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National Partners WebinarUpdates from the

Center for Tobacco ProductsLawrence R. Deyton, M.S.P.H., M.D.

Director, Center for Tobacco Products

Ann Simoneau, J.DDirector, Office of Compliance and Enforcement

May 26, 2011

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To make tobacco-To make tobacco-related death and related death and

disease part of disease part of America’s past, not America’s past, not America’s future, America’s future, and, by doing so, and, by doing so,

ensure a healthier life ensure a healthier life for every family.for every family.

Vision Statement

Center for Tobacco Products

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Family Smoking Prevention and Tobacco Control Act

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TobaccoProduct

Regulation

Prevention

Treatment Access

Surveillance

Education

Tax/Price Incentives

Clean Indoor Air Laws

Tobacco Product Regulation

TOBACCO CONTROL

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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 United States.”

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FDA’s Actions Underway - MentholFDA’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 science-

based 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 no-tobacco-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 AheadJune 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 FDAApril 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• Graphic health warning regulations takes effect

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U.S. Food and Drug Administration

Center for Tobacco Productshttp://www.fda.gov/tobaccoproducts

1-877-CTP-1373

For Formal Correspondence

Email: ctpexecsec@fda.hhs.gov