On this page:
- Setting Policy and Issuing Rules and Guidance
- Using a New Standard in Regulating Tobacco
- Developing and Issuing Rules and Guidance
- Participating in the Tobacco Rulemaking Process
This information describes how FDA’s Center for Tobacco Products (CTP) sets policy and develops rules (regulations) and guidance under the Tobacco Control Act.
“As new discoveries yield increasingly complex products, FDA’s experts need to be equipped to make science-based decisions resulting in sound regulatory policy.”
FDA Commissioner Margaret A. Hamburg, M.D.
August 17, 2011
When the Tobacco Control Act was signed into law, FDA received the authority to regulate tobacco products. FDA then established the Center for Tobacco Products (CTP), which is responsible for setting the policy that puts that law into action in part by issuing rules and guidance about the manufacturing, marketing, and distributing tobacco products.
Rules create mandatory requirements that must be complied with. Guidance documents do not create binding requirements, but rather reflect FDA’s current thinking on a specific topic. Guidances offer information to help those who must understand and comply with the law.
Tobacco is the only consumer product regulated by FDA which causes disease, disability, and death when used as intended. Therefore, Congress created a new regulatory standard in the Tobacco Control Act – one that’s geared to reducing the public health threat that tobacco use poses to all Americans, not just individual users.
Instead of using the usual FDA standard of approving “safe and effective” products, FDA regulates tobacco products based on a public health standard that considers the risks and benefits of the tobacco product on the population as a whole. Our ability to enact science-based regulation has the true potential to reduce the death and disease toll from tobacco products.
Our public health regulatory agenda focuses strongly on protecting young people, as well as reducing the dangers of those products, and encouraging current users to quit.
CTP develops rules and guidance documents that are intended to reduce the impact of tobacco use on the nation’s health. The development of a proposed rule from start to publication involves a number of steps, including drafting the document, different levels of review and clearance within CTP, FDA, U.S. Department of Health and Human Services (HHS), and the Office of Management and Budget (OMB), and finally, publication in the Federal Register. After the proposed rule is published, there is a public comment period (typically between 60 and 90 days). The development of the final rule is similar to the proposed rule, but with the critical step of reviewing and responding to the comments received during the comment period. For example, CTP has taken these actions:
- Asked the public to provide input on our options for regulating menthol in cigarettes. These options include setting standards for tobacco products, restricting sales and distribution, and possible other actions we might take. We asked for input through an Advanced Notice of Proposed Rulemaking (ANPRM), which is a way to get comments from you and others before we propose a rule.
- Developed guidance that explains how companies can comply with the requirement for tobacco companies to report to FDA on the quantities of certain harmful or potentially harmful constituents in tobacco products.
- Issued rules that restrict youth access to cigarettes, cigarette tobacco, and smokeless tobacco, such as setting the national minimum age of 18 for buying cigarettes and smokeless tobacco.
To learn more about our existing regulations, see our full list of FDA tobacco-related rules.
When you comment on proposed rules, you give us information and viewpoints that we may not find elsewhere. When you share your concerns and ideas, you may be alerting FDA to options or consequences of proposed rules that we have not thought about. Hearing from you gives us a chance to make the rules stronger, enhances our knowledge of the issues, and helps us determine the best solution to a problem or issue.
When a proposed rule or guidance document related to the Tobacco Control Act is available for public comment, you can see it on FDA's Comment Opportunities page.
When you submit a comment, you want to be sure it contains the best information possible, including data whenever possible. Because FDA regulatory decisions are based on law and science, our reviewers look for logic, good science, and other evidence as they evaluate your comments. To be sure your comments have the greatest possible impact, we suggest you review our fact sheet about commenting before you write your comment.
You can also learn more about FDA laws, regulations, and guidance documents.
To be the first to know about pending rules and guidance documents about tobacco products, sign up for email notices.
Other Key Areas of Focus
- Compliance and Enforcement - This information will help the public and those who work with CTP understand what FDA’s Center for Tobacco Products (CTP) is doing to ensure compliance with the Tobacco Control Act.
- Public Health Education Campaigns - As part of this approach, FDA’s Center for Tobacco Products (CTP) is investing in a number of tobacco prevention public education campaigns that directly support our mission by educating the public about the dangers of regulated tobacco products.
- Research - This information describes how FDA’s Center for Tobacco Products (CTP) funds and uses scientific research to better understand tobacco products, how they cause death and disease, and how to best reduce the harm from these products.