FDA and Tobacco
Congress empowered the Food and Drug Administration (FDA) to regulate the manufacturing and marketing of tobacco products with the Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA) that became law on June 22, 2009. Since then, the FDA has adopted a number of measures to implement the law. As directed by FSPTCA, the agency established the Center for Tobacco Products (CTP) in August of 2009 and Tobacco Products Scientific Advisory Committee (TPSAC) in March of 2010. The objective of the Center for Tobacco Products (CTP) is to oversee the implementation of the FSPTCA. The priority for the CTP is to keep young people from using tobacco products. To this end, it will employ and enforce a set of regulatory rules involving the manufacturing and marketing of tobacco products, and provide FDA information about the contents of tobacco products that are harmful or potentially harmful to public health as would be established by the TPSAC and approved by FDA.
FDA Issue Briefs by CTGR
- Summary of the Family Smoking Prevention and Tobacco Control Act
- Center for Tobacco Products
- Tobacco Products Scientific Advisory Committee
- The Use of Menthol in Cigarettes
Links to More Information from the FDA Website
World Health Organization’s Framework Convention on Tobacco Control (WHO FCTC)
The WHO FCTC is a global tobacco control treaty that was formally initiated at the 48th World Health Assembly in 1995. After years of negotiations it was adopted at the 56th World Health Assembly on May 21, 2003, and entered into force on February 27, 2005.
- WHO FCTC website
- List of Parties
- WHO FCTC Text
- CTGR Issue Brief on the World Health Organization’s Framework Convention on Tobacco Control
Recent Articles Concerning FDA Regulation:
March 12, 2012: Tobacco control groups push for appeal to allow graphic cigarette labels (American Medical News)
March 11, 2012: Report adds to debate over menthol cigarettes (Winston-Salem Journal)
March 8, 2012: FDA Reiterates Tobacco Retailers’ Obligations (NACS Online)
February 29, 2012: U.S. Judge Strikes Down F.D.A. Cigarette Labels (NY Times)
February 29, 2012: Grisly Tobacco Labels Thrown Out by Judge (The Wall Street Journal)
TPSAC’s third meeting on DTPs - March 1, 2012
In this meeting, the committee members reviewed the draft report that was prepared based on the presentations, public hearings and discussions in the previous two meetings. After making the necessary changes and amendments, the report was submitted to the FDA.
The report addressed three key issues: (1) the risks and benefits to the population as a whole, including both users and non-users of tobacco products, (2) the increased and decreased likelihood that existing users of tobacco products will stop using tobacco products, and (3) the increased and deceased likelihood that non-users of tobacco products will start using tobacco products.
With respect to the first issue, while they agreed that DTPs are likely to be associated with lower disease risks than cigarettes, they are concerned that their availability might affect the public perception of all tobacco products, leading to increased use. As a result, they could not reach a consensus on the risks and benefits.
In regard to the second issue, they noted that if DTPs proved to facilitate cessation, their availability could increase the likelihood that existing users of tobacco products will stop using them. On the other hand, if DTPs served to allow continued use of tobacco products and nicotine addiction by providing an opportunity for use in circumstances where smoking is not allowed, the availability of DTPs could decrease the likelihood that existing users of tobacco products will stop using them. As a result, they could not agree on the net consequences of DTPs.
In regard to the third issue, they concluded that the available evidence, would allow them to make a qualitative judgment that availability of DTPs could increase the number of users of tobacco products. However, they could not provide an estimate of the percentage increase in number of users of tobacco products as a result of the DTPs.
Generally, given a limited market penetration of DTPs, and limited studies and experience on use of DTPS, the advisory committee has not been able to determine the impact of the use of DTPs on the public health. They have rather offered recommendations for further information gathering. The next step will be for FDA to consider the report and the recommendations and then determine what future action(s), if any, are warranted. The final report and recommendations are required to be delivered to the Secretary of Health and Human Services by March 23, 2012.
TPSAC second meeting on DTPs - January 18-20, 2012
In this meeting, the committee hosted a number of presentations from the Center for Tobacco Products (CTP), academia, and the public. One group of presentations suggested that DTPs have lower health risks in view of the absence of the carcinogens of tobacco smoke, and the other group of presentations suggested that DTPs are of concern to the public in that they can be appealing to children and become a gateway to smoking.
The committee also hosted a series of presentations on the results of the review of over 20 articles and thousands of industry documents on DTPs made under contract between Research Triangle Institute (RTI) and CTP. In addition, they saw several presentations on issues related to toxic and carcinogenic constituents, marketing, and nicotine absorption. The three-day meeting also accommodated an open public hearing that covered a number of issues related to the behavioral and health effects of DTPs, toxicological and physiological effects, and marketing practices for DTPs. While some of the presentations have provided results that suggest a potential harm with the use of DTPs, they are based mostly on studies of smokeless tobacco products because DTPs are relatively new and there are few studies available specifically addressing the health effects of such products.
Center for Tobacco Grower Research
302B Morgan Hall
2621 Morgan Circle Drive
Knoxville, Tennessee 37932