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Summary: Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses" (Proposed Rule)

The proposed rule would reduce the 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 medical products rather than tobacco products. The reduction in ambiguity should increase appropriate market participation and thus increase welfare in the market, including greater clarity and less confusion for producers and consumers. While these clarifications would impact future marketing strategies, it is not expected to result in significant changes to current marketing costs.

Federal Register: 80 FR 57756, September 25, 2015

Docket: FDA-2015-N-2002