U.S. Food and Drug Administration Regulation of Tobacco Products | American Lung Association

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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 FDA the authority to regulate tobacco products in June 2009, the grading system for this category has been based on how FDA is implementing its new authority, and whether Congress is providing full funding to FDA with no policy riders to limit their authority.

The American Lung Association has identified four important items 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 – also known as the "deeming" rule;
  2. Issuing at least one product standard to reduce the toxicity, addictiveness and/or appeal of cigarettes and other tobacco products;
  3. Requiring large, graphic cigarette warning labels that cover the top 50 percent of the front and back of cigarette packs; and
  4. 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 four 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

18 to 20 Total Points

B

16 to 17 Total Points

C

14 to 15 Total Points

D

12 to 13 Total Points

F

Under 12 Total Points

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

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

  • +4 points: Final Rule asserting authority over all tobacco products is issued.
  • +2 points: Final Rule asserting authority over tobacco products is issued, but certain products are exempted from basic oversight.
  • +0 points: No Final Rule asserting authority over all tobacco products is issued.

Product Standards (4 points)

Target is FDA issues a product standard to reduce the toxicity, addictiveness and/or appeal of cigarettes and other tobacco products.

  • +4 points: Strong product standard that will be appropriate for the protection of public health that will reduce the toxicity, addictiveness and/or appeal of cigarettes and other tobacco products is finalized.
  • +1 points: Strong product standard that will be appropriate for the protection of public health that will reduce the toxicity, addictiveness and/or appeal of cigarettes and other tobacco products is proposed.
  • +0 points: No strong product standard is issued.

Graphic Cigarette Warning Labels (4 points)

Target is FDA requires large, graphic cigarette warning labels that cover the top 50 percent of the front and back of cigarette packs.

  • +4 points: FDA requires large, graphic cigarette warning labels that cover the top 50 percent of the front and back of cigarette packs.
  • +1 points: FDA proposes large, graphic cigarette warning labels that cover the top 50 percent of the front and back of cigarette packs.
  • +0 points: No graphic warning label requirement is issued.

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:Strong product standard is finalized that will be appropriate for the protection of public health that will eliminate menthol as a characterizing flavor in cigarettes.
  • +1 points: Strong product standard is proposed that will be appropriate for the protection of public health that will eliminate menthol as a characterizing flavor in cigarettes.
  • +0 points: No strong product standard is issued.

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.
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