Tobacco

Altria Receives FDA’s OK for Discontinued Oral Tobacco Product

Marketing order authorizes sale of Verve chews, discs in 4 flavors
U.S. Smokeless Tobacco Co.

SILVER SPRING, Md. — U.S. Smokeless Tobacco Co., part of Altria Group, received marketing approval from the U.S. Food and Drug Administration (FDA) on Oct. 19 for four oral tobacco products under its Verve brand, which was discontinued in February 2019.

When asked whether this authorization would result in Verve returning to the market, the answer appeared to be no. Instead, an Altria spokesperson said, the company “applied learnings from this successful application to our On submissions, which remain under review by FDA.”

The FDA granted marketing orders for Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint and Verve Chews Green Mint, the agency said. Verve products contain nicotine derived from tobacco, but they do not contain cut, ground, powdered or leaf tobacco, the FDA said. The four authorized products are intended to be chewed and then discarded once the user is finished. The discs and chews differ in part by their texture.

After the FDA’s comprehensive review of scientific evidence relevant to the premarket tobacco product applications (PMTAs) submitted by the company, the agency determined marketing the products is appropriate for the protection of the public health.

“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. “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. 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.”

Altria Group Inc., Richmond, Va., decided to discontinue Verve on Dec. 7, 2018, and the products were available for purchase online until Feb. 2, 2019. It submitted its PMTAs for its Verve products in July 2018, according to the FDA.

“We are pleased that FDA has determined that Verve oral nicotine products are appropriate for the protection of public health,” Altria said in a statement to CSP. “While we discontinued selling Verve on Feb. 2, 2019, we applied learnings from this successful application to our On submissions, which remain under review by FDA. Oral nicotine products play an important role in our vision of moving beyond smoking and remain an important part of our portfolio of products to transition adult smokers away from cigarettes.”

The FDA is reviewing PMTAs for 35 On products. The leaf-free nicotine pouches come in seven flavors and five nicotine strengths for a total of 35 SKUs. The flavors are Wintergreen, Mint, Cinnamon, Coffee, Citrus, Berry and Original.

Although it’s not currently on the market, the FDA said it is placing stringent restrictions on how PMTA products like Verve are marketed, particularly via websites and through social media platforms.

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