The Food and Drug Administration (FDA) has launched a new Searchable Tobacco Products Database — a user-friendly list of tobacco and e-cigarette products that may be legally marketed in the U.S.
“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 agency noted in a press release.
The database, which can be accessed at www.fda.gov/searchtobacco, will be updated on a monthly basis.
Within the database, the 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
- Provisional tobacco products that were removed from review
“The Center for Tobacco Products (CTP) remains committed to enhanced transparency in a way that is useful, timely and user-friendly,” said Brian King, director of the FDA’s CTP. “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, the 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, the 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 agency noted.
Retailers Receive Long-Awaited Clarity
Retailers have been waiting for the FDA to provide more clarity in terms of marketing grant orders (MGOs), marketing denial orders (MDOs) and premarket tobacco product applications (PMTAS). Before this database was launched, there was a lack of clarity when it came to what products could be legally marketed.
Just a few weeks ago, David Spross, executive director for the National Association of Tobacco Outlets (NATO), told CStore Decisions the following:
“Currently, there is a lack of clarity and information from the FDA regarding the premarket tobacco product application (PMTA) process. Specifically, it is difficult to identify products covered by timely-filed, still-pending PMTAs,” added Spross. “These PMTAs may be pending because FDA has not yet completed its review (even though many of these applications have been before the agency for over three years), or because FDA or a court has stayed a negative determination.”
Spross added that a list or database such as this was needed for retailers looking for clarity.
“Despite the diligence of responsible retailers, including requesting documentation of timely-filed PMTAs, it is often impossible to differentiate between products that blatantly flout the law — for example, those for which no PMTA was filed at all or a PMTA was filed after the applicable deadline for on-market products — and those that are the subject of PMTAs that were timely filed but are still waiting for FDA’s review process or completion of an appeal,” he said.
Anna Ready Blom, director of government relations for the National Association of Convenience Stores (NACS), had similar thoughts before the database was launched. Blom noted that the lack of clarity on products that cannot be sold poses real challenges for retailers who might want to continue to be responsible about what products they sell, and how they sell them.
This step by the FDA should give retailers a better idea about what products can or cannot be marketed in their stores.