FDA Authorizes Marketing For Nicotine Pouches For First Time – What Does This Mean?

The marketing authorization was given to the brand ZYN for 20 nicotine pouch products. These small pouches contain nicotine and are designed to be placed between the gum and lip or cheek, where they slowly release the drug to be absorbed.

Marketing authorization vs. approval

The first important thing to note about this announcement is that an FDA marketing authorization is not the same thing as approval – this isn’t exactly a green light from the agency to go popping a pouch in all day every day.

Approval is given to medical products that the FDA has evaluated to be safe and effective for their intended use; the agency states that there’s “no such thing as a safe tobacco product” so it doesn’t approve them.

However, products like nicotine pouches still need to get authorization from the FDA in order to be legally sold or distributed in the US – ZYN doesn’t contain tobacco leaf but the nicotine in it is derived from tobacco – and that still requires a certain standard of scientific evidence.

“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, PhD, director of the Office of Science in the FDA’s Center for Tobacco Products, in a statement. 

“In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

That’s not to say that the pouches are without their own risks. Nicotine is still an addictive substance after all – and though the FDA found that the pouches posed less risk of serious health conditions like cancer than cigarettes and some other smokeless tobacco products, that doesn’t mean they don’t carry any risks at all.

How many people are actually using nicotine pouches?

One of the concerns over nicotine pouches is that, with different flavors available and used by influencers, they would become popular with young people. As part of its evaluation of the products’ risks, the FDA looked into those specific to youths, including how many young people use nicotine pouches.

Despite rising sales, the National Youth Tobacco Survey 2024 found that 1.8 percent of middle and high school students reported using nicotine pouches – it was 1.5 percent in 2023’s survey, but that’s not considered to be a statistically significant change. In comparison, 5.9 percent of the same group reported using e-cigarettes – though the use of any tobacco product among youth has actually declined overall.

Use of nicotine pouches appears low among adults, too. A 2024 study of 39,557 US adults found that only 0.4 percent reported currently using the pouches, while 2.9 percent reported having ever used them.

While that might allay some people’s fears over the popularity of the pouches, the FDA is keen that those numbers don’t get any higher. “There is no safe tobacco product; youth should not use tobacco products and adults who do not use tobacco products should not start,” the agency said in the marketing authorization announcement.

What now?

With the go-ahead from the FDA, ZYN can now legally market the 20 nicotine pouches to adults in the US over the age of 21 – and it has to stick to strict rules in order to keep that authorization, including making sure that its ads and the products aren’t targeted to anyone younger. 

If things change – the FDA plans to keep an eye out – then authorization could be taken back.

“It’s critical that the manufacturer market these products responsibly to prevent youth use,” said Brian King, PhD, M.P.H., director of the FDA’s Center for Tobacco Products. “While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health.”

The content of this article is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of qualified health providers with questions you may have regarding medical conditions.