The Food and Drug Administration (FDA) is a science-based regulatory agency whose mission is to protect the public health. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides FDA the authority to regulate tobacco products. This legislation presents FDA with a unique challenge: fulfill its public health mission, while permitting the sale of an inherently unsafe product.
Tobacco use is the leading cause of preventable death in our nation. Tobacco products have been shown to cause cancer, heart disease, lung disease, and other serious adverse health effects.
FDA's Center for Tobacco Products - Protecting Public Health
Our goal at the Center for Tobacco Products (CTP) is to reduce the impact of tobacco on public health by:
- Preventing Americans from starting to use tobacco products
- Encouraging current users to quit
- Decreasing the harms of tobacco product use
Among other things, the Tobacco Control Act granted FDA new authority to:
- Regulate the manufacturing, marketing, and distribution of tobacco products
- Establish tobacco product standards appropriate to protect public health
- Require tobacco companies to submit:
- Premarket applications to FDA and receive written permission before marketing any new tobacco product
- Modified risk applications and receive written permission before marketing any tobacco product that claims to reduce harm or the risk of tobacco-related disease compared to other commercially marketed tobacco products
- Levels of all constituents identified by the agency as harmful or potentially harmful to health
Pathways to Market – Legally Marketing New Tobacco Products
FDA does not “approve” tobacco products, but the Tobacco Control Act provides legal ways for tobacco products to be marketed. If FDA determines a new tobacco product meets the relevant legal requirements, we will issue a written notification permitting the marketing of the new tobacco product.
Pathways to Market
- Substantial Equivalence– This pathway may be appropriate for a new tobacco product that demonstrates it does not raise different questions of public health from a predicate product. Learn more...
- Exemption from Substantial Equivalence– This pathway may be appropriate for new tobacco products with certain minor modifications to additives. Learn more...
- Premarket Tobacco Application– This pathway requires the applicant to demonstrate that FDA permitting the marketing of the new tobacco product would be appropriate for the protection of the public health. Learn more...
Tobacco manufacturers may use one of the three Pathways to Market to seek to legally market new tobacco products.
Denying a New Tobacco Product Application
FDA will not permit a new tobacco product to be marketed if the applicant does not demonstrate that permitting marketing of the product would be appropriate for the protection of the public health. In reviewing a new tobacco product application, we will take into account, among other things:
- The risks and benefits to the population as a whole, including users and nonusers of tobacco products
- Increased or decreased likelihood that existing users of tobacco products will stop using such products
- Increased or decreased likelihood that those who do not use tobacco products will start using such products
Modified Risk Tobacco Products
Regulating modified risk tobacco products is another way FDA is working to reduce the morbidity and mortality associated with tobacco use. Under the law, tobacco products may not be marketed as reducing harm or the risk of tobacco-related disease without a written order from FDA permitting marketing. In the written notification, FDA will describe the specific claims that can be made.
As explained in FDA Consumer Updates, prior public experience with products marketed as “low tar” and “light,” cigarettes demonstrates the importance of having sufficient data to support any claim of modified risk. FDA must make sure that modified risk claims are backed by sound, scientific evidence and that advertising and labeling help the public understand these claims in relation to total health. This includes helping the public understand all of the diseases and health-related conditions associated with the use of tobacco products.
The modified risk process provides industry with the opportunity to make product changes that substantially reduce, or even eliminate altogether, either the toxicity or addictiveness of tobacco products, or both.
Through these and many other initiatives FDA is working to make tobacco-related death and disease part of America's past, and not America's future.