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:
11 to 12 Total Points
10 Total Points
9 Total Points
8 Total Points
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
2014 is the 50th anniversary of the historic 1964 Surgeon General’s report on smoking and health, which linked smoking to lung cancer and other deadly diseases for the first time.
A recent article in the Journal of the American Medical Association found that about 8 million lives have been saved through tobacco control efforts since 1964, including 800,000 lung cancer deaths between 1975 and 2000.
Smoking is the number one preventable cause of death in the U.S., killing over 1,200 people per day.
Secondhand smoke kills almost 50,000 people each year.
28 states and Washington DC have passed laws prohibiting smoking in almost all public places and workplaces, including restaurants and bars.
New York has the highest cigarette tax in the country at $4.35 per pack.
Missouri has the lowest cigarette tax in the country at 17 cents per pack.
The average of all state plus the District of Columbia cigarette taxes is $1.53 per pack.
Alaska and North Dakota are the only two states that fund their tobacco control programs at or above the CDC-recommended level (in Fiscal Year 2014).
Massachusetts and Minnesota approved cigarette tax increases large enough to impact public health in 2013.
2 states – Indiana and Massachusetts – offer a comprehensive cessation benefit to tobacco users on Medicaid.
2 states – Alabama and Georgia – offer virtually no help with quitting to most tobacco users on Medicaid.
In 2009, the American Lung Association played a key role in the passage of the Family Smoking Prevention and Tobacco Control Act, which gives the U.S. Food and Drug Administration authority over tobacco products.
The American Lung Association played a key role in airplanes becoming smokefree in the 1990s.
40 states and Washington DC spend less than half of what the CDC recommends on their state tobacco prevention programs.
States spend less than two cents of every dollar they get in tobacco-related revenue to fight tobacco use.
Each day, almost 3,900 kids under 18 try their first cigarette and more than 1,000 kids become new, regular smokers.
Each day, 3,000 kids try their first cigar.
Smoking costs the U.S. economy $263 million in direct health care costs and $266 million in lost productivity each day.
The five largest cigarette companies spent over $22.9 million dollars a day marketing their products in 2011.
The American Lung Association has been fighting smoking and tobacco use since the 1950s.
Smoking rates for Medicaid recipients are over 50 percent higher than the general population.
Only 4 states – Maine, North Dakota, South Dakota and Wyoming – fund their quitlines at or above CDC-recommended levels.
A 2013 study of California’s tobacco prevention program shows that the state saved $55 in healthcare costs for every $1 invested from 1989 to 2008.
A 2012 study of Massachusetts’ comprehensive Medicaid quit smoking benefit found that Massachusetts saved $3 for every $1 spent helping smokers quit in just over a year.
Spread the Word
The American Lung Association’s annual "State of Tobacco Control" report was released nationwide on Wednesday, January 22, 2014.Learn More
Surgeon General’s Report
Despite the great progress of the past, in the last few years, tobacco control efforts have slowed and in some areas, even stalled.Learn More