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Issue link: https://read.dmtmag.com/i/116555
NATONEWS FDA Regulatory Update The agency announces a number of requests S everal months into 2013 and the FDA tobacco regulatory landscape includes the prospect of new proposed federal regulations on other tobacco products, a request by the FDA for comments on the current smokeless tobacco warning labels, and the agency's request to the Office of Management and Budget to restart a Web-survey of individuals 13 years and older on the impact of graphic cigarette health warnings. OTP Regulations During the last week of December, the Food and Drug Administration released its annual Regulatory Agenda, which states that the agency intends to issue a proposed rule to regulate other tobacco products under the terms of the Family Smoking Prevention and Tobacco Control Act. Currently, the FDA's Center for Tobacco Products regulates cigarettes, rollyour-own tobacco and smokeless tobacco products. The other tobacco products that the FDA intends to regulate and the extent of the proposed regulations will not be known until the proposed rule is made public. Thomas Briant is executive director of the National The Regulatory Agenda states that the Association of Tobacco FDA should issue a Notice of Proposed Outlets. NATO's toll-free number is (866) 869-8888 Rulemaking no later than April of 2013. and the association's Web Upon the issuance of the rulemaking site address is proposal, the public will have a period of www.natocentral.org. time to comment on the proposed regulations. Then, the FDA will review all of the public comments, consider making changes to the proposed regulations, and issue a final set of regulations. Smokeless Warnings The FDA has issued a notice requesting public comments about "what changes to the current smokeless tobacco product warnings, if any, would promote greater public understanding of the risks associated with the use of smokeless tobacco products." According to the FDA's notice, comments need to be supported by "scientific evidence" and should "address how any changes in the warnings would affect both users' and nonusers' understanding of the risks associated with the use of smokeless tobacco products." www.npnweb.com n NPN Magazine Under current federal law, one of the following four warning statements must appear pursuant to a required rotating basis on each of the two principal display panels of a smokeless tobacco product and comprise at least 30 percent of each display panel: • WARNING: This product can cause mouth cancer. • WARNING: This product can cause gum disease and tooth loss. • WARNING: This product is not a safe alternative to cigarettes. • WARNING: Smokeless tobacco is addictive. Besides being printed on smokeless tobacco product packages, one of these same warning labels must also be printed in an advertisement of smokeless tobacco products by a manufacturer, packager, importer, distributor, or retailer. Public comments must be filed by April 1, 2013 in electronic format at http://www.regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The comments must refer to Docket No. FDA2012-N-1032. Graphic Warning Survey Finally, the FDA has filed a request with the OMB seeking approval to conduct an Internet Web-based survey of individuals aged 13 and older to evaluate the effectiveness of graphic cigarette health warnings on cigarette packages. NATO has filed a set of comments with the OMB asking the agency to decline the FDA's request. NATO's comment points to a February of 2012 letter issued to the public by the FDA which states that "due to ongoing litigation, the implementation date for the [graphic cigarette health warnings]…is uncertain." Currently, there are two federal lawsuits pending that challenge the constitutionality of the graphic health warnings. With the FDA not implementing the graphic health warnings, NATO argues that asking for approval to conduct a survey for the purpose of implementing the graphic health warnings is contradictory and unnecessary. March 2013 11