RICHMOND, Va. — The Food and Drug Administration (FDA) will review On nicotine pouches from Altria’s joint venture Helix Innovations Inc.
The FDA accepted and filed for substantive review premarket tobacco applications (PMTAs) for 35 On products, according to the Richmond, Va.-based company.
Any tobacco or nicotine product put on the market or modified after Feb. 15, 2007, must be reviewed by the FDA to determine whether it can stay on stores shelves. The deadline for manufacturers to submit subsequent equivalence (SE) and PMTAs changed several times, partially due to COVID-19, and now is Sept. 9, 2020.
On nicotine pouches are tobacco leaf-free and come in seven flavors and five nicotine strengths for a total of 35 SKUs. The flavors are Wintergreen, Mint, Cinnamon, Coffee, Citrus, Berry and Original.
Altria submitted more than 66,000 pages of documentation, including six primary studies, to the FDA, the company said.
“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 non-combustible future.”
The FDA will now undertake a substantive scientific review of the applications, Altria said.