FDA authorizes ZYN to advertise as less harmful than smoking: a breakthrough or a risk?

What happened?

The U.S. Food and Drug Administration (FDA) authorized the manufacturers of ZYN, the popular tobacco-free nicotine pouches, to communicate in their advertising that they are a less harmful option than cigarettes for adult smokers. The decision, based on a scientific review of studies submitted by Swedish Match (acquired by Philip Morris International in 2022), allows claims such as “lower health risks than smoking” or “reduces exposure to harmful chemicals.” However, the FDA does not declare ZYN safe nor approves phrases like “risk-free.” The agency insists that the best option is not to consume nicotine at all. This authorization falls under the FDA’s Modified Risk Tobacco Product (MRTP) program, established in 2009 with the Family Smoking Prevention and Tobacco Control Act.

Why is this important?

This is the first time the FDA has authorized a reduced risk claim for a tobacco-free oral nicotine product. Historically, the agency has been cautious with “less harmful” claims to prevent consumers from perceiving these products as safe. The decision could set a precedent for other nicotine alternatives, such as vaporizers (e.g., Juul) and competing nicotine pouches (On!, Velo, etc.). For companies, it is a marketing opportunity targeting smokers looking to reduce their exposure to toxic chemicals in smoke. For public health, there is a risk that non-smokers, especially youth, may interpret the message as an endorsement and start using ZYN. The FDA has been criticized for its slow response to the teen vaping epidemic; it will now need to closely monitor that ZYN advertising does not attract minors. In the market, ZYN dominates the nicotine pouch segment in the U.S., with estimated sales of over $1.3 billion in 2023, according to Nielsen data.

Consequences and context

The FDA based its decision on studies showing that ZYN users have significantly lower levels of carcinogens and toxins compared to smokers. For example, a study published in the journal Nicotine & Tobacco Research (2022) found that nicotine pouch users had NNAL (a metabolite of the carcinogen NNK) levels 95% lower than smokers. However, nicotine remains addictive and can affect brain development in adolescents, as well as increase blood pressure and heart rate. The authorization includes strict restrictions: advertising must target only adult smokers (over 21), cannot use imagery suggesting a lifestyle attractive to youth (such as extreme sports or celebrities), and must include warnings about addiction. Additionally, the FDA requires ads to include the phrase “Not a safe product” and not show people using the product in situations that imply risk. This move aligns with the FDA’s strategy of promoting harm reduction, similar to the previous approval of IQOS (heated tobacco device) in 2020, but also sparks debate. While advocates like Dr. Michael Siegel (Boston University) argue that the decision sends a clear message to smokers about less harmful alternatives, critics like the American Lung Association fear it will normalize nicotine use and undermine decades of anti-smoking efforts. In 2023, the FDA had already denied similar applications for certain e-cigarettes, citing lack of evidence for population-level harm reduction.

What should readers know?

For an adult smoker who cannot or will not quit nicotine, switching to ZYN can reduce exposure to carcinogens. But it is not a safe product: nicotine remains addictive and has cardiovascular effects. Non-smokers, especially youth, should avoid it. The FDA’s decision is not a blank check; the agency will monitor compliance with advertising restrictions and could reverse the authorization if underage use is detected. In fact, the FDA has previously revoked authorizations for tobacco products (such as certain e-cigarette flavors) when youth use data emerged. In summary, ZYN is less harmful than smoking, but not harmless. Smokers considering switching should consult their doctor and remember that the healthiest option remains quitting all nicotine use. The FDA’s decision also opens the door for other nicotine pouch companies to seek similar authorizations, potentially transforming the smokeless nicotine product market.