SILVER SPRING, Md., Nov. 15, 2018 /PRNewswire/ -- As a
physician who cared for hospitalized cancer patients, I saw
first-hand the devastation that smoking-related diseases had
wrought on the lives of patients and their families, and dedicated
myself to helping ease this suffering.
As a cancer survivor myself, I understand too well the
uncertainty, grief and struggle that accompanies a cancer
diagnosis.
And as a father of three young children, I hear daily from
parents and teachers worried about the epidemic use of electronic
cigarettes and nicotine addiction among kids.
When I pledged last year to reduce addiction to nicotine, I was
driven by the fact that, in the U.S., tobacco use remains the
leading cause of preventable death and disease. Combustible
cigarettes cause the overwhelming majority of tobacco-related
disease. When used as intended, they are responsible for the death
of half of all long-term users.
Today, I'm pursuing actions aimed at addressing the disturbing
trend of youth nicotine use and continuing to advance the historic
declines we've achieved in recent years in the rates of combustible
cigarette use among kids.
These actions are grounded in hard evidence. But they also are
deeply personal.
When I first announced our comprehensive tobacco framework plan
in July 2017, I recognized my opportunity – an almost unprecedented
opportunity – to use the tools that the FDA had been given in the
Family Smoking Prevention and Tobacco Control Act to bring about
meaningful, lasting change to dramatically alter this cycle of
disease and death.
I envisioned a world in which cigarettes lose their addictive
potential through reduced nicotine levels. I envisioned a
regulatory paradigm that focused on nicotine and evaluated the
diverse nicotine delivery mechanisms along a continuum of risk. On
one end, there are combustible tobacco products. At the other end,
there are medicinal nicotine products sold as gums and patches. And
there is an array of products in between.
I saw the opportunity to advance new technologies like
electronic nicotine delivery systems (ENDS) as an alternative to
cigarettes for adults who still seek access to satisfying levels of
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 satisfying levels of nicotine to adults who
want them.
But as I said at that time, as I said at my confirmation
hearing, as I said in my first remarks to the professional staff of
the FDA three days after being confirmed as the FDA's Commissioner
in May of 2017, and as I've said dozens of times in the months that
followed: any policy accommodation to advance the innovations that
could present an alternative to smoking – particularly as it
relates to e-cigarettes – cannot, and will not, come at the expense
of addicting a generation of children to nicotine through these
same delivery vehicles. This simply will not happen. I will take
whatever steps I must to prevent this.
Today, I'm announcing proposals to help reverse these trends,
with the unwavering support of HHS Secretary Alex Azar, who shares
my deep commitment to protecting the health of our nation's
children. Today, we advance our efforts to combat youth access and
appeal with a policy framework that firmly and directly addresses
the core of the epidemic – flavors.
The data show that kids using e-cigarettes are going to be more
likely to try combustible cigarettes later. This is a large pool of
future risk. The policies I'm outlining now strives to strike a
careful public health balance between our imperative to enable the
opportunities to transition to non-combustible products to be
available for adults; and our solemn mandate to make nicotine
products less accessible and less appealing to children.The data
make unmistakably clear that, if we're to break the cycle of
addiction to nicotine, preventing youth initiation on nicotine is a
paramount imperative.
Almost all adult smokers started smoking when they were kids.
Nearly 90 percent started smoking before the age of 18, and 95
percent by age 21. Only about 1 percent of cigarette smokers begin
at age 26 or older. When I announced the FDA's Comprehensive Plan
for Tobacco and Nicotine Regulation in July 2017, I made clear my
concerns about kids' use of e-cigarettes, especially those products
marketed with obviously kid-appealing flavors. At the time,
however, the trends in youth use appeared to be changing in the
right direction – reported e-cigarette use among high school
students, which peaked at 16.0 percent in 2015, had decreased to
11.3 percent in 2016 and held steady in 2017. What I did not
predict was that, in 2018, youth use of e-cigarettes and other ENDS
products would become an epidemic.
Today, the FDA and the Centers for Disease Control and
Prevention are publishing data from the 2018 National Youth Tobacco
Survey (NYTS). The data from this nationally representative survey,
conducted of middle and high school students, show astonishing
increases in kids' use of e-cigarettes and other ENDS, reversing
years of favorable trends in our nation's fight to prevent youth
addiction to tobacco products. These data shock my conscience: 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 — that's 1.5 million more students using these products
than the previous year. Additionally, more than a quarter (27.7
percent) of high school current e-cigarette users are using the
product regularly (on 20 or more days in the past month). More than
two-thirds (67.8 percent) are using flavored e-cigarettes. Both
these numbers have risen significantly since 2017.
These increases must stop. And the bottom line is this: I will
not allow a generation of children to become addicted to nicotine
through e-cigarettes. We won't let this pool of kids, a pool of
future potential smokers, of future disease and death, to continue
to build. We'll take whatever action is necessary to stop these
trends from continuing.
Over the past months, the FDA has worked aggressively to address
youth use of e-cigarettes.
We deployed a range of our regulatory tools.
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 Federal Trade Commission
to target e-liquid manufacturers whose products used misleading,
kid-appealing imagery that mimicked juice boxes, lollipops and
other foods. We worked with eBay to remove listings for these
products on their websites. We launched innovative campaigns,
including "The Real Cost" Youth E-Cigarette Prevention Campaign, to
educate teens about the consequences of addiction to
e-cigarettes.
And I made clear – in speeches, in statements and in interviews
– that we were closely watching what appeared to be disturbing
trends. I repeatedly said that, although we continue to believe
that non-combustible tobacco products may provide an important
opportunity to migrate adult smokers away from more harmful forms
of nicotine delivery, these opportunities couldn't come at the
expense of addicting a generation of kids to nicotine. I told the
manufacturers of e-cigarettes that the youth use of their products
was an existential threat to this innovation. In short, over the
past year we weren't sitting still. And we weren't quiet about our
concerns. And yet these deeply disturbing trends continued to
build.
In September, after receiving the raw data from the NYTS survey,
I took additional action. I called on manufacturers to step up, to
take voluntary actions to prevent youth access to these products
and to take meaningful steps to curb their youth appeal. Some
manufacturers have already responded to these requests and pledged
to take some meaningful voluntary steps to curb youth access and
appeal to their products. I also said that the FDA would be
re-evaluating our own policy approach and that all options would be
considered. Given the startling and disturbing youth use rates in
the 2018 NYTS data being released today, it's clear that we must do
more – specifically, several policy changes to target what appear
to be the central problems – youth appeal and youth access to
flavored tobacco products.
Some of these changes would involve revisiting the FDA's
compliance policy, issued in 2017, which extended the dates by
which manufacturers of deemed tobacco products that were on the
market as of Aug. 8, 2016, were expected to submit premarket
applications to the FDA for review (after receipt of an
application, the FDA reviews the application and determines if the
product meets the applicable statutory standard to be marketed).
Under that policy of enforcement discretion, the premarket
application compliance date for newly regulated combustible tobacco
products, including certain cigars and pipe tobacco, was extended
to August 2021. The premarket application compliance date for newly
regulated non-combustible tobacco products was extended to August
2022. This applied to most ENDS or e-cigarettes.
Today, I'm directing the FDA's Center for Tobacco Products (CTP)
to revisit this compliance policy as it applies to deemed ENDS
products that are flavored, including all flavors other than
tobacco, mint and menthol. The changes I seek would protect kids by
having all flavored ENDS products (other than tobacco, mint and
menthol flavors or non-flavored products) sold in age-restricted,
in-person locations and, if sold online, under heightened practices
for age verification.
These changes will not include mint- and menthol-flavored ENDS.
This reflects a careful balancing of public health considerations.
Among all ENDS users, data suggests that mint- and menthol-flavored
ENDS are more popular with adults than with kids. One nationally
representative survey showed that, among ENDS users aged 12-17
years old, 20 percent used mint- and menthol-flavored ENDS while,
among adult ENDS users, 41 percent used mint- and menthol-flavored
ENDS. Any approach to mint- and menthol-flavored ENDS must
acknowledge the possibility that the availability of these flavors
in ENDS may be important to adult smokers seeking to transition
away from cigarettes. Moreover, I recognize that combustible
cigarettes are still sold in menthol flavor, including in
convenience stores. I don't want to create a situation where the
combustible products have features that make them more attractive
than the non-combustible products. Or a situation where those who
currently use menthol-flavored cigarettes might find it less
attractive to switch completely to an e-cigarette. This is a
difficult compromise that I'm trying to strike, recognizing the
public health risk posed by cigarettes still being available in
menthol flavor.
But at the same time, I'm deeply concerned about the
availability of menthol-flavored cigarettes. I believe these
menthol-flavored products represent one of the most common and
pernicious routes by which kids initiate on combustible cigarettes.
The menthol serves to mask some of the unattractive features of
smoking that might otherwise discourage a child from smoking.
Moreover, I believe that menthol products disproportionately and
adversely affect underserved communities. And as a matter of public
health, they exacerbate troubling disparities in health related to
race and socioeconomic status that are a major concern of mine.
Although I'm not proposing revisions to the compliance policy for
the mint- and menthol flavors in e-cigarettes at this time, we need
to address the impact that menthol in cigarettes has on the public
health.
I'm also aware that there are potentially important distinctions
even between mint- and menthol-flavored e-cigarette products. I'm
particularly concerned about mint-flavored products, based on
evidence showing its relative popularity, compared to menthol,
among kids. So, I want to be clear that, in light of these
concerns, if evidence shows that kids' use of mint or menthol
e-cigarettes isn't declining, I'll revisit this aspect of the
current compliance policy.
In addition, I'm directing CTP to revisit the compliance policy
for all flavored ENDS products (other than tobacco, mint and
menthol flavors or non-flavored products) that are sold online
without additional, heightened age-verification and other
restrictions in place. As part of that effort, I'm directing CTP to
publish additional information regarding best practices for online
sales. My aim is to have these best practices available soon, so
sites can quickly adopt them to help prevent youth access to these
flavored products. Of course, no tobacco products, including
non-flavored ENDS products or those with tobacco, mint and menthol
flavors, should be sold to kids. For this reason we'll continue to
enforce the law whenever we see online sales of these products to
minors and will closely monitor online sales of mint and menthol
ENDS products.
If youth trends don't move in the right direction, we will
revisit all of these issues.
I hope I'll soon see manufacturers of ENDS products preparing,
with the FDA input as appropriate, premarket tobacco product
applications (PMTAs) to demonstrate that their products meet the
public health standard in the Tobacco Control Act. In the coming
months, CTP plans to issue additional policies and procedures to
further make sure that the process for reviewing these applications
is efficient, science-based and transparent. We'll also explore how
to create a process to accelerate the development and review of
products with features that can make it far less likely that kids
can access an e-cigarette.
Other considerations of our policy framework would apply to
traditional forms of combustible tobacco products.
I noted that the popularity of menthol cigarettes with youth is
especially troubling. In fact, youth smokers are more likely to use
menthol cigarettes than any other age group. More than half (54
percent) of youth smokers ages 12-17 use menthol cigarettes,
compared to less than one-third of smokers ages 35 and older.
Prevalence of menthol use is even higher among African-American
youth, with data showing that seven out of 10 African-American
youth smokers select menthol cigarettes.
And, unlike menthol-flavored ENDS, there's no evidence to
suggest that menthol-flavored cigarettes may play a role in harm
reduction for adult smokers.
We will advance a Notice of Proposed Rulemaking that would seek
to ban menthol in combustible tobacco products, including
cigarettes and cigars, informed by the comments on our Advanced
Notice of Proposed Rulemaking (ANPRM).
Finally, to ensure that we're taking a comprehensive approach,
we must evaluate our regulatory approach to flavored cigars.
Flavors are added to cigars and other tobacco products for various
reasons, such as reducing the harshness, bitterness and astringency
of tobacco products during inhalation and to soothe irritation
during use. Research shows that, compared to adults (25 or older)
who smoke cigars, a higher proportion of youth who smoke cigars use
flavored cigars.
These data also indicate that eliminating flavors from cigars
would likely help prevent cigar initiation by young people.
Accordingly, I am also outlining policy goals to address the
presence of flavors in cigars – including those that were subject
to the compliance policy for newly deemed products, and those that
were "grandfathered."
Specifically, I propose a policy through appropriate means to
ban flavors in cigars.
The bottom line is that these efforts to address flavors and
protect youth would dramatically impact the ability of American
kids to access tobacco products that we know are both appealing and
addicting. This policy framework reflects a re-doubling of the
FDA's efforts to protect kids from all nicotine-containing
products. They also reflect a very careful public health balance
that we're trying to achieve. A balance between closing the on-ramp
for kids to become addicted to nicotine through combustible and
non-combustible products, while maintaining access to potentially
less harmful forms of nicotine delivery through ENDS for adult
smokers seeking to transition away from combustible tobacco
products.
This policy framework is an important step toward reversing the
epidemic that is underway and that is confirmed by the data from
the NYTS. I could take more aggressive steps. I could propose
eliminating any application enforcement discretion to any currently
marketed ENDS product, which would result in the removal of ALL
such products from the marketplace. At this time, I am not
proposing this route, as I don't want to foreclose opportunities
for currently addicted adult smokers.
But make no mistake. If the policy changes that we have outlined
don't reverse this epidemic, and if the manufacturers don't do
their part to help advance this cause, I'll explore additional
actions.
We've already seen some positive steps announced voluntarily by
manufacturers. Responsible manufacturers certainly don't need to
wait for the FDA to finalize these policies to act. They can stop
certain marketing and sales practices — the ones we believe are
part of the youth access and youth appeal problem — right now. We
hope that within the next 90 days, manufacturers will choose to
remove flavored ENDS products from stores where kids can access
them and from online sites that do not have sufficiently robust
age-verification procedures.
The FDA continues to take aggressive action to protect the
public health, especially among kids at risk of nicotine addiction
and tobacco use. As part of our Comprehensive Plan, in addition to
issuing the ANPRMs to hear the public's input on the role of
flavors in tobacco products, and on cigars, we also issued an ANPRM
on lowering nicotine in cigarettes. We have expedited the review of
many of the comments, and spent hours, days and months taking close
consideration of the questions raised and evidence presented by the
public and various stakeholders.
This policy framework reflects the FDA's consideration of
available data and information to get the most complete picture
possible of the causes of the epidemic rise in youth use of
ENDS.
We'll continue to base our actions on the best available
science. And when it comes to protecting our youth, we'll continue
to actively pursue a wide range of prevention and enforcement
actions. We'll leave no stone unturned.
This is one of our highest priorities.
The tobacco marketplace has changed dramatically in the past
year when it comes to youth use of ENDS. And the vision for public
health achievements from reduced use of combustible products and
reduced nicotine addiction is at risk.
But with implementation of the forceful and far-reaching actions
that are outlined today, and with the commitment of tobacco
manufacturers to take additional, voluntary actions to reduce youth
access to their products, we can reverse these trends.
As I said after becoming Commissioner, I can think of no more
impactful action the FDA could possibly take on my watch to help
American families.
Here are additional details regarding the policy framework that
I seek to advance:
1. Flavored ENDS products that are not sold in an
age-restricted, in-person location.
- Have all flavored ENDS products (other than tobacco, mint and
menthol flavors or non-flavored products) sold in age-restricted,
in-person locations. All ENDS products, including e-liquids,
cartridge-based systems and cigalikes, in flavors except tobacco,
mint and menthol, would be included. For instance, the proposed
policy would apply to flavors such as cherry, vanilla, crème,
tropical, melon and others.
- To advance this goal, the FDA is revisiting the compliance
policy on PMTA authorization for such flavored products sold in
physical locations where people under the age of 18 are
permitted.
- The FDA is not revisiting the compliance policy with respect to
ENDS products sold exclusively in age-restricted locations – for
instance, a stand-alone tobacco retailer (such as a vape shop) that
adequately prevents persons under the age of 18 from entering the
store at any time; or, a section of an establishment that
adequately prevents entry of persons under the age of 18 and the
flavored ENDS products are not visible or accessible to persons
under the age of 18 at any time.
- At this time, ENDS products with tobacco, mint or menthol
flavors, as well as any non-flavored ENDS products, sold in any
location, would not be included in any policy revisions. This
distinction among flavors seeks to maintain access for adult users
of these products, including adults who live in rural areas and may
not have access to an age-restricted location, while evidence of
their impacts continues to develop. It also recognizes that
combustible cigarettes are currently available in menthol in retail
locations that are not age-restricted. This approach is informed by
the potential public health benefit for adult cigarette smokers who
may use these ENDS products as part of a transition away from
smoking.
- The FDA, however, will not ignore data regarding the popularity
of mint- and menthol-flavored ENDS among kids. We will continue to
use all available surveillance resources to monitor the rates and
use patterns among youth and adults for these products, and we will
reconsider our policies with respect to these products, if
appropriate.
2. Flavored ENDS products (other than tobacco, mint and
menthol flavors or non-flavored products) that are sold online.
- In addition, we will seek to curtail the sale of applicable
flavored ENDS products that are sold online without heightened age
verification processes.
- The FDA will be working to identify these heightened measures
for age verification and other restrictions to prevent youth access
via online sales. These best practices would be available soon, so
sites can quickly adopt them.
- Because no tobacco products should be sold to kids (including
non-flavored ENDS products or those with tobacco, mint and menthol
flavors), the FDA will continue to enforce the law whenever we see
online sales of these products to minors and will closely monitor
online sales of mint and menthol ENDS products.
3. Flavored cigars.
- Research shows that, compared to adults (25 or older) who smoke
cigars, a higher proportion of youth who smoke cigars use flavored
cigars. This data also indicates that eliminating flavors from
cigars would likely help prevent cigar initiation by young
people.
- Given these public health concerns, I believe flavored cigars
should no longer be subject to the extended compliance date for
premarket authorization — regardless of the location in which the
products are sold.
- The FDA's proposal to revisit the compliance policy for
flavored cigars that are new tobacco products does not apply to the
entire product category, as some products were considered
"grandfathered." Accordingly, the FDA intends to propose a product
standard that would ban flavors in all cigars.
- In July, the comment period for our ANPRM on flavors in tobacco
products closed. The FDA has expedited review and analysis of these
comments, and we intend to proceed with developing a proposed
regulation. As included in the most recent Unified Agenda, the FDA
intends to prioritize the issuance of this proposed rule.
4. ENDS products that are marketed to kids.
- The FDA will pursue the removal from the market of those ENDS
products that are marketed to children and/or appealing to youth.
This could include using popular children's cartoon or animated
characters, or names of products favored by kids like brands of
candy or soda.
5. Menthol in combustible tobacco products.
- Informed by the comments from our ANPRM, the FDA will advance a
Notice of Proposed Rulemaking that would seek to ban menthol in
combustible tobacco products, including cigarettes and cigars.
- The FDA started this process several years ago with an ANPRM.
That ANPRM issued alongside the FDA's preliminary scientific
evaluation, which suggested menthol use is likely associated with
increased smoking initiation by youth and young adults.
- Now, armed with the additional years of data, comments from the
public – and with the perspective of our Comprehensive Plan and its
implementation – the FDA will accelerate the proposed rulemaking
process to ensure that our policies on flavored tobacco products
protect public health across the continuum of risk.
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
Media Inquiries: Michael Felberbaum, 240-402-9548;
michael.felberbaum@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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SOURCE U.S. Food and Drug Administration