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U.S. Food and Drug Administration Regulation of Tobacco Products

Since the passage of the Family Smoking Prevention and Tobacco Control Act giving the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products in June 2009, the grading system for this category is based on how FDA is implementing its new authority, and whether Congress is providing full funding to FDA.

The American Lung Association has identified two important items in 2013 that FDA was required by the Tobacco Control Act to implement or that FDA indicated they would take action on: 1) a rule asserting authority over all other tobacco products besides cigarettes, smokeless tobacco and roll-your-own tobacco; and 2) implementation of the recommendations on menthol in tobacco products from FDA’s Tobacco Product Scientific Advisory Committee.  Points were awarded on how FDA implemented these two items as well as whether Congress funded FDA’s Center for Tobacco Products at the levels called for in the Family Smoking Prevention and Tobacco Control Act.

The FDA regulation of tobacco products grade breaks down as follows:

Grade

Points Earned

A

11 to 12 Total Points

B

10 Total Points

C

9 Total Points

D

8 Total Points

F

Under 8 Total Points

Proposed Rule to Assert FDA Authority over All Tobacco Products (4 points)

Target is FDA issues proposed rule to assert authority over tobacco products other than cigarettes and smokeless tobacco.

  • +4 points: Rule proposed that asserts authority over all tobacco products
  • +3 points: Rule proposed that asserts authority over all tobacco products, but some tobacco products not included in deeming.
  • +2 points: Proposed rule sent to the Office of Management and Budget, but not issued
  • +0 points: Rule not proposed

Implementation of the Menthol Report by the Tobacco Products Scientific Advisory Committee (4 points)

Target is FDA takes action to implement recommendations from 2011 report on menthol in tobacco products from the Tobacco Products Scientific Advisory Committee.

  • +4 points: FDA implements Committee’s recommendations
  • +3 points: FDA says publicly that it intends to implement Committee’s recommendations
  • +2 points: FDA publishes its internal report on menthol for public comment
  • +0 points: FDA takes no additional action on the Committee’s recommendations

Funding for FDA Center for Tobacco Products (4 points)

Target is Congress provides funding for FDA Center for Tobacco Products at levels called for in Family Smoking Prevention and Tobacco Control Act without attaching limiting policy riders.

  • +4 points: Congress provides full funding without attaching limiting policy riders
  • +2 points: Congress provides full funding but with policy riders
  • +1 points: Congress provides funding at previous year’s levels
  • +0 points: No funding at all provided
 

Did You Know

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The American Lung Association’s annual "State of Tobacco Control" report was released nationwide on Wednesday, January 22, 2014.

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Despite the great progress of the past, in the last few years, tobacco control efforts have slowed and in some areas, even stalled.

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