The FDA authorized marketing for four new chewable tobacco products targeted towards adults, all of them manufactured by U.S. Smokeless Tobacco Company LLC under the brand name Verve.
The four products—Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint, and Verve Chews Green Mint—contain nicotine derived from tobacco but do not contain any cut, ground, powdered, or leaf tobacco. And, according to the FDA, data on the products show that kids, non-smokers, and former smokers are “unlikely to initiate or reinitiate tobacco use with these products.”
“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. 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 Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products. “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.”
Alongside the announcement, the FDA published a decision summary describing the agency’s rational for the decision.
The FDA announcement follows exactly one week after another tobacco authorization—the agency authorized marketing of three e-cigarette products on Oct. 12, marking the first time that electronic nicotine delivery systems (ENDS) have gained authorization under the FDA’s Premarket Tobacco Product Application (PMTA) pathway. That earlier decision was excoriated by the American Medical Association (AMA), with AMA president Gerald E. Harmon, MD, issuing a statement saying the move “risks hooking another generation of young people on tobacco products… Allowing this product into the marketplace signals that it’s safe, and nothing could be further from the truth.”
With the current authorization, which was also granted under the PMTA pathway, the FDA is imposing “stringent restrictions” on the chewable products’ marketing to ensure that they are only sold to adults.
“The FDA will evaluate new available data regarding the products through postmarketing records and reports required in the marketing order,” the agency wrote. “The company is required to regularly report to the FDA with information regarding the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, information on current and new users, manufacturing changes and adverse experiences.”
And, the FDA added, it will withdraw the marketing order if it “determines that the continued marketing of a product is no longer appropriate for the protection of the public health, for example, as a result of significant uptake of the product by youth.”
John McKenna, Associate Editor, BreakingMED™
Cat ID: 143
Topic ID: 86,143,730,143,192,725,925
