FDA Regulatory Update

Thomas A. Briant, NATO Executive Director

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June marks the fourth anniversary of the FDA’s regulation of tobacco products. With the upcoming anniversary, the FDA tobacco regulatory landscape for 2013 includes the prospect of new federal regulations on other tobacco products, are quest by the FDA for comments on the current smokeless-tobacco warning labels, and the agency’s request to the Office of Management and Budget (OMB) to restart a Web survey of people 13 years and older on the impact of graphic cigarette health warnings. And a final report on the use of menthol in cigarettes remains under consideration by the FDA.

OTP Regulations

In December, the FDA 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, roll-your-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.

The Regulatory Agenda states that the FDA should issue a Notice of Proposed Rulemaking no later than April 2013. Upon the issuance of the rulemaking proposal, the public will have a period of 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 needed 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.” Public comments were due April 1.

Under current federal law, one of the following warning statements must appear pursuant to a required rotating basis on each of the two principal display panels of a smokeless tobacco product and take up at least 30% 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; or 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.

Graphic-Warning Survey

The FDA has filed a request with the OMB seeking approval to restart a Web-based survey of individuals age 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 2012 letter issued to the public by the FDA that states that “due to ongoing litigation, the implementation date for the [graphic cigarette health warnings] … is uncertain.”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’s comment argues that asking for approval to conduct a survey for the purpose of implementing the graphic health warnings is contradictory and unnecessary.

Menthol Update

The FDA’s Tobacco Product Scientific Advisory Committee studied the issue of menthol in cigarettes for more than a year and issued a report on its findings. The FDA reviewed the report from the Tobacco Product Scientific Advisory Committee and then submitted the committee’s report and findings to peer scientific reviewers. The FDA is expected to issue a final report on the use of menthol in cigarettes, but there is no deadline for the issuance of the final report.

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