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Altria submits new PMTA

15 May 2020. Altria has submitted Premarket Tobacco Product Application (PMTA) for its on!® Nicotine Pouches to the US Food and Drug Administration (FDA), the company reported.

Altria Client Services submitted PMTA to the FDA for 35 on!® products on behalf of Helix Innovations LLC, an Altria joint venture responsible for manufacturing and selling on!® nicotine pouches globally. According to the company’s press release, on!® products in seven flavours and five nicotine levels offer the broadest portfolio of choices in the fast-growing nicotine pouch category for adult tobacco consumers seeking alternatives 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,” said Paige Magness, Senior Vice President, Regulatory Affairs for Altria Client Services. “We believe the supporting science is strong and are committed to working with the Agency on these important product submissions.” FDA will now undertake an administrative review to determine whether to accept the applications.