![]() Exclusion From Tobacco Product Regulation (§ 1100.5)ī. Changes to Existing “Intended Use” RegulationsĪ. Comments and Responses Regarding Consumer Confusionį. Comments and Responses Regarding Brown & Williamson and SotteraĮ. Intended Uses For Products Made or Derived From Tobacco That Bring ProductsWithin the Structure/Function Prongĭ. Comments and Responses Regarding Modified Risk Tobacco ProductsĬ. Intended Uses For Products Made or Derived From Tobacco That Bring Products Within the Disease Prongī. History of 1996 Rulemaking and Relevant LitigationĪ. Comments and Responses Regarding Definitionsĭ. Drug/Device/Combination Product DefinitionsĬ. Start Further Info FOR FURTHER INFORMATION CONTACT:īryant Godfrey or Darin Achilles, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 87, End Further Info End Preamble Start Supplemental Information SUPPLEMENTARY INFORMATION: Table of Contentsī. ADDRESSES:įor access to the docket to read background documents or Start Printed 4comments received, go to and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. This action is intended to provide direction to regulated industry and to help avoid consumer confusion. The Food and Drug Administration (FDA) is issuing this final rule to describe 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). PART 1100-TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITYįood and Drug Administration, HHS.Executive Order 13175: Tribal Consultation Comments and Responses Regarding Marketing Concerns Comments and Responses Regarding Intended Use Exclusion From Tobacco Product Regulation (§ 1100.5) Changes to Existing “Intended Use” Regulations Comments and Responses Regarding Consumer Confusion Comments and Responses Regarding Brown & Williamson and Sottera Intended Uses For Products Made or Derived From Tobacco That Bring Products Within the Structure/Function Prong Comments and Responses Regarding Modified Risk Tobacco Products Distinction Between Modified Risk Claims and Claims That Are Evidence of Disease-Prong Intended Uses Intended Uses That Bring Products Within the Disease Prong ![]() Intended Uses For Products Made or Derived From Tobacco That Bring Products Within the Disease Prong History of 1996 Rulemaking and Relevant Litigation Comments and Responses Regarding Definitions Drug/Device/Combination Product Definitions
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