Judul : Ct Department Of Public Health
link : Ct Department Of Public Health
Ct Department Of Public Health
good morning, and welcome to the third session of our public health grand rounds. allow me just a few brief comments about the activities surrounding the grand rounds.
Ct Department Of Public Health, one is that our internet, intranet website is now up and running, so everybody throughout cdc can not only watch these events live,
but can watch archived presentations. in addition to the intranet and the iptv feed, i'm really pleased to announce that we are launching an external internet website, and so that will allow colleagues outside of cdc to participate in public health grand rounds, to watch these events live, and, again, to view previous broadcasts and our powerpoint presentations at their convenience.
for those of you who might already be watching and joining us, i'd like to welcome to you cdc. we're also very proud to announce that beginning january, a number -- all of our events are going to be eligible for continuing education credits in these categories. and this is a work that has happened thanks to a number of colleagues from throughout cdc,
and i would like just to recognize them for their efforts. those are the members of the planning committee. finally, we are looking for feedback always, as i mention every time. and we're looking to add a web survey that is going to be present in our intranet and internet sites, as well as feedback that is going to be available through the continuing education credits.
but in the meantime, we would like to assure that you can provide your feedback either to the content, topics, or anything else about the grand rounds to me or to my partner in crime, shane joiner, who is taking the lead on basically everything else -- communication, marketing, i.t. activities, and all else. and with that, i thank you for coming, and i'm turning it to the smoking hot tobacco team.
[ laughter ] i consider myself an honorary member of the tobacco control team, but tobacco remains the leading preventable cause of death in this country and globally. as you'll hear, not only does tobacco kill more people than aids, tb, and malaria combined, but unlike those three conditions, which, with a lot of cdc and other involvement,
are decreasing as causes of morbidity and mortality globally, tobacco is increasing as a cause of illness and death globally, despite the fact that we really know what needs to be done. there's been tremendous progress made in tobacco control over the last few decades, but over the last few years, we have stalled in this country overall, despite the fact that we have existing tools
that could make a huge difference, and we're exploring new tools that might be able to make a difference, as well. and thinking about the priority areas or strategic directions that i have piloted for cdc, i think tobacco is a great example. epidemiology and surveillance -- understanding better what's happening, including in the laboratory,
where you'll hear some really fascinating information. support the state and local governments, where there's a huge variability in tobacco control, where globally -- or nationally, i should say -- we've stalled. there are at least a half a dozen states which are doing much, not all, of what they could and should be doing, and they're getting really good results.
you do the right thing, you get the good results in tobacco control. globally, we're involved, and you'll hear about that some. and in terms of policies, policy implementation in tobacco control is what drives the needle down. program and clinical care can make a difference in individual patients' live, but to get a huge change in prevalence,
you need policy interventions. and this is a critical area for us to work with partners throughout the federal government and in states to get a big difference. so, i'm very much looking forward to the session, and there's really nothing that's more important in public health and nothing that has more potential. thank you, dr. frieden.
good morning. i'm lorna english, deputy director of the office of smoking and health. we are excited to have this opportunity to discuss tobacco regulation and its importance to public health. over the next hour, we will address in detail what regulation entails and how it will play an integral role
in reducing tobacco use nationwide. on june 22nd of this year, president obama signed legislation granting the food and drug administration the authority to regulate the content, marketing, and sales of tobacco products. regulation is a key component of comprehensive tobacco control and is expected to have a significant impact on the tobacco epidemic.
in its role as the lead federal agency for tobacco use prevention and control, cdc provides approximately $85 million in support to states, territories, and other national partners. the goals are to prevent youth initiation, eliminate secondhand-smoke exposure, promote quitting, and identify and eliminate tobacco-related disparities. as elements of regulation become effective
over the next several months, our agency will play a role in supporting fda. cdc will provide technical assistance and laboratory support as fda builds capacity. in addition, we will conduct post-market surveillance to monitor the impact of tobacco regulation. in addition, we will continue our ongoing activities, funding and supporting comprehensive tobacco-control programs
in states and communities, which will include coordinating their efforts to support fda. as we move forward, surveillance will be key to understanding the impact regulation has on the prevalence of tobacco use as well as industry practices. in collaboration with the fda, we will evaluate changes in product constituents, the public's attitude about tobacco use and regulation, and changes in smoking rates and cessation attempts.
today we will hear an overview of the burden of tobacco use and the impact of tobacco control in the united states, about the global burden and progress at the international level, about the importance of laboratory research in tobacco regulation, and, finally, a perspective from the director of fda's new center for tobacco products. so, to begin, i would like to introduce dr. terry pechacek,
associate director of science in the office of smoking and health. terry will talk about the evidence and effectiveness of comprehensive tobacco-control programs. terry? thank you, lorna. good morning. as we've already heard from dr. frieden, tobacco use is the single most preventable cause of disease and death in the united states.
about 443,000 americans die annually from tobacco, and another 8.6 million have a serious illness caused by smoking. smoking costs the united states $96 billion in medical costs and $97 billion in lost productivity each year. although adult smoking rates have declined over the last three decades, the decline among adult smokers has stalled during the past five years.
in fact, the healthy people objective to reduce the rate of smoking among adults to 12% or less by 2010 is becoming unattainable unless dramatic action is taken. as has been the case for many years, certain populations continue to disproportionately use tobacco. in the data we released last week, we updated the fact that among different racial ethnic group, the highest rate of smoking was 32.4%
among american indians and alaskan natives. additionally, we look at poverty. the rate of smoking among those living below the federal poverty level is 1.5 times higher than those living at or above, at about 31.5%. but the greatest disparity we see in the demographics is that the smoking prevalence was 41.3% among adults who had earned a ged certificate
as opposed to 5.7% among adults with a graduate degree. the goal line -- and i should used this. the goal line here on the chart shows the youth rates are better. there was a spike in youth smoking during the 1990s, and several factors contributed, including low tobacco-control funding, which had an impact, as well as the industry activities
in promoting joe camel and other things that targeted youth. by 2007, about 20% of high school students were current smokers. so, overall, the trend suggests that we could still attain the healthy people objective for youth smoking, which is to reduce the rates to 16% or less by 2010. we know exactly what to do if we want to cut tobacco use. we have to fund comprehensive tobacco control at a sustained basis.
we need to raise tobacco prices to decrease youth smoking and to promote quitting. smoke-free policies eliminate exposure to secondhand smoke, but they also encourage quitting and change social norms. we need to restrict advertising, promotion, and sponsorship, which can reduce tobacco's appeal. aggressive media campaigns prevent initiation and encourage smokers to quit and cessation programs help smokers to quit.
so, let me tell you a bit about each of these interventions. as state -- as state investments increase, we have found in our research that youth smoking rates decrease. this diagram shows this dramatically in the blue and gold lines. now, when we look at states, such as california and maine, that have made large and sustained efforts
in comprehensive tobacco-control programs, we have seen that cigarette sales drop about twice as much in those states as in the united states as a whole. additionally, states such as maine, new york, washington, and many others have seen dramatic drops in youth smoke. and in those three states, we've seen 45% to 60% reduction in youth smoking
with sustained comprehensive programs. this is a map that shows the current status in terms of funding in the tobacco-control efforts. cdc recommends that states spend between $9 and $16 per capita on tobacco control. this investment would counter the nearly $13 billion in advertising and promotions spent by the tobacco industry in the last reported numbers. as you can see in the two lighter colors --
these -- on this map, these lighter colors indicate that funding below 40% of the cdc recommended level is the norm and that most states are not spending enough. but they have the money. in fact, we could fully fund tobacco control at cdc's recommended level if they used only 15% of their annual revenue
from tobacco excise taxes and the master settlement agreement payments from the industry. at those funding levels, in only five years, we conservatively estimate that about 5 million fewer people would smoke and hundreds of thousands of premature deaths would be prevented. however, only about half the states are funded --
over half the states are funded -- it's in the lightest color -- at 20% or less of our recommended level. and without any changes in state investments, only north dakota will be funded at cdc's recommended level in 2010. increasing the price of tobacco products is a key to reducing tobacco use. one of the most direct ways to increase the price of cigarettes
is to raise the excise tax. we know from a large body of literature that a 10% increase in tobacco prices reduces consumption about 4% and can have an even greater effect among youth, low-income, and other price-sensitive populations. while price increases will reduce cigarette consumption among low-income smokers, we continue to stress the importance
of funding wider access to smoking-cessation services to address the greater financial burden felt from tobacco price increases. now i'm going to start a series of slides here that highlight this price effect. state excise taxes is one area where we've made significant progress over the last 10 years. since 1995, in fact, there have been 117 increases in state excise taxes on cigarettes,
with most happening since 2000, where i'll start the slide series. over the last 15 years, the average state tax has gone up over a dollar. we'll start here at 2000, where the average state tax was about 42 cents, and i'll show you the progress over time as states raise their taxes. here in 2001,
you'll see that maine and rhode island got greener. but here again, we're seeing a little bit more darker color, but still only about 31 states had the lightest color, which is less than 50 cents per pack. in this 2002, we see a few -- a little more progress in the middle of the country, with nebraska and kansas raising their tax. 2003, the west is now getting greener, and we're starting to make progress in the average tax.
but the southeast remains in the lightest color. 2004, we can see several states, such as michigan and rhode island and new jersey, have eclipsed $2 per pack, the darkest green color. 2005, more cigarette tax increases across the country, and the average state tax is now doubled to over 90 cents. 2006, there were 20 states with excise taxes of $1 or above. 2007, there were now eight states
with excise taxes of $2 or more. but once again, the southeast remains in the lightest green. so, 2008, the northeast now is becoming markedly green. and now 2000 -- why am i getting -- 2009. as of 2009, we had -- with the federal excise tax increasing in april from 61 cents to $1.01
we have surpassed the healthy people 2010 objective to have an average federal and state tax of more than $2 per pack. today, 15 states have excise tax rates of over $2 per pack, and connecticut and rhode island now are over $3 per pack. while some southeast states have made progress with small tax increases, most southeast states remain
below the 50 cents per pack rate. while not all communities have the ability to levy local tobacco taxes, some cities and counties do. when state, county, and local taxes are combined, chicago, at $3.66 per pack, and new york city, at $4.25 per pack, had the two highest cigarette tax rates in the country. put this in perspective.
a smoker in new york city pays more in tax than a smoker in kentucky or north carolina pays for a whole pack of cigarettes. it is important that tax increases continue to keep up with inflation, however, to ensure that we are continuing the impact of reducing the affordability of cigarettes. by not indexing tobacco taxes to inflation, that's a gradual erosion of health and economic benefits.
the ultimate goal of overall pricing and marketing strategies is to reduce the affordability of tobacco. now, shifting. smoke-free policy is also a key part of tobacco control. they improve -- these smoke-free policies improve indoor air quality, reduce negative health outcomes for nonsmokers, decrease consumption, encourage smokers to quit, and change social norms
regarding the general acceptability of smoking. in many cases, the air quality in a smoky bar or restaurant -- these light blue bars -- is 10 to 15 times more hazardous than the general outdoor air-quality standards set by epa. that's the outdoor standards. this graph shows, in the dark blue lines, how dramatically the dangerous small particle levels drop
after smoke-free policies are implemented and, in most cases, below the outdoor standards. two meta-analyses independently concluded that communities with smoke-free policies see a drop in heart attack hospitalization rates. this graph is from one of those studies, showing that an average meta-analysis estimate of 19% reduction in hospitalizations. the other analysis estimated
that if all states were smoke-free in this country, nearly 155,000 heart attack admissions would be averted annually saving billions of dollars in medical costs. last month, the iom released a report on secondhand smoke and cardiovascular effects. this report concluded that secondhand smoke causes heart attacks. also, the ion concluded that even brief secondhand exposure
could trigger a heart attack and that smoke-free laws prevent heart attacks and save lives. additionally, this report concurred with the established finding from the 2006 surgeon general report that approximately a 25% to 30% increase in cardiovascular risk comes from exposure to secondhand smoke. today, about 21 states and d.c. have laws that prohibit smoking in workplace, restaurants, bars, and other public places.
as this graph shows, this is progress. yet almost 100 million americans are still exposed to secondhand smoke. 29 states do not fully protect their nonsmokers in public places and 12 states prohibit local communities -- preempt local communities from passing smoke-free ordinances. those disproportionately affected
include people employed in blue-collar jobs, hospitality workers, such as bar and casino employees. and we see a significant geographic gap in coverage, with no southeast state having a comprehensive state law protecting their public. increasing the number of states with smoke-free laws will save lives. another important strategy is aggressive countermarketing campaign.
these increase the negative attitudes about tobacco, impact youth initiation, and encourage smokers to quit. research tells us that advertising that has an emotional appeal is very effective. let me share with you a version of this ad from australia that played in new york city earlier this year. it garnered significant media attention. roll. [ indistinct speaking on p.a. ]
announcer: if this is how your child feels after losing you for a minute, just imagine if they lost you for life. about 70% of the 45 million u.s. smokers want to quit, and over 40% of these smokers in this country try to quit each year, yet only about 2% of the people who want to quit access their state or national quit lines for free help. most smokers continue their addictive habit
until the health effects become serious enough to force them to quit. quitting tobacco dependence has been, historically, a top priority, but cessation funding needs to be examined in context. while cessation programs can be effective in helping individual smokers quit, the cost of achieving the desired impact is much larger than other interventions.
to effectively decrease prevalence, cessation must be part of a larger, comprehensive tobacco-control program effort. still, it is important to provide affordable cessation services to all smokers who want to quit. today, almost all quit attempts are made without help, but very few of -- but very few of these unaided quit attempts are successful. counseling through telephone quit lines
can significantly increase success rates, as shown by this middle bar. and there's even a much greater effect when this quit-line counseling is combined with medication. to reach more smokers who want to quit, we need to expand access to all cessation services, including expanding coverage under medicaid and other health-insurance plans. services need to be made more accessible
to low-income, less educated, and non-english-speaking tobacco users. now, how do all these things work together? in 2002, new york city began a tobacco-control program that combined these multiple interventions. as a result, from 2001 to 2007, shown in this gold line, youth smoking rates were cut by more than 50%. at the top of the slide -- uh-oh --
this blue line across the top shows that adult smoking rates had not declined for almost a decade but then started decreasing sharply during the six years that the program was implemented, with adult smoking rates decreasing from 21.6% to 15.8% from 2002 to 2008. this decrease in adult smoking in new york city since 2002 represents a much larger decline
than we were seeing in the states overall. it means that about 350,000 fewer smokers were created in new york city. new york city proves that when we combine the interventions and increase tobacco-control program funding across the board, we will be able to reach our targets so that by 2020, adult smoking rates in the u.s. could be cut in half,
and youth smoking rates could be cut by 75%. the retail environment is the only major channel remaining for the tobacco advertising and promotion, and somehow this environment has remained largely unregulated. we also know that there is a higher density of retail outlets and advertising dollars spent in the inner city and in neighborhoods where minorities live. we're optimistic because fda now has the authority to regulate
the content, sales, and marketing of tobacco products, which are the tools that the tobacco industry manipulates in order to reach youth. tobacco regulation, combined with these other interventions i have summarized and detailed today, will move us closer to ending the tobacco-use epidemic. now i'd like to introduce captain matthew mckenna, acting director of the office of smoking and health, who will tell us about the efforts
to control tobacco globally and what we might learn from these experiences. good morning, everybody. as we've already heard, tobacco use is now the single leading preventable cause of death in the world. it kills more people than aids, tb, and malaria combined, and unlike these other major killers, the number of deaths from smoking is increasing.
today, worldwide deaths from tobacco exceed 5 million a year, and, unchecked, they'll exceed 8 million a year by 2030. now, where is this all happening? where are these changed and bad things happening? the tobacco industry is exploiting vast new global markets. the epidemic has shifted from high-income developed countries with the highest burden of tobacco-caused deaths now in the developing world.
in fact, 80% of the 5.4 million annual tobacco-related deaths are in developing countries. in fact, 10 countries are homes to 2/3 of the world's smokers. china and india together comprise 37% of the world's population and 40% of the world's smokers. yet, as we've heard, we know there are effective and proven strategies that can save millions of lives.
as a 2007 "lancet" article by frieden and bloomberg argues, we can prevent 100 million global deaths before the beginning of the next century, with a modest decline in prevalence from about 25% worldwide to 20%. and this assumes that about 1/3 of users will die from smoking-related diseases. and we can achieve this modest prevalence decline mainly through policy and regulation.
we know what needs to be done to turn the tide on the epidemic. however, worldwide progress, as i will review, has, so far, been very incomplete. to help countries improve their results, the world health organization developed a technical package called mpower. the components are "m," which represents monitoring policies, programs, as well as tobacco use.
this is an area where cdc has focused much of its global contributions, mainly through management of the global tobacco surveillance system. "p" represents protecting people from secondhand smoke through smoke-free regulation. and "o" is offering help to quit through treatment programs for nicotine addiction. "w" deals with warning about the dangers of tobacco use
through countermarketing, including warning labels on packages. "e" relates to enforcing regulations on ad marketing about the dangers of tobacco. and "r" is raising prices, primarily through taxes, on tobacco, an intervention that is the most effective in reducing consumption. now, next, we'll go through
a series of maps and other graphs that will review effective policies and regulations in more depth and look at the global status. regarding smoke-free areas, we've already heard about the reports confirming the importance of smoke-free policies. in this map, yellow and red are good, indicating countries with strong policies,
and blue and green indicate weak policies. as you can see, many countries lack a comprehensive smoke-free policy for public places. in 2008, only eight countries, in a barely perceptible yellow, had complete indoor smoking ban that covered all public places. some of these countries are places you might not expect, such as uruguay, turkey, and new zealand. other countries you might not expect, like italy, france, and ireland,
have passed strong bans, in the orange. however, countries with good laws don't always have good enforcement. and in a 2008 who report, only about a third of the countries with strong smoke-free laws were deemed as having even moderate enforcement by a panel of experts. now, smoke-free regulation is a real area of opportunity.
besides being simple and a low-cost way to protect the population, smoking bans receive strong public support, whether you're in new york or new zealand. in many cases, support for smoke-free policies increases, even among smokers, after the policies go in place. warning labels are another opportunity for global progress. effective warning labels must be large with dramatic images, include very specific health warnings,
be changed out periodically, and ban deceptive terms such as light and low tar. in brazil, over half of those surveyed said they changed their opinion about health consequences of smoking after seeing graphic warning labels. close to 70% of brazilian smokers said they wanted to quit as a result of the labels, and that number also indicated they approved
of the hard-hitting images that you see here that were placed on the packs of cigarettes in that country. now, this map looks at the variability of warning-label size. countries in red, such as canada and brazil... ...have led the way, but many countries, such as china, in the green have limited warning labels that consume less than 1/3 of the pack,
and russia has the same situation. now, in the next few years, as you're going to hear about, the fda regulation will lead to bigger and stronger warning labels in the u.s. that include graphic images, such as we've seen in the previous presentations. marketing bans. regulating tobacco advertising and promotion is another effective way to reduce tobacco prevalence.
however, as you can see on this map, there's a lot of work to do in this arena. the countries in light purple have no bans, and while those in dark purple may prohibit ads in certain media, such as television and radio, they don't have comprehensive ban. only the countries in aqua, such as south africa and yemen,
have complete marketing bans in place. now, it should be noted that these are countries without constitutional protections for commercial speech. the most effective advertising bans are comprehensive ones that prevent tobacco companies from moving spending from one advertising category to another. this graph shows a 9 times faster reduction in consumption
in a group of 14 countries with a comprehensive ad ban, versus countries without. now, terry told us earlier the raising tobacco price of products is one of the most effective ways to reduce use. price affects consumption consistently in the u.s., and we find the same thing throughout the world. as the price goes down, consumption goes up. as price goes up, consumption goes down.
this is south africa. similar findings in morocco. as price goes down, consumption goes up. we find this over and over again. it's a universal law. this speaks to this worldwide phenomena, and it is a very important intervention. but where -- what's the status of the intervention? the focus on taxes should be on affordability.
the mpower goal is to achieve a tax that is at least 75% of the total cigarette price for the pack, noted by countries in red on this slide. unfortunately, taxes frequently don't keep up with inflation. the effect would be essentially lost when this happens. even in some countries where the tax constitutes 60% or more of the sale price, which are countries in orange here --
and this includes mexico and india, as well as the united kingdom -- the real price of cigarettes declined from 2002 to 2007. and the countries tagged with small circles are places where that occurred. so, even where the taxes were high, there was losing ground because of inflation. so, summing up, what's the situation? there are bright spots, certainly, and shining examples,
but the share of the world covered by effective tobacco-control policies is quite low. 8% or less of the world's population benefits from complete or comprehensive interventions. in the u.s., we've made good progress in cessation services, and we'll have very effective warning labels in a few years. but we've lots of ground to cover, as we've heard, when it comes to protecting everyone
from secondhand smoke exposure. enforcing advertising bans, and raising cigarette prices. now, worldwide, a fact that's in our favor is that we're beginning to see a matching of strategies with resources. significant investment by the bloomberg philanthropies and the gates foundation in recent years means that we realize more and more of a payoff in effective tobacco control.
now, let me conclude with the most prominent cdc contributions and successes, particularly in the area of monitoring surveillance and evaluation. this year, cdc celebrated the 10th anniversary the youth survey, identified as gyts, or the global youth tobacco survey here, has been completed in 163 countries. and most of them have conducted this survey nationally.
there's thus more red and pink on the map than green. 14 countries conduct the newer adult tobacco survey, or global adult tobacco survey, also known as gats, and this is done exclusively on a national basis. the addition of gats in a country is indicated by the darker shading of either color, either the green or the red. the key point is that we now have a thriving global surveillance system
covering most of the world and positioned to play a key role in measuring and managing the epidemic in the coming years. now i'd like to introduce dr. david ashley to discuss the promise inherent in regulating tobacco product content and design. thanks, matt, and good morning. today i'll be speaking to you on how product regulation fits into tobacco control.
we'll be addressing three questions. the first is, why are differences in the design, packaging, and marketing of the product important? second, how can product regulation reduce morbidity and mortality from tobacco use. and the third is, how do we make sure that changes to the product actually benefit public health? because tobacco products kill so many of their users, it's necessary to appeal to the next generation
to attract new tobacco users. to do that, products have been designed to appeal to youth through applying... i'm not getting it. there we go. applying candy-like and exotic flavorings, controlling the form of nicotine so that the emissions are smoother and easier for novices to start, marketing sophistication
to attract those developing their own self-image, and presenting a cool and classy image of smoking. but maintaining users can be equally challenging. there are many factors that might lead users to quit. to prevent people from quitting, product ducts have been engineered to maintain addiction by modifying the product through ventilation so they appear to have lower delivery, developing complex sensory properties
that encourage continued use, developing nicotine in a form that is more addictive, providing false promises to health-conscious smokers who might consider quitting, and producing products that can be used when smokers cannot smoke to provide ways to maintain their use. these efforts at engineering the product have resulted in both a complex product and market.
there are many different products available besides cigarettes and traditional smokeless. there's water pipes, there's kreteks, dissolvables, snus, and a wide variety of other nonsmoke products. there are approximately 1,500 different cigarette-brand variants in the united states alone. there are more than 4,000 chemicals
present in tobacco smoke. and tobacco products are not all the same. they each present specific challenges and questions. it's a very complex set of toxic and addictive products. the design of tobacco products greatly impacts the levels of toxic chemicals to which people are exposed. the data in this slide shows that the levels of the carcinogenic tobacco-specific nitrosamines
vary by a factor of 20 in cigarettes as a result of using multiple types of tobacco which are found in cigarettes in different countries. for example, because of the differences in the blend of tobacco used and the curing methods, carcinogenic tobacco-specific nitrosamine levels in marlboro cigarettes in china are a factor of 22 higher than the chinese brand hongtashan.
the design of tobacco products also greatly impacts the levels of addictive chemicals to which people are exposed. this slide shows the association between the sales of marlboro cigarettes and smoke ph between the years 1964 and 1972. this was the time period when marlboro cigarettes rose from a limited market seller to the highest-selling cigarette in the united states. ph is an adjustable product design feature
which influences the levels of the more addictive form of nicotine, commonly called free or free-based nicotine. in the same way that the free base of cocaine is more addictive, the free-base form of nicotine is more addictive. the adjustment of ph results in much higher sales of the product that can deliver the right amount a free-base nicotine
to the tobacco user. so, what can be done about product features that impact the toxicity and addiction of the product? there are no product standards now, but for the first time, with product regulation, we can use product standards to make the products less appealing to youth. we can prevent changes to the products that make them more addictive or toxic,
and we can use product standards to reduce exposure to toxic and addictive emissions of people who continue to use the products. let's just show you a couple of examples of this. this slide shows the levels of free nicotine in 40 different smokeless tobacco products in the united states. each point of the curve represents a different smokeless tobacco product.
in these products, ph has been modified to create graduated free-nicotine levels. youth start with low-free-nicotine products, which are less harsh and encourage experimentation. then, when the nicotine no longer meets their needs, they graduate to levels which are much higher and much more likely to sustain addiction. product standards can make the products less appealing to youth.
if low-free-nicotine starter brands are removed from the market, it will be harder for youth to start down this road to tobacco use. it may not stop all smokeless experimentation, but it could have a significant impact. with the regulation of tobacco products, they can no longer be altered without completely evaluating
the impact of the changes on public health. this slide shows some levels of free nicotine in skoal bandits between january 1999 and may 2007. sometime between august 2004... ...and december 2006, the levels of free nicotine in the products we measured were changed from a starter product to a higher free-nicotine product. this was done without assessing the impact to public health
or informing users. they did not announce, "now more addictive." with tobacco-product regulation, before changes like this can be made, the impact on public health must be assessed. product standards can be used to reduce exposure to toxic emissions in people who continue to use the products. this slide shows an association
between the levels of the carcinogenic nitrosamine nnk and its biomarker, nnal, in cigarette smokers from five different sites. recent research by others has shown an association between urinary nnal and lung-cancer risk. the design of the cigarettes may be leading to a higher lung-cancer risk in the united states compared to other countries. by setting product standards, we'll be able to lower exposure
to toxic and carcinogenic emissions in people who continue to use the product. before we enforce product standards, though, we must be prepared to do three things to make sure that changes to the product benefit public health. we must monitor the impact of product regulation. we've got to develop clear messages and communicate about product risk.
and we've got to prevent the use of product messages to imply safety without scientific validation. we already have systems in place at cdc to conduct surveillance on the impact of regulatory actions. this is illustrated in this slide, which shows the decreased exposure to secondhand smoke in nonsmokers largely resulting from instituting state and local laws preventing indoor smoking in public places.
we've already done this with nonsmokers. the same can be done to measure the exposure of smokers to ensure that the product standards are having the desired effect. we need to expand this surveillance activity to collect baseline data on smokers as a comparison for the period after product standards go into place. continued vigilance is also needed
to monitor for changes to the product, which may be altered to circumvent product regulations. we must also work with experts to develop clear messages explaining what it means for a product to meet these standards, particularly that it does not mean the product is now safe. and we need effective means of communicating these messages. and we must develop ways, based on effective strategies from other other public health actions, to prevent product standards
from being used to promote tobacco use. so, in conclusion, using the lessons we have learned from past experiences, keeping a watchful check on the changes in tobacco users and the products that result from regulation, and developing and communicating clear health messages, product regulation can be an integral part of our effort to reduce the morbidity and mortality from tobacco use,
especially for those who continue to use tobacco. i'd now like to introduce dr. lawrence deyton, the director of fda's new center for tobacco products, who will give an overview of the family smoking prevention and tobacco control act. dr. deyton: thank you, and good morning. it's a pleasure to be here today. on june 22nd, president obama signed the family smoking prevention and tobacco control act
into law. make no mistake about it. this law would not be possible without the sustained effort of cdc, state and local health officials, and tobacco control advocates around the world. we wouldn't be standing here today having this discussion with this new regulatory authority without the decades of dedication
of people on this campus and around the country. the passage of the family smoking prevention and tobacco control act obviously is a significant new component of the larger tobacco-control efforts in this nation and around the world. obviously, there's still a lot of work for us all to do, but this law presents multiple opportunities for all of us in public health
to increase actions around tobacco control at every level. very importantly, and as i already referred to, establishes new standard for fda regulation, and that is to regulate tobacco products based on a public health and population health standard. that is a different standard than fda uses to regulate foods, drugs, and devices. those standards are safety and effectiveness. this standard is a public health and population health standard.
fda tobacco-control goals are synergistic with cdc and other tobacco-control goals, to prevent youth tobacco use, to help adults who use tobacco to quit, to promote public understanding of contents and consequences of use of tobacco products, and, very importantly, to develop and expand the scientific base to begin meaningful product regulation to reduce the toll of tobacco-related disease,
disability, and death. let me take a few moments and review a few of the specific features very importantly, the act provides fda with immediate authority to implement what is called the final rule of the 1996 fda activities related to tobacco. some of you who have worked in tobacco a long time remember fda attempted to exert authority over tobacco products
a while back and issued a rule related to the marketing and advertising of and access to tobacco products, particularly related to youth access and to minimizing youth initiation. so, one of the provisions of this law allows fda to implement the 1996 rule. another authority granted to fda is that industry is now required to submit health information
to the food and drug administration on tobacco-product ingredients, nicotine content, research done by industry on health and physiologic effects, and on marketing practices and effectiveness. also, this law requires industry to register every year with the food and drug administration. they will not be able to sell tobacco products in this country
or import without registration with the fda. another provision allows fda to set product-performance standards, already referred to several times. the first, you will recall, is the banning of the manufactured distribution and sale of cigarettes with certain characterizing flavors. also, fda will be allowed to establish other product standards,
such as those deemed appropriate for protecting the public health. additional authority under the law requires industry to submit to the fda applications for review of new products, review and approval of new products. and fda needs to establish standards for approval of those new products. very importantly, the tobacco control act
gives fda authority over what's called modified risk products. first, there will be banned and outlawed the use of the terms "light," "low," and "mild," implying health claims for certain tobacco products. and if industry wants to market products with those health claims, they have to prove them to the fda, in a process akin to that which is put in place for review and approval of foods and drugs.
in addition, the tobacco control act establishes the tobacco product scientific advisory committee made up of seven scientists, and, importantly, there are three seats on this advisory committee for various representatives of tobacco industry. also, the tobacco control act gives fda very broad authority over cigarette labels and advertising warnings with a lot of specificity,
and that will obviously be a very interesting feature. i think one of the most interesting and important aspects of the tobacco control act is the importance of state and local involvement and coordination that we need to do with states and localities. this is primarily related to inspection of retailers and enforcement provisions, but, very importantly also, it gives fda ability to work with state and local
public-health and tobacco-control authorities in many, many areas. so, very importantly, fda will be building bridges to our state tobacco-control programs. we look forward to learning from and figuring out how fda and our regular authority can assist states to do their tobacco-control jobs. very important in all of these activities, what this new authority and fda does
is not done in isolation of everything else in tobacco control that is going on in the department of health and human services and elsewhere. we've already begun lots of coordination with the office of the assistant secretary for health. dr. howard koh, you know, was a leader of tobacco-control programs when he was commissioner in massachusetts.
work with the cdc obviously already has been in the past, will continue to be huge in terms of the success of the fda programs with the office on smoking and health, national center for environmental health, these fine people that we've already heard from, and many others. the substance abuse and mental health services administration in their role in tobacco outreach and surveillance,
very importantly with the national institutes of health as well, in terms of tobacco research topics to advance all of these areas. as i said, the president signed this law on june 22nd, and since then, there has been an aggressive implementation, starting in july with listening sessions with state and local authorities on tobacco control and public health. in august, the bureaucratic establishment
of the center for tobacco products was put in place, as well as the scientific advisory board and creation of the user fee program. you know, this whole program is paid for not out of tax dollars but user fees levied on the industry. in september, fda continued listening sessions both with public-health advocates
as well as with the tobacco industry. i was hired in september. and on the first day of my tenure, we enacted the ban on flavored cigarettes. and in october and november, we issued final guidance on the registration and listing -- that is, the registry of industry with fda and the listing of their tobacco products with the fda. and next week we will issue the final guidance
on how industry will submit their listing of ingredients to the food and drug administration. there's a very aggressive set of regulatory deadlines for the fda. in january, the industry is required to have submitted their ingredients to us. in april, the reissuing of that 1996 rule. and in july of 2010, both the ban on the use of misleading marketing terms
and smokeless tobacco warning labels will go into effect. and then two years hence, the new cigarette warning labels. there are many challenges and many opportunities as fda implements this new law. obviously, fda regulatory authority is new to the tobacco industry. and so far, they have been responding quite appropriately, i think.
obviously, creating a new regulatory authority within fda presents its own challenges and opportunities. we're essentially beginning to stand up a major new arm of fda while we're actually having to execute it. as you can tell by the past couple of slides, we are having to meet very aggressive regulatory and statutory deadlines set by congress. very importantly, also,
one of the challenges as well as opportunities for us will be to meet the very diverse expectations from the various stakeholders, from the tobacco industry, from marketing and advertising, public health community, congress, et cetera. i think collaborating with state and local agencies on tobacco-control activities is gonna be just a fascinating and wonderful opportunity for the fda. we're really looking forward to it.
and i think one of the most important opportunities, really, is to establish effective and interactive communications on education and outreach with all of the stakeholders. i think that's one of the most important ways that we can lead to success here. again, we are here today talking about this law because of the sustained efforts of people in this room and around the country, and i really appreciate the opportunity to be here today.
thank you very much. [ applause ] woman: thank you, dr. deyton, and with that, we've concluded our presentations and now have a few minutes to open the floor -- 10 minutes -- 20 minutes, thank you. 20 minutes to open the floor for questions or comments. so, if you'd like to proceed to the microphones? thank you.
man: good morning. is the microphone on? i'm bob brewer with the chronic disease center. a really fabulous set of presentations. very inspiring and provocative. it was striking to me in looking at some of the data that you presented in particular, terry, the extent to which intervention's really focused on the general population, take new york city as an example.
tax increases, indoor air policies, et cetera, actually seemed to have a disproportionately large impact on the smoking behavior of youth. and i wondered if you could comment a little bit on some of the lessons learned from the tobacco experience about the relative desirability of focusing interventions on particular population groups, typically youth, as has been discussed quite a bit in the alcohol area.
thanks. dr. pechacek: one of the key lessons that has been learned over the last 15 years is that youth are much more malleable. their behavior changes much more quickly. it went up when we took our eye off the ball in the '90s and let the industry have the field. rates dramatically increased. when we started paying attention to the problem again
by the mid to late '90s, we turned it around, and it dramatically declined. but notice that it stalled again. so, youth rates are one that change can go in either direction rapidly, and one of the key things that we're learning is that the environmental factors are much more important than individual factors. certainly, individual choices are going on,
but they're largely driven by the environmental influence. price is a primary characteristic of this. the price sensitivity of youth is about double that of older smokers, and that continues on into young adulthood. but as well as smoke-free policies, other types of things, one of the things that we've learned is having the consistency of message -- smoke-free schools, tobacco-free campuses,
tobacco-free campuses in schools and colleges sends this consistency of message that makes the general health education work. in the absence of that kind of environmental perspective, we have a much harder road to produce our traditional health education effects. and one of the key things that we've learned from the starting of the florida truth campaign in the late 1990s
is how effective hard-hitting media can be. youth are very sensitive to the media, and, again, this is one of the domains that we have allowed the tobacco marketers to have an open field for decades, and the few times that we entered the field with enough reach and frequency, we have a dramatic impact. one of the key adverse kind of phenomena
is that if you look at the history over the last 15 years, anytime a state mounted a very hard-hitting, aggressive, well-funded media campaign, they usually were defunded. that doesn't happen by accident. one of the rare examples is california, where the voluntary agencies sued the state government to maintain the media campaign. other places, like massachusetts or florida or minnesota,
the programs were defunded. now, that said something about the efficacy. so those kind of broad environmental programs work, and youth are more quickly to respond. woman: thank you, terry. any other comments, panel? okay, question? i had question about the status of efforts to regulate internet tobacco sales and also the status of preemption efforts.
certainly, it's within fda authority to monitor and do regulatory action for internet sales, and we are doing that. the first regulatory action, which was the ban on manufacture, sale, and distribution of cigarettes with certain characterizing flavors. and was it just last week? i think it was just last week. we did announce the issuing of warning letters to multiple -- i think it was 14 --
internet sale sites for those products. so, that's happening. that's fda authority, and we're exerting that authority. in terms of preemption, i don't know the answer. woman: thank you. question on the right. i'm with the global aids program. question for dr. mckenna. you mentioned the warning letter just now. i was wondering what other penalties
for noncompliances exist in the tobacco control act to make sure that the companies are doing what they're supposed to be doing. say a little more about why -- fda has broad authority to -- over all of the aspects of the tobacco control act. i think many of them are legislated in the act -- that is immediate actions we can do -- but also others by regulation
that we will be anticipating. but the authorities in the act all are backed by the enforcement action -- or the enforcement authority of the food and drug administration. so, i'm not sure what you're referring to. i was wondering, for example, you mentioned that they need to submit data regularly. what are provisions if the data is late
or if they don't submit the data. what so the of authority does fda have to promote compliance? well, they can't sell their product in the united states if they don't submit, ultimately. if you go through the act in a lot of detail, we certainly have graded regulatory authority. let's say company "x" doesn't register with us or doesn't submit the information that's required. we obviously would ask what happened.
did it get lost in the mail? and then issuing warning letters and action can be stepped up. but ultimately, to sell product in this country, they have to submit certain information, and it's quite nicely specified in the act. it's a regulatory agency. we've got depth and breadth of authority and are exerting that authority already. yeah.
another fda question. i think in the earlier presentations, it became very apparent that the taxes have the major bang for the buck as far as a measure to cut down on smoking, and yet hearing about the new fda authorities, i was trying to figure out if that would play in any way into the taxes. and there's such variation between states,
and yet fda has a lot of regulatory authority over anything that's interstate. so, i'm wondering -- and also, fda's going to be able to exert some pressure on states by funding programs and so may be able to influence what states decide to do about their own taxes. so, i'd just like you to speak to that issue as a major control measure and what you see legislation helping you with.
yeah, i think that the fda's authority is to use the best available science to exert public-health good around tobacco-control issues. the regulatory authorities granted to the fda don't relate to taxation issues, and certainly we want to learn about those and work -- states and local authorities have huge authority in those areas.
but that is not one of the authorities granted to the fda. so we will be looking for those product standards, warning labels, access-to-youth issues, and new products and modified risk, et cetera. so, taxation is not one of the arrows in the fda's quiver. however, i think we all have to recognize that tobacco-control activities -- there's a multipronged approach using multiple avenues through various federal, state, and local agencies.
cdc has, again, decades of experience in laying foundation of public health, surveillance, epidemiology, and science related to tobacco control that really has allowed the sustained growth and understanding of the importance of this movement. taxation issues are elsewhere, and i think all the data here shows it's a very important issue,
but it's not not under the umbrella of fda. mckenna: i'd like to make a couple of comments about that. first of all, one of the things that was alluded to is the way the fda activities are funded are through levying these user fees on the industry. and already as those fees are being collected, there has been an increase of 4 to 6 cents per pack in the united states, 'cause the industry's gonna pass those costs on.
so, price is the important thing. we're already seeing that. the other thing is it's not just the tax. it's the actual price. and of the $10 billion to $15 billion a year the industry spends on promoting the product, 3/4 of that is on discounting. they have very targeted discounting efforts through coupons and other two-for-one sales
types of activities to undercut the impact of tax increases. one of the things that has opened up with this law is local areas can now stop that from happening. they can outlaw, because preemption has been lifted. the federal level preemption from doing has stopped retailers from discounting. they can basically get rid of a major promotional activity, particularly in low-income communities that the industry uses
to undercut the taxes that do exist. i had a couple points about the importance to fda of building those relationships with state and local to understand what their issues are and how fda authorities can be used by them to continue to advance their goals. so, that's gonna be a major feature as we begin to build our center at fda. that's exciting.
woman: thank you. question on the right?? my name is shilak pitun from the committee guide. in the just-concluded meeting, one of the sessions i attended, a group presented on the research from canada, one of the universities in canada. and they were discussing about how the tobacco industry is trying to bring in new products and trying to target youth,
but not just bringing in new products. it's not just about the changing the flavors and changing the packaging, but in terms of their regulations, they're trying to beat the regulations. precisely, they were presenting cigarillos as against cigars, there were targeting the fact that, if you went beyond 1.4 grams, then you can consider it a cigar.
now they're trying to make it lower than 1.4 grams and then calling it a new name and packaging that and targeting youth with making it in different shapes, like they look like lipsticks or things like that, so it's more fashionable, more trendy, and it becomes a trend thing. now, my question is, an agency like the fda, with this new act that they have, does it have the capacity to be more proactive
in preempting such actions by the tobacco industry, rather than waiting for them to hit the market with these kind of ways of circumventing the laws and then we start chasing after them? i think the short answer is yes. it's a complicated calculus, but when you look at the different provisions of the family smoking prevention and tobacco control act, there's multiple places where the fda does have authority now
to do many of the things you talked about, both from new product standards as well as marketing, labeling standards, advertising, youth access. so, there's five or six or eight different provisions in the act where fda does have authority related to those aspects. dr. pechacek: one other thing that i'll add is that the key role of cdc in terms of surveillance is to expand our already existing surveillance of youth,
but particularly to ensure that we're picking up what types of promotions, products, strategies, both traditional strategies as well as on the web and other broad-reaching types of things that our youth are more sensitive to, that we're ensuring that we're picking up the real-time surveillance of what youth are seeing, what youth are reacting to, and what they're viewing as attractive.
one of the lessons learned, both in this country and around the world, over the last 50 years is how nimble the tobacco industry is and how aggressive they are at getting their replacement smokers. so, we have to assume that they're going to remain using the best available minds that they can buy to be nimble in their marketing
and assume that we have to put a similar level of creativity to staying ahead of them. you may have noticed that we have extended the event to one hour and 15 minutes, and i thank everybody for their patience and their interest, and i thank everybody for coming, and i look forward to seeing you all in four weeks.
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