What to know about FDA's review of new Zyn advertising proposal

WASHINGTON — Americans who smoke may soon be hearing a lot more about Zyn, the flavored nicotine pouches that have generated billions in sales while going viral on social media.

The Food and Drug Administration convened a public meeting Thursday to consider whether Philip Morris International should be allowed to advertise its pouches as a less-harmful alternative for adults who smoke cigarettes.

Government documents and presentations made at the meeting suggest FDA regulators are leaning toward approving the company's request.

But a panel of independent experts asked pointed questions about the company's research, the risks of underage use and whether the new marketing language would really steer smokers away from cigarettes. Nevertheless, they said the proposed risk statement is likely accurate.

''There are very few things that are legally available and worse for you than cigarettes, so it's a pretty low bar to be safer than cigarettes,'' said Lisa Postow, a panel member and scientist at the National Heart, Lung and Blood Institute.

The FDA is not bound to follow the panel's guidance and will make the final decision on whether to approve the marketing claims. There is no deadline for a decision.

Zyn contains nicotine powder and comes in 10 flavors, including mint, coffee and citrus. Nicotine pouches have been a rare source of growth in the tobacco industry, where companies have struggled to replace shrinking revenue from cigarettes, chewing tobacco and other legacy products.

Why is FDA reviewing Zyn now?

Philip Morris asked the agency to approve new marketing language for Zyn, emphasizing its relative health benefits when compared with cigarettes.

Specifically, the company wants to say that using Zyn reduces the risk of ''mouth cancer, heart disease, lung cancer, stroke'' and other smoking-related diseases. Adding that language to Zyn promotional materials would further cement the brand in the U.S., where it dominates sales of nicotine pouches.

Last January, the FDA authorized Zyn to remain on the market after years of federal review, saying company data showed the small pouches are less harmful than cigarettes and other traditional tobacco products. Zyn was the first nicotine pouch to win FDA authorization.

If FDA signs off on the ''reduced risk'' claims, Philip Morris would be able to use the language in ads, mailing materials and online posts.

What's the evidence?

FDA scientists appeared to back the company's proposal, saying ''the totality of the evidence'' supports the statement that Zyn reduces the risk of various smoking-related illnesses.

But the outside experts noted that Philip Morris did not conduct long-term studies of Zyn users or whether reading messages about lower risks led more smokers to switch.

''Whether or not the claim is going to accelerate that switching, there is no data here to answer that question,'' said Cristine Delnevo of the Rutgers Institute for Nicotine and Tobacco Studies, who led the panel.

Philip Morris already sells a similar oral tobacco product, snus, a type of tobacco pouch popular in Sweden and other Scandinavian countries. Studies in those countries have consistently shown lower rates of lung cancer, mouth cancer and related diseases among snus users when compared with smokers.

''The more you communicate to adult smokers with this type of claim it will hopefully only increase switching to Zyn,'' Lenihan said.

What about underage use?

In addition to considering potential benefits for smokers, the FDA is required to review the potential harms to young people and nonsmokers.

Representatives from anti-tobacco groups pointed to worrying signs: Videos from ''Zynfluencers'' and other young people using the pouches have racked up tens of millions of views on social media platforms in recent years.

Andrew Tardiff of the Campaign for Tobacco-Free Kids noted that Philip Morris did not test how its marketing messages might influence teenagers.

Tardiff and other speakers also said that teenagers could be attracted by a Zyn rewards program that allows purchasers to accrue points that can be exchanged for electronics, gift cards and apparel.

Despite such factors, FDA staffers note that teenage use of nicotine pouches remains relatively low at 2.4% of high school students, according 2024 federal survey data.

How popular is Zyn?

Less than 1% of U.S. adults use nicotine pouches, but the products make up the fastest-growing segment of the tobacco market.

Within the category, Zyn is the overwhelming U.S. leader. Last year, it had more than $3.24 billion in sales, or more than two-thirds of the market, according to Nielsen data analyzed by Goldman Sachs.