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 three important items in 2012 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 tobacco products besides cigarettes and smokeless tobacco; 2) implementation of the recommendations on menthol in tobacco products from FDA's Tobacco Product Scientific Advisory Committee; and 3) submission of the recommendations on dissolvable tobacco products from FDA's Tobacco Product Scientific Advisory Committee. 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:
|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 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
Submission of the Dissolvable Tobacco Products Report by the Tobacco Products Scientific Advisory Committee and Implementation of Recommendations by FDA (4 points)
Target is report on dissolvable tobacco products submitted to FDA by the Tobacco Products Scientific Advisory Committee on time, and the FDA takes some action on those recommendations.
- +4 points: Committee submits report to FDA on time and FDA takes some action on the 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 2012
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
Notes Concerning FDA Grading:
Implementation of the graphic cigarette warning labels is also an item that would normally factor into this grading category. However, pending litigation prevented FDA from implementing its proposed rule on graphic warning labels in 2012. Therefore, this item will not be scored or factor into the grade for this year's report.
In the Federal Overview, "State of Tobacco Control 2013" also examines FDA's failure to act on substantial equivalence, namely, ensuring that tobacco companies are not permitted to introduce new products on the market unless FDA has authorized their sale in advance of the product's introduction. Given the very limited publically available data, this area was also not included as part of the evaluation of FDA's 2012 grade.