Database Lists Tobacco Products—Including E-Cigarettes—That May Be Legally Marketed
Today, FDA launched the Searchable Tobacco Products Database, a new user-friendly list of tobacco products—including e-cigarettes—that may be legally marketed in the United States. The database is designed to serve the public—especially retailers—by providing this key information in a single location, with easy-to-use search capabilities. The database, which can be accessed at www.fda.gov/searchtobacco, will be updated on a monthly basis.
Within the database, FDA provides information on three categories of products:
- new tobacco products that received marketing authorization through one of FDA’s three pathways to market a new tobacco product;
- pre-existing tobacco products established through a voluntary determination program (commercially marketed as of Feb. 15, 2007); and
- provisional tobacco products that were removed from review.
“CTP remains committed to enhanced transparency in a way that is useful, timely, and user-friendly,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We hope that this database will be an asset to stakeholders—including retailers—that will be used to help facilitate compliance with the law.”
At the time of launch, the database contains nearly 17,000 tobacco products, with over 12,000 being pre-existing tobacco products. For each entry, FDA provides available information on the tobacco product, including the product name, company, category, sub-category, the authority permitting its sale in the U.S., and the date of FDA action. Additionally, the database also includes links to regulatory and scientific documents, such as the Order Letter, Decision Summary, as well as the Environmental Assessment (EA) and related documents associated with a tobacco product application.
To help explain some of the terminology and context about the content of the database, FDA has also developed the Searchable Tobacco Products Database – Additional Information webpage. The webpage also includes answers to potential questions about the database, including a question related to unauthorized products with pending applications. In general, FDA is unable to provide information on pending applications in order to protect confidential commercial information. Moreover, for new products that require authorization, a pending application does not create a safe harbor to sell that product.
The launch of this public database is part of the Center’s continued commitment to providing regulated industry with resources and providing clear communication about the agency’s actions to the public. Additional recent activities to enhance transparency include those listed in the Center’s quarterly updates on activities in response to the Reagan-Udall Foundation evaluation.
Posted in FDA and USDA Regulatory Update, Tobacco.