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U.S. Department of Health and Human Services

Tobacco Products

Center for Tobacco Products Update (November 6, 2009)

FDA intends to provide regular updates to inform Congress and the public on its progress in implementing the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
In September and October 2009, the Center:

Publicized and Began Enforcing the Flavored Cigarette Ban
On September 22, 2009, in accordance with one of the provisions of the Tobacco Control Act, a ban on cigarettes containing certain characterizing flavors went into effect. The Center took several important steps to publicize and enforce the ban, including:

    • Establishing a dedicated Web site for flavored tobacco products to provide information to consumers, industry and health professionals about these products
    • Issuing a letter to regulated industry reminding them of the ban
    • Issuing a letter to tobacco control partners providing ways they could share information about possible violations of the ban
    • Holding a media briefing and issuing a press release
    • Publishing a notice in the Federal Register containing general questions and answers about the ban
    • Issuing a parental advisory and fact sheet on flavored tobacco products
    • Establishing mechanisms for the public to report information about possible violations of the law
    • Issuing warning letters to firms who violated the ban

To read more about FDA’s actions related to the ban on characterizing flavors in cigarettes, and to view the documents listed above, please see: www.fda.gov/flavoredtobacco.

Published Draft Guidance for Industry and FDA Staff on the Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated by FDA
In September, FDA published a draft guidance document intended to assist industry and FDA staff with respect to the scope of Section 201(rr)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, prohibiting the marketing of a tobacco product in combination with another product regulated under the FD&C Act.
A copy of the draft guidance document can be viewed at: www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm184283.htm

Published Draft Guidance for Industry on Registration and Product Listing
In October, FDA published a draft guidance document intended to assist persons making tobacco product establishment registration and product listing submissions to FDA. The guidance document explains, among other things:

    • Statutory requirements under Section 905 of the FD&C Act
    • Who is responsible for providing registration and product listing submissions
    • What information is included in the submissions
    • How to submit the information
    • When to submit the information
    • FDA’s compliance policies

A copy of the draft guidance document may be viewed at: www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm186954.htm

Began Pilot Test of Registration, Product Listing, and Ingredient Information Tool
The Center intends to release an electronic tool to be used in submission of registration, product listing and ingredient information, as well as submission of certain health and research documents. Before launching this submission system, the Center plans to pilot test each section of the tool with industry representatives. The first round of pilot testing involved submission of information to satisfy the registration requirements in Section 905(b) and the product listing requirements specified in Section 905(i)(1).

Held Listening Sessions with Stakeholders
In September, the Center held a series of listening sessions with a variety of stakeholders, including: National Tobacco Control groups, State and Local government organizations, federal partners, and tobacco manufacturers, distributors, importers, and retailers. The purpose of the listening sessions was to hear comments and concerns regarding implementation of the Tobacco Control Act.
In addition, in October, the Center held the first in a series of listening sessions to provide industry additional opportunities to make comments and raise concerns about the registration, product listing, and ingredient information requirements.

Collected User Fees
The Tobacco Control Act authorized the Agency to collect user fees from manufacturers and importers of cigarettes, cigarette tobacco, roll-your-own tobacco, and any other tobacco product subject to Chapter IX - Tobacco Products of the FD&C Act. FDA has started collecting user fees.

Posted on the Web a Q&A with Dr. Lawrence Deyton, Director of the Center for Tobacco Products
In September, the Center posted an interview with Dr. Lawrence Deyton, M.S.P.H., M.D., Director, Center for Tobacco Products, on the Web. The Q&A may be viewed at: www.fda.gov/ForConsumers/ConsumerUpdates/ucm183919.htm

Extended the Comment Period to Receive Public Input
In July, FDA opened a docket to seek public input on the implementation of the Tobacco Control Act. In response to a request, FDA extended the comment period to December 28, 2009, to allow interested persons additional time to submit comments.

The Federal Register notice including instructions on how to submit comments may be viewed at: http://edocket.access.gpo.gov/2009/pdf/E9-15549.pdf.

To date, the Agency has received more than 1,700 comments. Comments may be viewed online at: http://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2009-N-0294.

Posted Job Announcements to Hire New Staff for the Center
The Center for Tobacco Products continues to actively recruit new staff and has posted several job announcements for key positions. A list of the open positions may be viewed at: http://www.fda.gov/AboutFDA/CentersOffices/About