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Regulatory SciencePublic Education & CommunicationsLaws & PoliciesCompliance & EnforcementFDA’s Action Plan to Combat the Public Health Threat of Tobacco UseJune 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

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 ingredientsReporting levels of harmful and potentially harmful constituents

by brand and sub-brandEstablishing tobacco product standards Premarket submissions for new and modified risk tobacco

products to protect the public healthHealth warnings on labels and in advertisingAdvertising and promotion restrictionsAuthority 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

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 FDAFDA regulations have the force and effect of law, and create requirements with which regulated industry must complyFDA 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

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

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

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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 products2.Control product changes that affect public health3.Prohibit false or misleading product claims that state or imply reduced risk4.Decrease harms of tobacco products5.Expand the science base for regulatory action and evaluation6.Restrict marketing and distribution to protect public health7.Ensure industry compliance with FDA regulation8.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 productsIngredient reporting Companies must provide a list of ingredients for regulated productsHarmful 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 Products on the market as of February 15, 2007 and unchanged

since that date

b. New tobacco product applications

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 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

d. Substantial equivalence exemption 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 productsProduct 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 agenciesResearch 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): 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 compliance check inspection contracts awarded to date

American Samoa

Hawaii

Guam

DC

Puerto Rico

U.S. Virgin Islands

Alaska

Northern Mariana 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

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:

See our overview of the Act for a snapshot of its significance and

FDA authorities for tobacco product regulations

Search the Act by “Audience,” “Type of Tobacco Product,” and

“Topic” to more easily find relevant sections

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

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

Disseminate information about -- and submit comments as appropriate -- concerning draft guidance and proposed regulations through relevant dockets http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm

Attend and participate in public meetings

Collect and share relevant research, surveys, evaluation and surveillance data

Share policy direction and innovation with CTP

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Current AI/AN Engagement Activities

Collaboration with the National Native Network

Individual Tribal Outreach

− Dear Tribal Letter – April 2013 Outreach to National Indian Organizations

− NCAI− NIHB− NCUIH− AICF− AAIP

Outreach to Regional Area Indian Health Boards

− All 12 IHS Regions contacted and assigned a Tribal Policy Analyst

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Current AI/AN Engagement Activities – Cont.

Outreach to Tribal Epi-Centers

− All regional Tribal Epi-Centers contacted Listening Sessions

− NIHB and NCUIH Listening Session – June 2013 Meet and Greet

− 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.

National Forums

− 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

− IHS− CDC

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Amplify CTP Communications

Work with partners to share messages through new technologies

Visit www.fda.gov/tobacco to– 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

Consumer Questions:AskCTP@fda.hhs.gov or 1-877-287-1373

Formal correspondence, and speech and meeting requests:ctpexecsec@fda.hhs.gov

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

AlbuquerqueBillingsCaliforniaNavajoOklahomaPhoenixTucson

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Regional Approach – Cont.

Paul R. Allis, Pool Tribe, Tribal Policy Analyst Paul.Allis@fda.hhs.gov

AberdeenAlaskaBemidjiBillingsNashville

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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