The Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) has announced an enhancement of its website to more easily present information about tobacco compliance check outcomes.
The database is designed to be a resource for a variety of audiences, including the general public, public health groups and the tobacco industry, the agency noted in a statement.
The new database offers the ability to search for a variety of compliance and enforcement outcomes among both brick-and-mortar and online retailers, including warning letters, civil money penalties and no-tobacco-sale orders.
Previously, this information lived in various locations across the FDA website, so the enhancement will allow site visitors to more easily find outcomes from FDA’s compliance and enforcement efforts of retailers in one centralized location.
This centralized database will be updated monthly with the latest compliance check outcomes.
“The enhancements to this database reflect CTP’s continued efforts to optimize transparency and communication with stakeholders,” the statement continued.
To view the database, click here.
FDA’s Recent Efforts
Over the past few years, the FDA has received backlash from operators regarding the lack of clear regulation guidelines and straightforward compliance practices for vape products.
In an attempt to alleviate these concerns, in March of this year, the agency launched the Searchable Tobacco Products Database. Through the database, retailers can search for the following information:
- New tobacco products that received marketing authorization
- Pre-existing tobacco products established through a voluntary determination program
- Provisional tobacco products that were removed from review
The centralized database was designed to “serve the public — especially retailers — by providing this key information in a single location, with easy-to-use search capabilities,” the FDA noted at the time of the launch.
When it was introduced, the database contained nearly 17,000 tobacco products, with over 12,000 being pre-existing tobacco products. For each entry, the 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.
Before the launch of the database, 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.”
This enhanced database is a step in the right direction for retailers looking to ensure that they are in compliance with the ever-changing tobacco and vape landscape.
