FDA recently announced the launch of a new searchable database containing almost 17,000 tobacco products that may be legally marketed in the U.S. The database provides information on each tobacco product including product names, company names, categories (e.g., cigarette, roll-your-own, e-cigarette, cigar, heated tobacco product), sub-categories (e.g., e- components, filler, leaf wrap), source of U.S. marketing authority (e.g., marketing granted order, substantially equivalent order, found exempt order), and the date of FDA’s action on the tobacco products. FDA indicates that it plans to update the database on a monthly basis. This database is helpful to industry members seeking more transparency from FDA about which products are authorized for sale in the U.S. The database is not, however, without limitations.
The database does not, for example, provide information on pending premarket authorization applications, whereby certain products with applications submitted by September 9, 2020 can be marketed under FDA’s exercise of enforcement discretion. Nor does the database cover all tobacco products that may be legally marketed in the U.S., because pre-existing tobacco products that were commercially marketed as of February 15, 2007 may have not been submitted to FDA for consideration through its voluntary determination program.
In sum, while the new database is a useful tool, and should be viewed as a step in the right direction to increase transparency, stakeholders should be aware of its limitations.