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Smokefree Pennsylvania’s Bill Godshall meets with White House OMB/OIRA November 30, 2015 urging rejection of FDA deeming ban
Meeting Outline
The FDA has failed miserably on both sides of their cost/benefit analysis of deeming’s impact on vapor products. FDA failed to quantify ANY benefit of banning the products, and FDA have either not quantified at all, or dramatically under counted on the cost side as well as their assessment of impacts on small businesses.
1.FDA admits that "this proposed rule would have a significant economic impact on a substantial number of small entities" (page 6)
2."we cannot predict the size of these benefits (of deeming) at this time" (page 7)
3.But at no time do they consider the possibility that restricting access through regulation would cause harm to the public. So the benefit would actually be negative.
4.The FDA does allow that not regulating new products like e-cigarettes "may induce people to switch to products that FDA does not regulate at all or with the same stringency"(page11) - In the case of people switching from cigarettes to ENDS, this would improve public health - so not regulating would convey a benefit and the proposed rule would convey a harm. This is not considered in the cost benefit analysis.
5.In the RIA Benefit Analysis, FDA anticipates that “the largest benefit of the proposed provisions would be the improvements in health and life expectancy resulting from reductions in the use of combustible tobacco products deemed under this proposed rule” (page 13) But those benefits will be reduced by the rule’s application to electronic cigarettes which are not combustible tobacco products, and provide a safer alternative.
6. There is no discussion of ENDS during the analysis of welfare gains, expected life years saved, or reduced mortality (other than the final statement “The effect of other tobacco products on morbidity may differ.”)
7.In section 2(b) of the RIA, “Electronic Cigarettes and Other Non-combustible, Novel Tobacco Products” – FDA states it plainly. “The benefits of including electronic cigarettes in this proposed rule are unknown and therefore cannot be quantified.”(page19)
8.The proposed rule goes on to evaluate possible relative health effects of ENDS on health and welfare, and conclude that: If electronic cigarettes are safer (as most literature shows clearly) and if they are substitutes for smoking (again, all data points this way), then there would be positive health and welfare effects from increasing consumption of electronic cigarettes (Table 12, page 20).
9.The following paragraph, FDA admits that deeming would likely require premarket application, which would limit products from coming to market, and would require warnings that would serve as a negative signal to consumers and possibly discourage use. These two bullets alone show that the rule could harm public health and welfare, and that the rule would be the direct cause.
10.The FDA’s cost analysis does NOT estimate number of manufacturers or importers affected. They do not include any data on establishments that sell e-cigarettes. They do not estimate the costs for e-cig manufacturers or importers. They do not quantify the costs for adulteration and misbranding, they do not quantify the costs for restricting free samples, they do not estimate the costs for advertising restrictions on e-cigs, and they do not know the benefits of: registration and product listing; ingredient listing, labeling requirements or warning label requirements. In fact, they fail to count 6 of the 10 categories of costs, and fail to identify ANY benefit from deeming E-cigs! (Table 36, page 51)
11.They estimate that “Considerable product consolidation and exit (from the market entirely) would occur…”(page 27) and they estimate that 50 (TOTAL) electronic cigarette product applications would be submitted in the first two years, and 15 products over the next 18 years! (Table 21. Page 36). That is 65 total products over 20 years, including e-liquid flavors, mods, attys, wicks, coils, and every other product that is part of vaping.
FDA product and cost estimates of deeming reg/ban not even close
- 1,675 products - - - in reality, millions of different vapor products
- 25 PMTAs in 2017, (which is >98.5% ban) - - - in reality, >99.9% ban)
- $333,554/PMTA - - - in reality, >$20 Million/PMTA
- only Altria, Reynolds, Imperial, BAT, PMI, JTI, perhaps NJOY and/or several other companies will be able to submit PMTAs
Real costs to vapor industry never considered by FDA
- >99.9% of products banned
- 10,000 vapor companies destroyed, to be replaced by FDA created cartel of <10 (probably <5) large companies selling <20 (probably <10) closed system vapor products
- >50,000 jobs lost
FDA also failed to consider costs of deeming reg ban on pipe tobacco and shisha/hookah, and decimation of small cigar companies
Real costs to consumers never considered by FDA
- vapers will either switch back to cigarettes, switch to FDA approved products, or buy from newly created black/gray markets
- consumer costs to switch back to cigarettes or FDA approved products,
- healthcare and productivity costs to switch back to cigarettes,
- health and safety risks/costs for buying products from black markets,
Real government costs never considered by FDA
- Healthcare costs for vapers who switch back to cigarettes (now $15/pack, of which $11 is paid by governments)
- Enforcement of e-cig ban beginning 24 months after final rule issuance
Deeming ban's economic benefits for Big Pharma and Big Tobacco (twice for the latter if PMTA is approved) never considered by FDA
FDA failed to consider any alternative regulatory scheme since announcing intent on April 25, 2011 (deadline of FDA’s Writ of Certiori to appeal 1st e-cig ban to SCOTUS); FDA just switched from Prohibition Plan A to Plan B
- Same as FDA’s Option 2 for premium cigars
- Congressionally mandated picture warnings on cigarette packs
- Process 3,000+ Congressionally mandated SE reports filed in 2011
Give Charts/Graphs showing
Public Health England (95% less harmful - - - in reality, 99% less harmful)
New CDC chart US adult smoking rate at 14.9% (35.5 million) in 2015 (down from 43.8 million in 2011)
CDC chart finding 9 million US adult vapers in 2014 (NHIS),
Cigarette smokers 40X more likely to vape than never smokers, and
Recent former smokers 55X more likely
Rodu chart of 2011-2014 NYTS found sharp decline in cigarette smoking, sharp increase in vaping among teen smokers.
New UK survey table found 0% of never smoking teens regularly (weekly) use an e-cig
Tax Burden on Tobacco chart/data - Cigarette consumption continues declining since 2010 (tax year) largely due to skyrocketing vaping
Bonne Herzog chart - vapor product sales sharply increased ($2.5B in 2014, $3.5B in 2015);
Open tanks and e-liquid slightly more $$ than cigalikes, but 2-3X more vapor consumption than cigalikes
Euromonitor data charts (US $2.8B in 2014), 44% of $6.5B worldwide market
Our 2013 White House Petition urging them to not let FDA ban e-cigs, Mitch Zeller’s response falsely claiming deeming won’t ban e-cigs
Give them 110 page 2014 FDA deeming regulation comment (analyzing impacts of deeming regulation, analyzing scientific and empirical evidence, exposing false fear mongering claims by DHHS since 2009).
Meeting Outline
The FDA has failed miserably on both sides of their cost/benefit analysis of deeming’s impact on vapor products. FDA failed to quantify ANY benefit of banning the products, and FDA have either not quantified at all, or dramatically under counted on the cost side as well as their assessment of impacts on small businesses.
1.FDA admits that "this proposed rule would have a significant economic impact on a substantial number of small entities" (page 6)
2."we cannot predict the size of these benefits (of deeming) at this time" (page 7)
3.But at no time do they consider the possibility that restricting access through regulation would cause harm to the public. So the benefit would actually be negative.
4.The FDA does allow that not regulating new products like e-cigarettes "may induce people to switch to products that FDA does not regulate at all or with the same stringency"(page11) - In the case of people switching from cigarettes to ENDS, this would improve public health - so not regulating would convey a benefit and the proposed rule would convey a harm. This is not considered in the cost benefit analysis.
5.In the RIA Benefit Analysis, FDA anticipates that “the largest benefit of the proposed provisions would be the improvements in health and life expectancy resulting from reductions in the use of combustible tobacco products deemed under this proposed rule” (page 13) But those benefits will be reduced by the rule’s application to electronic cigarettes which are not combustible tobacco products, and provide a safer alternative.
6. There is no discussion of ENDS during the analysis of welfare gains, expected life years saved, or reduced mortality (other than the final statement “The effect of other tobacco products on morbidity may differ.”)
7.In section 2(b) of the RIA, “Electronic Cigarettes and Other Non-combustible, Novel Tobacco Products” – FDA states it plainly. “The benefits of including electronic cigarettes in this proposed rule are unknown and therefore cannot be quantified.”(page19)
8.The proposed rule goes on to evaluate possible relative health effects of ENDS on health and welfare, and conclude that: If electronic cigarettes are safer (as most literature shows clearly) and if they are substitutes for smoking (again, all data points this way), then there would be positive health and welfare effects from increasing consumption of electronic cigarettes (Table 12, page 20).
9.The following paragraph, FDA admits that deeming would likely require premarket application, which would limit products from coming to market, and would require warnings that would serve as a negative signal to consumers and possibly discourage use. These two bullets alone show that the rule could harm public health and welfare, and that the rule would be the direct cause.
10.The FDA’s cost analysis does NOT estimate number of manufacturers or importers affected. They do not include any data on establishments that sell e-cigarettes. They do not estimate the costs for e-cig manufacturers or importers. They do not quantify the costs for adulteration and misbranding, they do not quantify the costs for restricting free samples, they do not estimate the costs for advertising restrictions on e-cigs, and they do not know the benefits of: registration and product listing; ingredient listing, labeling requirements or warning label requirements. In fact, they fail to count 6 of the 10 categories of costs, and fail to identify ANY benefit from deeming E-cigs! (Table 36, page 51)
11.They estimate that “Considerable product consolidation and exit (from the market entirely) would occur…”(page 27) and they estimate that 50 (TOTAL) electronic cigarette product applications would be submitted in the first two years, and 15 products over the next 18 years! (Table 21. Page 36). That is 65 total products over 20 years, including e-liquid flavors, mods, attys, wicks, coils, and every other product that is part of vaping.
FDA product and cost estimates of deeming reg/ban not even close
- 1,675 products - - - in reality, millions of different vapor products
- 25 PMTAs in 2017, (which is >98.5% ban) - - - in reality, >99.9% ban)
- $333,554/PMTA - - - in reality, >$20 Million/PMTA
- only Altria, Reynolds, Imperial, BAT, PMI, JTI, perhaps NJOY and/or several other companies will be able to submit PMTAs
Real costs to vapor industry never considered by FDA
- >99.9% of products banned
- 10,000 vapor companies destroyed, to be replaced by FDA created cartel of <10 (probably <5) large companies selling <20 (probably <10) closed system vapor products
- >50,000 jobs lost
FDA also failed to consider costs of deeming reg ban on pipe tobacco and shisha/hookah, and decimation of small cigar companies
Real costs to consumers never considered by FDA
- vapers will either switch back to cigarettes, switch to FDA approved products, or buy from newly created black/gray markets
- consumer costs to switch back to cigarettes or FDA approved products,
- healthcare and productivity costs to switch back to cigarettes,
- health and safety risks/costs for buying products from black markets,
Real government costs never considered by FDA
- Healthcare costs for vapers who switch back to cigarettes (now $15/pack, of which $11 is paid by governments)
- Enforcement of e-cig ban beginning 24 months after final rule issuance
Deeming ban's economic benefits for Big Pharma and Big Tobacco (twice for the latter if PMTA is approved) never considered by FDA
FDA failed to consider any alternative regulatory scheme since announcing intent on April 25, 2011 (deadline of FDA’s Writ of Certiori to appeal 1st e-cig ban to SCOTUS); FDA just switched from Prohibition Plan A to Plan B
- Same as FDA’s Option 2 for premium cigars
- Congressionally mandated picture warnings on cigarette packs
- Process 3,000+ Congressionally mandated SE reports filed in 2011
Give Charts/Graphs showing
Public Health England (95% less harmful - - - in reality, 99% less harmful)
New CDC chart US adult smoking rate at 14.9% (35.5 million) in 2015 (down from 43.8 million in 2011)
CDC chart finding 9 million US adult vapers in 2014 (NHIS),
Cigarette smokers 40X more likely to vape than never smokers, and
Recent former smokers 55X more likely
Rodu chart of 2011-2014 NYTS found sharp decline in cigarette smoking, sharp increase in vaping among teen smokers.
New UK survey table found 0% of never smoking teens regularly (weekly) use an e-cig
Tax Burden on Tobacco chart/data - Cigarette consumption continues declining since 2010 (tax year) largely due to skyrocketing vaping
Bonne Herzog chart - vapor product sales sharply increased ($2.5B in 2014, $3.5B in 2015);
Open tanks and e-liquid slightly more $$ than cigalikes, but 2-3X more vapor consumption than cigalikes
Euromonitor data charts (US $2.8B in 2014), 44% of $6.5B worldwide market
Our 2013 White House Petition urging them to not let FDA ban e-cigs, Mitch Zeller’s response falsely claiming deeming won’t ban e-cigs
Give them 110 page 2014 FDA deeming regulation comment (analyzing impacts of deeming regulation, analyzing scientific and empirical evidence, exposing false fear mongering claims by DHHS since 2009).
This might be understood if it was 2009, but at this point in time with all that has been published, it appears to be a total absence of any care for the public health of which they proclaim to be their raison
