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

WASHINGTON (AP) — 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 is holding a public meeting Thursday to consider whether Philip Morris International can advertise its pouches as a less-harmful alternative for adults who currently smoke cigarettes.

Government documents posted before the meeting suggest FDA regulators are leaning toward approving the company’s request. But the meeting will give an outside panel of health experts a chance to weigh in and ask questions of both the company and the agency.

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.

Here’s what to know about Zyn’s review before the FDA:

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 marketing and promotional materials would further cement the brand in the United States, where it dominates sales of nicotine pouches.

Last January, the FDA officially 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 Zyn ads targeting customers who smoke or use other tobacco products.

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, which has been shrinking steadily as customers quit, die or switch to other products such as electronic cigarettes.

Within the market for nicotine pouches, 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. In December, the FDA authorized the No. 2 selling pouch brand, on! Plus, from Altria.

Most Zyn users are in their 30s and 40s and have higher incomes than people who use cigarettes or e-cigarettes, according to Philip Morris investor materials.

What’s the evidence?

FDA scientists appear poised to sign off on the company’s proposal, according to a preliminary review posted by the agency Tuesday. After evaluating “the totality of the evidence,” FDA tobacco staffers said the statement that Zyn reduces the risk of smoking-related illnesses is “scientifically accurate.”

The FDA review notes that Philip Morris did not conduct long-term health studies of Zyn users but provided other data supporting its position.

The company 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.

Philip Morris argues that Zyn has even lower health risks than snus, in part because it does not contain any tobacco leaves, only the nicotine. Research by the company showed Zyn had unquantifiable levels of 36 out of 42 carcinogens and other harmful chemicals found in tobacco products.

Of the remaining six chemicals, FDA reviewers said the amounts “were below the level that would be expected to pose a health risk.”

What about underage use?

In addition to considering potential benefits for adult smokers, the FDA is required to review the potential harms to young people and nonsmokers who may begin using it.

Anti-tobacco groups have 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.

A recent study conducted by an anti-tobacco nonprofit, the Truth Initiative, showed that spikes in viral TikTok videos about Zyn in 2022 and 2023 were followed by jumps in product sales. The authors note that it is unclear whether the Zyn videos actually triggered higher sales or were just an indicator of increasing popularity.

Despite such trends, teenage use of nicotine pouches remains relatively low at 2.4% of high school students, according to the latest federal survey data.

What happens next?

The FDA panel of independent public health experts are set to debate and make recommendations on these issues and others at Thursday’s all-day meeting. The FDA is not bound by that advice and is under no deadline to make a final decision.

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