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FDA’s Action Plan to Combat the
Public Health Threat of Tobacco Use
June 26, 2013
The information in these materials is not a formal dissemination of information by FDA and does not represent agency position or policy.
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Public Health Impact
 Smoking causes more than 440,000 deaths per year in the United
States
 Each day over 3,800 youth under 18 smoke their first cigarette
 Nearly 9 out of 10 adult daily smokers used their first cigarette by
age 18 (88%)
 Approximately 69% of current US adult smokers report that they
want to quit using tobacco
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AI/AN Tobacco-Related Health Facts

AI/AN adults are, overall, more likely than any other racial/ethnic
subgroup to be current smokers

31.5% of AI/AN adults smoke

Lowest rates are in the Southwest (21.2%), and highest rates are in
the Northern Plains (44.1%) and Alaska (39.0%)

Smokeless tobacco use among adults and youth in the U.S. is
highest among AI/AN
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Presentation Overview
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The Tobacco Control Act and FDA
FDA Center for Tobacco Products (CTP)
FDA and the Larger Tobacco Control Community
FDA’s Public Health Regulatory Framework for Tobacco
Collaboration: Important Ways to Work with FDA
Questions
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June 22, 2009:
The Family Smoking Prevention
and Tobacco Control Act was
signed into law
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FDA Authority Under the Tobacco Control Act
 Grants authority to regulate tobacco products intended for
human consumption (products marketed for use in
smoking cessation are regulated as drugs)
 Recognizes FDA as the “primary Federal regulatory
authority with respect to the manufacture, marketing, and
distribution of tobacco products”
 Gives FDA direct authority over cigarettes, cigarette
tobacco, roll-your-own tobacco, and smokeless tobacco
 Enables FDA to assert jurisdiction over other tobacco
products through rulemaking (cigars, pipe tobacco,
hookah, e-cigarettes that do not make drug claims, etc.).
FDA has announced its intent to do so
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Specific Authorities Include:
 Tobacco manufacturer registration with FDA
 Listing of products and ingredients
 Reporting levels of harmful and potentially harmful constituents
by brand and sub-brand
 Establishing tobacco product standards
 Premarket submissions for new and modified risk tobacco
products to protect the public health
 Health warnings on labels and in advertising
 Advertising and promotion restrictions
 Authority to conduct public health education and research to
support tobacco product regulation
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Tobacco Control Act – Limitations
In general, CTP’s regulatory authorities do not extend to:
 Setting tax rates for tobacco products
 Regulating therapeutic products, such as those marketed
to treat tobacco dependence
 Setting clean indoor air policies
 Regulating tobacco growing
 Requiring the reduction of nicotine yields to zero
 Banning all cigarettes, smokeless tobacco products, little cigars,
other cigars, pipe tobacco, or roll-your-own tobacco products
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Impact of Tobacco Control Act on State, Territorial,
and Local Policy

Section 916 of the Federal Food Drug and Cosmetic Act (FD&C Act),
as amended by the Tobacco Control Act:
 Preserves the authority of state, local, and tribal governments to
regulate tobacco products in certain specific respects (e.g.,
taxation)
 Prohibits, with certain exceptions, state and local requirements
that are different from, or in addition to, requirements under the
provisions of the FDCA relating to specified areas (tobacco
product standards, premarket review, adulteration, misbranding,
labeling, registration, good manufacturing standards, or modified
risk tobacco products)
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Tobacco Control Now Includes
Tobacco Product Regulation
Tobacco Product Regulation
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FDA’s Regulatory Tools
FDA’s authority is derived from a set of laws:

The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the
primary federal law that governs FDA’s work
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The Tobacco Control Act amends the FD&C Act to give FDA the
authority to regulate tobacco products
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FDA’s Regulatory Tools
FDA routinely issues regulations and guidance documents to
implement and explain these laws
FDA guidance describes the agency's current thinking on a
regulatory issue---guidance is a generally recommended approach
for meeting a legal requirement, but it is not legally binding on the
public or FDA
FDA regulations have the force and effect of law, and create
requirements with which regulated industry must comply
FDA uses the best available scientific evidence in developing its
regulations and guidance
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FDA Tobacco Regulation Uses a Public
Health/Population Health Standard
 Tobacco products cannot be regulated using FDA’s traditional
“safe and effective” standard
 The Tobacco Control Act mandates tobacco product regulation
using a population health standard that takes into account both
users and non-users of tobacco products
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CTP Vision and Mission
Vision:
 To make tobacco-related death and disease part of America’s
past, not America’s future and, by doing so, ensure a healthier
life for every family
Mission:
 To protect Americans from tobacco-related death and disease
by regulating the manufacture, distribution, and marketing of
tobacco products and by educating the public, especially young
people, about tobacco products and the dangers their use
poses to themselves and others
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CTP’s Public Health Goals
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Prevent youth tobacco initiation
Encourage youth and adults who
use tobacco to quit
Reduce product harms and
addictiveness
Expand the science base and
continue meaningful product
regulation to reduce the toll of
tobacco-related disease,
disability, and death
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CTP Priorities: 2009 to 2013
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Build the Center, including
staff, infrastructure, and
processes
Meet statutory deadlines
Develop the FDA tobacco
product public health
regulatory framework
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CTP Organization
Office of the
Center Director
Office of
Compliance
and
Enforcement
Office of
Management
Office of Policy
Office of Health
Communication
and Education
Office of
Regulations
Office of
Science
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Statutory Milestones
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FDA’s Public Health Framework for Tobacco
Product Regulation
FDA is using our regulatory authority to:
1. Understand the regulated products
2. Control product changes that affect public health
3. Prohibit false or misleading product claims that state or imply
reduced risk
4. Decrease harms of tobacco products
5. Expand the science base for regulatory action and evaluation
6. Restrict marketing and distribution to protect public health
7. Ensure industry compliance with FDA regulation
8. Educate the public about FDA's regulatory actions
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1. Understand the Regulated Products
Registration and listing
 Companies must register manufacturing facilities and provide a list of
all their regulated products
Ingredient reporting
 Companies must provide a list of ingredients for regulated products
Harmful and potentially harmful constituents (HPHC) reporting by brand
and sub-brand
 Final guidance issued January 2011 defining HPHC as constituents
that cause or have the potential to cause direct harm (toxicity,
addictiveness) or indirect harm (increases initiation or decreases
cessation) to users or nonusers
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2. Control Product Changes That Affect Public Health
 The law requires manufacturers to inform CTP of any changes to
existing products or about new tobacco products over which we
have jurisdiction
 New products cannot be introduced to market without FDA
evaluating the science and making a decision to permit marketing
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2. Control Product Changes That Affect Public Health
 Under these provisions, there are four ways a tobacco product can
be available for distribution or retail:
a.
"Grandfathered” tobacco products
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b.
Products on the market as of February 15, 2007 and unchanged
since that date
New tobacco product applications
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Premarket review required
Permitting the product to be marketed would be appropriate for the
protection of public health
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2. Control Product Changes That Affect Public Health
c.
Substantial equivalence
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d.
An alternative pathway to new product applications where
characteristics are the same as grandfathered products or the
change does not raise different questions of public health
Substantial equivalence exemption
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An alternative to substantial equivalence in which a modification
to the tobacco product is minor and where the only change is to
an additive and where other statutory conditions are met
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3. Prohibit False/Misleading Claims of Reduced
Risk
FDA will allow reduced risk claims only when scientifically
demonstrated and an order is issued by FDA
Modified risk application guidance:
 Pre-market review required
 Marketing of the product will (or is expected to) reduce the risk of
tobacco-related disease and benefit the population as a whole
 Draft guidance issued in April 2012 outlining the scientific
evidence FDA requests for its pre-market review
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4. Decrease Harms of Tobacco Products
Cigarette flavor ban
 Cigarettes cannot have fruit, candy or herb characterizing flavors
(except tobacco or menthol)
Deeming regulation
 FDA has announced its intent to expand jurisdiction to include other
tobacco products
Product standards
 FDA can issue standards appropriate for the protection of public
health including to make regulated products less addictive and/or
less harmful
 FDA cannot set nicotine yields to zero
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5. Expand Science for Regulatory Action and Evaluation
To expand the scientific foundation for FDA tobacco product regulation,
FDA is conducting research and partnering with other agencies
 Research supported through:
 Supplements to existing NIH grants or cooperative agreements
 FDA will be funding Tobacco Regulatory Science Centers of
Excellence in areas of importance to FDA tobacco product
regulation
 PATH tobacco longitudinal cohort study
 Survey implementation with CDC
 CDC laboratory activities
 Contracts
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6. Restrict Marketing and Distribution
To reduce youth initiation FDA restricts access and marketing of
cigarettes, cigarette tobacco, and smokeless tobacco.
FDA prohibits (implemented June 2010):
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Sales to people younger than 18
Sales of cigarette packs with fewer than 20 cigarettes
Distribution of free samples of cigarettes and restricting the distribution
of free samples of smokeless tobacco products
Brand name sponsorship of athletic, musical, or other social events and
of teams
Hats and tee shirts, etc., with brand names or logos
Sales in vending machines or self-service displays except in adult-only
facilities
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7. Ensure Industry Compliance - Retailers
 Tobacco retailer
inspections to check on
compliance with FDA
regulations
– FDA contracts with
45 States and Territories
– More than $62 million in
Alaska
Hawaii
compliance check
inspection contracts
awarded to date
DC
American
Samoa
Guam
Northern Mariana
Islands
Puerto
Rico
U.S.
Virgin
Islands
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Ensure Industry Compliance – Retailers, Cont.
 Support Compliance & Enforcement
– Provisions of the Tobacco Control Act, including those related to
the retail sale of tobacco products, also apply to tribal
jurisdictions (Indian Country).
– Tobacco Control Act directs FDA to contract with States,
Territories, and Indian tribes, where feasible.
– FDA wants to collaborate with federally-recognized tribes and
other tribal entities to ensure understanding of the provisions
and comply with the law.
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8. Educate the Public
Public education campaigns related to
statutory authorities and regulatory actions
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Raise public awareness about FDA
regulatory actions
– Banned flavored cigarettes
– Prohibited misleading advertising (e.g.,
“low,” “light,” and “mild”)
– Established list of harmful and
potentially harmful constituents (HPHCs)
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How You Can Be Part of FDA’s Work
1. Know the Tobacco Control Act
2. Support compliance and enforcement by reporting potential
violations and promoting educational materials
3. ACTIVELY engage in FDA rulemaking
4. Amplify FDA health education campaigns
5. Stay informed and connected with FDA activities
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Know the Tobacco Control Act
Visit www.fda.gov/TobaccoControlAct to:
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See our overview of the Act for a snapshot of its significance and
FDA authorities for tobacco product regulations
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Search the Act by “Audience,” “Type of Tobacco Product,” and
“Topic” to more easily find relevant sections
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Check out our graphic timeline of the Act to learn about its history,
key events, and milestones
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Support Compliance and Enforcement
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Submit potential violations:
– Phone: 1.877.CTP.1373 (option #3)
– Email: CTPCompliance@fda.hhs.gov
– Electronic reporting form:
http://www.fda.gov/TobaccoProducts/ProtectingKidsfromTobacco/
ucm330160.htm
– Write: FDA Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850
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Ways to Engage CTP
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Disseminate information about -- and submit comments as
appropriate -- concerning draft guidance and proposed regulations
through relevant dockets
http://www.fda.gov/RegulatoryInformation/Dockets/Comments/defa
ult.htm
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Attend and participate in public meetings
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Share policy direction and innovation with CTP
Collect and share relevant research, surveys, evaluation and
surveillance data
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Current AI/AN Engagement Activities
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Collaboration with the National Native Network
Individual Tribal Outreach
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Dear Tribal Letter – April 2013
Outreach to National Indian Organizations
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NCAI
NIHB
NCUIH
AICF
AAIP
Outreach to Regional Area Indian Health Boards
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All 12 IHS Regions contacted and assigned a Tribal Policy Analyst
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Current AI/AN Engagement Activities – Cont.
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Outreach to Tribal Epi-Centers
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All regional Tribal Epi-Centers contacted
Listening Sessions
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NIHB and NCUIH Listening Session – June 2013
Meet and Greet
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HHS Office of Intergovernmental and External Affairs
NIHB – June 2013
NCUIH – June 2013
NCAI – Projected July 2013
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Current AI/AN Engagement Activities – Cont.
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National Forums
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National Indian Health Board Tribal Public Health Summit – June
2013
7 Generations Conference – April 2013
NCAI Mid-Year and Annual Conferences
Projected – NIHB Annual Consumer Conference
Federal Meetings
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IHS
CDC
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Amplify CTP Communications
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Work with partners to share messages
through new technologies
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Visit www.fda.gov/tobacco to
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–
–
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Find more information
Order materials
Sign up for email subscriptions, like “This
Week in CTP”
Join us on Twitter
Promote Break the Chain of Addiction
Retailer Education Campaign
Materials.
–
Free materials available at:
www.fda.gov/BreaktheChain
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Stay Informed and Connected

Office of Policy - Public Health Liaison Branch:
Paul.Allis@fda.hhs.gov
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Consumer Questions:
AskCTP@fda.hhs.gov or 1-877-287-1373
 Formal correspondence, and speech and meeting requests:
ctpexecsec@fda.hhs.gov
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CTP Ombudsman:
les.weinstein@fda.hhs.gov
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Regional Approach to Indian Country
Capt. Gail Cherry Peppers, Tribal Policy Analyst
Gail.Cherry-Peppers@fda.hhs.gov
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Albuquerque
Billings
California
Navajo
Oklahoma
Phoenix
Tucson
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Regional Approach – Cont.
Paul R. Allis, Pool Tribe, Tribal Policy Analyst
Paul.Allis@fda.hhs.gov
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Aberdeen
Alaska
Bemidji
Billings
Nashville
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Office of Compliance and Enforcement Contacts
Heather Althouse
heather.althouse@fda.hhs.gov
Evonne Bennett-Barnes,
Navajo/Comanche
evonne.bennett-barnes@fda.hhs
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