FDA

FDA Issues 'ANPRM' on Regulating Premium Cigars

FDA issued an Advance Notice of Proposed Rulemaking: Regulation of Premium Cigars

Submit your comments by June 25, 2018 to protect Premium Cigars! 


 March 23, 2018

The Food and Drug Administration issued an advance notice of proposed rulemaking (ANPRM) to seek comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars to inform the agency's regulatory policies. The agency is specifically requesting comments and information not previously submitted in response to the deeming rule. 

View the unpublished Proposed Rule by the FDA: Regulation of Premium Cigars

Request for Comments and Information

All tobacco products, including "premium" cigars, remain subject to manufacturing, distribution and marketing oversign by FDA. However, given the ongoing interest from many parties on this issue - as well as the potential for new data on the topic since the deeming rule published-we're providing stakeholders an opporturnity to submit revelent new information that could inform FDA's regulation of "premium" cigars," said Mitch Zeller, director of FDA's Center for Tobacco Products. 

Through the ANPRM announced today, the agency is requesting comments, data, research, results, or other information not submitted in response to the proposed deeming rule on topics including, but not limited to: 

  • The definition of "premium" cigars
  • Use patterns of "premium" cigars generally and among youth and young adults specifically
  • Public health considerations associated with "premium" cigars, including the health effects
  • Studies or information regarding consumer perceptions of the health risks of "premium" cigars
  • Studies or information on whether any applicable manufacturing, marketing, sale, distribution, advertising, labeling, and/or packaging requirements and restrictions should be applied differently to "premium" cigars compared to other tobacco products, including other cigars

Comments

The FDA will consider all submissions to help inform the agency's regulatory decision-making regaring "premuim" cigars.

The ANPRM will be available for comment from March 26 through June 25, 2018. 

Anyone can submit a comment on a proposed rule by the FDA. 

For tips on submitting effective comments, click here.

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