskegee syphilis study decades ago.
Instead of issuing a Final Rule for the deeming regulation, the FDA should complete the tasks mandated by Congress in the TCA, and should begin to truthfully informing smokers and the public that all smokefree tobacco and nicotine products are far less hazardous alternatives to cigarettes.
The free market for e-cigs has saved the lives of many smokers and will continue doing so. In sharp contrast, FDAs proposed Deeming Regulation would protect cigarette markets, ban >99% of e-cig products now on the market, give the e-cig industry to Big Tobacco companies, create a huge black market for banned e-cig products, and threaten the lives of vapers, smokers and secondhand smokers.
If the FDA remains misguidedly intent upon imposing regulations on e-cig products, however, the agency should propose far less onerous e-cig regulations similar to those proposed as an option for large premium cigars, which are more hazardous than e-cigs when smoked and inhaled daily.
[h=1]Economic Impact of proposed Deeming Regulation[/h]
Under the FSPTCA, the only way for a tobacco product (that is regulated by Chapter IX, which will include e-cigs if FDA approves its proposed deeming regulation) can be legally marketed in the US is if the FDA issues a marketing order (for either an SE Report or New Product Application), although companies that submitted SE reports can continue marketing their product until FDA rules on their SE report.
FDA still hasn't taken final action on about 4,000 SE reports for different cigarette, smokeless tobacco and RYO brands. Although FDA hasn't provided any numbers, it appears likely that cigarettes comprise 50%-75% of all SE reports that were submitted to FDA. While FDA has now approved 46 SE orders for cigarette brands, it is very likely the agency will approve >1,000 more SE orders for cigarette brands within the next several years, as Mitch Zeller has promised to make processing the huge backlog of SE reports a priority.
In sharp contrast, under the FDAs proposed Deeming Regulation, no SE reports would be allowed to be filed for e-cig products, as there were only about a half dozen first generation e-cig products that were sold in the US back in February 2007 (i.e. by NJOY, Ruyan and Crown 7), and those products were not SE substantially equivalent to any of today's far superior cigalike products (which are significantly inferior to more recently developed and marketed tank systems and e-liquids). Thus, it is unlikely that any SE reports would be filed for any e-cig products if a Final Rule is issued for the proposed Deeming Regulation.
The only way e-cig products can receive a marketing order from FDA (under the proposed Deeming Regulaiton) is if the manufacturer submits a New Tobacco Product application. In its proposed deeming regulation, the FDA estimated that 25 New Product applications for e-cig products would be submitted annually (Table 9), an estimate that appears realistic.
Regulations.gov
FDAs proposed Deeming Regulation also states (on page 179): We are clarifying here that a PMTA may require one or more types of studies including chemical analysis, nonclinical studies and clinical studies. FDA expects that chemical and design parameter analysis would include the testing of applicable HPHCs and nonclinical analysis would include literature synthesis and, as appropriate, some combination of in vitro or in vivo studies, and computational analyses. For the clinical study component, one or more types of studies may be included to address, as needed, perception, use pattern, or health impact.
FDA also estimated that each Application for Premarket Review of New Tobacco Products for an e-cig product would cost an average applicant just 5,000 staff hours (i.e. 2.5 FTE) (Table 9) and average just $333,554 (Table 21)
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM394914.pdf?
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf
But in June, 2014, Swedish Match submitted a 100,000+ page MRTP application to the FDA to truthfully market General Snus to smokers as less hazardous alternative to cigarettes.
http://www.washingtonpost.com/busin...2bfe18-f0b6-11e3-85d2-cda8aebfefe0_story.html
Swedish Match Submits a Modified Risk Tobacco Product (MRTP) Application | Business Wire
Since the FDAs proposed Deeming Regulation would require e-cig companies to conduct most (or more) of the same unwarranted research to submit a New Tobacco Product application (that the agencys guidance requires for the submission of MRTP applications), the FDAs estimated cost of $333,554 (utilizing just 2.5 FTEs for one year) for an e-cig company to submit a New Tobacco Product application is significantly lower than the actual cost e-cig companies would have to spend.
Realistically, each Application for Premarket Review of New Tobacco Products submitted by an e-cig company would cost successful applicants at least $3 million, and perhaps up to $20 million.
(Docket No. FDA-2014-N-0189,RIN 0910-AG38)
Deeming tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
August 8, 2014
Comments
Executive Summary
The growing mountain of scientific and empirical evidence (detailed in these comments) consistently indicates that electronic cigarettes (e-cigs):
- are 99% (+/-1%) less hazardous than cigarettes,
- are consumed almost exclusively (i.e. >99%) by smokers and exsmokers who quit by switching to e-cigs,
- have helped several million smokers quit and/or sharply reduce cigarette consumption,
- have replaced about 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,
- pose fewer risks than FDA approved Verenicline (Chantix),
- have not been found to cause any disease or death in users,
- pose no risks to nonusers,
- have further denormalized cigarette smoking,
- have never been found to create nicotine dependence in any nonsmoker, and
- have never been found to precede cigarette smoking in any daily smoker.
Accordingly, the FDA should never issue a Final Rule for its recently proposed Deeming Regulation because it would protect cigarette markets, threaten the lives of millions of vapers and tens of millions of smokers, and give the entrepreneurial e-cig industry to Big Tobacco companies by banning >99% of vapor products now on the market, including all of the products that have proven most effective for smoking cessation and reducing cigarette consumption.
Instead, the Obama administrations FDA (and all other DHHS agencies) should correct, clarify and apologize to vapers, smokers and the public for knowingly and intentionally misrepresenting the scientific and empirical evidence on e-cigs since 2009, for continuously confusing and scaring the public about e-cigs, for unlawfully banning e-cigs in 2009, for funding and encouraging others to demonize and ban vaping, for misrepresenting the public health impact of the Deeming Regulation, and for aggressively campaigning to impose the deadly Deeming Regulation.
According to the US Surgeon General, daily cigarette smoking causes 480,000 deaths annually in the US. In sharp contrast, the scientific and empirical evidence indicate that cigar smoking causes no more than several hundred deaths annually, smokeless tobacco causes no more than several dozen deaths annually, pipe smoking causes no more than several deaths annually, theres no evidence that e-cigs or dissolvables have ever caused any disease or death.
More than 99% of all tobacco attributable morbidity, mortality and health care costs in the US are caused by daily cigarette smoking, while <1% are caused by the use of smokeless tobacco, cigars, pipe tobacco, e-cigs and dissolvables all COMBINED.
But five years ago, FDA spokesperson Rita Chappelle revealed the agencys unscientific, unethical and inhumane policy to deceive Americans about e-cigs to defend the FDAs unlawful e-cig ban We dont want the public to perceive them as a safer alternative to cigarettes.
Unfortunately for smokers and public health, this is still an underlying policy of Obamas DHHS, which also has deceitfully and repeatedly claimed that tobacco use (instead of cigarette smoking) is the nations leading cause of disease and death. Just as it would be public health malpractice for DHHS to repeatedly claim insect bites (instead of mosquito bites) are the leading cause of malaria to confuse and scare the public, it is egregious public health malpractice for DHHS (or any other public health agency or official) to falsely claim that tobacco use is the leading cause of disease and death.
For nearly thirty years, Congressionally mandated warnings on smokeless tobacco products and the DHHS have deceitfully claimed that smokeless tobacco is NOT a safe alternative to cigarettes despite consistent epidemiologic evidence that smokeless tobacco is 99% less hazardous than cigarettes and despite survey evidence that many smokers have quit smoking by switching to smokeless tobacco.
Obama appointed federal health officials (and their staff and funding recipients) have been maliciously deceiving smokers and the public to believe that all tobacco/nicotine products are as addictive and hazardous as cigarettes (except for the tobacco derived nicotine products marketed by drug companies, which DHHS continues to deceptively tout as most effective for quitting smoking even though gums, lozenges and patches have a 95% failure rate as smoking cessation aids).
Since e-cigs have already helped more than a million cigarette smokers quit smoking and since e-cigs appear to be 99% less hazardous than cigarettes, the only way public health could be negatively impacted by e-cigs is if 100 million nonsmokers begin vaping and no more smokers do so, which isnt going to happen. The same is true for smokeless tobacco products, which the FDA and other DHHS agencies have denied for the past three decades.
Although there is no evidence that public health would benefit if FDA imposes the Deeming Regulation, the FDA and other DHHS agencies (and many of their funding recipients) have falsely claimed otherwise since 2011. To achieve its regulatory agenda, the FDA has been falsely claiming that its regulations are based upon scientific evidence.
The FDA did remove one false statement (after two years of criticism) from one of its many misleading websites stating: 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." But DHHS has never corrected or clarified its hundreds of other false and misleading claims about e-cigs, smokeless tobacco or cigars.
So what would be the impact of the deeming regulation?
Sections 905(j) and 910 would ban ALL e-cigs (and most cigars, pipe tobacco and dissolvable products) not on the market prior to February 15, 2007 because the manufacturers didnt file Substantial Equivalence (SE) reports with FDA before the May 2011 deadline, and because no e-cig products on the market today are Substantially Equivalent to a product on the market before February 15, 2007.
Under the proposed deeming regulation, ALL e-cig products would be banned two years after the Final Rule is issued unless a manufacturer submits a New Tobacco Product application to the FDA (that would cost millions of dollars for each application), and the FDA approves the application.
While Judge Richard Leons 2010 ruling overturning the FDAs unlawful 2009 e-cig ban and the largely free market have enabled vapor products to significantly benefit the health of more than a million smokers during the past several years, the FDA Deeming Regulation would not only halt, but would reverse, all that progress because many vapers would return to cigarettes or resort to buying e-cigs from a newly created black market. The Deeming Regulation also would deny tens of millions of cigarette smokers legal access to the most effective smoking cessation products ever invented, and would halt further improvements in e-cig product development.
The FDA has not yet approved any Premarket Tobacco Applications or any MRTP applications for any products currently regulated by Chapter IX of the FSPTCA, and it would cost e-cig manufacturers several million dollars to file each New Tobacco Product application. Recently the FDA announced that it has refused to accept four Premarket Tobacco Applications for currently regulated tobacco products, as well as six MRTP applications, with just one recently submitted MRTP application that is more than 100,000 pages in length.
Meanwhile, the FDA still hasnt taken action on more than 3,000 SE reports filed for products back in 2011, and still hasnt proposed new color graphic warnings for cigarettes packs (after a federal court struck down the agencys previously approved warnings as unconstitutional), which were required by Congress in the FSPTCA.
The TCA requires the FDA to consider the potential impact of black markets before approving new tobacco product regulations. Since FDAs 2009 e-cigarette import ban created a thriving and rapidly growing black market for e-cigarettes, and since black markets have been created by every country that has banned e-cigs, the FDAs proposed Deeming Regulation would almost certainly create a huge black market (perhaps surpassing $1 Billion annually) due to explosive sales growth in recent years. While the TCA requires FDA to consider the black market potential of all new regulations, the FDAs proposed Deeming Regulation failed to do so.
Section 911 of the TCA also would ban truthful claims that e-cigs are less hazardous than cigarettes by the several e-cig manufacturers (primarily Big Tobacco companies) whose cigalike e-cig products would be approved by the FDA. Meanwhile, unless the FDA extends the current smokeless tobacco exemption in Section 911(b)(2)(C) to e-cigs, those manufacturers could be banned from truthfully claiming that e-cigs are "smokefree" or emit "no smoke".
Since the proposed Deeming Regulation would apply to all of the tens of thousands of different e-liquid products containing nicotine, and to all parts and components of e-cigs, the Deeming Regulation also would authorize the FDA ban all e-cig hardware, cartridges, batteries and rechargers unless and until the FDA approves New Tobacco Product applications for each of those products, which would cost millions of dollars for manufacturers to submit each application.
According to the FDAs estimates, the Deeming Regulation would reduce the number of legal e-cig products from tens of thousands (perhaps 100,000) to less than a half dozen, and would reduce the number of legal e-cig manufacturers from several thousand to fewer than a dozen. In sum, the deeming regulation would decimate the e-cig industry and give it to Altria, Reynolds, Imperial Tobacco, British American Tobacco, Philip Morris International, Japan Tobacco and perhaps one or two of the largest e-cig companies.
Although the cigalike products made by the largest e-cig companies are excellent starter products for smokers, they are far less effective for smoking cessation than are the rapidly expanding billion dollar plus market segment of tanks/mods/premium vaporizers and e-liquid products (all of which would be banned). The proposed Deeming Regulation also would further protect cigarette markets by increasing the price of the several e-cig products that are approved by the FDA.
During the past 20 years, Johnson & Johnson, GlaxoSmithKline, Pfizer and other drug companies have given several hundred million dollars to the Campaign for Tobacco Free Kids, American Cancer Society, American Heart Association, American Lung Association, American Medical Association, American Academy of Pediatrics, Pinney Associates (which employed Mitch Zeller as a lobbyist/consultant for most of 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/or unwarranted regulations on smokeless tobacco products, dissolvables, and e-cigs.
Forty states have now banned the sale of e-cigs to minors, and many more would have done so by now had it not been for opposition lobbying by CTFK, ACS, AHA, ALA, which (after falsely accusing e-cig companies of target marketing to youth) have been hypocrticially opposing state bills to ban e-cig sales to minors as a tactic to lobby for the FDA deeming regulation (so they can continue claiming the Deeming Regulation is necessary since some states still havent banned e-cig sales to minors).
Please note that the US DOT still hasnt issued a Final Rule on the airline vaping ban it proposed back in 2011, which DOT first attempted to unlawfully impose by fiat.
Cigarette smokers have a human right to truthful health information and legal access to less hazardous alternatives. Consistently, public health officials and agencies 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 as long as highly addictive and lethal cigarettes remain on the legal market.
The actions and misleading claims by DHHS on smokeless tobacco and e-cigs are probably the most egregious public health malpractice ever committed by the US government, as the several million vapers and 45 million smokers whose lives DHHS is threatening far exceed the number of victims of the US Public Health Services infamous Tuskegee syphilis study decades ago.
Instead of issuing a Final Rule for the deeming regulation, the FDA should complete the tasks mandated by Congress in the TCA, and should begin to truthfully informing smokers and the public that all smokefree tobacco and nicotine products are far less hazardous alternatives to cigarettes.
The free market for e-cigs has saved the lives of many smokers and will continue doing so. In sharp contrast, FDAs proposed Deeming Regulation would protect cigarette markets, ban >99% of e-cig products now on the market, give the e-cig industry to Big Tobacco companies, create a huge black market for banned e-cig products, and threaten the lives of vapers, smokers and secondhand smokers.
If the FDA remains misguidedly intent upon imposing regulations on e-cig products, however, the agency should propose far less onerous e-cig regulations similar to those proposed as an option for large premium cigars, which are more hazardous than e-cigs when smoked and inhaled daily.
[h=1]Economic Impact of proposed Deeming Regulation[/h]
Under the FSPTCA, the only way for a tobacco product (that is regulated by Chapter IX, which will include e-cigs if FDA approves its proposed deeming regulation) can be legally marketed in the US is if the FDA issues a marketing order (for either an SE Report or New Product Application), although companies that submitted SE reports can continue marketing their product until FDA rules on their SE report.
FDA still hasn't taken final action on about 4,000 SE reports for different cigarette, smokeless tobacco and RYO brands. Although FDA hasn't provided any numbers, it appears likely that cigarettes comprise 50%-75% of all SE reports that were submitted to FDA. While FDA has now approved 46 SE orders for cigarette brands, it is very likely the agency will approve >1,000 more SE orders for cigarette brands within the next several years, as Mitch Zeller has promised to make processing the huge backlog of SE reports a priority.
In sharp contrast, under the FDAs proposed Deeming Regulation, no SE reports would be allowed to be filed for e-cig products, as there were only about a half dozen first generation e-cig products that were sold in the US back in February 2007 (i.e. by NJOY, Ruyan and Crown 7), and those products were not SE substantially equivalent to any of today's far superior cigalike products (which are significantly inferior to more recently developed and marketed tank systems and e-liquids). Thus, it is unlikely that any SE reports would be filed for any e-cig products if a Final Rule is issued for the proposed Deeming Regulation.
The only way e-cig products can receive a marketing order from FDA (under the proposed Deeming Regulaiton) is if the manufacturer submits a New Tobacco Product application. In its proposed deeming regulation, the FDA estimated that 25 New Product applications for e-cig products would be submitted annually (Table 9), an estimate that appears realistic.
Regulations.gov
FDAs proposed Deeming Regulation also states (on page 179): We are clarifying here that a PMTA may require one or more types of studies including chemical analysis, nonclinical studies and clinical studies. FDA expects that chemical and design parameter analysis would include the testing of applicable HPHCs and nonclinical analysis would include literature synthesis and, as appropriate, some combination of in vitro or in vivo studies, and computational analyses. For the clinical study component, one or more types of studies may be included to address, as needed, perception, use pattern, or health impact.
FDA also estimated that each Application for Premarket Review of New Tobacco Products for an e-cig product would cost an average applicant just 5,000 staff hours (i.e. 2.5 FTE) (Table 9) and average just $333,554 (Table 21)
http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM394914.pdf?
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf
But in June, 2014, Swedish Match submitted a 100,000+ page MRTP application to the FDA to truthfully market General Snus to smokers as less hazardous alternative to cigarettes.
http://www.washingtonpost.com/busin...2bfe18-f0b6-11e3-85d2-cda8aebfefe0_story.html
Swedish Match Submits a Modified Risk Tobacco Product (MRTP) Application | Business Wire
Since the FDAs proposed Deeming Regulation would require e-cig companies to conduct most (or more) of the same unwarranted research to submit a New Tobacco Product application (that the agencys guidance requires for the submission of MRTP applications), the FDAs estimated cost of $333,554 (utilizing just 2.5 FTEs for one year) for an e-cig company to submit a New Tobacco Product application is significantly lower than the actual cost e-cig companies would have to spend.
Realistically, each Application for Premarket Review of New Tobacco Products submitted by an e-cig company would cost successful applicants at least $3 million, and perhaps up to $20 million.
