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10/20/2021

FDA Grants PMTA Approval to Verve Oral Tobacco Products

Research shows a low likelihood that youth, nonsmokers or former smokers would initiate or reinitiate tobacco use with the products.
The products are manufactured by U.S. Smokeless Tobacco Co. LLC.

SILVER SPRING, Md. — Four new oral tobacco products have been granted premarket tobacco application (PMTA) approval by the Food and Drug Administration (FDA).

The products, manufactured by U.S. Smokeless Tobacco Co. LLC under the Verve brand, have been determined by the FDA to be consistent with the statutory standard, "appropriate for the protection of the public health." This includes a review of data showing that youth, nonsmokers and former smokers are unlikely to initiate or reinitiate tobacco use with these products.

The products include Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint, and Verve Chews Green Mint.

"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, 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."

Verve — which has been discontinued since 2018 — is intended for adult oral tobacco users and contain nicotine derived from tobacco, but do not contain cut, ground, powdered, or leaf tobacco. They 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.

Before authorizing new tobacco products via the PMTA pathway, the FDA must 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, nonsmokers or former smokers would initiate or reinitiate tobacco use with the Verve products, according to the agency.

Current users 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 FDA added.

The marketing authorizations issued allow 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."

Additionally, the FDA is placing stringent restrictions on how Verve products are marketed, including via websites and through social media platforms, to help ensure that marketing targets only adults. The FDA will evaluate new available data regarding the products through post-marketing records and reports required in the marketing order.

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.

The FDA will 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, for example, as a result of significant uptake of the product by youth.

U.S. Smokeless Tobacco Co. manufactures smokeless tobacco products, including dipping tobacco, chewing tobacco, snus, and dry snuff. It is a subsidiary of Altria Group.