against the fast track, he is 100% in favor of free trade but if you round up the voting it was anst-track, issue that was raised at his townhall meeting. host: bob quast remapped a bit of there. our viewers can go to citizens trade.org to learn more about the texas prayer trade coalition. i want to thank mr. cash. i want to thank all of our guest this morning. the city of laredo, u.s. customs board and protections for access to our locations while we were in the laredo over the past few days here at all of the officers and agents there who spoke to us while we were on the ground back in april. letting our viewers get a better idea of what it is like to live in this border town. going to bring it to

the american enterprise institute where they are discussing here in washington e-cigarette regulations. thanks for watching. have a good day. will not detail their eminent qualification, but i argue to look to the biographical material where you can see it in detail. today we were here first from saul shipman of the university of pittsburgh who brings an overview of the relevant issues. then my colleague sally will discuss the culture of tobacco control and how it has influence regulation. next to julian morris will discuss the regulations health implications. stacy will discuss potential legal challenges to the regulation. and finally my colleague alex will discuss potential congressional response straight each panelist was because 50-20 minutes, followed by every discussion, then we will open it to audience questions.

>> thank you. let's see if the slides are there. i'm going to do a basic introduction to eat cigarettes. -- e-cigarettes. they little bit about what are, why we care, and what the data says about them. my background as a health psychologist working both in academia and industry. i have been doing tobacco and smoking research for a little over 40 years. relevantly have been involved both with pharmaceutical products as well as now e-cigarettes and other harm reduction products as well as academic activity. i want to start with a basic facts which is that smoking is bad for you. you may have heard of this. often people don't realize just how bad it is. in america, alone, we kill off

almost half a million people every year. 6 million a year worldwide. in this century it is going to be 500 million people. that is a very important background. because it is against this background that we have to consider the potential public health benefits of e-cigarettes. another more personal way to put these health risks is that a smoker who does not quit has a 50-50 chance of dying prematurely due to smoking. this is a huge risk in a huge public health disaster. if you think about the cause of it, you may remember the clinton economyt it is the stupid. and this case it is the smoke stupid. that is really the smoke, the products of combustion that are responsible for a muscle of the adverse health effects of smoking.

there are thousands of chemicals in many no card -- known carcinogens. and the point is that they are primarily products of combustion. so it is smoking, not necessarily tobacco and certainly not nicotine that is the problem. in fact, nicotine by and large has very modest harms. back in the 70's when i was starting out in this field, michael russell, a leading researcher in the u.k. put it very compellingly. that people smoke for nicotine, but die because of the car and the smoke. -- tar and the smoke. in a sense, you can think of smoking kind of the way we came to think of injected drug use and hiv. which is that it is not a drug that is the problem, it is the dirty need appeared in this case, it is not the nicotine that is the problem, it's the dirty delivery vehicle of smoking. so against this background, we can understand what e-cigarettes are in why they are important.

and very briefly as i suspect you all know, although there are differences among the devices the will be talking about, basics are straightforward. which is that there is a heating element that feeds nicotine and a carrier,. aerosoler -- vapor or isn't held by the user. there are variety of types. there has been quite a bit of evolution in e-cigarettes. ciga progression from -alikes, two rechargeable pipes. to tank and the effectiveness of nicotine delivery increases across the spectrum. you will be hearing more about that. that is important because this is a field that is still young and where there is a lot of

integration going on in regards to the devices. -- animation going on in regards to the devices. what does science tell us about the development of e-cigarettes? reporttly wrote release makes the point that the risk attributable to e-cigarettes is probably very small and smaller than- way the risk of smoking. in an early report had put a number to this which was that they estimated that the risk of e-cigarettes was on the order of 5% to that of smoking. you have a huge risk i described and presumably a huge reduction in the risk of people could switch from smoking to these products. so what does the american public actually hear about the risk of e-cigarettes? unfortunately what they hear, is mostly information. e-cigarettes are no safer than smoking.

are one million times more harmful than aaron hong kong -- air in hong kong. the public is being misinformed about the risks of e-cigarettes. not only by the press and by scientists, but we are hearing messages like this come from the centers for disease control for example. thread of alarm that people are getting. ohch is about things like they blow up in your face. they can cause fires. there are actual cases that are very rare. they reflect very poor manufacturing practices. again if you hold it up against the risk of fires due to smoking, this is absolutely tiny

. and indeed one of my favorites at the bottom there was a very recent case that declared a significant case for public health based on the report of two cases. cornea wasals who damaged by an exploded device. not surprisingly, the public's belief that e-cigarettes are safer has been declining. because instead of getting them accurate information, we are simply generating a lot of alarm. fundamentally is that the issue is not absolute risk, but relative risk. no one would claim, i would not claim, that e-cigarettes are completely safe. but, that is not the point. the point is being safer than smoking. they are not intended as devices for everyone to use. they are intended to be safer for you than smoking. if you think about relative

risk, nothing is absolutely safe. certainlya few things pharmaceutical medications which are enormously helpful are not completely safe. methadone we give drug addict's methadone, not because it is completely safe, but is because ands safer in the and -- then heroin. bicycling is not safe even if you wear a helmet. not that they should be absolutely safe, but that it is way safer than smoking. in that context, what is not to like? .here are concerns the concerns in essence can be framed in terms of a population health benefit, which is a standard that is baked into the law that authorized fda's authority over tobacco products. which is that rather than looking just at the risks to the

individual user of a tobacco product or e-cigarette, that the fda is mandated to look at the effect on the overall population. that means you need to look at people who may not currently be , and may notettes currently be using any tobacco product at all. so because the devices are presumably not completely safe, uptake by someone who is not currently smoking or using riskco presumably presents , rather than benefit to the individual. and there has been a lot of concern about the issue of gateways to smoking. that is the theory that if you that ise-cigarettes, going to lead you to take up smoking. even if e-cigarettes themselves were relatively harmless, if it would notd who otherwise smoking to smoking, that would be a source of population harm. i will touch on that a little

bit. there is a much bigger concern about re-normalizing smoking. is it going to make smoking seem ok? even though it is not smoking. people who are using e-cigarettes are clearly not smoking. you will notice that a lot of the alarm and frankly a lot of the emotion and tension around this has to do with protecting kids. it is important to realize that. that is something that gets everyone's emotions up and perhaps makes it hard to consider rationally a sort of public health balance. but there is also concerns about -- that have also been raised with regard to adult smokers which is that if adopting e-cigarettes deterred people from quitting smoking rather than helping them quit smoking, that could be a source of public health harm. i will touch on most of these and give you a sense of what i think the data say about these.

adults andregard to two is using e-cigarettes, i don't know if you can see that very well, that is the entire adult population. this is from a survey, the national tobacco behavior monitor, that was conducted by reynolds american. you can see the vast majority of adults of horse don't use e-cigarettes. more important, you will hear a lot of statistics about how many people are current users. often what that means is that they say they have used it in the past 30 days. most of those people have used it one day out of the last 30. in other words, someone with an e-cigarettes says here try this, they have one puff, and the statistics they are users. if you break it down by how many days out of the last 30, they had use, you see that red or orange slice is the ones who are

using it of these 27 days in the last month. sort of roughly daily users is a very, very small slice. at least it is important. is overwhelmingly among those who are well smokers. and among those who are using many of those were established smokers, but have now quit, which suggests that e-cigarette used may be associated with quitting rather than persistent smoking. if you look retrospectively at the history, the overwhelming majority of those were smoking first and then adopted e-cigarettes. not the other way around. now -- or try to look at kids. this is from a survey funded by fda. again you can see that the prevalence of e-cigarette use in

teens is actually very, very low. it gets vanishingly low if you at least 10t -- e-cigarettes rather than just had a thought. i want to arm you as you see more statistics in the press to whenre -- a bit skeptical they talk about prevalence. because what often with their measuring is if you have ever had a puff or you have had a tough in the last 30 days. rather than what you would normally think of as use, which would imply some regularity. on top of that is the concern is turns out that roughly 70% of those teams are using e-cigarettes are using e-cigarettes without nicotine. at all. again the statistics as often cited don't often accurately reflect -- are not interpreted in a way that is accurate. if we then look at the ordering which e-cigarettes smoking were adopted, the green section of

this pie chart are the ones who were smoking before they started e-cigarettes. and the red are the ones who may have started and e-cigarette first. which goes to this gateway notion. let's look at this idea of a gateway. the gateway hypothesis is a that taking up and e-cigarette had actually causes you to start smoking. there arem is -- a teen that show that who is using an e-cigarettes at time one is more likely to be using -- to be smoking at time two. that does not mean one called the other. it is the same kids who are interested in using e-cigarettes as in using cigarettes. the kids who are curious, rebellious, willing to it experiment with anything and everything. that is the kind of thing people try to control for statistically in these analysis, but it is really not possible to control

for everything. fact, there is some evidence that e-cigarettes are a gateway out of smoking. there are now two analyses showing that in states restricted sales to minors, the smoking rate among teens went up relative to expectations. if you block that exit from smoking, you actually make -- may cause markets to start smoking. the other way to look at gateways to look at what is happening in the population over time. this is the data on the use of e-cigarettes over the last two years. you can see a very steep rise over time, particularly 2013 22014. affect wasway working, you would expect smoking among teens to be rising at that height to. the data shows the opposite. that along with this rise of e-cigarettes, we are seeing a decline in teen smoking, which is inconsistent with a gateway

effect, and probably consistent with a gateway out effect. adults ank about deterrent from quitting. e-cigarettes impede quitting. but, although this looked at 18 studies, the basic principle of the garbage in which out applies. which is if you put together 18 studies that are not valid issue, you of the do not generate from that a valid assessment of the issue. among the problems with their studies, was that -- those studies, was that the people who were not smoking at the time of assessment, were not counted. anyone who actually succeeded years ago in quitting with e-cigarettes is not counted. then we try to assess the effect of e-cigarettes on quitting. but also that the studies often

a look at long ago e-cigarette use in relation to current smoking. like imaginee bit a study that you did that shows that someone who took an aspiring of one da -- one day when they were 15 still got a headache when they were 30. look aspirin causes headaches. some of these studies are even worse than that in terms of illogic. again, one needs to be very skeptical of some of these claims. what do we know in terms of data? fort as i've shown you teens, it is equally true of adults. that at the same time that e-cigarette use has been rising, smoking prevalence among adults has actually been declining. we have had a record decline in the past year. that shows from federal data that the incidence

of quit attempts is also rising. inconsistent with the idea that we are deterring people from making quit attempts. in the u.k. among people are trying to quit, those who said they used e-cigarettes trying to quit were actually more successful even than those who use nicotine replacements like, patches. this is one ofk the more interesting studies. paper has been publishing that if you poke is not on just who used e-cigarettes, but who use them with some sort of intensity, that is the word she use, that is at least daily for at least two months. those people were significantly more likely to quit. and furthermore, it turns out there's tended to be people who were heavy smokers, who had many quit attempts, and two had

previously failed on naked 10 replacement. nicotine replacement. it is exactly the people you would want to switch to and e-cigarette to quit. another issue that comes up has to do with the appeal of e-cigarettes. i think it is worth thinking about the role of appeal and harm reduction shot at you. the two dimensions here are the axis is a- on the y peeler satisfaction. cigarette smoking is brought -- both very appealing and harmful. one can imagine a product down here which is very non-toxic and very unappealing. no it would have absolutely public health benefit. because if it is not appealing, and it does not compete with cigarettes, for consumers use, it has no benef.

what we really want is a product to year, that has low harm and a lot of appeal. so that it can compete with cigarettes and get people to switch. and a lot of the discussion about appeal has focused on dovors because flavors presumably increase product appeal. showing thatey teen non-smokers were really not very interested in e-cigarettes no matter what flavor they were offered in. where is adult smokers did care about flavors. e-cigarette users tend to switch to flavors when they are quitting. so it is not at all clear that flavors are hazard. in fact, they may be a public health benefit. summary, byhereby saying, clearly e-cigarettes are much safer than smoking.

they address the current intolerable death tolls that we from smoking. the absolutism that demands absolute safety and so on is i think, likely to do more public health harm than good. there is a will for regulation. e-cigarettes probably should not explode in your pocket. hear, thewill regulation has to be shocked in a way that protects the potential for e-cigarettes to provide a public health benefit. thank you. [applause] thank you, saw. ul. what a great overview. you just heard an outstanding database outline of what we know about electronic cigarettes and bathing. -- vaping. we know for sure that no one is

claiming they are entirely safe, but again it, it is relative safety. it is undeniably true. it is also true there are things example, wew, for don't know what 20 years of inhaling that will do. most of the things that are limited in terms of our knowledge are simply products out -- a product of the fact that these devices have not been around and use for really more than about seven years. and as far as the gateway effects, we say at least to date, we do not see that kind of a phenomenon. smoking is for teens and adults at the lowest rate it has ever been in history. would beare all -- encouraging, very encouraging bits of data. we've been collecting them for at least five years and of course we will continue. that for also clear harm reduction products, that is

a key issue here, these devices are harm reduction products. , think of them that way, much more than as a -- well they can't even be considered a medical product, they are tobacco products. is somethinghem that we necessarily have to subject to the clinical trials -- it's not clear. those are data that would be excellent to have. whetherce people choose they would like to use e-cigarettes, they are often failed more conventional quit attempts. this way it is almost more of a consumer products. the kind of data we have so far reasonably suggests that people should have greater access.

as much access to these as possible. tyth as you mentioned, safe regulations. everyone i know is interested in safety regulations. are not contaminants, that batteries do not heat up, these kinds of things. that goes without question. there remains so much of alarm of a speculative dangers and misleading spin. outrightigh misrepresentation. like thed entities and event of health -- the regulations themselves reflect an overcautious approach in my view for a harm reduction product. so why is this?

that's what i want to talk about today p why is the picture of e-cigarettes and kind of the social policy so misaligned with the evidence that we have so far? and in a sense whether they could be called bathing wars -- wars is really not a coincidence. in the sense that to a large extent, culture wars are not so much about facts, but about our worldviews. and components of worldview may be a tolerance for risk, tolerance for complexity, loyalty to affinity groups, and in this case that affinity group would be the tobacco control movement. be inrt, there seems to this policy arena a lot more that is driven by positive style and ideology than by the evidence. bathingly you could put

-- vaping and the famous as other have a -- hot button social topics such as frank great, gun ownership, global warming, gmo's, this kind of thing, affirmative action. kind of teeingw off of a great body of research done by people like jonathan hite at yale university. they've done much quantitative they call cultural cognition. or moral intuition. there is a big literature on this kind of analysis. it has not been done for the -- on a electronic cigarettes, but a lot on global warming and other of these issues. i think one can make a pretty good analogy to the e-cigarettes situation.

without ank that appreciation of the moral psychology of the bathing wars, it is very easy to get confused about why there is such controversy. this arenapoff that was a controversy went well is thethe data inconsistency in the public health community added towards harm reduction. thementioned -- before classics of needle exchange and methadone happen too often -- to also work with heroin addict part-time. right now, in the midst of this heroin epidemic, we are even considering a more radical forms of harm reduction borrowed from europe with actual heroin distribution. .his is just been contemplated i know ithaca and a few other cities who are actually thinking about that. tose are classic responses

classic harm reduction responses and agencies like the cdc are certainly in favor, rightly so, of needle exchange and methadone and condoms in all this. yet, so this kind of harm reduction for heroin addiction is warmly embraced by the public health community. i'm not saying it is not controversial, there are politicians and citizens who are not in favor of some of these approaches. but within the public of community, there is really not debated. why is that? why is our reduction and acceptable approach -- harm reduction and acceptable approach to heroin, but not a acceptable approach to nicotine. i should say the public health community is not monolithic and the --suspicion about

electronic cigarettes. you can even see the suspicion for example reflected in burwell's comments when she introduced the dimming regulations on may 5. as hear what she said cigarette smoking among those under 18 have fallen, and the use of other nicotine products including e-cigarettes is taking a drastically. all of this is creating a new generation of americans at risk for addiction. i don't know quite what that means. i have one slide i wanted to show you. cdc ad. from a about 34.woman who is

her name is chris did. she started smoking at age 13. and then at somewhere over the last year or so decided to try e-cigarettes. i think she may have tried what e, those arecigalik the ones that look like figure straight they work for some people, but they are often considered rather weak by committed smokers. and people often prefer their second and third generation devices. the point is, she tried an e-cigarette. and it did not work for her. that is a fairly common scenario. she went back to smoking. and that is what her long have collapsed. collapsed lungs are not a very common side effect of long-term smoking, but they do happen. incidentsno reported of lung collapses with e-cigarettes. she was exposed to e-cigarettes probably -- for several months. this is annt is,

obvious attempt to compel e-cigarettes with an effective smoking. it is really quite misleading. i was surprised i could find us online, but the cdc actually advertised this. it was part of a larger campaign called tips where they have individuals talk about how they quit. much of it is constructive. it is good advice for many people. this is the only one that has to do with e-cigarettes. but they had specifically advertise for someone who had ever tried e-cigarettes and had had one of the following complications. and one of them was a collapsed lung. so you are basically advertising for someone who had to events, ways to imply causation. one that is not the case at all. that is highly misleading. that is consistent with many of cdc whichents from

seem to be very suspicious of again. about the benefits of electronic cigarettes tending to downplay them, but increasing the alarm about what could happen to children. which is not an unreasonable thing to worry about. it is just that the data, the cdc data are showing this is not happening with children. american lung association, world health organization, california department of health has lost a campaign that utterly debunked .laims that paper mounts --are traces of

tiny trace amounts. there are much greater amount in cigarettes. the amount is not biologically significant. same with chicago. mayor rahm emanuel launched an initiative equating electric cigarettes to liquid poison. so if people think smoking is as ng is as bad as smoking, the obvious consequences on course that people who are contemplating switching and those that have already switched to e-cigarettes will go back to smoking. that is a big problem. as is its effect on public opinion. if you are alluded to a recent reuters poll showed that last , this year 47% of

that vapingd it bu was healthier again. part whylar siggins the controversy? i think lies between to castrate the precaution is and the pragmatist. the precaution is emphasize that the health risks of products and not been fully established. and there is truth to that. that, it is a matter of emphasizing that at the expense of what we do know. the relative safety. mentioned, they worry that cigarettes will read normalize smoking or undo the gains of five years of anti-smoking. something reasonable to worry about. but it has not happened. .he gateway as we said the precaution this which

frankly one could also substitute the words prohibitionists, or paternalist seem preoccupied with a yet to be demonstrated impact on children. and paying aying little attention to the established benefits to smokers. to betion this tend preoccupied with frankly a contaminate what i call a contamination effect did what i proximity tois the big tobacco. proximity in terms of nicotine. nicotine is an e-cigarette spirit nicotine come some tobacco. tobacco companies are involved with tobacco. there.e is a connection to that connection is taken -- it is a most like guilt.

it is an affected them guilt often by association. also the fact that two major tobacco companies do make e-cigarettes products. there again is kind of this patent association with tobacco. these of a folks that have been fighting valiantly for such a long time. largelyose lines they exaggerate the dangers of nicotine itself. and the stuff becomes very emotionally charged. threat to thed hard-earned progress against what used to be a stark villain. -- big tobacco. the pool of these historical allegiances is very very strong. and so accordingly, one would and to heavy regulation

oversight by fda. , icontrast, the pragmatists will finish up by describing who these folks are. they are not fixated on vaping as being completely safe, but whether it is safer. willing to make more policy trade-offs, more of a tolerance of ambiguity, and they want to make e-cigarettes more tracked into smokers. march activity smokers. ultimately, this comes down to a view of government. is it enabling states that and making their own choices with information and support. or a more paternalistic stated that wants to use the law and inulation to change behavior a particular way. i think this is an age-old be sure.n society to

but it really plays out here. i was as close by saying we can all agree, even that there is a tension between these two groups , and i have some thoughts on how they might be resolved, although i do think the regulations are making that more difficult now. that itwe can all agree is never a good policy when people are more invested in defending their speculations and intuitions than in testing them. and one first appears knowing where the data and the psychology begins. thanks. good morning. there we go.

about theto talk of the fda deeming regulations. i'm going to begin though with a discussion of where e-cigarettes come from. i'm going to then talk about some of the consumer update vp's and howding e those feedback into the process of development over time. and then, i will talk about that arethe product being developed might still be on the market after deeming regulations finally come into effect at the end of 2018. and what the constants are for the future of the kinds of products that current smokers and current vapers will end up using.

think it is helpful to understand where this all came from. in 2001, a chinese pharmacist based in beijing invented the concept of the electronic cigarette. at that time, he thought it was going to be using an electric avice to atomize a vapor -- liquid containing nicotine and some flavors. he realized in a couple of years that a better device, a more cost-effective and effective in general was to use the heating coil. he then developed that into what became the first electronic cigarette. company.rketed by his uyan. the brand r this electronic cigarette has been described earlier, has a battery and atomizer, and a cartridge. the cartridge contains this extra liquids.

water, ande, the some flavors. in this case, and the original cigarette, there was a tobacco like flavoring. the atomizer is a heating coil. liquid,ts up that vaporized it, does not burn it, that is a crucial point, does not burn it. and then is drawn into the lung. market,se came onto the in europe, in 2005-2006, people got excited about them and started using them. people also found them not to be entirely satisfying. others -- couple of brothers developed an alternative to the optimizer -- atomizer and cartridge, combining it into a thing called the caromizer.

it was a more effective device. it was able to deliver more mixing more quickly to the user. people found that a better substitute for cigarettes. some of the people using tomizers ran out of liquid, people started injecting liquid into them. to basically recharger. they found that the battery on the device was not -- did not last long enough. so than other groups of people developed a way of attaching the tomizer to a more powerful battery. they use a flashlight battery. these were consumers. these were not developed by manufacturers.

the next innovation came from another chinese company. which developed a combination larger, more powerful battery with a cartridge and anonymize or device. -- and at him as a device. this became quite popular. you could call this a vape pen. and then the following year a company developed a thing called a clearomizer. this is a tank with a clear outside in which you pour liquid ad in that tank you insert heating coil and a wick. thatake takes the liquid

is in the tank, and puts it into the heating coil, where when you press a button, it gets heated. and then the user inhales. became incredibly popular. they are more powerful, and the nicotine is much as expensive. they are easy to use and long-lasting. of hardwarel sorts innovations that came about as a result of the marketplace responding. of what would be better for delivering sexist -- satisfaction to the consumer. so larger tanks were developed. more liquid for all they've aping.

one of the problems with the top mizer was that once the liquid has more or less gone, if you carry on trying to pressing the button, you can burn the remaining liquid or even released some metal from the coils. apers don't like that. it does not taste nice. so they did not want that. they now favor the bottom coil with where the liquid remains at the bottom and is much less likely to cause burning. larger batteries that are long-lasting and more powerful were developed. you see these big square batteries. variable current low resistance devices. these enable more rapid vaporized nation. wereg the user a hit quickly, then more closely

replicating the smoking. but also creating much, much more vapor. towardssee now a trend thisvaping where people will draw in huge amounts of paper and then exploded out in a torrent. perhaps more important than much of the above that the development of a temperature control. one of the health concerns that the possibility that at very high temperatures, you can generate accessible subsequentother toxins from decomposing the glycerin in the liquid. with the use of micro-processes, temperature control is possible to prevent that. to eliminate that. all of these innovations came about as a result two responses to what was seen as desirable in the market. prefersee that users

these newer generation e-cigarettes. this is a survey of 2800 current e-cigarette users. who perceive them to be more satisfactory and more effective from refraining from smoking than other older models. in the u.s., a recent survey found that over half of those adult users using these theyronic paper systems -- systemstems -- vapor used tank models. adolescents, nearly 80% use these tank models. most of those adolescent users are using tank models without nicotine. or at least they think that it doesn't have nicotine in. so suggesting that that is not their main reason for using the

devices. u.k. bya survey in the action smoking and health, the uk's main anti-smoking group. the wayows that -- by has been a very vociferous advocate of allowing e-cigarettes. and not imposing excessive regulation. ash survey shows that over there has been a significant increase in the use of these larger tank, refillable, rechargeable systems in the u.k.. slightly more than in the u.s.. a cardiologist and active has shownof vaping

that the more recent devices deliver the nicotine to the user more quickly than the older devices and in larger quantities. you can see the comparison between the speed by which nicotine gets into the bloodstream from a tobacco that ise compared to -- the green line. the blue line is older e-cigarettes. and the red line is more recent tank models. in this case, 1.8% nicotine in them. another aspect of the impact on smoking is the degree to which consumers want to have different flavors available to them. and especially fruit flavors that you can see, the second-largest category of

flavors that are consumed by vapors in the u.k. are those fruit flavors. the e-cigarette has not had an attentionin terms of from academics analyzing their health effects. as we are ready heard. the mention was made of over 70% ofound e-cigarettes that they tested both to topple pino. these things are known to cause an obliterated -- what is called popcorn lung.

it is fatal. it is a nasty thing. certainly something people would want to avoid. the responsive one of the main --top -- online retailers many manufacturers responded by removing the flavorings that .ontained it is worth noting the concentration of doubt futile and one cigarette is approximately eight times the concentration of about a days

worth of the liquidating. one cigarette gives you about eight times. smokers arerette being exposed to much more of this. packs ofho switches cigarettes a response to this study, and there were concerns that that was happening. would be doing the wrong thing. what are they less than shock of the main lesson is the choice and competition has driven innovation. it has enabled vapors to attain products that meet their needs more effectively. i didn't -- have given you some of the examples of the developments that were -- that made this possible. with the introduction of regulation this month, a grave threat to this. the regulations essentially --

deeming regulations essentially limit -- they are going to limit the access of consumers to these products. whatever you want to call them, they deem those to be tobacco products. which means that the only products that can remain on the market without applying for permission are those that were on the market already in february, 2007 so what does that mean? possibly this. es that nobodyk uses anymore because they're not effective. it is possible in principle for manufacturers to get permission to sell their product. and for the next two years, there's manufacturers who -- those products for which a permit is applied will still be

able to market their products. there will not be enforcement actions taken against those products. in the next two years. 2018, will be have anything other than this on the market? -- we have anything other than this on the market? i don't know. we don't know. what are these products under the deeming regulations, because of these products on the left are battery, the middle is a flashlight, and on the right is learomizer.c some of these things be available? i guess so. will these be available? deviceleft, that is a

using a 3-d printer. and on the right is a 3-d printer. going to ban 3-d printing? because if it is not, you will be able to get the devices on the left. if you get the devices on the left, then you cannot -- do with the device what the fda wants you to do. this is the exact same product, but with zero milligrams of nicotine. are you going to ban this? it is absurd. what are vapors and smoking -- smokers going to do. ? some old maid do with the devices. some will develop their own devices and mix their own liquid from concentrated nicotine. that is going to say.

be safe. some of users are going to share recipes online including group -- blueprints for 3-d printing. these underground products are not going to be subject to the same oversight that you get in the existing product market where people are protected by consumer protection laws. where people are protected by laws of contract. sadly, some people with respect to cigarettes, given that the evidence is in and e-cigarettes whatever you want to call them, have huge potential and probably actual public health advocates. i think there's a grave risk that the fda deeming regulations as they are currently going to be implemented well harm public health rather than help it.

[applause] >> good morning. there we go. hi, i am stacy ehrlich. i'm an attorney here in d.c.. we do fda regulatory work. i've been looking at regulations quite extensively. i am primarily going to talk today about the legal challenges that has been filed onto the deeming regulations. but just a little more background on the deeming regulations. you have heard a bit about them, but fda officially publish the deeming regulations -- the so-called deeming regulations on 10 this year.ay

basically what that did was extend fda's jurisdiction over the named tobacco products in the act to any product that meets the definition of tobacco products in the statute which is quite a broad definition. if any product that is made or derived from tobacco including parts, components, and accessories to this product. it is a pretty broad definition in the statue. and what that does, the main part that is of concern to the panel and to people in the bathing -- vaping industry is that able require premarket fda review of all products that were on on the market as of four

february 15, 2007. fda has given some compliance. period. so that products may continue to be marketed for a two-year. ifwhich they essentially -- they file ap premarket approval application by that to your date, they can stay on the market pending the fda's review. although fda has said they will limit that review. to one year. there are many we are not sure how they will get through all of these in a year. the implications of that led to a number of lawsuits challenging regulations.

so, lawowing week or start liquids filed. -- lost art liquids filed. i'm going to quickly go through the claims in each of the lawsuits and then we will delve into the substance a bit. the claims include unlawful statutory interpretation because of the fda's broad interpretation of tobacco products. fda did not do an appropriate cost-benefit analysis which is .equired the alleged violations of the first amendment free-speech

claims for the modified risk tobacco product claiming that now require prior approval or will require prior approval by the fda. as of all of these lawsuits, the plaintiff requested injunctive relief to stop fda's enforcement of the regulations. lost art liquids are similar. likewise, unlawful cost-benefit analysis conducted by fda, violations of the first and fifth amendment right the fifth amendment claim is based on label statements. discretion because lacks jurisdiction. modifiedhallenge fda's risk tobacco product provision

because that provision will ban use of mild, which is in the name of the cigar. thes talk about the claims, first one is related to the requirements under the regulatory flexibility act which requires that agencies assess the impact of proposed and final rules on small business, which is a large chunk of the vapor industry, and consider less burdensome alternatives which accomplish the statutory objectives but also minimize economic impact on small entities. the small business administration filed comments that unequivocally stated that lackroposed rules essential information required under the act because it did not discuss the quantitative or proposalve process of on full entities. fda's final analysis is no better.

they admit their analysis is deficient. they acknowledge they have not quantified the proposed or final rule. then they list a long list of quantified costs, including consumer cost for users. these are real costs they just have not bothered to quantify. we will get to how significant that cost may be. you get the idea. and so, fda's required to consider alternatives that would produce the impact on small business. four alternatives that fda considered in their analysis. you will probably see that these

are not really helpful alternatives. they consider the exemption of premium cigars. they consider changing become plants period -- the compliance period to 36 months. and this fourth one you may have .ead about in the news the final rule did not provide a compliance period for flavored tobacco periods of any kind. this was actually written into the final rules. they adopted this alternative. as of the effective date, all flavored tobacco products that were not grandfathered would have to be removed from the market until they obtain the fda order permitting their marketing. that was going to happen but the white house intervened and made

them change that, we assume. are notncessions publicly available. from the redline version that was released in the docket, it appears all of those sections were crossed out while the rule was at omb. it could have been worse, right? bad.would have been very those are the only alternatives considered by fda. despite the fact that in comments, the proposed rule, there were many viable alternative suggested. many of them were very logical. fda could have adopted product standards. there were hundreds of thousands of otc products that had not been reviewed for efficacy yet.

thousands of applications. the fda could've avoided that urban on the industry in itself by implementing product standards. and exploding batteries, they could have adjusted that much sooner. talking about the first amendment claims, this is focused on the modified risk

position, the modified risk provision said that you cannot andunicate truthfully honestly the risks of your vapor products without going for an approval process. that is part of the deal. amendment,irst regulations must be narrowly tailored to directly advance a government interest. the modified risk has to -- was upheld but in that case, the court cited the extensive history of deception by the industry to conclude that a stringent standards such as prior approval of modified risk claims was the least restrictive means to ensure protection of the public health. that is a very different situation. it is a preamble to the final rule. endsknowledges that some

may transition away from tobacco use and it is possible there could be a public health benefit. fda acknowledged that the use of -- the lawsuits have argued that truthful and not misleading information should not be prohibited until the fda has a chance to review and approve those. fda itself in its right military flexibility -- in its regulatory possibility acknowledges that lacking information is a problem. productsilure about characteristics leads to non-optimal levels of consumption. they also acknowledge that consumers inability to make well-informed choices is a particular problem because tobacco problems are

we've heard that consumers not only had been uninformed, but misinformed about the relative tobacco products. fda colleges that this can be a real problem. the final claim the plaintiffs included in their lawsuit is that naming regulations are overly broad. as i mentioned earlier, the definition for tobacco products is quite broad and covers not only products made or derived from nicotine, but their component parts and accessories, although fda has excluded accessories. lawsuits have claimed that fda thought -- sought too broadly to

define the products and that undermines public health. to give you an idea of the scope of the naming regulations, not only will the naming regulation cover products made and derived from tobacco, but it will cover all components and parts. all these items will have to go through premarket review. you see the list. we've talked about the reach of this, and can it go to batteries, to software. fda said yes. it will even cover e-liquids that don't contain nicotine if they are intended or reasonably expected to be used with or for human consumption of the tobacco product. expans fda's-- jurisdiction a bit. the fda has said it plans to

regulate entire lines of e-liquid, even if they don't contain any nicotine. end my presentation with a few quotes from fda on the public health implications of the naming rule, as it will be applied. if going forward electronic cigarettes are proven safer than other tobacco products and are substitutes for other tobacco products -- which we believe is the case -- and if the effect of the market requirements on the supply and price of electronic products were large enough, than the welfare effects of a reduction in supply of electronic cigarettes could potentially be negative. likewise, they said if consumption of end products

contains individual health risks that are more moderate than those of other tobacco products, it's possible, if revisions of the rule tend to discourage their use disproportionately, any ongoing improvement in population level health risk could potentially be reduced. i will leave it at that. thank you. [applause] thank you. good morning, everyone. thank you for joining us here in the room. unlike the clinical and legal experts on the stage, i have approached the topic of e-cigarettes from a public focusedperspective and my research on questions related to the taxation of e-cigarettes. since then, i've looked at some of the related regulatory

issues, including what i would consider to be an impressive relive ration of federal regulatory activity outside of the skull of the activities we are discussing here in the fad, -- fda, regulations from the department of transportation and few.to name a to piggyback on the comments made earlier,, last fall i submitted comments to the fda as they prepared to make proposals to regulate warnings and child resistant packaging for liquid nicotine. i pointed out in that comment they must consider the relative risks, a term we have heard repeatedly this morning, and to dig in on that point, the point i made in those comments were that it's absolutely necessary and appropriate to pursue child safety type regulations. we need to understand those in the broader context.

arehould remember there over 7000 smoking-related fires and 14% ofnually, fire related deaths are the result of smoking related fires. there are serious risks associated with tobacco in addition to the risks described earlier. while policymakers need to encourage e-cigarette related safety measures and child safety, liquid nicotine are among them, it must be done so as not to discourage tobacco smokers from switching. that is consistent with the comments others have made as well. i'm actually not here to talk about relative risks. i'm here to focus on the congressional perspective. long before i heard of e-cigarettes, i think before they were widely available in the u.s. market, i spent a number of years working on capitol hill. i was the chief director of the

house, ways, and means committee. . aboutheard from others what's important and what the legal ramifications and opportunities may be. i will try to answer the question, so what does washington or congress intend to do? minutes,,t couple of let me touch on three issues in particular. know about the congressional's attitudes are perspectives with respect to the naming regulations and e-cigarette regulations generally, answer whether this is a partisan issue, and if so, what are the divides in congress that are relevant, and i will take a minute to step back from this particular issue, look beyond the deeming rigs, -- regs, and look at what role congress may play more broadly

in the future. with respect to the congressional perspective on the it's important to distinguish among the activities within the final rule, in particular separate the predicate issue from the rest of the rule. thecritical components in focus of others remarks is the need to go back, to take products of the markets i go back for approval before they are allowed to reenter the market. there are other aspects of the deeming regs related to safety and marketing. this is important from the congressional perspective. , and is bipartisan support little opposition to a federal regulatory role with respect to

e-6. this is significant. it's not obvious that would be a consensus. see a position of advocating zero activity. it's noteworthy. there has been a lot of activity on the state level. is beingand that imposed is not a new issue, it's not a federal issue. nearly all states have put these policies in place already. left we are seeing general consensus around a framework, butry not an outright prohibition. deemingpect to the regulation and predicate date issue, the ability of products to remain on the market now that the regs have been finalized, there is strong support for

change from congress. most of that support has been embodied in what is known as the coal amendment, adopted recently in the hud appropriation committee markup. optimistically that this was the most popular amendment considered that day. it passed by a vote of 31-19. technically it had bipartisan support and technically there were multiple democrats voting in favor of it. that multiple number is just the number two. we should also remember the role of the minority in the house. the role of the minority is to oppose the efforts of the majority. observers of the house will note that is more common than not. in particular in the current

clinical balance, it's the role of the house minority to support the president. if we want to be optimistic we would say that any support to the coal amendment could be seen as a positive sign and evidence of bipartisanship. if you are an optimist there is perhaps a bit of good news from the other chambers, the u.s. senate. after the deeming regs what thel, -- went final, senator wrote a letter praising the fda. the focus of the letter is noteworthy and what's absent from that letter is known or the as well. aboutrry letter was all marketing and unrestricted access, the importance of those issues. a lot of concerns in that letter , and a lot of rhetoric about

the mal intentions of manufacturers. was's not in that letter the issue of the predicate date. i would think if you want to be might bec that silence an opening. i don't want to oversell this point. the senate is not nearly as engaged in this issue as is the house. it's because of the senate's lack of interest on this issue that the predicate date did not change last year. there isi would say some agreement about safety issues in congress with respect to e-cigarettes and a willing for such willingness for there to be a regulatory role, and moderate support for the predicate date to be changed.

while will happen ultimately this year is yet to be seen. i think i started to answer the isond question, which is this a partisan issue. more often than not, nearly everything in washington is a .artisan issue these days the lack of enthusiasm from the house democrats should not come as a surprise. it doesn't mean there isn't a willingness for congress to engage on this issue. i think republicans who are pursuing a change here are looking for a deal. you can see the enthusiasm around the coal amendment if -- as they have emphasized the safety concerns. say that allowing these products to remain on the market is a small deal. it's what will allow these products and the innovation

around these products to continue. there is some common ground that is not being fought. with respect to what's next view --is issue, in my this is maybe not surprising, given i worked on the issue of tax policy in the past, i think the next battle that congress will look to tackle with respect tax-cig products is the question. we fight over tax policy has largely been confined to the states. the federal discussion about it has beenion of e-cigs

relatively quiet. at the same time, i believe the seeds have been planted. two bills that have been introduced in the senate, the tobacco tax equity act and s1129, tobacco tax and enforcement reform act have both been introduced by democrats with democratic cosponsors, senator berman and senator blumenthal. these bills both impose high .ederal taxes on e-cigarettes how high? we don't know exactly. the bill would authorize the secretary of the treasury to establish comparable tax rates on e-cigarettes to those imposed currently on cigarette taxes. one of the bills raises the cigarette tax as well. proposal.telling it goes to the heart of the issue.

to date these bills are not receive much attention. now that the fbi has completed the deeming process and seemed , these bills may politically begin to write them read -- right them. thank you. [applause] >> before we move forward i thought i would take a couple minutes to fill in some background concerning the premarket review requirements, which are the heart of the regulation and source of greatest concern. useful to take a step back and see how dramatic they are and how burdensome. i give a brief view of how they came to be and why they are now being applied to products they

are ill-suited for. under the federal food, drug, and cosmetic act, there are three ways a product introduced into the market after february 15, 2007, can be marketed. one of them is to show the product is substantially equivalent to a product that was on the market february 15, 2007. there are two possible ways that can be established. one is for it to have identical characteristics to a product in the market on february 15, 2007. and then the other way to show the substantial equivalent is to say there are differences in characteristics, but there are no new questions of public health. very stringent the definition that any of the characteristic differences that may arise have no new questions of public

health. there is no new questions at all. since there appeared to be inost no predicate products the vaping segment of this industry, it will be difficult for anyone to show substantial equivalence on the market -- in the market on that day. that in principle, someone tried to market and e-cigarette product could choose some other products like a combustible cigarette and try to show substantial equivalent for that. not by saying the characteristics are identical, because clearly they are not, but by trying to show the differences in characteristics raise no new questions of public health. the fda itself says that would be a very arduous showing. the second way to bring a product onto the market is

obtain an exemption from substantial equivalence. stringent andery i don't think there has been much attention to this possibility. that's to say the only difference is in an additive and the additive change this not propose any health issues and it is appropriate to exempt the new product from substantial equivalence. they would probably set that aside. that's the arduous process that some of the speakers have mentioned. extensive information is provided to the fda in order to submit a successful premarket tobacco application simply because the statutory standard for those applications is so stringent. the manufacturer by law must provide information about the

ingredients, additives, properties, processing, labeling, and health risks, in order to demonstrate that it would be appropriate for the protection of the public health to introduce this new product, where that consideration must take into account the risks and benefits to both users and consider the must effects on the likelihood that existing users of tobacco products will stop using them and the likelihood that nonusers will start. in practice, this will require full-fledged clinical trials of the new product because you are attempting to show, to make it affirmative proof that the product will have a net public health benefit. looking at that statutory framework, what makes it so extraordinary is that a new product that is going to imply with all of the substantive rules set forth by the fda in terms of claims of modified

risk, in terms of warnings, in terms of recording of ingredients, in terms of not being sold to minors. even a product that will comply with those substantive restrictions still cannot be introduced into the market unless there is an affirmative showing that it's actually a net benefit to public health to bring it into distribution. a requirement we usually imposed. it does impose precisely that requirement on cigarettes. that is appropriate because we know cigarettes are deadly to minors and we don't think there is any gain from having new cigarette varieties introduced. problem with extending it to e-cigarettes is twofold. first, we know there is almost nothing out there that can serve as a product that is already existent that can either be

grandfathered or that you can use to show substantial equivalence. there are many cigarettes on the market so using that date would allow many of these deadly cigarettes to remain in circulation and then applying it to e-cigarettes where almost none of these safer products would be able to benefit from grandfathering is really quite an extraordinary extension. the other difference is that e-cigarettes are much safer. cigarette market into stasis, which i think was the intent of the review requirement is a sensible objective given what we know about the deadly nature of cigarettes. the february 15 2007 date was chosen because it was the date when sick -- when consideration started in congress and it seemed appropriate for the therette industry because were many cigarette products already in circulation and nobody thought we needed new

ways for people to kill themselves with new brands. statute, that date needs to apply to any other products that are deemed by the fpa -- fda. that the fda did not consider all these less burdensome regulatory alternatives that would have involved premarket review. do you believe the fda had any such discretion once they had deemed e-cigarettes? once atatute says product is deemed, it has to be subject to everything included -- including premarket review. all of us would like to see some more moderate regimes like you were describing. but would there be an option for that? had thenk they discretion to do that and in the comments that were submitted to the docket, there were numerous arguments as to why they had

discretion to different approaches that would reduce the burden on these products. statute justifying the -- does to find the tobacco product and it excluded accessories from the scope. that is a clear example of the fact that fda believes it has allauthority to not apply the statutory provisions to all of the products that would be covered either definition of tobacco product. -- tobacco products. i think they chose not to put themselves out there. have used their discretion to take numerous different approaches that would be less onerous to this market. point to make a different since i am not a lawyer and don't even play one on tv. we need to consider two different things. how are products going to

initially get on the market? there is no question there is a significant burden. some of that may be good. it may not be such a great idea to have nicotine liquids that someone mixed in their bathtub in the back of the store. there is going to be initially what products and what companies are going to be able to get the resources to do a successful premarket tobacco application. another point we must not miss is that them improving a product is going to require a new premarket tobacco application. i have seen this movie in the pharmaceutical industry, it squelches innovation because there is a very high cost to making any small change. it iscremental image -- going to become very difficult. frankly, a company is going to repeatedly face a dilemma.

do i spend two and a half million dollars with something that may make the product better, even safer? " someone is going to say let's just spend that on more advertising." that is a real dilemma. it is not what gets in the market initially but what happens afterwards. >> it is interesting the fda tries to claim the review was going to expedite innovation and it is hard to imagine how that type of product could really have that effect. can stayned, the f da out there for two years and if an application is submitted, they can stay out for another year while the application is being reviewed. to awouldn't even apply product that was introduced after the date. on the markete

august 8 and it cannot be modified in any way without getting prior approval. something about some of their requirements is that the premarket approval, one of them is the public health impact as opposed to individual health impact. the public health impact mainly that is typically the concern, that is an important question. but it could be done post market. i don't think anyone is denying that this is worth pursuing -- it will be pursued, the cdc will continue to follow it as it should. does it need to be a condition of allowing these to continue on the market? i would argue no. i just wanted to reinforce the the questions of

the fda asks are good ones, it's just that they are ending up being a barrier to innovation and the industry as opposed to something that should be done but will be less of a barrier. >> you've heard a lot from all of us, so let's open this up to our audience discussion. if you have a question, raise your hands and wait for the microphone and identify yourself and who you are with so we can include that in the broadcast. >> my name is guy bentley with the daily news foundation. alex's point,of making regular tobacco taxes and e-cigarette taxes comparable, how would you see the public health movement's response to in that cigarettes and

e-cigarettes will be purchased on an even playing field in terms of price, would that this incentivize any price incentives to switch in the cost of buying regular cigarettes. how much public health support is there for that kind of move? do you think people would say, we still have a lot of doubts, they are still probably less risky, therefore they shouldn't be taxed in the same way, how would you see the response to those debates coming up? >> i think the states have a big interest in wanting them to be -- the e-cigarette taxes to be as high as possible as a replacement revenue for potentially what would be lost if people stopped smoking. , wheny, the only place you think about it, it is an

extreme example, but you would love a situation where if you were a public health purist, no cigarettes would be available at all, so the only alternative vuld be shaping -- would be aping or quitting by other means. i suppose it is different from a public health standpoint but i would like to be able to have a patient who would pay very little in terms of tax, relative nothing,ttes, arguably so that would be an incentive to switch. they would be able to fate -- vape in public places, that would broaden.

anything that makes e-cigarettes more attractive to smokers is, from a public health standpoint, the rational thing. forcesre so many other we have talked about in terms of politics and other stakeholder -- that i am sure the tax will never be zero, but from the standpoint of behavioral change, you want these devices to look much more attractive than cigarettes. >> i would add to sally's point respect to the tax policy, the focus has been on the state level around the need for revenue or the desire for revenue, whether it even if -- the declining revenue. more broadly, the concept of a prevalence. these are both rods with the

word cigarette in the name. both products have new teen -- have nicotine. people are trying to draw equivalences between these products and then pursue that concept with respect to tax. discussioneen some about having lower taxes on e-cigarettes but even that doesn't make sense to me when we should be trying to encourage the switching. we think there is evidence that the gateway is going towards e-cigarettes. different,ence were the tax policy could be different as well. both the tax policy with respect to cigarettes as well as e-cigarettes. opportunitye is an to use tax policy to affect the relative prices in a way to encourage the switching. study done aa

couple of years ago about state budget solutions showing that they can save money by encouraging consumers to switch to e-cigarettes because of the reduction in expenditures on health care. >> that's the kind of thing that is lost sight of. taxing and budgeting are often very short run focuses. when people are smoking less, that means less revenue for us. that means a lot of payoff down the road when people are not being hospitalized and suffering from the diseases of smoking but when the state sees a threat to its revenue source, and says we need to do something about it -- i do hope zero is the tax rate that applies to his -- applies to e-cigarettes. they are still at zero tax in the large majority of states but the pressure to introduce taxes on them certainly seems to be widespread. several states have already done

that. the proposals to do so have been made in dozens of other states. >> outside the united states, other countries are considered -- in addition to what allen describes as the short run or , there is also a division in where the public health officials that are looking at these issues are in a different office and different department and facing different objectives than those who are focused on fiscal and budgetary issues. we often have clinical and health-related discussions in one audience and then we have focused on the ministry of finance, having very different discussions. a point about the individual user's perspective, it is important to recognize while we have talked about health benefits, smokers often fight the cost of smoking as one motive to quit.

cite of e-cigarettes often the lower cost to them as a motive for switching. at that level, this is an important letter. lever.rtant >> catherine cows are from the european liaison, my question is to all of you. how does the current u.s. regulations compared to how other nations are treating e-cigarettes? >> probably better than australia. but worse than europe. regulations are more to our standards, still onerous but much less extreme. >> the rest of the world is all over the map, you might say. >> in australia, e-cigarettes are banned. in canada, the ban is not enforced, so there are shops

everywhere. the u.k. is a jurisdiction we should look to. as you saw in my quoting, the including its regulators, have taken a very different view. see e-cigarettes as a potentially beneficial harm duction strategy, have been very open about approving the productas a therapeutic with a relatively low bar and burden. know, they, as you have the national health service which has a very active smoking sensation service and they have indance to support smokers using e-cigarettes as a way of shifting away from combustibles. think the u.k. has exercised a lot of very strong leadership.

>> i would like to tell you about a public health policy currently. policiesarbon emission for more taxation but on the on public policy, they have no smoking policies for most of them, democrats. they say no smoking but in front of our congress, they still smoke. what do you anticipate the tax rate and advertising -- in legaly --

policies? >> i'm not sure what the question is. one is by carbon emission taxation toher is discourage pollution and health consequences. on the other hand, you have legal marijuana that you don't -- that everything is touchable and everything will be restricted. , democrat orbate republican, they have debated

rhetoric only because they don't -- >> thank you for your comment. >> this is -- this may have actually come up before but i just wanted to know, what is the data of who the e-cigarette users are? are they new users or people switching from cigarettes? is obviously irrelevant because the epa is betting there are more he -- more new users than those switching from tobacco. what does the data show on that? ,> >> i did present some data but overwhelmingly, current e-cigarette users are tobacco smokers. some are using both products which may be a transitional stage and many were smokers and

have transitioned lately -- transitioned completely into e-cigarettes. you see very little use among non-smokers. overwhelmingly, people start with smoking and transition to e-cigarettes. >> high, i worked with penney associates on their noncombustible products. i think there are a lot of misconceptions about what changes to the predicate date would mean and i don't think there is enough discussion about the other products that would come along if the date is changed. can you talk a little bit about what authorities, the fda would have over the product if the date is changed? >> everything else would be applicable to these newly deemed products.

where fda to change the ,randfather date, any product for example if the grandfather date was may 10 of this year, the publication of the final rule, any product on the market by may 10 would not need to go through premarket approval but all of the other requirements in the act that are applied to deemed products would apply to those products. product listing, ingredient listing, modified risk claims, minimum age, potentially good manufacturing practices, all of those things would apply to these products even if they didn't have to go through premarket review. you would still kill subsequent innovation because anything that came on subsequently would have to go through the premarket. >> that is a valid point. it doesn't make sense to have any kind of predicate date.

it is still a barrier to future innovation but obviously much less than if is february 15, 2007 where almost nothing was on the market. this country, we have a long rich history of comparison between the u.k. public health establishment and the u.s.. in the affordable care act there was a lot of conversation about what the u.k. was doing in terms of its regulatory regime and delivery reform systems. is the conversation back and forth between the fda and public health advocates in the united states and u.k.? to theseany pathway very divergent points of view with regard to regulation coming together and meeting in the middle somewhere? >> i certainly hope so. i don't know if the fda has

discussions with them but i think affect the u.k. is a beacon for us, they have 90% of and wemokers now vape are at 10%. planned, continue as we are probably going to constrict our market considerably. to not around that is have a predicate date but rather have an imposition of safety standards. frankly, that is it. a lot of post-market surveillance. wonderful.. is they have a very -- frankly, i would like to put a lot of stock in the concept of a bottom-up movement, which is a lot of what happened in the u.k..

what makes it active and vibrant is the more people are attracted to it because the more new devices are available. this has a chilling effect, it would be hard to have a bottom-up dynamic from here. also, the royal college public health in england, which is the cdc of england, their major intellectuals are in favor of -- they see the virtues of e-cigarettes. they understand they are a thing we still have to learn more again, for smokers, the relative risk is undeniably much lower. .hey are very vocal about that health service has adopted vapor product.

i think even more on a bottom-up , which thecess regulations could actually stifle, which is an added worry. briefly, certainly within the scientific and tobacco control communities, and at fda, people in the u.s. are very aware of the uk's position. u.k. may in a way, the end up producing the evidence we need to convince policymakers here because certainly, the public health community, the regulators have been very supportive. we see smoking prevalence falling. they are going to be the experiment that shows the things the precautionary folks are worried about. i'm going to comment on what sally brought up about a bottom-up movement and i

reference the fact that i work with the start of -- with the pharmaceutical industry on smoking products. ,t was widely held, still is that we had a problem, products that were safe and effective for smoking cessation and nobody could use them. you could barely give them away. onas part of an initiative consumer demand to make the products and their positioning attractive enough that people would want to use them to quit smoking and save their lives. haveast that to where we an active grassroots movement where people are lining up to pay their dollars to get a product that has nicotine and is safer and now we are seeing that as a problem instead of a solution. i want to clarify something

from earlier about the predicate see and the subsequent innovation. if congress were to change the predicate date, subsequent modifications would have to go through premarket review but they could avail themselves a substantial equivalent process. still not an easy process, but more manageable than the fda process. u.s., the u.k. versus community of public health advocacy in the u.k. has been more favorably displaced towards the idea of harm reduction especially in the context of tobacco. partly that comes down to psychiatry and having trained up a generation of harm reduction scholars, but that has been diffused into the organization.

both of those groups have been very active in advocating for people to use lower harm products, including e-cigarettes. there were harm reduction people in the u.s.. these tribesow emerge in a line and are reinforced by federal dollars. my name is emily anderson with wilkinson barker and i am interested in the required -- what we call it -- the advertising goals and be required health warnings and labels that are required? can you speak more on that and affectt would

advertising and broadcasting in other media? there are no advertising restrictions in the deeming but the warnings would be required. what is your question on laboring? labeling's, would that have any effect on the broadcast in general? that ought to not have an impact but networks have their own guidelines. >> the ruling is different to the ones on existing tobacco products. nicotine is an addictive chemical, so it is much different from saying this product may cause some sort of diseases. in a sense, the differentiated warning might be better.

but any warning that discourages people from switching, i think, we should be concerned about. >> would there be any effects from the restrictions on modified risk claims? >> absolutely. you couldn't discuss in advertising that your product is lower relative risk or that even it doesn't contain certain components. the fda will consider on a case-by-case basis whether you can talk about the fact that it doesn't contain tobacco. there were a few they would a lot ofbut really truthful and not misleading information about vapor products would be prohibited. >> i don't think we've fully exhausted this important and white rated top it. -- wide-ranging topic.

we have come to the end of our allotted time. willhoping panelists answer questions individually if you didn't get a chance to ask something but please join me now in thanking our panel.