U.S. Senator Durbin Urges FDA To Publish List Of ENDS Products Submitting PMTA’s
Last week, U.S. Senator Durbin (D-IL) urged the Food and Drug Administration (FDA) to publish a public list of currently marketed e-cigarette products for which the Agency has received a premarket tobacco product application (PMTA) by the September 9, 2020 deadline.
“It has been more than one month since PMTA applications were submitted to FDA. In order to protect public health and uphold the duty to enforce against products on the market that are out of compliance, I urge FDA to immediately publish a comprehensive product listing of all relevant e-cigarette applications received by FDA,” said Senator Durbin.
In a statement last month, Mitch Zeller, Director of the FDA’s Center for Tobacco Products (CTP) stated, “We request your patience as we work through the appropriate processes to ensure the posted information is accurate and compliant with federal laws. In the interim, we encourage retailers and other interested parties to refer to the public statements made by the companies or contact the companies directly to get information about applications they may have submitted.”
Under a court order from the District Court of Maryland, e-cigarette products that were on the market prior to August 8, 2016, are required to submit PMTA’s for the FDA to review and approve by the September 9, 2020 deadline.
PMTA’s require a product to meet a regulatory hurdle that can be complex and costly. E-cigarette products will be permitted to stay on the market for one year while the agency reviews the applications, or until the agency rejects them.
If e-cigarette manufacturers did not submit PMTAs by the September 9th deadline, their products must be removed from shelves.
By the FDA providing a public list of e-cigarette products that meet the proper requirements, retailers of these products will be informed as to which they can sell legally in their stores.
The Energy Marketers of America formerly known as PMAA recently joined the National Association of Convenience Stores (NACS), the National Association of Truckstop Operators (NATSO), the Society of Independent Gasoline Marketers of America (SIGMA) and the Food Industry Association (FMI) in signing a letter to the FDA urging it to release a list of approved e-cigarette products.