A new product is approved under the FDA PMTAs. The only catch is this: it’s not marketed in the US anymore.
SILVER SPRING, Md. — The US Food and Drug Administration (FDA) announced that they had approved a premarket tobacco product application (PMTA) approval for a discontinued Altria Group-owned product line terminated during the winter of 2018.
The product line is the Verve oral nicotine brand, notes FDA.
“Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is a critical part of our mission to protect the public—especially kids,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products, in a press statement.
“Importantly, evidence shows these products could help addicted smokers who use the most harmful combusted products completely switch to a product with potentially fewer harmful chemicals,” said Zeller.
Zeller is an attorney and has headed the agency’s Center for Tobacco Products since the Obama White House.
Verve products were manufactured under Altria Group’s US Smokeless Tobacco Company. The design of the Verve products was intended for adult oral tobacco users and contained nicotine derived from tobacco but did not contain tobacco whatsoever.
Products were chewed and then discarded rather than swallowed once the user was finished with the product. Discs and chews differ in part by their textures and overall product designs.
Like other tobacco products approved under the PMTA regulatory pathway, the FDA reserves the right to withdraw a marketing order if it determines that the continued marketing of the product in question is not appropriate for the protection of public health.
This includes potential significant results and uptake by a group of youth or other at-risk population groups.
“While these are mint-flavored products, data submitted to the FDA show the risk for youth uptake of these particular products is low, and stringent marketing restrictions will help prevent youth exposure,” said Zeller in the statement.
Here is a list of the approved Verve PMTA products.
|Manufacturer||Product Name and Order Letter||Product Category||Date Issued||Decision Summary|
|US Smokeless Tobacco Company LLC||VERVE® Discs Blue Mint||Other||10/19/2021||PM0000470|
|US Smokeless Tobacco Company LLC||VERVE® Chews Blue Mint||Other||10/19/2021||PM0000471|
|US Smokeless Tobacco Company LLC||VERVE® Discs Green Mint||Other||10/19/2021||PM0000472|
|US Smokeless Tobacco Company LLC||VERVE® Chews Green Mint||Other||10/19/2021||PM0000473|