Tobacco Products

Rules and Regulations

The decisions made by FDA in the regulation of tobacco products are grounded in science.

A New Standard of Effective Regulation

Regulations icon

FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco products. FDA evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole, including users and nonusers. Similarly, when developing certain regulations, the law requires FDA to apply a public health approach that considers the effect of the regulatory action on the population as a whole, not just on individual users, with respect to initiation and cessation of tobacco use.

FDA regulations are based on the laws set forth in the Tobacco Control Act and the Food, Drug, and Cosmetic Act (FD&C Act). FDA regulations are also federal laws.

Rules and Regulations (click arrows to sort)


Contact FDA

(9am EST-4pm EST)

For General Inquiries:

Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center

Building 71, Room G335
Silver Spring, MD 20993-002

Courier Deliveries

Page Last Updated: 03/28/2019
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