FDA Approves Six on! PLUS Nicotine Pouch Products for Adult Consumption in the US

The U.S. Food and Drug Administration (FDA) has granted permission for the sale of six nicotine pouch products by the on! PLUS brand. This landmark approval allows these pouches to be legally marketed to adults nationwide.

Announced on Friday, the authorization is part of a pilot program designed to expedite the review process for certain tobacco and nicotine products. This marks the inaugural approval through this fast-track initiative, introduced in September.

The six approved products come from Helix Innovations LLC, a collaboration that includes Altria. The company submitted its application in June 2024, and following a thorough review of the scientific evidence, the FDA concluded that these products meet the necessary criteria for market entry.

The available on! PLUS nicotine pouches are offered in several flavors, including mint, tobacco, and wintergreen, and feature two levels of nicotine: 6 milligrams and 9 milligrams. Adults can now legally purchase these products across the United States.

The FDA’s decision was influenced by data indicating that these nicotine pouches have lower harmful chemical levels than traditional smokeless tobacco products. As a result, they are associated with a decreased risk of cancer and other serious health concerns.

It’s important to note that the FDA's authorization is strictly for these six products; other nicotine pouch variants from the same manufacturer require distinct approvals before they can be sold.

Nicotine pouches are discreet packets placed under the upper lip, which do not emit smoke, necessitate no burning, and are free from tobacco leaf. Their non-inhalative nature positions them as potentially lower-risk alternatives to cigarettes and traditional smokeless tobacco.

In the U.S., nicotine pouches have surged in popularity, becoming the fastest-growing nicotine product category. Many adult smokers are increasingly opting for these alternatives as cigarette usage declines.

Earlier this year, the FDA authorized 20 Zyn nicotine pouch products, associated with Philip Morris International, marking the first approvals in this domain, albeit after a lengthy five-year review process.

In response to the FDA’s decision, Altria announced it would resume accepting new orders for on! PLUS nicotine pouches in states like Florida, North Carolina, and Texas, with plans to offer them for online sales as well.

Health experts continue to underscore that nicotine is not without its risks. The U.S. Centers for Disease Control and Prevention warns about its potential adverse effects on brain development in adolescents, impacting learning, mood, attention, and self-regulation.

Consequently, the FDA emphasized that these approved products should only be used by adults and not by minors or adolescents. The agency intends to keep a close watch on the marketing and sales practices surrounding these products.

This approval illustrates the regulatory challenge of balancing the support for lower-risk alternatives for adult smokers while safeguarding youth from nicotine addiction. As new products make their debut, this balance will remain a pivotal public health concern.