Altria Group Inc. submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) for its On! Plus oral nicotine pouch products. The PMTAs were submitted by Altria’s wholly owned subsidiary Helix Innovations LLC (Helix).
Helix submitted PMTAs for three distinct On! Plus varieties: tobacco, mint, and wintergreen. Each variety comes in three different nicotine strength options.
On! Plus is described by Altria as “a spit-free, oral tobacco-derived nicotine (TDN) pouch product made from a proprietary ‘soft-feel’ material to provide a more comfortable product experience.”
“Helix’s submission of the On! Plus applications underscores Altria's commitment to addressing consumers’ evolving preferences through innovation in potentially reduced risk products. We firmly believe that On! Plus is a transformative product that will meaningfully contribute to Helix’s growth in the U.S. market, upon timely FDA authorization,” said Nick MacPhee, managing director and general manager, Helix.
“We’ve long believed in the value of a robust marketplace of authorized smoke-free products for adult tobacco consumers. We believe that these PMTAs demonstrate that responsibly marketed On! Plus pouches can provide a compelling alternative in the marketplace,” said Paige Magness, senior vice president of regulatory affairs, Altria Client Services LLC.
R.J. Reynolds Vapor Company filed its final PMTA submission for its Vuse Pro age-gated device.
The electronic nicotine delivery system (ENDS) device platform connects to a mobile application that verifies the consumer’s age through a third-party provider prior to unlocking for use. Once verified, the device will unlock and uses a unique design to only allow compatible Vuse Pro pods to be used. The technology and mobile application also enable features such as auto-lock and proximity lock to further secure device access.
“Our PMTA submissions to the FDA underscore our commitment to both offering adult tobacco and vapor consumers choices as well as underage access prevention,” said Tim Nestor, Reynolds executive vice president of scientific research and development. “We don’t want our products in the hands of youth, period. The Vuse Pro ENDS platform provides a solution that limits access to adult consumers while also offering flavors that appeal to current adult smokers and a unique vapor experience.”
To secure market authorization under a PMTA, manufacturers must demonstrate that the marketing of a new tobacco product is appropriate for the protection of public health. This requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products and youth.