November 30, 2015 Patrick Lagreid Federal,  Regulations

FDA Reopens Comments On Tobacco Related Rules

The United States Food & Drug Administration (FDA) has reopened public comments on its proposed document titled “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding Intended Uses.”

In the announcement issued Monday morning, FDA is reopening the comment period for 30 days, running Nov. 30 – Dec. 30, 2015. This comes in response to requests made to the agency to do so following the notice of proposed rulemaking (NPRM) that appeared in theFederal Register of Sept. 25, 2015. In that NPRM, FDA requested comments on the proposed regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

Comments on the proposed rules can be made electronically here.

An earlier version of this story suggested that this reopening of comments would “almost certainly guarantees there will be no announcement from FDA on the regulation of premium cigars this year.” This was an incorrect assumption and we apologize for the error.

Deeming Document Deeming Regulations FDA U.S. Food & Drug Administration
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Patrick Lagreid

I strive to capture the essence of a cigar and the people behind them in my work – every cigar you light up is the culmination of the work of countless people and often represents generations of struggle and stories. For me, it’s about so much more than the cigar – it’s about the story behind it, the experience of enjoying the work of artisans and the way that a good cigar can bring people together. In addition to my work with halfwheel, I’m the public address announcer for the Colorado Rockies and Arizona Diamondbacks during spring training, as well as for the Salt River Rafters of the Arizona Fall League, the WNBA's Phoenix Mercury, the G-League's Valley Suns, and previously the Arizona Rattlers of the Indoor Football League. I also work in a number of roles for Major League Baseball, plus I'm a voice over artist. Prior to joining halfwheel, I covered the Phoenix and national cigar scene for Examiner.com, and was an editor for Cigar Snob magazine.

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