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Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (Final Rule)

Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (Final Rule)

The final rule will reduce ambiguity in the market for products made or derived from tobacco and clarify FDA's interpretation and application of its existing intended use regulations. The rule clarifies the types of claims and other evidence that would result in these products being regulated as drugs, devices or combination products rather than tobacco products. Products made or derived from tobacco that are intended to 1) diagnose, cure, mitigate, treat or prevent disease, including use in smoking cessation, or 2) affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco prior to March 21, 2000, such as an intended use for improving respiratory function, will be subject to regulation as drugs, devices or combination products.

Regulatory Impact Analysis

Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (Final Rule) RIA  (PDF - 115KB)

Federal Register: 82 FR 2193, January 9, 2017 

Docket: FDA-2015-N-2002