Daily Rules, Proposed Rules, and Notices of the Federal Government
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control Act) into law. Section 204 of the Tobacco Control Act amended section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (Smokeless Tobacco Act), 15 U.S.C. 4402, to prescribe revised requirements for health warning statements that must appear on smokeless tobacco product packages and advertisements, and to require the submission of warning plans for smokeless tobacco product packages and advertisements to FDA for review and approval, rather than to the Federal Trade Commission (FTC). Section 3(b)(3) of the Smokeless Tobacco Act requires the equal distribution and display of warning statements on packaging, and the quarterly rotation of warning statements in advertising, for each brand of smokeless tobacco product “in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer” to, and approved by, FDA. These requirements took effect on June 22, 2010.
In a notice published in the
FDA is withdrawing this guidance because it is no longer warranted. FDA has completed its review of all of the warning plans for smokeless tobacco products that were submitted to FDA by July 22, 2010, and the transition from FTC to FDA of the responsibility for reviewing warning plans for smokeless tobacco products has been accomplished. Further, this guidance included an incomplete definition of smokeless tobacco. Section 101(c) of the Tobacco Control Act amended the Smokeless Tobacco Act to give smokeless tobacco the meaning that term is given by section 900(18) of the Federal Food, Drug, and Cosmetic Act. Under this definition, “smokeless tobacco” means any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral
For information regarding the submission of warning plans for smokeless tobacco products, you may contact the Office of Compliance at FDA's Center for Tobacco Products (see
We note that FDA has made available for public comment a draft guidance that, when finalized, will represent the Agency's current thinking on the “Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products.” You can obtain an electronic version of this draft guidance document at either