Federal Regulation of Tobacco Products Methodology

Since the passage of the Family Smoking Prevention and Tobacco Control Act giving the U.S. Food and Drug Administration the authority to regulate tobacco products in June 2009, the grading system for the Federal Regulation of Tobacco Products category has been based on how the federal government is implementing its new authority, and whether Congress is providing full funding to FDA with no policy riders to limit the agency’s authority.

The American Lung Association has identified three important items that FDA was required by the Tobacco Control Act to implement, that FDA indicated they would take action on or would significantly improve the public health: 1) implementation of 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) requiring large, graphic cigarette warning labels that cover the top 50% of the front and back of cigarette packs; and 3) issuing at least one product standard to reduce the toxicity, addictiveness and/or appeal of tobacco products, including removal of flavored tobacco products from the marketplace. Points were awarded based on how the federal government has implemented these three 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 Federal Regulation of Tobacco Products grade breaks down as follows:

GradePoints Earned
A15 or 16 Points
B13 or 14 Points
C12 Total Points
D10 or 11 Points
FUnder 10 Total Points

Implementation of Final "Deeming" Rule Giving FDA Authority over All Tobacco Products (4 points)

Target is implementation of final rule that gives FDA authority over all tobacco products in addition to cigarettes and smokeless tobacco.

  • +4 points: Deeming rule fully implemented; pre-market review of all deemed tobacco products complete; products without PMTA are removed from marketplace.
  • +3 points: FDA has begun the PMTA process for all deemed tobacco products.
  • +2 points: FDA only implementing portions of deeming rule.
  • +0 points: FDA postpones implementation of the entire rule.

Graphic Cigarette Warning Labels (4 points)

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

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

Product standards to address toxicity, addictiveness and appeal of tobacco products, including removal of Flavored Tobacco Products, such as Menthol Cigarettes (4 points)

Target is FDA takes action to reduce the toxicity, addictiveness and/or appeal of tobacco products, including removing flavored tobacco products from the marketplace.

  • +4 points: Strong product standard is finalized that will be appropriate for the protection of public health, including eliminating all flavored tobacco products.
  • +3 points:Strong product standard is finalized, including removing some but not all flavored tobacco products.
  • +2 points: Strong product standard is proposed that will be appropriate for the protection of public health, including eliminating all flavored tobacco products.
  • +1 points: Product standard is proposed, including removing some but not all flavored tobacco products from the marketplace.
  • +0 points: No product standard is issued and all flavored products remain on the marketplace.

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 a level inconsistent with the Tobacco Control Act
  • +0 points: No funding at all provided.

Page last updated: February 9, 2022