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HomeLatest Pharma-NewsFDA Permits Marketing of New Oral Tobacco Products through Premarket Application Pathway

FDA Permits Marketing of New Oral Tobacco Products through Premarket Application Pathway

October 19, 2021: “The U.S. Food and Drug Administration announced it has authorized the marketing of four new oral tobacco products manufactured by U.S. Smokeless Tobacco Company LLC under the brand name of Verve.

Based on the FDA’s comprehensive review of available scientific evidence in the company’s premarket tobacco product applications (PMTAs), the agency determined the marketing of these products would be consistent with the statutory standard, “appropriate for the protection of the public health.”

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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 four products are: 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, J.D., 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.”

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, nonsmokers, 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 agency has posted the decision summary that further describes the basis for issuing marketing orders for these four products.

The marketing authorizations issued today 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,” as there are no safe tobacco products.

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 postmarketing 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.

The agency continues to conduct premarket review of thousands of tobacco product applications and remains committed to communicating with the public about progress, including the issuance of marketing denial orders for more than one million flavored e-cigarette products that lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health concern posed by the well-documented and considerable appeal of such products to youth.”

https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-new-oral-tobacco-products-through-premarket-tobacco-product-application

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