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FDA Center for Tobacco Products Update: June - September 2010
FDA Center for Tobacco Products (CTP) 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). This summary does not contain all actions taken by CTP.
Enforcement Action Plan for Promotion and Advertising Restrictions
On September 29, FDA posted the Enforcement Action Plan for Promotion and Advertising Restrictions, which includes FDA’s plan to enforce the restrictions on promotion and advertising of menthol and other cigarettes to youth in minority communities. The implementation strategy includes the use of tobacco marketing surveillance, compliance inspections and imports programs, enforcement tools, and education to encourage voluntary compliance.
Completion of First Round of State Enforcement Contracts
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gives FDA the authority to contract with States and U.S. Territories to assist with compliance and enforcement activities to help limit the availability of tobacco products to young people. Beginning in June 2010 and ending in mid-September 2010, FDA awarded contracts to the following states in response to the initial Request for Proposal:
Note: In Fiscal Year 2011, FDA will reissue a Request for Proposal to continue to award contracts to assist with compliance and enforcement.
Menthol Report Subcommittee of the Tobacco Products Scientific Advisory Committee Meeting
The Subcomittee met on September 27 to discuss the drafting of the Menthol Report. They discussed logistics including deadlines, format, and writing assignments.
Draft Guidance on Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers
FDA issued a guidance document that describes how FDA intends to indentify FDA tobacco regulation violations and when FDA may decide to seek civil money penalties and/or no-tobacco-sale orders. The draft guidance also details the procedure and amount of these penalties.
- Draft Guidance for FDA and Tobacco Retailers: Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers
Tobacco Product Constituents Subcommittee of the Tobacco Products Scientific Advisory Committee Meeting
Continuing discussions from the previous meeting, the Subcommittee met on July 6. The Subcommittee received presentations and discussed the analytic methods and ancillary and normalization standards applicable to the measurement and reporting of harmful or potentially harmful constituents in tobacco products, including smoke constituents. The Subcommittee also finalized its proposed list of harmful or potentially harmful constituents, the rational for inclusion of each substance, validated methods for measuring the constituents and the ancillary and normalization standards for the identified constituents for presentation at a future meeting of the full Tobacco Products Scientific Advisory Committee.
- Meeting Materials
- Draft 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
Tobacco Products Scientific Advisory Committee Meeting
The Committee held its second meeting on July 15-16 to receive updates on upcoming committee business related to menthol, including Agency (FDA) requests for information from industry on menthol cigarettes in order to prepare for the Tobacco Products Scientific Advisory Committee’s required report to the Secretary of Health and Human Services regarding the impact of use of menthol in cigarettes on the public health. The Committee also heard and discussed industry presentations on menthol in cigarettes as they relate to: characterization of menthol, clinical effects of menthol, biomarkers of disease risk, marketing data, and population effects.
Tobacco Retailer Compliance Training Sessions - Five Regional Meetings
In July, CTP launched live training sessions for retailers on the new federal tobacco regulations put in place by the Tobacco Control Act. These regional sessions provided retailers across the country with information about how to comply with the regulations and an opportunity to ask questions. Sessions were held in Boston, MA; Atlanta, GA; Chicago, IL; Dallas, TX; Los Angeles, CA.
Tobacco Products Scientific Advisory Committee Meeting
The Committee held its third meeting to receive a report from the Tobacco Product Constituents Subcommittee meetings held on June 8-9 and July 7-8. The Committee discussed and voted on the Subcommittee’s finalized initial list of harmful and potentially harmful constituents and the Subcommittee’s recommendations on smoking machine regimen; parameters important in comparing analytical methods; and their recommendations on what FDA should consider in developing a sampling plan for tobacco product testing.
June 22, 2010 marked the one year anniversary of the Family Smoking Prevention and Tobacco Control Act. On June 22, extensive tobacco product regulations designed to protect kids from tobacco went into effect as well as other important provisions of the Tobacco Control Act.
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products
On June 22, the FDA issued a final rule containing a broad set of federal requirements designed to significantly curb access to and the appeal of cigarettes and smokeless tobacco products to children and adolescents in the United States. The new rule, effective June 22, 2010, and has the force and effect of law.
Among other things, the rule
- Prohibits the sale of cigarettes or smokeless tobacco to people younger than 18.
- Prohibits the sale of cigarette packages with fewer than 20 cigarettes.
- Prohibits the sale of cigarettes and smokeless tobacco in vending machines, self-service displays, or other impersonal modes of sales, except in very limited situations.
- Prohibits free samples of cigarettes and limits distribution of smokeless tobacco products.
- Prohibits tobacco brand name sponsorship of any athletic, musical, or other social or cultural event, or any team or entry in those events.
- Prohibits gifts or other items in exchange for buying cigarettes or smokeless tobacco products.
- Requires that audio ads use only words with no music or sound effects.
- Prohibits the sale or distribution of items, such as hats and tee shirts, with tobacco brands or logos.
- Information on Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco
Light, Low, Mild and Misleading Descriptors
Effective June 22, 2010, FDA prohibited manufacturing any tobacco products labeled or advertised as containing “light,” “low,” or “mild,” or any similar descriptor, without an FDA order. As of July 22, 2010, manufacturers could no longer distribute for sale any of these products.
- Put Out The Myth On Light, Low, and Mild Cigarettes
- Guidance for Industry and FDA Staff: Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products
Smokeless Tobacco Product Warning Labels
On June 22, FDA began requiring the new warning labels for Smokeless Tobacco Products to rotate in packaging and advertising for smokeless tobacco products. After July 22, 2010, manufacturers may not sell any smokeless tobacco unless its packaging complies with the Smokeless Tobacco Act.
- Information on Smokeless Tobacco Product Warning Labels
- Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products
Break the Chain of Tobacco Addiction Campaign
FDA launched the Break the Chain of Tobacco Addiction campaign to educate retailers about the Regulations Restricting the Sale and Distribution of Tobacco Products and other provisions of Tobacco Control Act. The campaign includes:
- Break the Chain of Tobacco Addiction Website with all of FDA’s educational material for retailers on the FDA tobacco regulations.
- Podcast Series available for download and listening.
- Website Badges that can be added to websites and blogs to share information about FDA’s tobacco regulations.
- Widget for websites with the latest FDA Tobacco News, features and an educational quiz.
- Flyers and Posters for downloading and printing.
- Mobile Text Messaging Program that offers subscribers educational text messages about tobacco regulations and to participate in a quiz for an opportunity to be recognized on FDA.gov.
- More information is available at www.fda.gov/breakthechain
Draft Guidance on Tobacco Retailer Training Programs
FDA issued draft guidance to help tobacco retailers implement effective training programs for employees to learn about federal tobacco laws on sales, access, and advertising of cigarettes and smokeless tobacco products.
Draft Guidance on Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
FDA published draft guidance to help industry understand how to comply with the Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.
- Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
Web-based Public Meeting on the Development of an Enforcement Action Plan
On June 30, 2010, CTP held a Web-based public meeting to discuss the development of an action plan to enforce restrictions on the promotion and advertising of menthol and other cigarettes to youth, including youth in minority communities. The purpose of this meeting was to gather data, information and views from any interested parties, including public health organizations, minority community groups and leaders, other stakeholders with demonstrated expertise and experience in serving minority communities, groups serving youth, patient groups, advertising agencies, and the regulated industry.