Loading ...

Last December, the FDA issued marketing authorizations for six nicotine pouch products sold under the on! PLUS brand. These authorizations were the first outcome of a pilot program launched in September to streamline the review process for such applications, following the January 2025 authorization of 20 products from Zyn, the current market leader in the oral nicotine space.

While the FDA positions these as lower-risk alternatives to smoked tobacco, high-quality research on their effectiveness for smoking cessation remains scarce. Experts are now questioning whether regulatory frameworks can keep pace with emerging usage trends, particularly among young people, to avoid repeating the mistakes that led to the current e-cigarette crisis.

Are Pouches Safer Than Cigarettes and e-Cigarettes? 

Oral nicotine pouches contain a mixture of synthetic or tobacco-derived nicotine, sweeteners, stabilizers, and flavors, such as coffee, menthol, peppermint, wintergreen, tobacco, and cinnamon. Unlike traditional products such as snus or chewing tobacco, nicotine pouches are tobacco-free and do not require inhalation. They also avoid heating e‑liquids, unlike e-cigarettes. Heating e‑liquids produces aerosols containing variable, poorly regulated chemicals.

With pouches, the nicotine is absorbed through the oral mucosa into the bloodstream, much like medicinal nicotine replacement therapy (NRT). Authorized Zyn pouches come in 3-mg or 6-mg strengths, while the new on! PLUS products are authorized at 6-mg and 9-mg strengths.

However, tobacco-free does not mean risk-free. Recent research shows that some brands deliver nicotine at levels as high as smoked tobacco, though not as rapidly. This high delivery efficiency “could get people who have never smoked addicted to these products,” said Hayden McRobbie, PhD, a professor of public health at Queen Mary University of London in London, England.

Beyond addiction, pouches are also associated with gastrointestinal issues, oral health complications, and cardiovascular toxicity, just as any other nicotine product.

Despite these risks, the FDA considers nicotine pouches a “lower-risk alternative” to other products. But Maureen George, PhD, a pulmonary clinical nurse and a professor of nursing at Columbia University Irving Medical Center, New York City, told Medscape Medical News that pouches are not approved as cessation tools.

Nicotine pouches are not designed to be an NRT, said Katrina Roux-Bernstein, a nurse practitioner who specializes in pulmonology at the University of Maryland Baltimore Washington Medical Center. However, she is optimistic about having one additional tool to help patients quit smoking. “We have not had a lot of different medications, or even options for patients who have tried to quit smoking several times, but nothing has really ever helped,” she said. “I want to stay positive. These are extra little things that patients can use.”

On the risk continuum, McRobbie said, nicotine pouches are likely less harmful than cigarettes and vaping for people who already smoke. That’s because they eliminate tobacco leaf and the inhalation of aerosols containing flavorants and aldehydes. But for nonsmokers and young people, pouches raise concern about nicotine addiction and unclear long-term harms, he said. “Switching is good, [but] starting it isn’t,” he said.

Smoking Cessation Tool or New Addictive Trend?

Research around the effectiveness of nicotine pouches as a harm reduction tool for cigarette smoking is scant, George said. However, smokers are already using them to quit smoking.

A recent study showed that pouch use is common among those looking to quit smoking or vaping in Great Britain. In the US, too, research has found that nicotine pouch use was highest among adults who had recently quit smoking or vaping, or were current users of smokeless tobacco products. Studies have also found that dual use of pouches alongside cigarettes or e-cigarettes is common. “An increasing number of people are using these products for smoking cessation,” said McRobbie. “Although they’re not approved and we don’t have strong evidence for their effectiveness, we are seeing a rise, and we’ll continue to see it.”

The primary public health concern involves the potential of these products to attract nicotine-naive populations, particularly adolescents. “It might become the next cool thing,” said Roux-Bernstein.

Vibrant packaging, fun colors, and flavors target younger audiences. “We know that these products are attractive to kids and young adults,” George agreed.

Promotional posts on social media are countless. In one ad, a young man says the pouches are “surprisingly different” and “low profile and hassle-free.” “So that I can enjoy them pretty much everywhere,” adds a young woman. The discreet nature of the products allows for use in environments where smoking or vaping is prohibited. It removes the stigma linked to tobacco smoking, potentially increasing the frequency of nicotine consumption. Roux-Bernstein also pointed out that while traditional NRTs, such as gums or patches, are designed to manage acute cravings and aim to taper down nicotine consumption, the palatable nature of pouches may encourage recreational overconsumption. “There is a potential here for increased use simply because they taste good,” she said.

Trends on pouch use are still emerging, and while rates are currently low, uptake is increasing rapidly. In 2022, the Population Assessment of Tobacco and Health survey showed that less than 1% of adolescents had ever used pouches in the US. But according to a study published last year, the use of pouches reported by 10th and 12th graders rose from 2.4% to 4.6% from 2023 to 2024.

Regulation Should Catch Up Quickly

The FDA’s current strategy focuses on a harm-reduction model for adults aged 21 and older, specifically those seeking to transition away from combustible cigarettes. However, federal guidelines emphasize that no tobacco product is risk-free, explicitly warning that nonusers and youth should abstain entirely.

But all experts who spoke with Medscape Medical News agreed that the regulatory response to nicotine pouches must be more proactive than the response to the e-cigarette epidemic. McRobbie said that delays in oversight could lead to a repeat of previous public health setbacks. “I think this is where we missed the boat with e-cigarettes,” he said. “The horse had already bolted by the time we got around to regulating.”

McRobbie suggested a bifurcated regulatory pathway: one that ensures accessibility for chronic smokers who have failed other cessation methods, while simultaneously imposing restrictions on access for young, never-smokers. He said that current marketing and targeting strategies are a primary driver of initiation among youth, carrying a significant risk for lifelong nicotine dependency.

“Current enforcement mechanisms lack the necessary teeth to prevent youth access,” George said. “You can go into any bodega or rest stop and buy this.”

“These pouches were introduced [by the tobacco industry] as a way to keep a toehold in a growing market,” she said. “They were really meant to work around the regulations of the e‑cigarette, particularly the flavored e‑cigarettes, and create a market for use.”

McRobbie, George, and Roux-Bernstein reported no relevant financial relationships.

Manuela Callari is a freelance science journalist specializing in human and planetary health. Her work has been published in The Medical Republic, Rare Disease Advisor, New Scientist, The Guardian, MIT Technology Review, and others.