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FDA Announcements
FDA issues new warning letters
The U.S. Food and Drug Administration (FDA) recently issued its 10,000th tobacco retailer warning letter. The warnings are sent to ensure that the tobacco industry and retailers comply with existing laws designed to reduce the health risks associated with tobacco use and prevent youth tobacco use. Warning letters are issued for first-time violations against retailers, manufacturers, distributors, and importers who do not comply with the laws to prevent youth access to tobacco. The FDA also recently issued warning letters to three tobacco manufacturers and one retailer for illegally promoting cigarettes or roll-your-own tobacco mislabeled as “pipe tobacco.” Click here for a statement from the FDA, or click here to read a statement from the Campaign for Tobacco-Free Kids. Click here to read a response from NACS, a trade association of convenience stores.
FDA releases report from independent evaluation of menthol as a cigarette flavor, invites public comments
The U.S. Food and Drug Administration has released a much-anticipated independent report that summarizes the research on the public health effects of menthol being used as a characterizing flavor in cigarettes. The agency also issued an Advance Notice of Proposed Rulemaking (ANPRM) to collect information from the public to help the agency make informed decisions about menthol in cigarettes. Click here to read FDA's press release, or click here for the report, "Preliminary scientific evaluation of the possible public health effects of menthol versus nonmenthol cigarettes." Comments may be submitted online or in writing in response to the ANPRM under Docket #FDA-2013-N-0521 until September 23, 2013; click here to view the ANPRM and submit a comment. Public health groups responded to the release of the report by calling on the agency to take swift action to remove menthol products from the market based on the conclusions in the report that menthol flavoring is associated with increased smoking among youth, greater progression toward addiction, and decreased success in quitting smoking, especially among African Americans. Click here for a joint statement from the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, and Campaign for Tobacco-Free Kids. Previously, the Tobacco Control Legal Consortium and eighteen other leading public health groups filed a formal Citizens Petition urging the FDA to prohibit menthol flavorings. Click here to visit the Legal Consortium’s FDA Action Center to learn more about this issue and other opportunities to guide FDA’s regulation of tobacco.
Scientific workshop and request for comments: Tobacco product analysis
The Food and Drug Administration, Center for Tobacco Products (CTP) hosted a scientific workshop to obtain input on the chemical analysis of tobacco products on July 30-31, 2013, and the agency has also opened a docket to collect written comments on the topics addressed at the meeting. The workshop and docket have been set up to collect information to guide rules about the chemical testing of tobacco filler and smoke from cigarettes, roll-your-own tobacco, and smokeless tobacco products. To learn more about the workshop, click here. Click here to submit a comment to Docket #FDA-2012-N-0212 by September 30, 2013.
FDA discusses banning online sales of e-cigarettes
The Wall Street Journal recently reported that at e-cigarette companies’ request Food and Drug Administration, Center for Tobacco Products (FDA-CTP) representatives have engaged in Listening Sessions to hear the companies’ perspectives on a ban on online e-cigarette sales. According to FDA-CTP Director Mitch Zeller: “The FDA did not raise or weigh in on potential regulatory options—including any potential restrictions on e-cigarettes or any other particular product category—during these listening sessions. Any details about the agency’s intent to regulate additional categories of tobacco products will be made publicly available to all interested parties at the same time, through the issuance of a proposed rule.” Zeller stated in an interview that he expects the agency to release proposed regulations in October. The agency will issue a ruling regarding whether e-cigarettes should be regulated as tobacco products under FDA-CTP’s authority. Read more here, or click here for information from FDA about e-cigarettes. Note: corrections requested by FDA are stated at the end of the WSJ article.
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