On Oct. 19, the U.S. Food and Drug Administration (FDA) issued marketing granted orders to U.S. Smokeless Tobacco Company LLC (USSTC) for four oral tobacco products under the brand name of Verve. The four products are: Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint and Verve Chews Green Mint.
After FDA’s comprehensive review of scientific evidence relevant to the premarket tobacco products applications (PMTAs) submitted by the company, the agency determined marketing these products is appropriate for the protection of the public health.
The Verve products are oral tobacco products that contain nicotine derived from tobacco, but they do not contain cut, ground, powdered or leaf tobacco. All four products are chewed and then discarded, rather than swallowed, once the user is finished with the product. The discs and chews differ in part by their texture. Both are flexible, but the discs are firm, and the chews are soft. These products are intended for adult tobacco users.
Before authorizing new tobacco products via the PMTA pathway, the FDA must, by law, take into consideration, among other things, the likelihood that current tobacco users will stop using tobacco products and the likelihood that current nonusers will start using tobacco products.
Research shows a low likelihood that youth, non-smokers or former smokers would initiate or reinitiate tobacco use with the Verve products. Current users of Verve products and users who switch completely to Verve products are generally exposed to fewer harmful and potentially harmful constituents compared to cigarettes and other smokeless tobacco products.
The issuance of marketing orders allows the four tobacco products to be legally sold or distributed in the United States, but it does not mean the products are safe or “FDA approved,” as the FDA asserts there are no safe tobacco products.
Additionally, FDA is placing stringent restrictions on how PMTA products like Verve are marketed, particularly via websites and through social media platforms. FDA will evaluate new available data regarding these products through post-marketing records and reports required in the marketing order.
The company is required to report to FDA regularly, providing 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.
FDA may withdraw a marketing order if it determines that the continued marketing of a product is no longer appropriate for the protection of the public health, such as if there is an uptake of the product by youth.
The agency has posted the decision summary that further describes the basis for issuing these marketing orders.