- Apr 2, 2009
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Bill Godshall and Smokefree Pennsylvania submitted a lengthy (150+ pages) comment to FDA today (first several pages below) urging the agency to withdraw its proposal to ban vapor and smokeless tobacco companies from making truthful comparisons of their products to exponentially more harmful cigarettes.
The text of the FDA disasterous proposal is at
Federal Register | Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
But to submit a comment (note deadline at 12:50PM Eastern US time), go to, and click on COMMENT NOW (since the comment period was extended to Dec 30)
Regulations.gov
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Food and Drug Administration
Docket No. FDA-2015-N-2002-0008
December 30, 2015
Comments by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
BillGodshall@verizon.net
on
Clarification of When Products Made or Derived From tobacco Are Regulated as Drugs, devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
This disgraceful proposal should be withdrawn because it would allow FDA bureaucrats to continue protecting cigarette markets by denying the 1st Amendment rights nicotine vapor and smokeless tobacco product manufacturers to make thruthful commercial claims that compare their far lower risk alternatives to highly addictive and deadly cigarettes.
This proposal would allow FDA to continue commiting public health malpractice (i.e. its 7 year old unscientific, unethical and inhumane War on Vaping) by redefining “smoking”, “tobacco use” or even “vaping” as diseases and/or disorders to deceitfully prohibit vapor product and smokeless tobacco companies from truthfully informing consumers that millions of smokers have quit smoking and/or sharply reduced their cigarette consumption by switching to vapor products or smokeless tobacco products, and/or that their smokefree alternatives are intended to be used, or can be used as a substitute for cigarettes.
This proposal also appears to expand FDA’s definition of banned “therapeutic claims” to include truthful claims by vapor and smokeless tobacco product manufacturers related to the “prevention” of smoking attributable diseases that has occurred for millions of smokers who switched to exponentially less harmful vapor or smokeless tobacco productss tobacco products and vapor products.
This proposal would allow the FDA to ban virtually all truthful marketing claims for low risk vapor and smokeless tobacco products simply because some FDA bureaucrat interprets a truthful product claim as “intended for use in the . . . prevention of disease” or “intended to affect the structure or any function of the body in any way that is different from effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.”
This proposal also would allow FDA bureaucrats to contravene the provision in Judge Richard Leon’s 1/14/2010 ruling striking down FDA’s 2009 e-cig ban as unlawful, and stating FDA can regulate an e-cigarette as a drug or device only if the manufacturer makes a “therapeutic claim” about their product.
https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54
This proposal by FDA is strikingly similar to warning letters FDA sent on 9/8/2010 to five e-cigarette companies and a trade group alleging that dozens of truthful marketing claims made by those companies (urging smokers to try or switch to their alternative product) and even posted research studies and news stories violated the FDCA in conflict with Judge Leon’s ruling (since smoking isn’t a disease, and since just one of the dozens of FDA alleged violations could be considered a “therapeutic claim” to treat the disorder of “tobacco dependence”).
FDA acts against 5 electronic cigarette distributors
Johnson Creek Enterprises, LLC 9/8/10 (Johnson Creek)
Gamucci 9/8/10 (Gamucci)
E-CigaretteDirect, LLC 9/8/10 (E-CigaretteDirect)
Ruyan America, Inc. 9/8/10 (Ruyan America)
E-Cig Technology Inc. (E-Cig Technology Inc)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM225263.pdf (Electronic Cigarette Association)
But the growing mountain of scientific and empirical evidence (detailed in these comments) consistently indicates that nicotine vapor products (aka e-cigarettes):
- are 99% (+/-1%) less harmful than cigarettes,
- are consumed almost exclusively (i.e. >99%) by smokers and exsmokers who switched to vaping,
- have helped several million smokers quit smoking and have helped several million additional smokers sharply reduce cigarette consumption,
- have replaced about 5 Billion packs of cigarettes worldwide 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 disorders in users,
- pose no health risks to nonusers,
- have further denormalized cigarette smoking,
- have never been found to create nicotine dependence in any nonsmoker,
- have never been found to precede cigarette smoking in any daily smoker.
Accordingly, the FDA should withdraw this proposal, and the 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-cigarettes since 2009, for continuously confusing and scaring the public about e-cigs, for unlawfully banning e-cigs in 2009, for funding and encouraging hundreds of others to demonize and ban vaping, for misrepresenting the disasterous public health impact of this proposed regulation as well as the FDA’s Deeming Regulation, which would ban the sale of >99.9% of nicotine vapor products.
- - -
Note that the additional 150+ pages of comments were the same as the ones I submitted to FDA in June, 2015 evaluating virtually every study on vapor products and vaping, and exposing hundreds of false and misleading claims about vaping by Obama's FDA, many other DHHS agencies, and by many DHHS funding recipients.
The text of the FDA disasterous proposal is at
Federal Register | Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
But to submit a comment (note deadline at 12:50PM Eastern US time), go to, and click on COMMENT NOW (since the comment period was extended to Dec 30)
Regulations.gov
- - - - -
Food and Drug Administration
Docket No. FDA-2015-N-2002-0008
December 30, 2015
Comments by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
BillGodshall@verizon.net
on
Clarification of When Products Made or Derived From tobacco Are Regulated as Drugs, devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
This disgraceful proposal should be withdrawn because it would allow FDA bureaucrats to continue protecting cigarette markets by denying the 1st Amendment rights nicotine vapor and smokeless tobacco product manufacturers to make thruthful commercial claims that compare their far lower risk alternatives to highly addictive and deadly cigarettes.
This proposal would allow FDA to continue commiting public health malpractice (i.e. its 7 year old unscientific, unethical and inhumane War on Vaping) by redefining “smoking”, “tobacco use” or even “vaping” as diseases and/or disorders to deceitfully prohibit vapor product and smokeless tobacco companies from truthfully informing consumers that millions of smokers have quit smoking and/or sharply reduced their cigarette consumption by switching to vapor products or smokeless tobacco products, and/or that their smokefree alternatives are intended to be used, or can be used as a substitute for cigarettes.
This proposal also appears to expand FDA’s definition of banned “therapeutic claims” to include truthful claims by vapor and smokeless tobacco product manufacturers related to the “prevention” of smoking attributable diseases that has occurred for millions of smokers who switched to exponentially less harmful vapor or smokeless tobacco productss tobacco products and vapor products.
This proposal would allow the FDA to ban virtually all truthful marketing claims for low risk vapor and smokeless tobacco products simply because some FDA bureaucrat interprets a truthful product claim as “intended for use in the . . . prevention of disease” or “intended to affect the structure or any function of the body in any way that is different from effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.”
This proposal also would allow FDA bureaucrats to contravene the provision in Judge Richard Leon’s 1/14/2010 ruling striking down FDA’s 2009 e-cig ban as unlawful, and stating FDA can regulate an e-cigarette as a drug or device only if the manufacturer makes a “therapeutic claim” about their product.
https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54
This proposal by FDA is strikingly similar to warning letters FDA sent on 9/8/2010 to five e-cigarette companies and a trade group alleging that dozens of truthful marketing claims made by those companies (urging smokers to try or switch to their alternative product) and even posted research studies and news stories violated the FDCA in conflict with Judge Leon’s ruling (since smoking isn’t a disease, and since just one of the dozens of FDA alleged violations could be considered a “therapeutic claim” to treat the disorder of “tobacco dependence”).
FDA acts against 5 electronic cigarette distributors
Johnson Creek Enterprises, LLC 9/8/10 (Johnson Creek)
Gamucci 9/8/10 (Gamucci)
E-CigaretteDirect, LLC 9/8/10 (E-CigaretteDirect)
Ruyan America, Inc. 9/8/10 (Ruyan America)
E-Cig Technology Inc. (E-Cig Technology Inc)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM225263.pdf (Electronic Cigarette Association)
But the growing mountain of scientific and empirical evidence (detailed in these comments) consistently indicates that nicotine vapor products (aka e-cigarettes):
- are 99% (+/-1%) less harmful than cigarettes,
- are consumed almost exclusively (i.e. >99%) by smokers and exsmokers who switched to vaping,
- have helped several million smokers quit smoking and have helped several million additional smokers sharply reduce cigarette consumption,
- have replaced about 5 Billion packs of cigarettes worldwide 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 disorders in users,
- pose no health risks to nonusers,
- have further denormalized cigarette smoking,
- have never been found to create nicotine dependence in any nonsmoker,
- have never been found to precede cigarette smoking in any daily smoker.
Accordingly, the FDA should withdraw this proposal, and the 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-cigarettes since 2009, for continuously confusing and scaring the public about e-cigs, for unlawfully banning e-cigs in 2009, for funding and encouraging hundreds of others to demonize and ban vaping, for misrepresenting the disasterous public health impact of this proposed regulation as well as the FDA’s Deeming Regulation, which would ban the sale of >99.9% of nicotine vapor products.
- - -
Note that the additional 150+ pages of comments were the same as the ones I submitted to FDA in June, 2015 evaluating virtually every study on vapor products and vaping, and exposing hundreds of false and misleading claims about vaping by Obama's FDA, many other DHHS agencies, and by many DHHS funding recipients.
