Reynolds Seeks FDA Nod to Reintroduce Mixed Berry E-Cigarettes

Reynolds American submitted applications to keep selling its Vuse Alto e-cigarette in the U.S. just days ahead of the deadline for all vaping companies to pursue review from the Food and Drug Administration.

Reynolds, a unit of British American Tobacco Plc, filed applications for its Vuse Alto-branded device and 12 cartridges in various flavors and nicotine strengths. It’s seeking FDA permission to keep selling a menthol and two tobacco-flavored products, and to reintroduce the mixed berry nicotine liquid it stopped selling earlier this year to comply with an FDA ban on sweet flavors that might attract minors.

These submissions are the last from Reynolds, which filed its first batch last October for its Vuse Solo products and has since submitted applications for its other Vuse-branded e-cigarettes, and for its Velo-branded oral nicotine pouches and lozenges. In total, Reynolds has filed 530,000 pages of scientific data to support its applications.

“It’s a great relief to have it done and we’re obviously very thrilled about that, and we look forward to working with the FDA as these applications move through the process,” Jim Figlar, Reynolds’ head of scientific and regulatory affairs, said in an interview Friday.

Vuse Alto is the second-most popular e-cigarette brand in the U.S., according to data from market-research firm IRI.

Reynolds’ seeking FDA permission to resume selling a berry-flavored nicotine pod will test the regulator’s previous stand on flavors seen as drawing young people to vaping. The company already filed applications for flavored products for its other e-cigarette lines, Figlar said.

All newly-regulated tobacco products must file applications by Wednesday in a review process that will reshape the U.S. e-cigarette landscape. The largest companies have all submitted their materials, while smaller manufacturers are staging a last-ditch effort to convince the Trump administration to delay the deadline or ease regulations.

Vape advocates will take their case to President Donald Trump on Saturday with a rally outside the White House. The movement, dubbed “We Vape, We Vote” persuaded Trump to back down from his administration’s pledge to all ban flavored e-cigarettes last year.

Small companies and vape shops that produce their own nicotine liquids have said the hurdles are too steep for them to compete with giants like Reynolds and Juul Labs Inc., which filed its application to keep selling e-cigarettes with the FDA in July.

Reynolds started preparing for the review as early as 2014, two years before the FDA began regulating all tobacco products. Its applications are moving through the FDA, though the pandemic has made it more difficult for regulators to complete facility inspections, Figlar said. The FDA had questions about Reynolds’ submissions for its Vuse Solo products and the company plans to respond soon, he said.

The FDA in January prohibited companies from selling flavored nicotine pods except menthol and tobacco unless the agency reviewed and cleared the products. Market leader Juul decided against submitting applications for mango, mint and the other flavors it pulled after a federal survey revealed these were the ones teens favored most.

Michael R. Bloomberg, the majority owner of Bloomberg LP, the parent company of Bloomberg News, has funded efforts to ban flavored vaping products.

©2020 Bloomberg L.P.

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