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Tobacco Products

Letter to Industry Regarding New Health Warnings Required By Amendments to the Smokeless Tobacco Act

Food and Drug Administration
Center for Tobacco Products
9200 Corporate Boulevard

 Rockville MD 20850-3229


June 28, 2010

Dear Sir or Madam:

The Food and Drug Administration (FDA) is providing this notice to remind regulated industry that effective June 22, 2010, new health warnings are required by amendments to Section 3 of the Comprehensive Smokeless Tobacco Health Education Act (Smokeless Tobacco Act), 15 U.S.C. 4402.  These warnings must be displayed on all packaging and advertising for smokeless tobacco, which is defined in the Smokeless Tobacco Act as any tobacco product that consists of cut, ground, powdered or leaf tobacco and that is intended to be placed in the oral or nasal cavity. 

These warnings must begin to rotate in advertising for smokeless tobacco products beginning on June 22, 2010, and must be distributed and displayed on the packaging of smokeless tobacco products manufactured on or after June 22, 2010.  Section 3(b)(3) of the Smokeless Tobacco Act, as amended.   In addition, on or after July 22, 2010, manufacturers may not introduce any smokeless tobacco product into domestic commerce unless it complies with Section 3 of the Smokeless Tobacco Act.  Id.

Among the requirements in Section 3(b)(3) is that the rotation of label statements on packaging and advertising for each brand of smokeless tobacco must be “in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer” to, and approved by FDA.  Thus, companies should now submit their plans to FDA rather than to the Federal Trade Commission (FTC), which formerly had responsibilities over the review and approval of those plans. At this time, as an exercise of enforcement discretion, FDA does not intend to commence or recommend enforcement of the requirement that a smokeless tobacco manufacturer, distributor, importer, or retailer must have an FDA-approved rotational warning plan so long as a rotational warning plan has been submitted to FDA by July 22, 2010. This enforcement policy pertains only to the requirement that smokeless tobacco manufacturers, distributors, importers, or retailers must have an FDA-approved rotational warning plan. FDA expects compliance with regard to all other requirements of Section 3 of the Smokeless Tobacco Act, including the requirements relating to size, formatting, location, and use of required warning statements.

If you have questions about this provision of the new law, please e-mail them to:





Lawrence R. Deyton, M.S.P.H., M.D.
Director, Center for Tobacco Products

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