Dive Brief:
- Helix Innovations, the oral nicotine company owned by Altria Group, has received marketing approval from the U.S. Food and Drug Administration for four On! nicotine pouches, the department announced on Tuesday.
- These approvals bring the number of nicotine pouches with marketing approval to 30. The list includes 10 products made by Helix and 20 from Swedish Match’s Zyn brand.
- The newly authorized products — 2-milligram Rich Berry and Autumn Spice-flavored pouches and 2- and 4-milligram cappuccino-flavored pouches — were authorized as part of an FDA pilot program that aims to increase efficiency in the review process of nicotine pouches.
Dive Insight:
Altria CEO Salvatore Mancuso said during the Q2 earnings call on July 30 that the company hoped to receive marketing approval for more pouches this year. Less than a week later, it received its next wave of authorizations.
Helix previously gained marketing approval for six products in its On! Plus line in December. Altria has also released new products that haven’t yet received marketing approval, including some 12-milligram varieties and new flavors like blueberry mint and mango pineapple.
The FDA’s pilot authorization program seeks to streamline multiple parts of the review process, including enacting real-time communication with applicants to provide feedback and ask questions or request missing information faster, the agency said when announcing the program.
The FDA said it plans to apply what it has learned from early reviews of nicotine products to other applications.
While the FDA began granting marketing approval to fruit-flavored vapes about three months ago, it has been much more open to a variety of flavors in nicotine pouches. The berry and Autumn Spice flavors join Zyn options like cinnamon, citrus and coffee.
