Altria has submitted premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration (FDA) for 35 on! products on behalf of Helix Innovations, LLC, an Altria joint venture that is responsible for manufacturing and selling on! globally.
on! is an oral tobacco-derived nicotine (TDN) pouch product. In June 2019, Altria announced its intent to acquire 80 percent ownership of groups belonging to Switzerland-based Burger Söhne Holding AG (the “Burger Group”) and that it would in turn commercialize on! products worldwide [read more here]. Upon closing, Altria formed a new subsidiary, Helix Innovations, LLC, that has served as the parent company of the Burger Group subsidiaries that were responsible for manufacturing and selling on!
on! Is available in seven flavors and five different nicotine levels, offering a broad portfolio of nicotine pouches to consumers seeking an alternative to traditional tobacco products.
“On! Nicotine pouches are a key part of our vision to responsibly lead the transition of adult smokers to a non-combustible future,” commented Paige Magness, senior vice president of Regulatory Affairs at Altria Client Services. “We believe the supporting science is strong and are committed to working with the Agency on these important product submissions.”
The FDA will now review Altria’s PMTAs for on! and decide whether or not to accept them or not.
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