FDA Plans to Issue Proposed Regulations on Other Tobacco Products by October 2013

By Thomas A. Briant


Tobacco E-News

This week, the Food and Drug Administration (FDA) released an updated version of the agency’s “Unified Agenda” indicating that the Center for Tobacco Products (CTP) intends to issue a Notice of Proposed Rulemaking by October 2013 on other products that fall within the definition of tobacco products under the Family Smoking Prevention and Tobacco Control Act.

This means that the FDA plans to issue proposed regulations on other tobacco products that may include cigars, pipe tobacco or electronic products such as electronic cigarettes and electronic cigars. Currently, the FDA regulates traditional cigarettes, roll-your-own (RYO) tobacco products and smokeless tobacco products.

The extent of the proposed regulations to be issued by the FDA on tobacco products other than cigarettes, RYO products and smokeless tobacco will not be known until the proposed rule is made public. Accompanying this issue of Tobacco E-News is a copy of the new “Unified Agenda” notice indicating that the proposed tobacco regulations should be issued by October of this year.

When the FDA’s CTP issues the proposed regulatory rules, the public–including industry members such as manufacturers, wholesalers, retailers and trade associations–will have a period of time to submit written comments about the proposed regulations.

As it has done in the past, NATO will submit comments to the proposed regulations on behalf of its members. Once the comment period closes, the FDA will review all of the comments and may make changes to the proposed regulations based on the comments submitted before finalizing the regulations for other tobacco product categories.

There is no timeline or deadline under the Family Smoking Prevention and Tobacco Control Act for the FDA to finalize new regulations on products such as e-cigarettes, cigars and pipe tobacco.

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