FDA historically approves ZYN nicotine pouches, and the global regulatory framework for harm reduction products emerges

Introduction : On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced the approval of 20 ZYN nicotine pouches from Philip Morris International (PMI) for marketing, and determined that they "have a lower cancer risk than cigarettes and snus." This is the first time that the FDA has issued an official safety conclusion on nicotine harm reduction products, providing an important reference for global regulation.

Behind the approval: scientific evidence rewrites industry cognition

The FDA's approval is based on 12 years of research data submitted by PMI, which shows that the exposure of ZYN users to harmful ingredients is more than 95% lower than that of cigarettes, and no new health risks have been found. It is particularly pointed out that "adults who switch from cigarettes to ZYN can benefit", and this conclusion subverts the traditional perception that "nicotine is harmful".
After the news was announced, PMI's stock price rose 1.7% on the day, and the increase in the past year reached 27%, highlighting the confidence of capital in the harm reduction track. During the same period, Chinese companies such as Xinnuo Technology accelerated FDA certification applications, and the nitrosamine content of their oral film products has been controlled below 0.1ppm, reaching the same level as ZYN.

Regulatory chain reaction: Different policies in different countries

· The US loosens up while the EU tightens up : FDA approval opens the door to the US market, but the EU immediately initiates the revision of the "Guidelines for the Regulation of New Tobacco Products", intending to include nicotine pouches in the management of pharmaceutical products;

· Opportunities in emerging markets are emerging : Traditional tobacco-consuming countries such as Indonesia and Russia are open to harm reduction products. PMI has launched ZYN products with localized flavors in Indonesia, with sales increasing by 34% in 2024.
"Regulatory differences are forming new market barriers." Analysts at investment bank Jefferies pointed out that companies with multi-country compliance capabilities will have the upper hand.

Industry impact: from "barbaric growth" to "compliant competition"

FDA approval marks the entry of harm reduction products into the "scientific regulatory era". It is expected that more than 50 nicotine pouches/oral film products will apply for listing in the next three years. But at the same time, the risk of adolescent use has become a regulatory focus – FDA requires PMI to implement measures such as "child-resistant packaging" and "prohibition of marketing to minors" for ZYN.

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