FDA to Review Altria Nicotine Pouches

The U.S. Food and Drug Administration (FDA) has accepted and filed for substantive review premarket tobacco product applications for 35 On! products manufactured by Helix Innovations, an Altria joint venture.

To support these applications, Altria submitted more than 66,000 pages of documentation, including six primary studies.

“We believe the scientific evidence in these applications demonstrates that the marketing of On! is appropriate for the protection of public health,” said Paige Magness, senior vice president of regulatory affairs for Altria Client Services. “On! nicotine pouches are a key part of our vision to responsibly lead the transition of adult smokers to a noncombustible future.”

On! nicotine pouches are tobacco-leaf-free and are available in seven flavors and five nicotine levels. In the fast-growing nicotine pouch category, On! currently offers the broadest portfolio of choices for adult tobacco consumers seeking alternatives to traditional tobacco products, according to Altria.

On! was distributed in more than 28,000 stores at the end of the first quarter, including the top five U.S. convenience store chains by volume. According to IRI, total oral tobacco derived nicotine category sales in 2019 grew approximately 275 percent compared to 2018.