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Tobacco Products

FDA’s Center for Tobacco Products (CTP) works to ensure a healthier life for every family.

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Tobacco Product Marketing Orders

To legally market a new tobacco product, manufacturers must submit an application to FDA and receive a marketing authorization from FDA. When a new tobacco product is granted a marketing order, information is posted online for public awareness. FDA notes that in accordance with a court order, deemed new tobacco products that were on the market as of August 8, 2016 were required to submit an application to FDA by September 9, 2020 or risk enforcement.

Learn More About the Latest Marketing Decisions
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Regulation and Enforcement of Non-Tobacco Nicotine (NTN) Products

A new federal law gives FDA the authority to regulate tobacco products containing nicotine from any source. This law took effect April 14, 2022, and after July 13, 2022, any new non-tobacco nicotine (NTN) product that has not received premarket authorization from FDA cannot be legally marketed. FDA launched a webpage that includes up-to-date information about premarket review progress and compliance and enforcement actions.

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Market a Tobacco Product

New tobacco products may not be legally marketed in the U.S. without authorization from FDA. Learn more about the three pathways (SE, PMTA and EX) to market.

Small Businesses Assistance

CTP’s Office of Small Business Assistance is available to help industry understand and comply with FDA’s tobacco laws and regulations.

About the Center

FDA's Center for Tobacco Products regulates the manufacturing, marketing, and distribution of tobacco products to protect public health.

Food and Drug Administration at White Oak

Contact CTP

1-877-287-1373 (9am - 4pm ET)
For General Inquiries: [email protected]

Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center
Building 71, Room G335
Silver Spring, MD 20993-0002

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