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U.S. Department of Health and Human Services

Tobacco Products

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FDA Center for Tobacco Products Update (October 1, 2010 - January 15, 2011)

The FDA Center for Tobacco Products (CTP) intends to provide regular updates to inform the public and Congress on its progress in implementing the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). This summary does not reference all actions taken by CTP.


January 2011


FDA Issues Draft Guidance and a Proposed Rule to Require Substantial Equivalence Reviews for New Tobacco Products
FDA issued guidance that outlines a pathway for marketing new tobacco products whereby the company marketing the product must prove that it is “substantially equivalent” to products commercially available on Feb. 15, 2007.  In general, in order to continue to market these products, manufacturers of tobacco products that were introduced or changed after Feb. 15, 2007, which include cigarettes, roll-your-own tobacco and all smokeless products must apply for equivalency by March 22, 2011. Manufacturers intending to introduce new products into the market after that date must submit an application for the new product and obtain a marketing order from the FDA before introducing the product to market.  FDA also published a proposed rule on exemptions for Substantial Equivalence Requirements.  FDA hosted calls and webinars for stakeholders including Industry, Small Business, and Public Health and Tobacco Control Organizations.


CTP Issued the First No Violation Inspections and Warning Letters For Illegal Tobacco Sales to Minors

The first state to participate the FDA’s State Enforcement Program was Mississippi. The FDA established the program in 2010 and currently a total of 15 states have been awarded contracts to carry out inspections. Using state inspectors who have been commissioned by the agency, the FDA visited 493 different retail establishments in Mississippi over the past three months and issued 25 warnings.  FDA has listed on the website the retail establishments found to be in violation of the law, as well as those which have been inspected and where no violations were observed.


Tobacco Product Scientific Advisory Committee (TPSAC) Meeting

On January 10th and 11th, the Tobacco Product Scientific Advisory Committee met to receive an update on the Menthol Report Subcommittee and receive and discuss presentations regarding the data requested by the committee at the March 30 and 31, 2010, meeting of the Tobacco Products Scientific Advisory Committee.


December 2010


Stakeholder Discussion Series Session with Tobacco Manufacturers and Growers
On December 8, CTP hosted a Stakeholder Discussion Series session in Raleigh, N.C. with 31 representatives of large and small tobacco manufacturers, growers, and warehouses to facilitate a two-way dialogue and meaningful engagement.  Additional Stakeholder Discussion Series sessions are planned with minority communities and groups affected by tobacco related health disparities; public health advocates; American Indians/Alaska Natives; tobacco distributers, importers, retailers, and wholesalers; and youth.


Expansion of FDA’s support to States and Territories to Assist with Enforcement of the Tobacco Control Act

The Tobacco Retail Inspection Request for Proposals (RFP) for FY 2011 was released on December 30, 2010.  In FY 2010, FDA awarded compliance and enforcement contracts to 15 states.  FDA has the goal of establishing a contract with every U.S. State and all territories, by FY 2012.  In addition, FDA may conduct its own investigations using FDA personnel and take enforcement action when appropriate.


Report to Congress Regarding Enforcement Activities Related to Free Samples

CTP submitted a Report to Congress detailing enforcement activities related to the regulation of free samples of tobacco products including the Enforcement Action Plan.  The report was required by section 102 of the Tobacco Control Act.


November 2010
 

Proposed Graphic Health Warnings
FDA issued a proposed rule, Required Warnings for Cigarette Packages and Advertisements, which would modify the required warnings that appear on cigarette packages and in cigarette advertisements.  These proposed required warnings consist of nine new textual warning statements accompanied by color graphics depicting the negative health consequences of smoking.  The graphic health warnings will appear on at least the top 50 percent of the front and rear panels of cigarette packages and will occupy at least 20 percent of cigarettes advertisements.
The Tobacco Control Act requires FDA to issue final regulations requiring these color graphics by June 22, 2011 and that these requirements take effect 15 months after issuance of this final rule (September 2012). FDA also published the results of a consumer research study related to these proposed warnings.  This was the largest consumer stuff of cigarette health warnings ever conducted. The proposed rule was available for public comment. 


Tobacco Product Scientific Advisory Committee (TPSAC) Meeting

On November 18, the Tobacco Products Scientific Advisory Committee met to receive an update on the Menthol Report Subcommittee and to receive and discuss presentations regarding the data the committee requested during their March meeting.


October 2010
 

Enforcement Action Plan for Promotion and Advertising Restrictions
CTP published an action plan to enforce restrictions on promotion and advertising of menthol and other cigarettes to youth with a focus on promotion and advertising of menthol and other cigarettes to youth in minority communities.  To develop the plan, CTP consulted with public health organizations and other stakeholders, created two dockets to request information, and held a web-based public meeting.  This action plan was required under Section 105(a) of the Tobacco Control Act. 

Stakeholder Discussion Series Session with State, Territorial, and Local Tobacco Control Officials
CTP held its first Stakeholder Discussion Series session with 28 representatives from State, Local, and Territorial Governments on October 3, to discuss common interests, mission, relationship building, and priority issues of interest for future discussions.


First Round of State Enforcement Contracts in Effect
FDA began commissioning officers in states with FDA contracts to assist with compliance and enforcement activities to help limit the availability of tobacco products to young people. 

 
Tobacco Product Scientific Advisory Committee (TPSAC) Meeting
The full Tobacco Product Scientific Advisory Committee (TPSAC) met on October 7 to hear and discuss presentations on the publicly available industry documents as they relate to the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities.