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FDA Center for Tobacco Products Update (January 16, 2011 – April 30, 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.
Letter to Stakeholders about Electronic Cigarettes
On April 25, FDA announced in a letter to stakeholders that it will not appeal the recent decision in Sottera, Inc. v. Food & Drug Administration. This decision stated that products made or derived from tobacco can be regulated as tobacco products by FDA and that e-cigarettes and other products are not considered drugs or devices unless they are marketed for therapeutic purposes. Certain products made or derived from tobacco, such as e-cigarettes, are not currently subject to the pre-market review requirements of the Tobacco Control Act, but FDA is developing a strategy to regulate this emerging class of products as tobacco products. Products that are marketed for therapeutic purposes will continue to be regulated as drugs and/or devices.
Industry Site Tours Program
CTP announced that tobacco growers, tobacco warehousers, and tobacco product manufacturers are invited to offer to participate in the Site Tours Program to give CTP staff an opportunity to visit facilities involved in the growing, processing, or manufacturing of tobacco or tobacco products. The program will give CTP employees firsthand exposure to industry’s growing, curing, storage, and manufacturing processes. The tours are educational and not intended to include official FDA inspections of facilities.
Webinar Series for Tobacco Retailers
CTP launched a series of one-hour webinars on federal tobacco regulations that are designed to provide retailers with FDA compliance information. Retailers can ask questions during the Q&A session of each webinar. The first webinar was held on March 29 on the regulations restricting the sale and distribution of cigarettes and smokeless tobacco products to minors. The second webinar was held on April 26 and focused on warning letters and civil money penalties.
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. Two amendments were posted that contained some modifications to the RFP as well as answers to questions submitted to FDA. Some of these questions were discussed during the webinar held by CTP on January 26 with interested states. Proposals were due to FDA on March 1.
- Information for State, Local, and Territorial Governments
- FDA Tobacco Retail Inspection Contracts
- Archived Webinar
Tobacco Products Scientific Advisory Committee (TPSAC) Menthol Report
The Tobacco Control Act requires TPSAC to submit a report and recommendation on the impact of the use of menthol in cigarettes on the public health – including use among children, African Americans, Hispanics, and other racial/ethnic minorities – by March 23, 2011. The report has been received by FDA, and is available on the website. In addition, FDA has received an industry perspective document on the public health impact of menthol cigarettes from industry representatives who serve on TPSAC.
FDA will consider the report and recommendations of TPSAC, the industry perspective document, and continue to review all of the available science concerning menthol cigarettes. FDA will then make a determination about what future regulatory action(s), if any, are warranted. The Tobacco Control Act does not set a required deadline or timeline for FDA to act on the recommendations provided by the Committee in the report. Any future action(s) taken by FDA to regulate the sale or distribution of menthol cigarettes or establish a tobacco product standard for menthol cigarettes will require rule making that includes public notice and the opportunity for public comment. Therefore, FDA’s receipt of the final report and recommendations does not have a direct and immediate effect on the availability of menthol products in the marketplace.
FDA intends to provide its first progress report on the review of the science in approximately 90 days from the TPSAC report due date.
- Menthol Report: Overview
- Menthol Cigarettes and Public Health: TPSAC'S Review of the Scientific Evidence and Recommendations
- Menthol Report: Frequently Asked Questions
- Remarks by Dr. Lawrence Deyton on the TPSAC's Report and Recommendation
- Industry Menthol Report
Final Guidance on Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products
On March 19, 2010, FDA published its final regulations prohibiting the sale of cigarettes and smokeless tobacco to any person younger than 18 years of age and imposed restrictions on marketing, labeling, and advertising of cigarettes and smokeless tobacco. Based on stakeholder feedback, FDA issued minor revisions to the draft guidance that is intended to assist manufacturers, distributors, and retailers in understanding the final regulations.
- Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
Tobacco Products Scientific Advisory Committee (TPSAC) Meetings
On March 2, 2011, the Tobacco Products Scientific Advisory Committee (TPSAC) continued to receive updates from the Menthol Report Subcommittee and received and discussed presentations regarding the data requested by the Committee at the March 30-31, 2010, TPSAC meeting.
On March 17 and 18, 2011, TPSAC continued to receive updates from the Menthol Report Subcommittee and discussed plans for finalizing the report regarding the impact of use of menthol in cigarettes on the public health.
- Background Materials - March 2, 2011
- Archived Webcast - March 2, 2011
- Background Materials - March 17-18, 2011
- Archived Webcast - March 17-18, 2011
Enforcement of Illegal Tobacco Sales to Minors
FDA continued to enforce the illegal sale of tobacco products to minors through the State Enforcement Program. Since the program’s establishment in the summer of 2010, a total of 15 states have been awarded contracts to carry out inspections. FDA now lists on the website the retail establishments who received warning letters because they were found to be in violation of the law, as well as those which have been inspected and where no violations were observed.
CTP launched a Spanish-language website (fda.gov/tabaco) to help connect Spanish-speaking retailers and consumers to credible, science-based information and resources. The Spanish-language website has all of CTP’s guidance documents and is full of vital tips, downloadable tools, and information that Spanish-speaking retailers need to comply with FDA rules.
Stakeholder Discussion Series Session with Minority Communities and Groups Affected by Tobacco-Related Health Disparities
On February 8, CTP hosted a Stakeholder Discussion Series session in Oakland, CA with minority communities and groups affected by tobacco-related health disparities to provide an opportunity to learn more about the ideas, issues, and concerns of this stakeholder group and to establish good lines of communication and productive working relationships with CTP. Additional Stakeholder Discussion Series sessions are planned with: public health advocates; American Indians/Alaska Natives; distributors, importers, retailers, and wholesalers; and youth.
- Minority Communities and Groups Affected by Tobacco-Related Health Disparities Information
- Stakeholder Discussion Series
Tobacco Products Scientific Advisory Committee (TPSAC) Meetings
On February 10, 2011 the Tobacco Products Scientific Advisory Committee (TPSAC) met to receive updates from the Menthol Report Subcommittee and receive and discuss presentations regarding the data requested by the Committee at the March 30-31, 2010, TPSAC meeting.
On February 11, 2011, the Menthol Report Subcommittee of TPSAC received presentations and discussed the timelines and structure of TPSAC’s required report to the Secretary of Health and Human Services regarding the impact of use of menthol in cigarettes on the public health.
- Background Materials - February 10, 2011
- Archived Webcast - February 10, 2011
- Archived Slides - February 11, 2011
Family Smoking Prevention and Tobacco Control Act Overview
As part of an effort to better explain the Tobacco Control Act and in response to questions from stakeholders, CTP published an interactive timeline and fact sheet that broadly summarizes the Act. This overview outlines the Act: the authorities it gives FDA, what else it requires, and FDA’s role in its implementation. The fact sheet provides links to the full text of the Act to help readers understand the full context of each section described from the overview and also includes links to specific sections of the Tobacco Control Act.
- Overview of the Family Smoking Prevention and Tobacco Control Act
- Timeline: Family Smoking Prevention and Tobacco Control Act
Final Guidance on Harmful and Potentially Harmful Constituents in Tobacco Products
The Tobacco Control Act requires FDA to establish, and periodically revise, a list of harmful and potentially harmful constituents to health in each tobacco product. This also includes smoke constituents. Each constituent must be listed by brand, and quantity in each brand and subbrand. FDA issued guidance that discusses the meaning of “harmful and potentially harmful constituent.” For the purpose of establishing this list, FDA believes that the phrase “harmful and potentially harmful constituent” includes any chemical or chemical compound in a tobacco product or in tobacco smoke that is potentially inhaled, ingested, or absorbed into the body or that causes or has the potential to cause direct or indirect harm to users or non-users of tobacco products.
- Final Guidance for Industry and FDA Staff: “Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act
Online Clearinghouse for Retailer Education Campaign Materials
Break the Chain of Tobacco Addiction is FDA's campaign to educate retailers and raise awareness about tobacco product regulations. CTP launched an Online Clearinghouse to make free Break the Chain of Tobacco Addiction promotional materials available to retailers.