New member- a retired toxicologist & tobacco harm reduction proponent
- Thread starter JonathanD
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hack400
Olympian
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Hello @JonathanD and welcome to POTV!
MajorVape: I'm not sure I understand what you refer to as "pressure" from either traditional tobacco, emerging independent vaping product manufacturers, or the major US tobacco companies who have entered into the vaping market sector. I was delighted to see the major, former exclusively combustible cigarette manufacturers- including those that employed me throughout my career- develop a serious interest in offering potential reduced-risk vaping, lozenge & pouch products. The writing was on the wall- combustible cigarette use was in decline due to the well-documented public health burdens & growing social stigma that accompany cigarette smoking.
I can honestly say that I never experienced any sort of pressure to fight or resist this natural evolution toward safer nicotine products. I've always been free to express my scientific opinions as an inhalation toxicologist in support of tobacco harm reduction throughout my working career.
The more profitable manufacture of traditional cigarettes was the financial engine that enabled the initial start-up R&D investments of multiple $millions of dollars required to produce novel vaping products that could pass muster to receive marketing orders under the new & highly restrictive post-2009 US FDA-Center for Tobacco Products' regulatory paradigm. The emerging vaping products companies like Juul and others made some missteps early on, but have largely learned how to do business in the Brave New World of US tobacco/nicotine regulation. The FDA-Center for Tobacco Products is also in a steep learning curve in figuring out how to best fulfill their tobacco regulatory obligations. All involved in the equation have a fundamental interest in reducing the adverse public health consequences of cigarette smoking.
The responsible, major US vape manufacturers invested the tens of millions of dollars required to perform the necessary human clinical biomarkers, behavioral, and large population survey studies to obtain marketing orders from FDA for their cigarette-alternative products.
The small, independent US vape shops and minor manufacturers typically just didn't have the necessary financial or scientific resources to perform the needed studies, and FDA has stated that it has issued Market Denial Orders for something like 99% of those submissions from minor manufacturers & shops. I realize that many/most Forum members here are enthusiasts of the later-generation open systems, and at this writing these are continuing to be available at vape shops here in the USA- but FDA enforcement actions against them are ongoing. In the coming years I think many of those options will be removed from the market here.
The open systems pose a very difficult regulatory challenge for FDA, which considers any combination of particular device hardware with a particular e-liquid to be a specific "product". A shop offering 4 hardware devices and 100 e-liquid options is regarded to be a "manufacturer" offering 400 different products- each requiring a separate pre-market tobacco product marketing application [PMTA].
The US FDA lacks historical experience in regulating products that are neither nutritious, efficacious, nor "safe" in an absolute sense, but instead apply a nebulous "appropriate for the protection of public health" standard in regulating new tobacco & nicotine products. In essence, getting a Marketing Approval Order for, say, a novel vape product requires a sound science-based data package that demonstrates that a particular product is less harmful than a conventional cigarette in terms of both individual user risks as well as population-level hazards.
That might sound like an easy standard to meet, but detailed scientific evidence for the specific product of interest, and not just published evidence for e-cigarettes generally, is what FDA has required to date here in the USA. There are certain data-bridging strategies that may be used to advance a product with something less than a comprehensive, $10 million data package toward a Marketing Order, but they require contributions from well-informed scientists that most small vaping interests simply do not have at hand.
[As always, these are all my own personal opinions, and not those of any other person or organization.]
I can honestly say that I never experienced any sort of pressure to fight or resist this natural evolution toward safer nicotine products. I've always been free to express my scientific opinions as an inhalation toxicologist in support of tobacco harm reduction throughout my working career.
The more profitable manufacture of traditional cigarettes was the financial engine that enabled the initial start-up R&D investments of multiple $millions of dollars required to produce novel vaping products that could pass muster to receive marketing orders under the new & highly restrictive post-2009 US FDA-Center for Tobacco Products' regulatory paradigm. The emerging vaping products companies like Juul and others made some missteps early on, but have largely learned how to do business in the Brave New World of US tobacco/nicotine regulation. The FDA-Center for Tobacco Products is also in a steep learning curve in figuring out how to best fulfill their tobacco regulatory obligations. All involved in the equation have a fundamental interest in reducing the adverse public health consequences of cigarette smoking.
The responsible, major US vape manufacturers invested the tens of millions of dollars required to perform the necessary human clinical biomarkers, behavioral, and large population survey studies to obtain marketing orders from FDA for their cigarette-alternative products.
The small, independent US vape shops and minor manufacturers typically just didn't have the necessary financial or scientific resources to perform the needed studies, and FDA has stated that it has issued Market Denial Orders for something like 99% of those submissions from minor manufacturers & shops. I realize that many/most Forum members here are enthusiasts of the later-generation open systems, and at this writing these are continuing to be available at vape shops here in the USA- but FDA enforcement actions against them are ongoing. In the coming years I think many of those options will be removed from the market here.
The open systems pose a very difficult regulatory challenge for FDA, which considers any combination of particular device hardware with a particular e-liquid to be a specific "product". A shop offering 4 hardware devices and 100 e-liquid options is regarded to be a "manufacturer" offering 400 different products- each requiring a separate pre-market tobacco product marketing application [PMTA].
The US FDA lacks historical experience in regulating products that are neither nutritious, efficacious, nor "safe" in an absolute sense, but instead apply a nebulous "appropriate for the protection of public health" standard in regulating new tobacco & nicotine products. In essence, getting a Marketing Approval Order for, say, a novel vape product requires a sound science-based data package that demonstrates that a particular product is less harmful than a conventional cigarette in terms of both individual user risks as well as population-level hazards.
That might sound like an easy standard to meet, but detailed scientific evidence for the specific product of interest, and not just published evidence for e-cigarettes generally, is what FDA has required to date here in the USA. There are certain data-bridging strategies that may be used to advance a product with something less than a comprehensive, $10 million data package toward a Marketing Order, but they require contributions from well-informed scientists that most small vaping interests simply do not have at hand.
[As always, these are all my own personal opinions, and not those of any other person or organization.]
richard46
Postman
- Joined
- Dec 4, 2014
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- 63
The challenge 'open systems' posed was to how the tobacco industry could squash an alternative to cigarettes that could not be turned into a large scale profitable consumer and preferably disposable product.
Hey, MajorVape- I now noticed you had posted this year's [2023] call for nominations for the Lifetime Achievement Award from the Tobacco Science Research Conference [TSRC], with sponsorship support from Juul Labs. I don't recall offhand who the main sponsor/host may have been for my own award back in 2021, but the meeting where I received my award was in Boston, Massachusetts, which is not exactly a hotbed of Tobacco Harm Reduction activity. Traditionally, the TSRC host organization rotates year-to-year among academic institutions with a tobacco interest [ e.g. the University of Kentucky, which is involved with the Kentucky Reference Cigarettes program] or other tobacco or nicotine companies sponsorship such as Juul Labs' 2023 meeting sponsorship. The meeting sponsors don't have any input on what scientific stuff is presented. The TSRC is akin to a miniature international CORESTA meeting, but with a USA-centric focus. The US FDA-CTP usually sends some attendees to the TSRC meeting and to the CORESTA meetings to keep abreast of what's new in tobacco/nicotine science. Most of the papers presented at TSRC are technical reports of new methods & the like from industry & academic authors. The TSRC was originally an analytical chemistry-focused org, but since 2010 they've had more toxicology/biomedical sciences papers reporting e-cig and other harm-reduction findings. [In 2021, TSRC covered my hotel costs to receive my Lifetime Achievement Award, but I had to cover my own travel expenses to get up to Boston for the meeting & award ceremony.]
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@JonathanD
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vapervince
Achiever
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Hi JonathanD and welcome to the forum, do you have any thoughts on the UK Government swap to stop scheme, put briefly, the UK Government is giving up to 1 million beginner vape kits to smokers ostensibly as an aid to quit, if there are any plans to follow up either empirically or medically, I haven`t seen or heard about them.
'Big Tobacco' [BT] has been a convenient whipping boy for Open Systems advocates/manufacturers here in the USA and perhaps elsewhere, but that criticism is misplaced and inappropriate. I don't at all agree that BT tried to squash Open Systems here in the USA. The FDA regulators made it very clear at the outset that Open Systems- produced by anyone- would be extremely difficult to impossible to get approved for marketing under their vision of how e-cig products should be regulated.
The major tobacco companies pursued development and registration of closed and pods systems simply because it seemed clear that Open Systems could never meet FDA's standards for a marketing authorization as the Agency had drafted them.
If FDA might reconsider their vision of what might be an acceptable e-cig product, I'm all for that & am sure that 'BT' would be first in line to offer a more widely consumer-acceptable vapor/aerosol nicotine product to adult current smokers. I'm sure that BT could most definitely produce a very competitive product in the Open Systems product sector if there was any prayer of such a product receiving a Marketing Order. Currently, that situation simply does not exist.
Companies in the Open Systems sector should simply read & comprehend FDA's published Guidance and policies re ENDS rather than whining & trying to blame their inability to argue for a Marketing Approval Order for such products on "Big Tobacco". BT certainly didn't make the rules- FDA did.
As always, I express my personal scientific opinions here, & not those of anyone else.
Thanks, I'll try to do that. I'm new here [day 1 of my participation] & am learning as I go along. Jonathan D
@vapervince - I salute the UK government for breaking away from the EU's 'Precautionary Principle' thinking that has caused them so many common-sense regulatory problems in many areas. Our US FDA tobacco regulatory authority has explicitly stated that their regulatory oversight will be based on sound scientific evidence & not on the default presumptions of the 'Precautionary Principle.' I think this is the proper approach to advance the public health.
I also salute the UK for thinking creatively to accomplish the primary Tobacco Harm Reduction goal - getting smokers to abandon cigarette smoking by any means necessary in the near term, and to adopt a far less harmful means to use nicotine in a manner that is familiar enough to them to facilitate their transition to vaping as a short term or long term strategy to leave cigarettes behind. Surely some issues with the 'swap to stop' initiative will emerge, but those criticisms can be dealt with as they present themselves.
I am hopeful that a new era is now within reach- an era when cigarette smoking is a rare, antiquated habit. An era when nicotine consumers do not have any substantive health risks arising from their use of this 'social alkaloid', just as they do from their daily use of caffeine. Credit to the UK for embracing this novel approach toward retiring smoking to the status of an historical oddity that will no longer present such an enormous public health burden.
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