Feb. 15, 2007, is the “grandfather date” in the Family Smoking Prevention and Tobacco Control Act, which granted the FDA authority to regulate tobacco products. Products on the market before this date, also known as the “predicate date,” do not have to file FDA applications in order to stay on the market, and they can serve as predicate products for future substantial equivalence (SE) applications.
Ten years later in February 2017, the FDA launched a searchable database of these grandfathered products, meaning retailers and manufacturers can now go to the agency’s website and search whether a specific product qualifies as grandfathered.
The FDA said the database will be periodically updated and that “this database contains grandfathered determination information from standalone Grandfathered Submissions that were voluntarily submitted to CTP (Center for Tobacco Products)—[it] does not list all grandfathered tobacco products.”