August 7, 2012
As part of ongoing efforts to enhance and expand our website, the Center for Tobacco Products (CTP) is launching a new section: Tobacco Product Review and Evaluation. This section can be found by selecting the Product Requirements, Marketing and Labeling link on the CTP home page.
The Tobacco Product Review and Evaluation area of the site provides information on the three pathways available to legally market new tobacco products:
- Submitting a Substantial Equivalence Report
- Requesting an Exemption from Substantial Equivalence
- Submitting a Premarket Tobacco Product Application
There is also information on modified risk tobacco product applications in this area of the site.
Benefits to You
These web pages centralize previously released information on how to legally market new tobacco products. They also streamline information and resources, providing more accessible web content.
As a part of this new content, CTP developed an interactive tool that provides greater understanding about which pathway may be appropriate for a particular new tobacco product.
Protecting Public Health
FDA has created this new content to provide information about an important part of tobacco product regulation: the criteria for review and evaluation of new tobacco products. This review occurs before they are marketed and is vital to determining these products’ impact on public health. This information will allow FDA to make science-based regulatory decisions that protect the public health.
Although FDA may issue a marketing order for a tobacco product, the marketing order does not indicate that the tobacco product is either safe or “approved.” There is no known safe tobacco product. If FDA issues a marketing order for a tobacco product, it means that the manufacturer has complied with the requirements under the law to bring its product to market.
Learn more about how FDA is protecting public health through tobacco regulation.
Visit the Tobacco Product Review and Evaluation page to learn more.