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,” a move that almost certainly guarantees there will be no announcement from FDA on the regulation of premium cigars this year. 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.
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