2Firsts Feature | Chinese Entrepreneurs and Experts Discuss ZYN’s 1st PMTA Approval: Boosting Market Acceptance of Nicotine Pouches and Accelerating Global Compliance Trends

On January 17, 2025, the US Food and Drug Administration (FDA) for the first time approved 20 ZYN nicotine pouch products for sale, marking the first time nicotine pouch products have received PMTA authorization. The decision, made after a rigorous review by the FDA, signifies a significant step forward in the FDA's scientific regulation of novel tobacco products. (Related reading: FDA Grants First-Ever Authorization for Nicotine Pouch Products, Approves 20 ZYN Variants)

In response to this event, 2Firsts conducted inquiries with multiple nicotine pouch manufacturing companies in China and several experts in the field, with the aim of gaining a deeper understanding of the impact of FDA's measures on the nicotine pouch market.

Here are the expert opinions:

Li Youqiang

Founder and Senior Expert in the Field of Nicotine Pouches

Shenzhen Tuwu Enterprise Management Co., Ltd.

Li Youqiang is experienced in founding and operating overseas nicotine pouch manufacturing factories.

The FDA has only approved ZYN products with nicotine concentrations of 3mg and 6mg, indicating that the FDA believes low nicotine concentration products pose less harm to the body and have a more pronounced harm reduction effect. Therefore, even though ZYN applied for a 9mg product, the FDA did not approve it.

Furthermore, in terms of flavors, the FDA has approved products with 10 different flavors, including several non-tobacco flavors, which is clearly different from the restrictions on e-cigarettes. This means that the FDA believes that the appeal of nicotine pouch flavors to adolescents is lower than other tobacco products.

Furthermore, nicotine pouch products are allowed to conduct a certain level of advertising, which I believe is a true advantage. This is because all other tobacco products are actually not allowed to advertise, indicating the FDA's more favorable attitude towards nicotine pouch products compared to other tobacco products such as e-cigarettes and heated tobacco, which is crucial.

Regarding the impact of this measure on the nicotine pouch market in the United States and globally: Firstly, this measure will drive the trend of transitioning oral nicotine products to new tobacco alternatives. There are primarily three regulatory approaches to nicotine pouches globally: categorizing them as tobacco products, pharmaceuticals, or regular consumer goods. Represented by the United States, countries like Canada and Australia classify them as pharmaceuticals, while countries like the UK, Dubai, and Pakistan categorize them as regular consumer goods. However, whether in the US or globally, the core trend is towards transitioning oral nicotine products (such as gums, gels, and dissolvable films) from pharmaceuticals to new tobacco alternatives, and FDA's measure may accelerate this transition.

Furthermore, this measure provides a scientific basis and reference for global regulation of new tobacco products. The content reviewed by the FDA, including harm indicators and other related information, can offer valuable insights for regulating new categories of tobacco products globally, promoting their adoption worldwide. After all, the FDA has already made it clear that these products are much less harmful than many traditional tobacco products.

For Chinese nicotine pouch manufacturers, I recommend prioritizing the technology used in the production of nicotine pouches. Since the core of the entire FDA review is the product's harmfulness, Chinese companies should focus on improving their technology, rigorously control the harmfulness of their products, and reduce the harm of nicotine pouches on the human body.

Vic

Chief Marketing Officer 

HongKong Jadehare Biotechnology Co.,Limited

HongKong Jadehare Biotechnology Co.,Limited is a well-known brand of nicotine pouches.

The approval by the FDA, as a globally recognized health regulatory agency, is significant. It not only signifies official recognition of product safety, but also provides guidance for industry compliance and development. The successful compliance experience of ZYN is expected to encourage more brands to follow its path, quickly enter the market to meet consumer demands, and drive the industry towards a healthier and more standardized direction. This will provide assurance for the legalization and standardization of the global nicotine pouch market.

Regarding the impact of this measure on the nicotine pouch market in the United States and globally, I believe that the approval in the US, being a major consumer market globally, will greatly increase acceptance of nicotine pouches in the market, especially among consumers seeking tobacco alternatives. This not only lowers the market entry barriers, attracting more brands to enter, but also prompts more countries and regions to reexamine and adjust their regulatory policies. The compliance path of ZYN provides a reference for the global market, helping more companies achieve compliance and promoting the mature expansion of the market. In addition, the approval of non-tobacco flavors will also attract more consumers and drive diversified development in the market.

The FDA's approval has indeed changed my expectations for the development of the nicotine pouch industry by 2025. This decision has created a more favorable regulatory environment, allowing more brands to enter the market legally. With the growing market demand, product diversification and innovation will become the focus of industry development. The enthusiasm for research and development and production by companies will be stimulated, and industry competitiveness will be further enhanced. In the coming years, the industry will see a more standardized and mature development stage.

In response to this new situation, we will take two measures targeted at the U.S. market. The first is to carefully refine products that better meet U.S. compliance requirements, simplify flavors and content systems, and efficiently advance compliance processes through collaboration with professional organizations. The second is to support more partners who are interested in entering the U.S. market to complete compliance.

Hou Weifeng

General Manager

Suzhou Changqi Plastic Mold Products Co., Ltd.

Suzhou Changqi is a leading supplier of nicotine pouch packaging solutions in China.

We see this as positive news for the market, representing an official acknowledgment of nicotine pouch products. This recognition will also create consumer consensus and boost sales of these products. This move will not change our expectations for the market but instead reinforces our confidence in it. At the same time, we will keep up with this trend and swiftly work towards compliance within the supplier system to ensure our products meet the strict standards of the FDA.

Jiang Wenqiang 

General Manager 

Li Chen 

Analyst 

New Consumer Research Center at Cinda Securities Institute

Cinda Securities Research Institute's New Consumer Research Center is a long-term researcher in the NGP industry.

We believe that the logic of FDA's PMTA review process is becoming increasingly clear, which has strong guiding significance for both Smoore and other applicant companies in the future. Despite the rapid growth of nicotine pouches in the past two years, and even a trend towards disposable e-cigarettes, FDA has clearly pointed out that the benefits of nicotine pouches to adults outweigh the harms to minors. This indicates that FDA is not banning all popular products, but truly considering from the perspective of social health balance. This reinforces a viewpoint: as long as brands can provide evidence, FDA will give full consideration.

In addition, the approved flavors in this case do not only include tobacco and mint, but also cover popular flavors such as coffee and mint. This clearly shows that flavors are not absolutely restricted, but just one parameter to consider. This has very positive implications for the future of vaporized and HNB (Heat-Not-Burn) products.

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