FDA Clears Six on! PLUS Nicotine Pouch Products for Adult Sale in the US

Post by : Saif Nasser

The US Food and Drug Administration (FDA) has approved the sale of six nicotine pouch products under the on! PLUS brand. The decision allows these products to be legally sold to adults across the United States.

The FDA announced the approval on Friday, saying the products were cleared under a new pilot program that aims to speed up the review of certain tobacco and nicotine products. This is the first approval made through this fast-track system, which was launched in September.

The six approved products are made by Helix Innovations LLC, a joint venture owned by Altria. The company applied for permission to sell the products in June 2024. After reviewing the scientific data, the FDA decided the products met the required standards for market authorization.

The approved on! PLUS nicotine pouches come in mint, tobacco, and wintergreen flavors. They are sold in two nicotine strengths, 6 milligrams and 9 milligrams. These products can now be marketed legally to adults in the United States.

The FDA said its decision was based on evidence showing that these nicotine pouches contain lower levels of harmful chemicals compared to traditional smokeless tobacco products. Because of this, the agency said they carry a lower risk of cancer and other serious health problems.

The FDA also made it clear that the authorization applies only to these six specific products. Other nicotine pouch products made by the same company are not covered and would need separate approval before being sold.

Nicotine pouches are small packets that users place under their upper lip. They do not produce smoke, do not require burning, and do not contain tobacco leaf. Because there is no inhalation, these products are often seen as lower-risk options compared to cigarettes or other smokeless tobacco.

In the United States, nicotine pouches have become the fastest-growing type of nicotine product. Many adult smokers are choosing them as an alternative as cigarette use continues to fall.

Earlier this year, the FDA approved 20 Zyn nicotine pouch products, owned by Philip Morris International. Those products were the first in this category to receive FDA authorization, though their approval process took more than five years.

Major tobacco companies have been investing heavily in smoke-free and reduced-risk products as they adjust to changing consumer habits and stricter health rules. These companies argue that such products can help adult smokers move away from cigarettes.

Following the FDA’s decision, Altria said it will restart taking new orders for on! PLUS nicotine pouches in states such as Florida, North Carolina, and Texas. The products will also be available again through online sales.

Health officials continue to warn that nicotine is not risk-free. The US Centers for Disease Control and Prevention says nicotine can harm brain development in teenagers, affecting learning, attention, mood, and self-control.

For this reason, the FDA stressed that the approved products are meant only for adults and should not be used by children or adolescents. The agency said it will continue to monitor how these products are sold and promoted.

The approval shows how regulators are trying to balance two goals: helping adult smokers find lower-risk alternatives while protecting young people from nicotine addiction. As more new products enter the market, this balance is likely to remain a major public health issue.