FDA Center for Tobacco Products Update (April 7, 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.
Issued Final Rule Restricting Access and Marketing of Cigarettes and Smokeless Tobacco Products to Youth
In March, 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. Published March 19, 2010, the new regulations become effective on June 22, 2010, and have the force and effect of law.
Titled Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, the rule restricts the sale, distribution, and marketing of these products to make them less accessible and less attractive to kids. 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 distribution of free samples of cigarettes, restricts distribution of free samples of smokeless tobacco, and prohibits tobacco brand name sponsorship of any athletic, musical, or other social or cultural events. The entire rule can be found at www.fda.gov/protectingkidsfromtobacco.
CTP took several important steps to publicize the new rule and engage stakeholders, including establishing a special Web site section designed to help protect kids from tobacco by providing information to consumers, industry, and health professionals about the new rule such as:
- Answers to anticipated questions most frequently asked by retailers, consumers, and others about the restrictions under the new regulations
- Consumer and retail factsheets
- Protecting Kids From Tobacco Web buttons, which give people an opportunity to put a graphic element on their Web sites, blogs, or social networking sites to share information about FDA's new regulations
- Holding a media briefing and issuing a press release
- Issuing a letter to retailers about the new rule and outlining the role retailers play in protecting children and adolescents from the risks associated with using tobacco products
Issued Advance Notice of Proposed Rulemaking for Outdoor Ads
FDA issued an Advance Notice of Proposed Rulemaking (ANPR) to obtain information including comments, data, research, or other information related to the regulation of outdoor advertising of cigarettes and smokeless tobacco.
Issued Request for Proposals for Enforcement
On March 23, 2010, FDA published a Request for Proposals (RFP) solicitation for States or U.S. Territories to enforce certain provisions of the Tobacco Control Act and implementing regulations. Each State or U.S. Territory interested in submitting a proposal for these competitive contracts must identify a single agency within its jurisdiction, with enforcement authority, whose employees would be commissioned and trained to conduct FDA inspections at retail establishments. Examples of appropriate agencies may include: public health departments, attorneys general offices, law enforcement agencies, and food and drug agencies.
Many of the provisions for which FDA will contract with the States and U.S. Territories to enforce will take effect on June 22, 2010. Interested States and U.S. Territories must submit their proposals to FDA by 4 p.m. on April 27, 2010. The RFP solicitation can be found at www.FedBizOpps.gov. The solicitation number is FDA-10-Tobacco.
Launched Call Center for Tobacco Product Inquiries: 1-877-CTP-1373
On March 19, 2010, FDA launched the CTP Call Center to ensure timely and accurate responses to a broad array of questions from the public and all other stakeholders.
Convened the Tobacco Products Scientific Advisory Committee
FDA held the first meeting of the Tobacco Products Scientific Advisory Committee on March 30-31. It focused on the public health impacts of the use of menthol in cigarettes as it relates to the demographics of users, preferential use by persons initiating tobacco use, and the effects of menthol on addiction and cessation.
To publicize the meeting, CTP issued a Federal Register Notice and press release in addition to posting meeting information on the FDA Advisory Committee Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/
TobaccoProductsScientificAdvisoryCommittee/default.htm. FDA also webcast the TPSAC meeting to make it more open and transparent to all stakeholders. The webcast is archived and is available at www.fda.gov/tobacco.
Opened Public Docket for Comment on the Impact of Dissolvable Tobacco Products Use on Public Health
In March, FDA established a public docket to provide an opportunity for interested parties to share information, research, and ideas on how the use of dissolvable tobacco products may impact public health, including the health of children. This information will be used to support the work of the Tobacco Products Scientific Advisory Committee, which is charged with evaluating this issue. For more information, visit the FDA tobacco products public dockets page at: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm198169.htm
Issued Letter to Industry on Dissolvable Smokeless Tobacco Products
In February, FDA issued a letter Star Scientific, Inc., and a letter to R.J. Reynolds Tobacco Company requesting information about the perception and use of dissolvable smokeless tobacco products by individuals, including those 25 years old and younger, and about consequences associated with their misuse. This information will be used to support the work of the Tobacco Products Scientific Advisory Committee, which is charged with evaluating this issue. A copy of the letters can be viewed at: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm
Issued Letters to States and U.S. Territories Regarding Competitive Request for Proposals to Enforce Certain Provisions of the Tobacco Control Act and Implement Regulations
FDA issued a letter to governors of States and U.S. Territories discussing the shared efforts to reduce youth access to and use of tobacco products; making them aware of the competitive request for proposals (RFP) to enforce certain provisions of the Tobacco Control Act and implement regulations regarding conducting tobacco retail inspections. A copy of the letter to States can be viewed at: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm203593.htm
Opened Public Docket for Comment on the Use of Tobacco Marketing Descriptors to Convey Modified Risk
FDA established a public docket to provide an opportunity for interested parties to share information, research, and ideas on tobacco product marketing descriptors that may be considered similar to the prohibited terms “light,” “mild,” and “low.” This information will be used to further FDA’s efforts to reduce misleading and deceptive advertising practices. The comment period closed February 18, 2010.
Published Federal Register Notice Requesting Comments on Approved Tobacco Retailer Training Programs
FDA established a public docket for interested parties to provide information and share views on elements that should be included in an effective retailer training program as provided for in the Tobacco Control Act.