National Partners Webinar
Updates from the
Center for Tobacco Products
Lawrence R. Deyton, M.S.P.H., M.D.
Director, Center for Tobacco Products
Ann Simoneau, J.D
Director, Office of Compliance and Enforcement
May 26, 2011
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To make tobaccorelated death and
disease part of
America’s past, not
America’s future,
and, by doing so,
ensure a healthier life
for every family.
Vision Statement
Center for Tobacco Products
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Family Smoking Prevention and
Tobacco Control Act
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TOBACCO CONTROL
Tobacco
Product
Regulation
Prevention
Treatment Access
Surveillance
Education
Tax/Price Incentives
Clean Indoor Air Laws
Tobacco Product Regulation
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Product Regulation Means:
•
Requiring manufacturers to register
•
Requiring ingredient reporting
•
Requiring health document reporting
•
Evaluating new products before they are
marketed
•
Evaluating products claiming to be
substantially equivalent
•
Evaluating the accuracy and impact of
proposed modified risk claims
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Product Regulation Does Not Mean:
•
•
•
An end to the tobacco epidemic
An end to the need for good scientific
studies
An end to the need for public health action
Tobacco product regulation is one more tool to
reduce the disease and death caused by
tobacco use
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The First 20 Months of FDA
Tobacco Product Regulation
• Establishing the regulatory framework for
tobacco product regulation
• FDA has met all statutory requirements
• FDA has interacted with a number of
stakeholders
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Listening to Stakeholders
• Meaningful communication is important for a
regulatory agency
• Meaningful communication is important when
implementing a new law
• Trust can be improved in all directions
• Everyone is new to tobacco product regulation
called for in the Tobacco Control Act
• FDA wants and needs input from every
stakeholder including manufacturers, retailers,
public health advocates, tobacco consumers,
and all citizens
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Stakeholder Discussions
• State and Local Tobacco Control Officials
– October 3, 2010 (Atlanta, GA)
– http://www.fda.gov/TobaccoProducts/NewsEvents/ucm224215.htm
• Tobacco Product Manufacturers, Growers, and
Warehousers
– December 8, 2010 (Raleigh, NC)
– http://www.fda.gov/TobaccoProducts/NewsEvents/ucm233921.htm
• Minority Communities and Groups Affected by
Tobacco-Related Health Disparities
– February 8, 2011 (Oakland, CA)
– http://www.fda.gov/TobaccoProducts/NewsEvents/ucm240182.htm
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Upcoming Stakeholder Discussions
• Public Health Advocates
– June 9, 2011 (Rockville, MD)
• American Indians/Alaska Natives
– June 28, 2011 (Gila River Indian Community, Near Phoenix, AZ)
• Distributors, Importers, Retailers, Wholesalers
– August 24, 2011 (Dallas, TX)
• Youth
– September 13, 2011 (Boston, MA)
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Status - Menthol
• Critically important issue
• Illustrates the complexities of tobacco
product regulation
• TPSAC Menthol report (advising FDA)
– TPSAC does not set policy, it advises FDA
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TPSAC Findings in the Menthol Report
• TPSAC did not make any specific recommendations
about what FDA actions would be most appropriate to
achieve its findings:
• Evidence most strongly supported that:
– Menthol cigarettes increase experimentation and the transition to
regular smoking.
– Menthol cigarettes increase the likelihood of addiction and the
degree of addiction in youth smokers.
– Menthol cigarettes result in lower likelihood of smoking cessation
success in African-Americans.
– Menthol cigarettes increase the prevalence of smoking in the general
population and African Americans.
– Menthol cigarette marketing increases the prevalence of smoking for
the whole population, youth and African Americans.
• TPSAC concluded that, “Removal of menthol cigarettes
from the marketplace would benefit public health in the
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United States.”
FDA’s Actions Underway - Menthol
FDA’s scientific review activities have been
underway for months and include:
• An analysis of health documents that were
submitted by the tobacco industry.
• An examination of the peer-reviewed sciencebased literature.
• An independent analysis of available large-scale
and national studies.
If the science dictates action, the TCA gives FDA
many options to protect public health
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Status – Dissolvable Tobacco
Products
• Tobacco Control Act requires the FDA to review
and allow the marketing of tobacco products
introduced after February 15, 2007
– Feb. 2010 FDA requested information from Star
Scientific and RJR on dissolvables (received in
March)
– March 2010 FDA opened a docket requesting
comments on the nature, use and impact of
dissolvable use on the public health; research and
data on ways these products are used by
children/youth; how the risks are perceived by users
and non-users; and how they affect health
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Dissolvable Tobacco Products
(cont’d)
– Oct 2010 FDA announced intention to require tobacco
companies to submit their internal documents relating
to marketing practices and research on health,
toxicological, behavioral and physiological effect of
dissolvables
• Tobacco Control requires the TPSAC to study
and issue a report by March 2012 on the issue
of the nature and impact of the use of
dissolvable tobacco products on the public
health, including such use among children.
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Status – E-Cigarettes
• U.S. Court of Appeals decision – e-cigarettes
and other products “made or derived from
tobacco” can be regulated as “tobacco products”
and are not/drugs/devices unless they are
marketed for therapeutic purposes
• Tobacco products other than cigarettes,
smokeless tobacco and roll-your-own tobacco
are not currently regulated by FDA
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Status – E-Cigarettes (cont’d)
• Letter to Stakeholders issued April 25, 2011
outlining FDA’s intended actions:
– Proposing a regulation extending the Agency’s
“tobacco product” authorities
– Considering whether to issue a guidance and/or a
regulation on “therapeutic claims”
– Finalizing a draft guidance on prohibition of marketing
of “tobacco products” in combination with other FDA
regulated products
– Issued draft guidance to manufacturers on requesting
a determination for “grandfathered” product
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Status – Graphic Health
Warnings
• Proposed rule issued on November 12,
2010
• Issuance of final rule is required by June
22, 2011
• FDA plans to assess the impact of the
required warnings via comprehensive
research and evaluation mechanisms to
enable us to adapt and enhance
effectiveness of messaging
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Status – New Product Review
• New tobacco product defined as:
– “Any tobacco product (including those
products in test markets) that was not
commercially marketed in the United States
as of February 15, 2007;” or
– “Any modification*. . . of a tobacco product
where the modified product was commercially
marketed in the United States after February
15, 2007” (section 910(a)(1))
* including change in design, any component, any part or any
constituent, including a smoke constituent, or in the content, delivery
or form of nicotine, or any other additive or ingredient
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New Product Review (cont’d)
• Pathways for legally marketing tobacco products:
– Grandfathered products – 2/15/2007
– 3 potential pathways to market a “new tobacco product”
• Substantial equivalence (SE) reports
• SE exemption (pursuant to regulation)
• Premarket tobacco product applications (PMTA)
• Pathway for legally marketing tobacco products
with modified risk claims:
– Modified risk tobacco product applications (MRTP)
• Separate guidance or regulation
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Office of Compliance and
Enforcement
Ann Simoneau, Director
• Enforcement and Manufacturing Group
– Joanna Weitershausen, Acting Group Leader
• Promotion, Advertising, and Labeling Group
– Ele Ibarra-Pratt, Group Leader
• State Programs Group
– Terry McDonald, Group Leader
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State Programs
• Coordinates implementation of FDA
tobacco retailer inspection contracts
• Provides commissioning and training for
inspectors
• Reviews results from compliance check
inspections
• Initiates enforcement actions for violations
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FDA Tobacco Retail Inspection
Contracts
• 15 States were awarded 1 year contracts in FY
2010
• Up to 75% of U.S. States/Territories in FY 2011
• Currently reviewing contract proposals
submitted by States for FY 2011
• Contracts will be awarded to all jurisdictions that
wish to participate in FY 2012
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States Awarded FDA Tobacco
Enforcement Contracts in FY 2010
(Alabama, Arkansas, Arizona, Colorado, Idaho, Kansas, Maine,
Maryland, Massachusetts, Mississippi, Missouri, Illinois, Pennsylvania,
Tennessee, and Washington)
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Inspection Results/Enforcement
Actions
• A warning letter will be issued by FDA if
violations are found during the first time
compliance check inspection of a retailer
• All warning letters are posted on the FDA
website
• A list of retailers that were inspected and where
no violations are found is posted on the FDA
website
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Inspection
Results/Enforcement Actions
• After a tobacco retailer receives a warning letter,
FDA intends to conduct follow-up compliance
check inspections at that outlet
• If violations are found during follow-up
compliance check inspections at that retail
outlet, FDA will seek civil money penalties
• Other enforcement actions may include notobacco-sale orders, seizures, and/or injunctions
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Compliance Check Inspections
As of May 19, 2011:
• Total Number of retailer compliance check
inspections: 9,418
• Total number of warning letters
issued to retailers: 337
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Enforcement Actions
• Ban on flavored cigarettes
– 30 Warning Letters
• Light, low, or mild cigarettes
– 11 Warning Letters
– Tobacco-Related Health Fraud
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Compliance Training for Tobacco
Retailers
• FDA is committed to finding more ways to
educate tobacco retailers
• Tobacco retailers make up a large and diverse
community – often with no experience with FDA
• Tobacco retailers need information and education
about the Tobacco Control Act
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Compliance Training for
Tobacco Retailers
• In FY 2010, OCE held five training retailer sessions
held in Boston, Atlanta, Chicago, Dallas, and Los
Angeles
• Over 1,000 retailers, their representatives and
trade associations attended in person, via live
webcasting and/or telephone
• Sessions provided information about how to
comply with the law and opportunity to ask
questions on federal tobacco product regulations
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Compliance Training for
Tobacco Retailers
• FY 2011 Tobacco Retailer Compliance Webinars
– Upcoming: June 28, July 26, September 20
– Topics include warning letters for violations; civil
money penalties; age, access, and promotional
restrictions, impersonal modes of sale,
smokeless tobacco packaging and advertising
– FDA will also solicit stakeholders for topics to be
covered in future webinars
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Working with FDA
• Educate retailers on the Tobacco Control
Act and its implementing regulations using
the information on our website
• Report potential violations
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Reporting Tobacco-Related
Complaints/Violations to CTP
• 1.877.CTP.1373 (press #3 to report a
violation)
• Email: CTPCompliance@fda.hhs.gov
• Correspondence: CTP’s Office of
Compliance and Enforcement
• Electronic Tobacco Violations Reporting
Form (in development)
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Looking Ahead
June 2011
• Issue final rule on graphic health warnings
• CTP will issue a status report on menthol
• Issue FY2011 State contract awards (thru Sept. 2011)
March 2012
• TPSAC report on dissolvable tobacco products to be
submitted to FDA
April 2012
• Establish list of harmful/potentially harmful constituents
• Issue guidance or regulations on scientific evidence to
be used in assessing modified risk products (to be
developed in consultation with the Institute of Medicine)
September 2012
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• Graphic health warning regulations takes effect
U.S. Food and Drug Administration
Center for Tobacco Products
http://www.fda.gov/tobaccoproducts
1-877-CTP-1373
For Formal Correspondence
Email: ctpexecsec@fda.hhs.gov