2018-174 Youth Tobacco Enforcement OrdinancesDate: November 30, 2018 Report No. 2018-174
INFORMAL STAFF REPORT
TO MAYOR AND CITY COUNCIL
SUBJECT
Provide additional information regarding smoking regulations and age restrictions, including a
recent ordinance approved by the City of San Antonio, and a recent Food and Drug Administration
(FDA) announcement about limiting the use of tobacco products and electronic cigarettes by
minors.
BACKGROUND
Following requests from the City Council, staff provided two Informal Staff Reports under
reference numbers 2018-141 and 2018-157. The two reports discuss current policies and
background information regarding smoking and electronic cigarette regulations. More specifically,
the reports outlined:
No. 2018-141: History of the City’s Smoking Ordinance No. 2015-121
No. 2018-157: Information on current laws and policies in the City which regulate the sale
and usage of electronic cigarettes. This includes the City’s Smoking Ordinance, State
Statutes for School Districts, and Denton ISD’s Policy.
A Council Member recently requested additional information about the tobacco ordinance
approved by the City of San Antonio1. Additionally, the FDA recently issued an announcement
about tobacco and e-cigarette use by minors which staff wanted to update Council with since it is
relevant to the issue.
DISCUSSION
San Antonio’s Tobacco 21 Ordinance
The San Antonio ordinance (Attachment 1), also known as the “Tobacco 21 Ordinance”, took
effect on October 1, 2018 and increased the minimum age for the sale of tobacco products from
18 years of age to 21 years of age.
The Tobacco 21 Ordinance defines the term “tobacco products” to include “… any product that is
made from or derived from tobacco, and is intended for human consumption or is likely to be
consumed, whether smoked, heated, chewed, absorbed, dissolved, inhaled or ingested by any other
means including but not limited to, a cigarette, a cigar, pipe tobacco, chewing tobacco, snuff, snus,
or an electronic smoking device or liquids used in electronic smoking devices.”
Enforcement of the Tobacco 21 ordinance is carried out by the San Antonio Metropolitan Health
District (“Metro Health”), the public health agency that is designated by State law, City code, and
1 January 11, 2018, the City of San Antonio passed Ordinance 2018-01-11-0001 which amended Chapter 36 of the
San Antonio City Code and increased the age for sale of tobacco products to 21 years of age. The amendment also
defines the term “tobacco products” to include electronic smoking devices, prohibits providing tobacco products to
anyone under 21 years of age, and provides criminal penalties for violating the ordinance.
Date: November 30, 2018 Report No. 2018-174
County resolution with the responsibility for providing public health programs in San Antonio.
Metro Health is a City/County organization but administrative control is under the City of San
Antonio and is operated as a City department. Violations of the Tobacco 21 ordinance will be
enforced by Metro Health as class “C” misdemeanors and can result in a fine up to $500.
It is important to note that the Tobacco 21 ordinance only addresses the selling, distributing, or
providing tobacco products to someone who is under 21; in other words the in-store retailers in the
City of San Antonio could be fined for selling to someone under 21. The Tobacco 21 ordinance
does not apply to the individuals under 21 who purchase, use, or is possess a tobacco product.
These individuals would be addressed under Texas State tobacco laws which provide individuals
under 18 who purchase, use, or possess tobacco can be fined up to $250 and required to attend a
tobacco awareness program.2
Before starting Citywide enforcement, a nine month grace period is in place to allow Metro Health
to provide education to the public to raise awareness of the new law and to educate tobacco retailers
and staff on the changes.
For reference, Attachment 2 is a presentation given to the San Antonio City Council on January
11, 2018 outlining the Tobacco 21 ordinance and associated research. Also attached is a timeline
(Attachment 3), education and implementation overview (Attachment 4), and a question and
answer (Attachment 5).
Food and Drug Administration Announcement
Staff also wanted to share some relevant information regarding proposed policy changes at the
federal level. On Thursday, November 15, 2018, the Food and Drug Administration (“FDA”)
announced that it will begin the process to ban menthol in cigarettes, ban flavor in cigars, and limit
the sales of flavored electronic cigarettes to youths. In a news release, the FDA released the
findings from the National Youth Tobacco Survey (NYTS) that showed that more than 3.6 million
middle and high school students were current users of electronic cigarettes in 2018, an increase of
1.5 million over the previous year. Scott Gottlieb, Commissioner of the FDA, laid out proposed
new steps in a statement (Attachment 6) and directed the FDA’s Center for Tobacco Products to
revisit the compliance policy by having “all flavored products, including all flavors other than
tobacco, mint and menthol, sold in age-restricted, in-person locations and, if sold online, under
heightened practices for age verification.”
While there has been no change in policy or federal law, the directives set forth in a statement from
Gottlieb are meant to speed up FDA action to limit the sale of flavored electronic cigarette products
to minors both in stores and online. This directive is the first step in the long process of banning
menthol in cigarettes, banning flavors in cigars, and limiting sales of flavored electronic cigarettes
to youths.
2 See Texas Health & Safety Code § 161.252 which prohibits individuals under 18 from possessing, purchasing, consuming, or
accepting a cigarette, e-cigarette, or tobacco product.
Date: November 30, 2018 Report No. 2018-174
ATTACHMENTS
1. San Antonio Ordinance (“Tobacco 21 Ordinance”)
2. San Antonio Tobacco 21 Presentation
3. Tobacco 21 Timeline
4. Tobacco 21 Education and Implementation Plan
5. Tobacco 21 Question and Answer
6. FDA Statement Regarding Youth Access to Tobacco and Electronic Cigarettes
STAFF CONTACT:
Stuart Birdseye
Management Analyst
940-349-8009
stuart.birdseye@cityofdenton.com
Sarah Kuechler
Director of Public Affairs
940-349-8356
sarah.kuechler@cityofdenton.com
LEGAL:
Stephanie N. Neal
Assistant City Attorney
940-349-8333
Stephanie.neal@cityofdenton.com
1
ur County Tobacco 21
Colleen M. Bridger, MPH, PhD
Director
City Council A Session
January 11, 2018
2
Tobacco
•Leading cause of preventable disease, disability,
and death in the United States.
•Every day, nearly 2,100 young people under the
age of 21 become daily cigarette smokers.
•Nicotine is highly addictive and the adolescent
brain is more susceptible to it.
2
3
Why Raise the Age?
•95% of adult smokers began smoking before they
turned 21.
3
•Only 2% of tobacco sold is
purchased by 18-20 year
olds, but that 2% supplies
90% of the addictive
tobacco to younger people.
4
Increasing the Sale Age to 21
A Public Health Solution
4
•Delay age of first tobacco
use and reduce risk of
becoming regular smoker.
•Help keep tobacco out of
schools.
•Younger teens have harder
time passing themselves off
as 21.
5
Where is T21 already in place?
5
25% of
Americans
covered
6
Timeline
Dates Activity
August 24th Introduced T21 to Community Health & Equity Committee
Sept. 15th – Oct. 23rd Community Survey
October 26th T21 presentation to Community Health & Equity Committee
November 3rd Mailed letter & town hall invite to over 1,600 local tobacco retailers
November 13th T21 Supporter / Stakeholder Meeting
November 16th Town Hall Meeting
December 6th City Council B Session
January 11th City Council A Session
Proposed implementation timeline:
January – Sept. 2018 Educate retailers and community on ordinance and enforcement
October 1, 2018 Tobacco sale age raised from 18 to 21
6
7
Local Survey Results
5,447 individuals responded to our Tobacco 21
survey that asked the question:
Do you believe that the minimum
tobacco sales age should be
raised from 18 to 21?
77.5% answered Yes Yes
77.5%
No
22.3%
Blank
0.2%
7
8
Economic data
Concern Response
Will this program save
lives?
Just under 500 San Antonio 18-20 year old lives will be
saved each year from implementing T21.
Is this program cost
effective?
The Texas DSHS estimated $406 million saved in health
care spending on pre-term birth and low birth weight
related expenses alone for statewide implementation.
Is this program bad for
business?
Since implementation in Needham, MA in 2005, no
convenience stores have gone out of business.
Smokers cost employers almost $6,000 more per year
than non smokers.
8
9
Needham Case History
9
10
Concerns Raised at B Session
10
Concern raised in December Addressed by
Proposed method of selecting
stores for unannounced
compliance checks
Will use random sampling
Enforcement on 18-20 year olds
purchase, use and possession
Have dropped enforcement on
18-20 year olds; retaining
enforcement on retailers
11
Draft Ordinance
11
Age group Tobacco Retailers (sale) Youth (PUP)
< 18 years
of age
State law
Violations of sale –
misdemeanor, with max.
fine of $500.
State law
Violations of youth PUP
– misdemeanor, with
max. fine of $250.
18-20 years
of age
COSA Ordinance
Mirror state law, but will
raise age restriction to 21
COSA Ordinance
No enforcement
12
Implementation Plan
•Nine month grace period – effective October 1, 2018
•Provide education to youth and families to ensure
awareness of new law and educate tobacco retailers
and staff on changes in law.
•Metro Health will lead enforcement
•Random sampling used to determine locations of
unannounced compliance checks at tobacco retailers
12
13
Fiscal Impact
•Minimal fiscal impact
•As proposed, the fine is up to $500 for the sale of
tobacco products to someone under 21 years of
age.
•Revenues from these fines will be deposited in the
General Fund.
13
14
Recommendation
Staff recommends City Council approve
the proposed changes to Chapter 36 of
the City Code, titled Smoking
14
15
Thank you. Any Questions?
Colleen M. Bridger, MPH, PhD
Director
15
Legend
Completed In Progress Target Month(s) Jan-18FebruaryMarchAprilMayJuneJulyAugustSeptemberOctober NovemberDecemberJan-19Metro Health Activities
Create Metro Health web page to inform community and tobacco retailers on T21
(www.sanantonio.gov/tobacco21)
Provide updates on Metro Health's T21 web page
Mail T21 letter to San Antonio tobacco retailers regarding passage of Tobacco 21 Ordinance
Create T21 Ordinance Fact Sheet for tobacco retailers
Distribute T21 Ordinance Fact Sheet to tobacco retailers
Create T21 retailer education kit
Distribute T21 retailer education kit to tobacco retailers (in-person, mail, online, social media).
Continue outreach to Tobacco Retailers
Send out and share invitations for T21 Stakeholder Meetings to community and tobacco retailers
(mail, email, social media, media interviews)
Host T21 Stakeholder Group Meeting A: March 29, 6 PM at Central Library
Host T21 Stakeholder Group Meeting B: April 11, 10 AM at Central Library
Host T21 Stakeholder Group Meeting C: April 11, 6 PM at Central Library
Send out and share invitations for T21 Stakeholder Meetings to the community and tobacco
retailers (mail, email, social media, media interviews)
Host T21 Stakeholder Meeting 1: August 8, 5:30 PM at Forest Hills Library (West)
Host T21 Stakeholder Meeting 2: August 13, 3 PM at Carver Library (East)
Host T21 Stakeholder Meeting 3: August 27, 10:30 AM at Tobin Library (North)
Host T21 Stakeholder Meeting 4: September 4, 6 PM at Mission Library (South)
Present T21 to Greater Bexar County Council of Cities (Includes Mayors of local municipalities)
Present T21 to Bexar County Suburban Cities Council (Includes Mayors of local municipalities)
Continue T21 outreach to other municipalitiesOther Cities Tobacco 21 (T21) Implementation - As of August 31, 2018
Retailer Education/ OutreachWeb PageRetailer and Community MeetingsPage 1 of 2
Legend
Completed In Progress Target Month(s) Jan-18FebruaryMarchAprilMayJuneJulyAugustSeptemberOctober NovemberDecemberJan-19Metro Health Activities
Tobacco 21 (T21) Implementation - As of August 31, 2018
Create T21 community education materials
Distribute T21 community education materials (schools, universities, colleges, events, military,
faith-based, non-profits, social media, online)
Create 30 second T21 video for young adults 20 and younger
Share T21 video on social media and with universities, colleges, schools and other organizations
Present T21 to the Joint Base San Antonio (JBSA) / Metro Health Public Health Briefing
Work with the JBSA leadership to obtain support and approval for a communication plan to
include Lackland, Randolph, Fort Sam Houston, the Air Force Basic Trainees, students at the
Medical Education and Training Campus, and dependents.
Present T21 to JBSA Student Commanders leading the Medical Education and Training at Fort Sam
Houston for the Army, Navy, Air Force, Marines and Coast Guard
Present T21 at the Fort Sam Houston (FSH) Community Information Forum open to the entire FSH
community
Work with community partners to create tobacco use surveys for both high school teens and
young adults ages 18-20 to measure current rates of youth tobacco use in San Antonio
Seek approval to administer both youth tobacco use surveys
Conduct both youth tobacco use surveys
Analyze youth tobacco use surveys and produce report
Issue press release and conduct media interviews announcing T21 will take effect October 1, 2018
October 1, 2018 - San Antonio T21 Ordinance becomes effective; Hold press briefing
Recruit 18-20 year old adults for T21 Decoy Compliance Visits
Health Inspectors begin annual T21 inspections on October 1, 2018
Provide T21 Decoy Compliance Training to selected 18-20 yr. old young adults
Health Inspectors & young adults (18-20) begin annual T21 Decoy Compliance Visits on January 1,
2019 (100 per year by random selection)Community Educ.Military Educ.SurveysComplianceMediaPage 2 of 2
Page 1; updated [1/26/18]
Tobacco 21 Education and Implementation Overview
Raising the minimum legal sale age for tobacco from age 18 to 21 will have a substantial
positive impact on public health and will save lives. To be effective, education, implementation
and enforcement will be critical elements in the City of San Antonio’s Tobacco 21 (T21)
initiative and Ordinance. The Ordinance will take effect nine months after passage. The San
Antonio Metropolitan Health District (Metro Health) will focus its efforts, on T21 education
throughout the San Antonio community and providing signage and resources to tobacco retailers.
The information and resources will require minimal funds supported by Metro Health’s current
operating budget.
T21 Education (January – September 2018)
Metro Health will collaborate with the San Antonio Tobacco 21 Coalition, the San Antonio
Council on Alcohol and Drug Abuse (SACADA), Tobacco Retailers and others such as the
Region 20 Education Service Center, local school districts, charter & private schools, and other
City of San Antonio departments, including Parks and Recreation, Human Services, Library, and
the Office of Equity, to provide T21 education in the San Antonio community.
Tobacco Retailer Education:
In the first nine months of passage of a T21 Ordinance, tobacco retailers will receive
education and resources to comply with T21.
Retailers will be able to participate in an educational session on T21 and the local
Ordinance.
Retailers will receive signage from Metro Health at no cost to comply with the T21
Ordinance to display in their establishments.
Retailers will receive T21 information from Metro Health at no cost to train their
employees on the new minimum sale age, types of tobacco products listed in the
Ordinance, fines, and a listing of local tobacco cessation programs.
Those selling tobacco products will be required to maintain the current standard of
verifying the age of people wanting to purchase tobacco products who appear to be under
the age of 27.
Retailers will also be able to download T21 information from the City of San
Antonio’s<Metro Health website, www.sanantonio.gov/health.
Youth & Families:
City of San Antonio departments who work with youth and families will provide them
with bilingual information on T21.
San Antonio youth focused institutions and organizations will receive bilingual T21
educational information to share with the youth and families they serve.
Organizations will be encouraged to include T21 information in their tobacco prevention
curricula and prevention programs.
Youth focused institutions, organizations, parents and youth will be able to download
T21 information from the City of San Antonio’s Metro Health website.
T21 information will also be disseminated via Social Media.
Page 2; updated [1/26/18]
T21 Implementation Philosophy
The overarching philosophy for implementation of this Ordinance is education and partnership
with retailers to achieve compliance with the new sale age. As well, the implementation
philosophy emphasizes educating youth about the dangers of tobacco addiction and access to
tobacco cessation services. Retailers and youth will be educated about the new law and every
effort will be made for retailers to achieve voluntary compliance. However, for those retailers
who fail to comply with the Ordinance, the following processes will apply as outlined below
(please also see a flow chart 1 beginning on page 3 of the implementation and enforcement
processes). According to the Texas Comptroller’s Office, currently less than 10% of retailers sell
to underage individuals, but non-compliance is unacceptable given the addictiveness of tobacco
and the health consequences to youth.
Enforcement Authority
Principal enforcement of the proposed T21 Ordinance will be by Metro Health’s Sanitarians.
Currently Metro Health Sanitarians have the capacity to fulfill the T21 enforcement authority
role since the majority of tobacco retailers already receive a routine inspection once per year.
The addition of a T21 compliance check to verify T21 signage and training requirements will
add minimal time to the current routine inspection. In addition, any person may register a
complaint with the City of San Antonio by calling 311 to report violations of this Ordinance.
Metro Health Sanitarians also currently follow up on complaints made by the community
through the 311 process. If fines for violations of the Ordinance generate additional revenue, it
will be collected by the General Fund.
Retailers:
Signage and Training Compliance (Beginning October 1, 2018)
If a violation is identified during an education visit after the nine month education period,
the tobacco retailer will be issued a warning and asked to immediately rectify the
violation (i.e., post appropriate signage) and information will be forwarded to the Metro
Health Sanitarians.
The Metro Health Sanitarians will subsequently conduct an unannounced compliance
visit within 30 days of the violation to verify that signage and/or training violations have
been corrected.
Continued violations will result in a citation.
Tobacco Sales to Under 21 Compliance (Beginning January 1, 2019)
If the retailer is suspected of selling tobacco products to minors (either due to 311
complaints or signage and/or training violations), Metro Health may check compliance by
sending in a person under 21 to see if the retailer will sell to them.
At least once per year, Metro Health will coordinate sales compliance checks in retail
establishments based upon received complaints and simple random sampling. Metro
Health will use random sampling to select 10 retailers from each Council District.
Page 3; updated [1/26/18]
If a tobacco retailer violates the T21 Ordinance by selling to a person under the age of 21,
the Metro Health Sanitarian will issue a citation.
The penalty for the sale of tobacco products to someone under 21 years of age is a
maximum fine of $500.
Chart 1: T21 Implementation and Enforcement Processes
Community and Retailer Education (January – September 2018)
Metro Health will collaborate with stakeholders and partners to provide T21 education throughout
the San Antonio community.
Metro Health will provide signage, training and additional resources to tobacco retailers.
Signage and Training Compliance (Beginning October 1, 2018)
Metro Health and tobacco education staff through community partners will conduct T21 compliance
checks to verify signage and training through routine visits to tobacco retailers.
No Was there a violation? Yes
No additional signage/training
compliance check for current
year
Retailer asked to immediately
address the violation and issued
a warning.
Information forwarded to the
T21 Enforcement Team.
Enforcement Team conducts
unannounced compliance visit
within 30 days to verify no
further signage or training
violations.
Was there a violation?
No Yes
No additional compliance check Issue citation
Continued on next page
Page 4; updated [1/26/18]
Tobacco Sales to Under 21 Compliance (Beginning January 1, 2019)
Sales compliance checks are done by the Metro Health Sanitarians who will monitor the sale of tobacco
to a person known to be under the age of 21.
Retailers are selected for Tobacco Sales enforcement through:
311 complaint process
Signage and training violations
Simple random sampling (10 retailers per Council District per year)
No Was there a violation? Yes
No additional compliance check Issue citation
06-05-18
Questions & Answers
• When does the Tobacco 21 Ordinance go into effect? October 1, 2018.
• Where does the City of San Antonio Tobacco 21 Ordinance go into effect? It goes into effect
within the boundaries of the City of San Antonio.
• How do I know if my store is within the City of San Antonio (the City) boundaries? Email us at
samhd@sanantonio.gov with your store address and we will let you know.
• What does the City’s Tobacco 21 Ordinance cover? The City’s Tobacco 21 Ordinance covers all
Tobacco Products meeting the following description: any product that is made from or derived
from tobacco, and is intended for human consumption or is likely to be consumed, whether
smoked, heated, chewed, absorbed, dissolved, inhaled or ingested by any other means,
including, but not limited to, a cigarette, a cigar, pipe tobacco, chewing tobacco, snuff, snus,
hookahs or an electronic smoking device or liquids used in electronic smoking devices.
o The City’s Tobacco 21 Ordinance does not include drugs, devices or combination
products authorized for sale as tobacco cessation aids by the U.S. Food and Drug
Administration, such as nicotine patches.
• Are synthetic tobacco products, tobacco free liquids, and CBD Oils (Cannaboid oils) included in
the City’s Tobacco 21 Ordinance? Yes. (The City’s Tobacco 21 Ordinance follows state law;
Health and Safety Code, Chapter 161.081).
• Within the City, can e-cigarette replacement parts be sold to those under 21 years of age? No.
(Tobacco 21 ordinance follows state law; Health and Safety Code, Chapter 161.081).
• Does the City’s Tobacco 21 Ordinance apply to the sale of rolling paper for hand-rolled
cigarettes to those under the age of 21? No - unless the rolling paper is made of tobacco.
• If my store sells tobacco products, what do I need to do to be in compliance? Starting on
October 1, 2018, tobacco retailers within the City will need to:
o Verify that customers who ask for cigarettes, other tobacco products or electronic
cigarettes are at least 21 years old. If a customer looks to be under 27 years old,
retailers must ask for proof of age. Any of these documents constitute proof of age;
A valid photo driver’s license or non-driver ID card issued by a state or other
U.S. government agency.
A valid passport
A photo ID issued by the armed forces of the United States.
o ID cards issued by employers, schools, or colleges are NOT acceptable forms of ID.
o Post Tobacco 21 signage in a location that is conspicuous (visible) to all employees and
customers and that is close to the place at which the cigarettes, e-cigarettes, or tobacco
products may be purchased.
o Ensure employees are educated on the City’s Tobacco 21 Ordinance.
06-05-18
o Ensure employees have signed the City’s Tobacco 21 Employee Notification-
Acknowledgement Form and these forms are kept accessible for inspection.
• Can my store remove the Texas Tobacco Law sign? No. The state’s signs must still be displayed.
Texas Tobacco Law still applies – No sale to minors under 18 years of age. Individuals under the
age of 18 who purchase, use or are in possession of a tobacco product can be fined up to $250.
• Where can I find the City’s signage and the City’s Tobacco 21 Employee Notification-
Acknowledgement Form? Metro Health will provide these Tobacco 21 materials to tobacco
retailers in the City before October 1, 2018. The materials will also be posted on
www.sanantonio.gov/tobacco21.
• What are the City’s fines for selling or distributing tobacco products to someone who is under 21
within the City? The sale or distribution of tobacco products to someone who is under 21
within the City of San Antonio is a Class C misdemeanor, and upon conviction, can result in a fine
up to $500.
• Will there be a fine within the City for someone who is 18, 19 or 20 years old who purchases,
uses or is found in possession of a tobacco product? No.
• Does the City’s Tobacco 21 Ordinance apply to cigarette/tobacco vending machines? Yes.
Cigarette vending machines within the City may not be situated in a premise or workplace
where persons under 21 are allowed entry and / or are employed.
• Within the City, regarding hookahs, if the person who purchases the hookah set up at the
business is 21 years of age or older, can people under 21 share the hookah set up with that
individual? No.
• Does the City’s Tobacco 21 Ordinance regulate online sales and delivery? No.
• Can Vape shops within the City work on or repair an e-cigarette unit for an 18, 19 or 20 year old
who purchased it legally before October 1, 2018? Yes, a repair is allowed, however, giving the
device back to someone who is under 21 is not allowed under the City’s Tobacco 21 Ordinance.
• Vape shops allow sampling without purchases. Would someone under 21 years of age be
allowed to sample within the City? No.
• Can clerks at stores within the City knowingly sell to someone who will be providing the product
to someone under the age of 21? No.
FDA Statement
Statement from FDA Commissioner Scott
Gottlieb, M.D., on proposed new steps to
protect youth by preventing access to
flavored tobacco products and banning
menthol in cigarettes
For Immediate Release
November 15, 2018
Statement
Español (/NewsEvents/Newsroom/ComunicadosdePrensa/ucm626115.htm)
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 (/NewsEvents/Speeches/ucm569024.htm) 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
(/TobaccoProducts/NewsEvents/ucm568425.htm) 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
(/TobaccoProducts/PublicHealthEducation/ProtectingKidsfromTobacco/ucm608433.htm). We escalated
enforcement (/NewsEvents/Newsroom/PressAnnouncements/ucm620184.htm) against retailers who illegally
sell ENDS products to minors. We partnered (/NewsEvents/Newsroom/PressAnnouncements/ucm618169.htm)
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 (/NewsEvents/Newsroom/PressAnnouncements/ucm620788.htm)
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 (/NewsEvents/Newsroom/PressAnnouncements/ucm620185.htm), 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) (https://www.federalregister.gov/documents/2018/03/21/2018-05655/regulation-of-
flavors-in-tobacco-products).
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
(/TobaccoProducts/NewsEvents/ucm568425.htm), 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
(https://www.federalregister.gov/documents/2018/03/21/2018-05655/regulation-of-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.
###
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