Two Supremacy Special Report | Chinese practitioners and experts comment on ZYN's first US PMTA authorization: it will greatly enhance the market acceptance of nicotine pouches and accelerate the global compliance trend

Two Supremacy Special Report | Chinese practitioners and experts comment on ZYN's first US PMTA authorization: it will greatly enhance the market acceptance of nicotine pouches and accelerate the global compliance trend

On January 17, the U.S. FDA approved 20 ZYN nicotine pouch products for sale for the first time. This move marks a key step for the FDA in the field of scientific regulation of new tobacco products. In response to this incident, 2Firsts questioned many Chinese nicotine pouch industry practitioners and experts in this field.
On January 17, 2025, the U.S. Food and Drug Administration (FDA) approved 20 ZYN nicotine pouch products for sale for the first time. This is the first time that nicotine pouch products have been authorized by PMTA. This decision was made by the FDA after a strict review, marking an important step for the FDA in the scientific regulation of new tobacco products. (Related reading: The U.S. FDA authorized nicotine pouch products for sale for the first time, and 20 ZYN nicotine pouches were approved)

In response to this incident, 2Firsts questioned many Chinese nicotine pouch industry practitioners and experts in this field to gain a deeper understanding of the impact of this FDA move on the nicotine pouch market.

The following are the opinions of experts:

Li Youqiang, founder of Shenzhen Tuwu Enterprise Management Co., Ltd. and senior expert in the field of nicotine bags

Li Youqiang has experience in establishing and operating overseas factories for nicotine bags

First, the FDA has only approved ZYN products with nicotine concentrations of 3 mg and 6 mg, which shows that the FDA believes that low-concentration nicotine products are less harmful to the human body and have more significant harm reduction effects. Therefore, even if ZYN applied for a 9 mg product, the FDA did not approve it.

Secondly, in terms of flavor, the FDA approved 10 flavors of products, including multiple non-tobacco flavors, which is significantly different from the restrictions on e-cigarettes. This means that the FDA believes that the flavors of nicotine bags are less attractive to teenagers than other tobacco products.

Furthermore, nicotine bag products are allowed to be advertised to a certain extent, which is a real benefit in my opinion. Because all other tobacco products are actually not allowed to be advertised, this reflects the FDA's more friendly attitude towards nicotine bag products compared to other tobacco products, such as e-cigarettes and heated tobacco, and is also the key.

Regarding the impact of this move on the US and global nicotine pouch market: First, this move will promote the trend of oral nicotine products transforming into new tobacco. There are three main ways to regulate nicotine pouches worldwide: classify them as tobacco products, medicines, and ordinary consumer products. Represented by the United States, Canada, Australia and other countries regard them as medicines, while the United Kingdom, Dubai, Pakistan and other places manage them as ordinary consumer products. But whether in the United States or globally, the core trend is to transform oral nicotine products (such as chewing gum, gel, orodispersible film, etc.) from medicines to new tobacco, and this move by the FDA may accelerate this transformation.

Second, this move provides a scientific review basis and reference for global new tobacco regulation. The content of the FDA review, including relevant content such as harmfulness indicators, can provide many references for the global regulation of new tobacco categories and promote the transformation of this product worldwide. After all, the FDA has made it clear that this product is much less harmful than many tobacco products.

For Chinese nicotine pouch manufacturers, I suggest that they should pay attention to the technology of nicotine pouch production. Since the core of the FDA's entire review is the degree of harm of the product, Chinese companies should pay more attention to technological improvement, strictly control the harm of the product, and reduce the harm of nicotine bags to the human body.

Vic, CMO of Hong Kong Yutu

Hong Kong Yutu is a nicotine bag brand service provider

As the world's authoritative health regulatory agency, the FDA's approval is of great significance. It not only means that the product safety is officially recognized, but also points the way for the compliance development of the industry. ZYN's successful compliance experience is expected to encourage more brands to learn from its path, quickly enter the market to meet consumer needs, and promote the industry in a healthier and more standardized direction, providing guarantees for the legalization and standardization of the global nicotine bag market.

Regarding the impact of this measure on the US and global nicotine bag markets, I believe that as an important global consumer market, the approval of the United States will greatly increase the market's acceptance of nicotine bags, especially for consumers seeking tobacco alternatives. This not only lowers the market entry threshold and attracts more brands to enter, but also prompts more countries and regions to re-examine and adjust regulatory policies. ZYN's compliance path provides a reference for the world, helping more companies to complete compliance and promote market maturity and expansion. In addition, the approval of non-tobacco flavors will also attract more consumers and promote the diversification of the market.

The FDA's approval has indeed changed my expectations for the development of the nicotine bag industry in 2025. This decision has created a better regulatory environment, allowing more brands to enter the market legally. As market demand grows, product diversification and innovation will become the focus of industrial development, the enthusiasm of enterprises for R&D and production will be stimulated, and the competitiveness of the industry will be further enhanced. In the next few years, the industry will usher in a more standardized and mature development stage.

In the face of this new situation, we will take two measures for the US market. The first is to carefully polish products that are more in line with US compliance requirements, simplify the flavor and content system, and efficiently promote the compliance process with the help of cooperation with professional institutions. The second is to help more partners who intend to enter the US market complete compliance.

Hou Weifeng, General Manager of Suzhou Changqi Plastic Moulding Products Co., Ltd.

Suzhou Changqi is China's leading nicotine bag product packaging supplier

We believe this is good news for the market and represents an official recognition of nicotine bag products. This recognition will also form a consumer consensus and help the sales of such products. This move will not change our expectations for the market, but will strengthen our confidence in the market. At the same time, we will keep up with this trend and achieve compliance in the supplier system as soon as possible to ensure that our products meet the strict standards of the FDA.

Jiang Wenqi, general manager of the New Consumption Research Center of Cinda Securities Research Institute, and Li Chen, analyst

The New Consumption Research Center of Cinda Securities Research Institute has long been concerned about the research of the new tobacco industry

We believe that the logic of FDA in PMTA review is becoming clearer and clearer, which has a strong guiding significance for both Smoore and other applicant companies in the future. Although nicotine bags have grown rapidly in the past two years, and there is even a trend of disposable small cigarettes, the FDA has clearly pointed out that the benefits of nicotine bags to adults outweigh the disadvantages to minors. This shows that the FDA is not banning all popular products, but is truly starting from the perspective of social health balance. This reinforces a point of view: as long as the brand can provide evidence, the FDA will give full consideration.

In addition, this approval not only includes tobacco and menthol flavors, but also popular flavors such as coffee and mint. This fully shows that flavor is not an absolute restriction, but only a parameter to be considered. This has a very positive directional significance for future atomization and heat-not-burn (HNB) products.