- Speech by
Scott Gottlieb, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( May 2017 - April 2019 )
Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Winter Meeting of the National Association of Attorneys General
(Remarks as prepared for delivery)
Thank you. It is a privilege to join you today.
As someone who’s spent many years tackling public health issues from the federal perspective, I appreciate the impact that state policies and actions can have on reducing the burden of disease.
On tobacco control; prevention and control of infectious diseases; promoting immunizations and cancer screening; and many other critical public health issues, the states have played pivotal roles in advancing historic public health achievements.
Time and again, states have been the incubators of public health policies that have yielded tremendous results.
Time and again, state attorneys general have used the power of their office, whether the bully pulpit or litigation to address deceitful or unfair practices that harm consumers.Today, I want to focus on two areas in which state actions have contributed to historic achievements for public health – achievements that, unfortunately, are in danger of being undermined or reversed if we don’t act quickly and work together to meet challenges we face.
They’re both areas where I know many of you have worked hard to advance public health goals.
The first is the fight to prevent tobacco use by children. The second are continuing efforts to promote more widespread immunization against dangerous, communicable disease.
First, on tobacco:
Nearly all tobacco use begins during youth and young adulthood, locking many people into a lifetime of nicotine addiction and hooking them to combustible products that are the leading preventable cause of death and disease in this nation. So, we know that in order to cut the devastating impact that tobacco use causes, we must prevent youth initiation in the first place.
And, in the past two decades, we’ve made important strides toward that goal.
Twenty-one years ago, in 1998, the CDC estimated that 47 million adults in the United States – or 24 percent – were smokers. Nearly 20 percent of adults were everyday smokers. And the prevalence of smoking was highest among 18- to 24-year-olds, marking an increase in this younger demographic that, the CDC theorized, could’ve resulted from the aging of a cohort of high school students among whom smoking rates had been high in the early 1990s.
In other words, in 1998, the smoking rates were not only troubling, but also moving in the wrong direction. Rates among young people began to fall in more recent years, but overall rates have leveled off. And in 2017, when I became Commissioner, tobacco use remained the leading cause of preventable death and disease in the United States. That’s why, as one of my first priorities, I unveiled a broad strategy that put reducing addiction to nicotine at the center of our efforts.
There were reasons to hope that we could turn the tide of nicotine dependence and burden of disease caused by smoking. We had new tools through product regulation to address tobacco products, and new technologies that might offer currently addicted adult smokers the opportunity to access satisfying levels of nicotine without all of the harmful effects of combustion.
We also had a backdrop where smoking rates had begun to fall. And a large share of the credit for those gains must be given to state tobacco control policies and public health interventions. States are on the frontlines with programs that prevent initiation; promote cessation; eliminate exposure to second-hand smoke; and raise awareness of the health effects of smoking.
More recently, a growing number of states are raising the minimum legal age to buy tobacco products. By law, the FDA is prohibited from raising the minimum age above 18. In the absence of change at the federal level, however, states are leading the way.
As of December, six states and the District of Columbia have a minimum age of 21, and three states have a minimum age of 19.
I applaud efforts to keep a new generation of children from being led down a lifetime of addiction to nicotine and smoking. We know that age is strongly correlated with initiation to tobacco use.
Among adults who become daily smokers, about 90 percent report first use of cigarettes before reaching 19 years old. And we know the ease with which underage users rely on social sources, like friends, to get tobacco products.
So, by raising the minimum age to 21, states are reducing the likelihood that legal purchasers will be in the same social networks as high school students. And by preventing opportunities for initiation, these state policies promise to make a meaningful dent in the number of tobacco users in years to come.
State attorneys general have made important contributions to reducing the death and disease from the use of tobacco products. Some of you in this room were probably part of one such effort. I’m referring, of course, to the lawsuits brought by state attorneys general against the tobacco industry in the mid-1990s.
When these lawsuits were brought, the FDA did not yet regulate tobacco products. As a result of the litigation, millions of pages of internal memoranda, reports, and other tobacco company documents were made public. The documents revealed significant inappropriate marketing practices, including marketing towards youth and young adults, such as emphasizing product features such as “low-tar,” package design, and advertising campaigns that appealed to the aspirations of adolescents – including themes of independence, freedom, and peer acceptance, and imagery that portrayed smokers as attractive, thin, athletic or admired.
These revelations helped catalyze future reforms, including congressional action that ultimately led to passage of the Tobacco Control Act.
This year marks the tenth anniversary of the TCA, which granted FDA the authority to regulate the manufacture, distribution, and marketing of tobacco products. When I last served at the FDA, we didn’t yet have this authority. Since then, the FDA has stood up the Center for Tobacco Products and notched a number of important accomplishments in protecting public health.
Among them, this past fall, we marked an historic milestone of conducting a total of one million tobacco retailer inspections. These inspections are conducted in partnership with the states, and they’re critical to fulfilling our mandate of preventing the illegal sales of tobacco products that contribute to youth use.
Since the program’s inception in 2010, it has grown to include compliance check contracts in more than 55 states and territories. As a result of these checks, the FDA has issued more than 81,000 warning letters – our response to an initial violative inspection. And we’ve issued nearly 20,000 civil money penalties for repeated violations.
But, even with these efforts, we know there’s much more work to do. We must continue to drive these violation rates down.
That’s why, yesterday, I issued a public statement calling out fifteen national retail chains whose rates of violative inspections exceed 15 percent. In one case, the Marathon chain of gas station retailers, the rate of violations was an astounding 41 percent out of 3,000 inspections. Unfortunately, this large retailer was hardly an outlier. Yesterday’s list included several gas station retailers; convenience stores, like 7-Eleven; and, grocery and pharmacy chains like Walgreens, Kroger and Wal-Mart with violation rates that suggest corporate-wide failures to ensure a culture of compliance.
We’ll continue to hold these companies accountable for illegally selling tobacco products to underage youth.
And we’ve put these companies on notice that we’re considering additional enforcement avenues to address high rates of violations.
Indeed, as we approach the TCA’s ten-year anniversary, I’m struck both by the progress we’ve made, as well as the risks that I see in the future. There’s been enormous change in the marketplace for tobacco products since I was last at the FDA.
In the last decade, an entirely new class of tobacco product has emerged that is able to deliver nicotine without having to burn tobacco. When I began my tenure as Commissioner, I saw the opportunity to advance new technologies like electronic nicotine delivery systems as an alternative to cigarettes for adult smokers who still seek access to nicotine, without all the deadly effects of combustion.
I believed then – and I continue to believe – that we must recognize the potential for innovative, less harmful products that can efficiently deliver nicotine to adults who want them. This is especially relevant as we’re advancing a proposed rule to regulate the levels of nicotine in combustible cigarettes to render them minimally or non-addictive. These e-cigarette products may offer a lower risk alternative to currently addicted adult smokers who still want to get access to satisfying levels of nicotine, but without all of the harmful effects of combusting tobacco.
But, advancing innovations that may present an alternative to smoking cannot come at the expense of addicting a generation of children to nicotine through these same delivery vehicles.
We know – thanks in no small part to documents exposed through the efforts of state attorneys general – that nicotine is astonishingly addictive. And we know that the developing adolescent brain is particularly vulnerable to nicotine addiction.
So although nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year, it’s what got them addicted initially, and will keep them addicted for the long term.
Unfortunately, as a result of the spiking popularity of e-cigarettes among kids, we currently risk addicting a new generation of young people to nicotine. And some proportion of these kids are going to migrate onto combustible cigarettes.
As a result of these trends, we risk losing the dramatic gains we’ve made in recent years at reducing smoking rates among teens.
Make no mistake about it: the data is revealing a crisis in this country.
Last Fall, the FDA and the CDC published data from the 2018 National Youth Tobacco Survey (NYTS). The data from this rigorous, nationally representative survey, conducted of middle and high school students, show shocking increases in kids’ use of e-cigarettes and other ENDS products. From 2017 to 2018, there was a 78 percent increase in current e-cigarette use among high school students and a 48 percent increase among middle school students. The total number of middle and high school students currently using e-cigarettes rose to 3.6 million. This is an increase of 1.5 million more students using e-cigarettes from the prior year.
And more than a quarter of high school current e-cigarette users are using the product regularly, which is defined as 20 or more days in the past month. Critics of this data will say that most of the kids aren’t using the e-cigarettes 20 days or more a month, so they’re not long-term users and we shouldn’t be worried.
Understand one point – we’re catching the start of an epidemic. Our surveys are catching many of these kids in their first months of experimentation with e-cigarettes.
Make no mistake about it, when we come back and survey these same kids a year or two into their addiction, I’m worried many more will be regular users of these products. There’s an evolution to long term addiction and it starts with occasional use.
Also, notably, almost 70 percent are using flavored e-cigarettes.
As this epidemic has emerged, I’ve heard the echoes of history repeating itself. To peruse the advertisements of e-cigarette companies is to step back in time. The companies say their products are meant for “adult smokers only.” But, their marketing tactics and advertising – which have focused on themes of independence, freedom, and peer acceptance, and imagery that portrayed e-cigarette users as attractive, thin, young, athletic or admired – sound remarkably familiar.
Indeed, they seem lifted from a historical playbook.
And accumulating evidence continues to point to a perfect storm of public health risk.
Studies demonstrate that exposure to e-cigarette advertising, such as on social networking sites, increases the likelihood of subsequent e-cigarette use among youth who have never used e-cigarettes before. Data illustrate how certain features of these products – in particular, their flavors and high nicotine concentrations – make them at once more appealing to kids and more addictive. And data show that kids who use e-cigarettes aren’t necessarily kids who would’ve otherwise tried cigarettes. We’ve stigmatized smoking. But, many kids don’t even associate e-cigarettes with smoking. Instead, they think they’re just “JUULing.”
That’s why the 2019 NYTS survey, which will be in the field starting this month, will not only ask about e-cigarette use. We worked with the CDC to make sure that it’ll also ask kids to report using specific, popular brands of e-cigarettes, including “JUUL”. This will help avoid underreporting by kids who don’t even think of JUUL as an e-cigarette. But, it’s likely to also mean another year-over-year increase in the total numbers of teenagers who report using tobacco products.
I’m worried the spike in e-cigarette use will be large again this year and the proportion of America’s youth who are using some form of tobacco product will reach levels that should disturb everyone.
And if, as data has started to show, these kids are more likely to try combustible cigarettes later, then there’s a large pool of future risk. We’ll lose the public health gains we’ve made.
Over the past year, the FDA has worked aggressively to try to arrest these trends.
We launched a multi-pronged Youth Tobacco Prevention Plan.
We escalated enforcement against retailers who illegally sell ENDS products to minors.
We partnered with the FTC to target e-liquid manufacturers whose products used misleading, kid-appealing imagery that mimicked juice boxes, lollipops and other foods.
We launched innovative campaigns to educate teens about the risks of addiction to e-cigs.
We’re investigating manufacturers of new products that appear to be recent market entrants without FDA authorization, such as counterfeit or “lookalike” products.
And we called on manufacturers to take voluntary actions to prevent youth access to these products and to take meaningful steps to curb their youth appeal.
But, given the startling youth use rates in the 2018 NYTS data, it’s clear that more must be done.
FDA has been pursuing changes to our compliance policy for ENDS products. That policy extended the dates by which manufacturers of certain deemed tobacco products, including e-cigarettes, were expected to submit premarket applications to the FDA for review. Under that policy, FDA hasn’t taken enforcement action against ENDS manufacturers or retailers for continuing to market and sell these products without authorization from the FDA.
But, we have the authority to change that policy. And given the spiking youth use of ENDS – especially flavored ENDS – we’re weighing appropriate changes targeted to reducing youth access to these products. If we can reduce access, we can reduce use. But, we want to do so in a way that’s consistent with our legal authority and which preserves the availability of these products for adults. So, we’re advancing policies to limit the access and appeal of the flavored e-cigarette products to kids, such as through heightened age verification, while we also identify best practices that retailers could adopt through the use of better technology.
It’s a fine needle to thread, preserving adult access while closing off the access and appeal to kids. But we’re committed to doing so in a way that is thoughtful, fair, and balances multiple public health considerations.
I’m heartened to see states taking on this issue as well.
I look forward to working together to confront this epidemic of youth use of these products.
I know we’ve had some dialogue already underway with the states and I look forward to building on these efforts.
I want to see how state enforcement action and state efforts can support our shared goals, and how we can be working with you better to advance efforts that achieve these purposes.
In my remaining time, I’d like to highlight another public health achievement that’s also now at risk, and for which state action is critical. In the past few years, outbreaks of preventable infectious disease – and measles, in particular – have sickened hundreds of people, particularly children, in pockets throughout the United States. This is a devastating setback from as recently as 2016, when the United States was declared free of endemic measles.
Far from being just a mild ailment that children may experience as a “rite of passage” growing up, measles is a highly infectious disease that’s associated with pneumonia in about one in twenty children. Measles kills about one in a thousand children who are infected with it.
These outbreaks are occurring most frequently in areas where immunization rates have fallen below a threshold for what’s referred to as “herd immunity.” In the case of measles, that threshold is between 93 and 95 percent. When immunization rates fall below that point, disease can spread more widely and rapidly, putting vulnerable groups at risk. These groups include children with very legitimate reasons for not being vaccinated – such as immune disorders or because they are receiving cancer chemotherapy – as well as adults in the community who cannot get vaccinated due to medical conditions, such as serious allergies.
States play a significant role in developing and enforcing the vaccination policies that prevent such outbreaks. But, of course, contagious diseases don’t respect state lines.
So, one state’s imprudent vaccination policies can impact the health and well-being among the citizens of its neighbors, as we’ve recently witnessed with outbreaks in the Northwest.
These recent outbreaks have demonstrated the importance of responsible state vaccination policies which, currently, are a patchwork. Although all 50 states have school entry requirements for vaccinations, 47 states permit vaccine exemptions on religious grounds, and 18 states permit exemptions for personal or philosophical reasons. To the extent states have liberal exemptions, these create the opportunity for outbreaks that have interstate, and potentially national, implications.
It seems that, as vaccines have eradicated or diminished the spread of certain illnesses like measles, mumps, and meningitis, the fear of them as faded in our collective memories.
As a result, there’s the risk that pockets can develop in our communities where there’s the susceptibility to diseases that can be debilitating, costly to treat, and are entirely avoidable with the immunity provided by the appropriate use of vaccines. These pockets can give rise to large outbreaks.
There are encouraging signs that states are taking up the issue. Such efforts are consistent with years of rigorous epidemiological and medical evidence. Their success is critical to maintaining one of the most significant public health achievements of the last century. It would be best for the states to accomplish this on their own. We need to promote sound vaccine policies.
I appreciate the opportunity to be here today, to celebrate our public health successes and to enlist your continued efforts to maintain and build on these achievements for the future.