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 legislation required FDA to take specific action on a number of items by specific deadlines. During 2011, there were three important items that FDA was required by the Tobacco Control Act to implement: 1) submission of recommendations on menthol in tobacco products from FDA’s Tobacco Product Scientific Advisory Committee; 2) a rule requiring graphic warning labels on 50 percent of the front and back of all cigarette packs starting in the fall of 2012; and 3) proposing a rule on non-face-to-face sales of tobacco products such as sales over the Internet. Points were awarded on how FDA 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 FDA regulation of tobacco products grade breaks down as follows:

Grade	Points Earned
A	14 to 16 Total Points
B	13 Total Points
C	11 to 12 Total Points
D	10 Total Points
F	Under 10 Total Points

Proposed Rule on Non Face-to-Face Sales of Tobacco Products (4 points)
Target is FDA issues proposed rule concerning non-face-to-face sales of tobacco products.

+4 points: Rule proposed
+2 points: Proposal delay
+0 points: Rule not proposed

Submission of the Menthol Report by the Tobacco Products Scientific Advisory Committee (4 points)
Target is report on menthol in tobacco products submitted to FDA by the Tobacco Products Scientific Advisory Committee on time.

+4 points: Committee submits report to FDA on time and FDA implements Committee’s recommendations
+3 points: Report submitted on time; FDA delays action on Committee’s recommendations
+2 points: Submission of report by TPSAC delayed
+0 points: Submission of report does not occur in 2011

Implementation of the Cigarette Graphic Warning Labels (4 points)
Target is a final rule requiring new, larger warning labels graphically depicting the health consequences of smoking on cigarettes on time as required by law.

+4 points: Final rule on warning labels issued on time
+3 points: Final rule on new warning labels delayed by several months
+2 points: Final rule on new warning labels delayed by FDA until 2012
+1 points: Final rule on new warning labels delayed by FDA indefinitely
+0 points: No action taken on implementation of warning label

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 level
+0 points: No funding at all provided