The Food and Drug Administration (FDA) is reopening the comment period for the notice of proposed rulemaking (NPRM) that appeared in the Federal Register of September 25, 2015. In the 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). The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Document
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period for the notice of proposed rulemaking (NPRM) that appeared in the Federal Register of September 25, 2015. ...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
80 FR 74737
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Reopening of the Comment Period,” thefederalregister.org (November 30, 2015), https://thefederalregister.org/documents/2015-30271/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or-combination-products-amend.