FDA Fast-Tracks Approval of Altria’s on! PLUS Nicotine Pouches Under New Pilot Program

The U.S. Food and Drug Administration (FDA) has authorized the marketing of six on! PLUS nicotine pouch products owned by Altria Group, marking the first approvals granted under the agency’s new pilot program designed to accelerate the review of certain tobacco-related products. The decision represents a significant milestone for the growing nicotine pouch market in the United States.

According to the FDA, the authorization applies specifically to six on! PLUS nicotine pouches manufactured by Helix Innovations LLC, a joint venture associated with Altria’s global on! PLUS portfolio. Altria submitted its premarket tobacco product applications for these products in June 2024, and the FDA cleared them under the pilot initiative launched in September to help streamline regulatory reviews.

The newly authorized on! PLUS nicotine pouches are available in mint, tobacco, and wintergreen flavors, with nicotine strengths of 6 mg and 9 mg. These products are now legally permitted for sale to adults in the U.S. The FDA emphasized that its decision was based on scientific evidence showing that the pouches contain lower levels of harmful chemicals compared to other smokeless tobacco products, which may translate into a reduced risk of cancer and other serious health conditions. The authorization is limited strictly to the approved products and does not extend to other Helix Innovations offerings.

Nicotine pouches are placed under the lip and do not involve combustion, inhalation, or the presence of tobacco leaf. As a result, they are widely viewed as among the lowest-risk alternatives to traditional smoking. This category has become the fastest-growing segment in the U.S. tobacco market as consumers increasingly seek smoke-free options.

Earlier in 2025, the FDA authorized 20 Zyn nicotine pouch products owned by Philip Morris International, making them the first in this category to receive U.S. market approval after a review process that lasted more than five years.

Following the FDA decision, Altria announced that on! PLUS will resume taking new retail orders in Florida, North Carolina, and Texas, as well as through e-commerce channels. While regulators continue to stress that nicotine products are intended only for adults, public health officials note that nicotine exposure during adolescence can negatively affect brain development related to attention, learning, mood, and impulse control.