0. FDA’s Action Plan to Combat the Public Health Threat of Tobacco Use
Compliance & Enforcement
Regulatory Science
Laws & Policies
Public Education & Communications
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.

1. 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

2. 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

3. 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

4. June 22, 2009: The Family Smoking Prevention and Tobacco Control Act was signed into law

5. 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

6. 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

7. 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

8. 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)

9. Tobacco Control Now Includes Tobacco Product Regulation

10. 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

11. 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

12. 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

13. 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

14. 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

15. CTP Priorities: to 2013
Build the Center, including staff, infrastructure, and processes
Meet statutory deadlines
Develop the FDA tobacco product public health regulatory framework

16. 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

17. Statutory Milestones

18. FDA’s Public Health Framework for Tobacco Product Regulation
FDA is using our regulatory authority to:
Understand the regulated products
Control product changes that affect public health
Prohibit false or misleading product claims that state or imply reduced risk
Decrease harms of tobacco products
Expand the science base for regulatory action and evaluation
Restrict marketing and distribution to protect public health
Ensure industry compliance with FDA regulation
Educate the public about FDA's regulatory actions

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 7. Ensure Industry Compliance - Retailers
American Samoa
Hawaii
Guam DC
Puerto Rico
U.S. Virgin Islands
Alaska
Northern Mariana Islands
Tobacco retailer inspections to check on compliance with FDA regulations
FDA contracts with States and Territories
More than $62 million in compliance check inspection contracts awarded to date

28. 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.

29. 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)

30. How You Can Be Part of FDA’s Work
Know the Tobacco Control Act
Support compliance and enforcement by reporting potential violations and promoting educational materials
ACTIVELY engage in FDA rulemaking
Amplify FDA health education campaigns
Stay informed and connected with FDA activities

31. Know the Tobacco Control Act
Visit 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

32. Support Compliance and Enforcement
Submit potential violations:
Phone: CTP.1373 (option #3)
Electronic reporting form:
Write: FDA Center for Tobacco Products
9200 Corporate Boulevard
Rockville, MD 20850

33. Ways to Engage CTP
Disseminate information about -- and submit comments as appropriate -- concerning draft guidance and proposed regulations through relevant dockets ult.htm
Attend and participate in public meetings
Collect and share relevant research, surveys, evaluation and surveillance data
Share policy direction and innovation with CTP

34. 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

35. 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

36. 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

37. Amplify CTP Communications
Work with partners to share messages through new technologies
Visit to
Find more information
Order materials
Sign up for subscriptions, like “This Week in CTP”
Join us on Twitter
Promote Break the Chain of Addiction Retailer Education Campaign Materials.
Free materials available at:

38. Stay Informed and Connected
Office of Policy - Public Health Liaison Branch:
Consumer Questions: or
Formal correspondence, and speech and meeting requests:
CTP Ombudsman:

39. Regional Approach to Indian Country
Capt. Gail Cherry Peppers, Tribal Policy Analyst
Albuquerque
Billings
California
Navajo
Oklahoma
Phoenix
Tucson

40. Regional Approach – Cont.
Paul R. Allis, Pool Tribe, Tribal Policy Analyst
Aberdeen
Alaska
Bemidji
Billings
Nashville

41. Office of Compliance and Enforcement Contacts
Heather Althouse
Evonne Bennett-Barnes, Navajo/Comanche