Altria Submits PMTAs for Oral Nicotine Products for FDA Review

RICHMOND, Va. — Altria Client Services filed premarket tobacco applications (PMTAs) for on! oral nicotine pouches for regulatory review.

In all, the tobacco company submitted 35 PMTAs to the Food and Drug Administration (FDA) for on! products on behalf of Helix Innovations LLC, an Altria joint venture responsible for manufacturing and selling on! nicotine pouches globally.

The oral nicotine pouches are available in seven flavors and five nicotine levels.

"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.

Altria entered the oral nicotine category with a definitive agreement to acquire 80 percent of certain companies of Burger Söhne Holding AG that will commercialize on! products worldwide in mid-2019.

At the end of the first quarter of 2020, on! nicotine pouches were sold in more than 28,000 stores, including the top five convenience store chains by volume, Altria CEO Billy Gifford said during the company's earnings call on April 30.

According to Vivian Azer, director and senior research analyst at Cowen and Co., manufacturers have turned to the modern oral category to complement their existing reduced-risk portfolios as tobacco consumers look for alternatives to combustible cigarettes.

"The market sits at the intersection of several large tobacco categories, given its reduced risk properties, while we have observed through our proprietary Cowen Consumer Survey that users tend to be not only former smokers but also current e-cigarette users," she said.

"Ultimately, we believe the category could reach approximately $3 billion in U.S. sales, based on 3 percent of the approximately $76 billion U.S. cigarette market and 10 percent of the approximately $8 billion smokeless segment," Azer added.

Richmond-based Altria's wholly owned subsidiaries include Philip Morris USA Inc., U.S. Smokeless Tobacco Co. LLC, John Middleton Co., Sherman Group Holdings LLC and its subsidiaries, Ste. Michelle Wine Estates Ltd. and Philip Morris Capital Corp.

Altria owns an 80-percent interest in Helix, and holds equity investments in AnheuserBusch InBev SA/NV, Juul Labs Inc. and Cronos Group Inc.