United States: FDA authorizes marketing of ZYN nicotine pouches

The U.S. Food and Drug Administration (FDA) has granted marketing authorization to Philip Morris' Zyn flavored nicotine pouches, marking the first such authorization for oral nicotine products that do not contain tobacco. The decision has been called a "dangerous precedent" by public health groups.[1].

Philip Morris, which acquired Zyn parent company Swedish Match in a $16 billion deal in 2022, continues to invest in scaling up production of nicotine pouches.

Authorized but regulated products

The FDA approval comes after a rigorous scientific review process. The agency said Zyn products have a “substantial reduction” in toxic chemicals compared to traditional tobacco products and pose minimal risks to nonusers, including youth. However, the FDA stressed that these products are not risk-free and should only be used by adults trying to quit smoking.

The agency's Center for Tobacco Products director, Brian King, defended the decision, saying the authorization came with major marketing restrictions to limit appeal to youth. “We have put in place safeguards to ensure that these products are marketed responsibly.”, King said. Zyn's packaging and advertising must avoid any images or messages that could appeal to minors, and Swedish Match is required to conduct postmarketing surveillance to detect potential misuse (by youth or nonsmokers). In addition, the FDA plans to monitor rates of use among youth and could revoke the approval if misuse becomes common.

Products already sold without authorization

According to industry data, Zyn already holds 70 % of the US nicotine pouch market and analysts predict that the market for oral nicotine products could grow significantly following the FDA decision. This could change the landscape of nicotine consumption in the US. The global nicotine pouch market is expected to surpass $10 billion by 2030, driven by growing consumer demand.

As of April 2024, the FDA has sent more than 100 warning letters and filed civil complaints seeking to penalize retailers involved in selling ZYN nicotine pouches to minors.[2]. Last December, Swedish Match North America (a Philip Morris subsidiary) has been ordered to pay $1.2 million in an investigation into violations of the ban on flavored tobacco and nicotine products, including ZYN pouches, in Washington state.[3].

Products that are not without risk

Organizations such as the Campaign for Tobacco-Free Kids criticized the decision, saying flavored nicotine products could attract young consumers. "This decision sets a dangerous precedent," said Matthew Myers, the organization's president. "While these products may pose lower risks to current smokers, the flavors and marketing around these products could undermine decades of progress in reducing nicotine addiction among youth."[4] he declared.

In recent months, tobacco and nicotine product control advocates have warned that nicotine pouches could follow the same path as e-cigarettes, which have created an “epidemic” of vaping among U.S. teens. They point to videos of young people smoking Zyn and other pouches, which have racked up millions of views on social media platforms.

Public health experts also question the long-term safety of nicotine pouches. Although these products are free of many of the carcinogens found in combustible tobacco, nicotine itself is highly addictive and poses cardiovascular risks. Research from the National Institute on Drug Abuse has also highlighted the potential of flavored nicotine products as a gateway to other forms of smoking.

A laboratory study conducted last December by INC-60 Million Consumers and the National Committee Against Smoking in France analyzed several brands of nicotine pouches, including the ZYN brand. In addition to high levels of nicotine, the analyses showed the presence of heavy metals, including arsenic, lead and antimony, as well as high levels of sweeteners such as sucralose.[5].

A new communication opportunity for tobacco manufacturers

While today's action allows these products to be legally marketed in the United States to adults 21 and older, the FDA emphasizes that this authorization does not mean that these tobacco products are safe, nor that they are "FDA approved." Aside from pharmaceutical nicotine products for which the benefit/risk is well known, there are no safe tobacco or other nicotine products. The agency reiterates in its statement that young people should not use these products and that nonsmoking adults should not introduce themselves to these nicotine pouches.

There are indeed precedents for a decision to authorize the marketing of a tobacco manufacturer's product. In 2020, Philip Morris' heated tobacco device IQOS was granted "modified risk product" status by the FDA. The manufacturer then changed its marketing pitch for the brand of this product. It literally hijacked the FDA's decision for the purpose of promoting a "reduced risk" product. The manufacturer's messages then highlighted reduced exposure to hazardous ingredients, and marketing actions with incentives to switch from traditional cigarettes to heated tobacco were widely developed.

This presentation strategy was not limited to the United States but was also deployed in other countries with the FDA's decision for this product presented as an approval of the product by the health agency. The product was thus massively promoted as being "safer" than traditional cigarettes. In France, PMF quickly welcomed the FDA's decision in a press release and affirmed the existence of a "independent international scientific consensus" on the lesser danger of IQOS. The cigarette manufacturer added that "The FDA concluded that IQOS is intended to benefit the health of the general population, both for users of tobacco products and [for] people who do not currently use tobacco products." ". In fact, the World Health Organization points out that there is no evidence that heated tobacco is less harmful than conventional tobacco products.[6].

AE

[1] Press Release, FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review, FDA, published January 16, 2025, accessed January 17, 2025

[2] Tobacco-free generation, FDA Warns Retailers Against Selling Philip Morris ZYN Nicotine Pouches to Minors, published on April 9, 2024, consulted on January 17, 2025

[3] Tobacco-free generation, United States: Philip Morris fined $1.2 million for illegal sale of flavored nicotine pouches, published on December 19, 2024, consulted on January 17, 2025

[4] Press release, FDA Authorization of Flavored Zyn Products Ignores Appeal to Kids and Risks Another Juul, CTFK published January 16, 2025, accessed January 17, 2025

[5] Press release, The CNCT and the INC/60 Million Consumers reveal the results of their study: lead and arsenic found in nicotine pouches, CNCT, published on December 10, 2024, consulted on January 17, 2025

[6] Press release, IQOS: Philip Morris France's deceptive and illegal offensive, CNCT, published on July 16, 2020, consulted on January 17, 2025