Exclusive interview with compliance expert: NJOY menthol e-cigarette passing PMTA is of great significance; FDA is expected to open multi-flavor review within 3 years

Exclusive interview with compliance expert: NJOY menthol e-cigarette passing PMTA is of great significance; FDA is expected to open multi-flavor review within 3 years

Zheng Zhi, a senior PMTA certification consultant and founder of Ziyuan Technology, believes that the FDA's approval of menthol e-cigarettes is a positive signal, indicating that multi-flavor e-cigarettes are showing a good development trend in the United States. He expects that in the next 2-3 years, the FDA will relax the review restrictions on multi-flavor products.

 

On June 21, local time in the United States, the U.S. Food and Drug Administration (FDA) issued a marketing authorization order (PMTA) to NJOY LLC for four mint-flavored e-cigarette products-NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5% and NJOY DAILY EXTRA Menthol 6%. This is the first time that the FDA has approved menthol e-cigarettes. (Related reading: The U.S. FDA approved the first batch of menthol e-cigarettes for sale in the United States, all of which are NJOY products)

 

NJOY is one of the largest e-cigarette manufacturers in the United States. In 2023, it was acquired by Altria Group, a tobacco giant that produces the Marlboro brand, for approximately US$2.75 billion.

 

What does the FDA's first decision to approve NJOY's menthol e-cigarettes mean? Taking this as a node, what impact and benefits will the development of Chinese e-cigarette companies facing the US market in the future? With these questions, 2FIRSTS communicated with Zheng Zhi, a senior PMTA certification consultant and founder of Ziyuan Technology.

 

Zheng Zhi believes that the FDA's approval of menthol e-cigarettes is a positive signal, indicating that multi-flavor e-cigarettes are showing a good development trend in the United States. He expects that in the next 2-3 years, the FDA will relax the review restrictions on multi-flavor products.

At the same time, this approval means that individually packaged e-liquid products are expected to be approved in the near future, which means that open products are expected to obtain PMTA.

 

In addition, international tobacco companies such as British American Tobacco, Altria, and JUUL insist on applying for PMTA, with the intention of not only promoting specific products, but also "opening the door", establishing a close relationship with the FDA, building an approval process, accelerating the listing of their products, and entering the huge US market. Therefore, this approval also provides some inspiration for Chinese companies, encouraging them to have a long-term vision to plan for the future.

 

The following is the content of the interview:

 

2FIRSTS: What do you think of the US FDA's decision to approve NJOY's menthol e-cigarette for the first time? Does this mean that the FDA's attitude towards the e-cigarette industry is changing?

 

Zheng Zhi: It has been five years since the FDA required companies to submit PMTA. It has been about three years since the first tobacco-flavored e-cigarette was approved. The FDA's decision to approve NJOY's menthol e-cigarette for the first time proves that the FDA has not given up on PMTA as the cornerstone of e-cigarette regulation, but is slowly but constantly improving it.

 

Moreover, the approval of menthol this time also sends out two specific clear signals: The first signal is that the FDA is still a technology-based approval agency. As long as the technical requirements and safety standards are met, the products applied by the company can be approved. The FDA and the United States will not consider introducing a comprehensive "package ban".

 

The second signal is that although it takes time, the FDA will relax the review of multi-flavor e-cigarette products. It is expected that in the next 2-3 years, the FDA will relax the review of multi-flavors.

 

I think that the FDA has always been an approval agency with "70% technology and 30% politics", and there must be a theoretical basis for making this decision. The TPLs (Technical Approval Documents) approved this time are all publicly available, and it can be seen that these four e-cigarettes were approved because there were no toxicological and clinical problems, not because of the NJOY brand.

 

2FIRSTS: What positive significance does this decision have for the e-cigarette industry?

 

Zheng Zhi: At present, the e-cigarette industry has a clear trend of preference for multiple flavors.

 

JUUL, which was once fined for "flavors attracting teenagers", spent billions of dollars to settle. A few years later, the FDA also slowly changed its attitude of "talking about flavors" and turned to normal review and loosened the restrictions on flavors. It is understood that the clinical trials led by the FDA will effectively prove that multiple flavors help adults quit smoking. Therefore, this decision will enable the e-cigarette product line to meet consumer needs to the greatest extent without forcibly separating it from market preferences.

 

In addition, this approval means that individually packaged e-liquid products are expected to be approved in the near future, which means that open products are expected to obtain PMTA.

 

In terms of technology, functions such as age recognition are constantly improving. The regulatory focus of regulators is no longer to restrict e-cigarettes under the pretext of focusing on protecting teenagers, but to focus on the safety of the product itself.

 

Chinese companies are particularly "competitive". In the past few years, although they actively sought compliance to innovate products at the beginning, they seem to have gradually given up hope for the US market due to the unsuccessful progress of PMTA in recent years, and chose a short-term strategy, that is, to engage in small-batch production and "make a quick buck". However, this strategy is bound to make them eliminated in the long run.

 

However, it is worth looking at the world. International tobacco companies such as British American Tobacco, Altria, and JUUL insist on applying for PMTA. Their intention is not only to promote specific products, but also to "open the door", establish close relations with the FDA, build approval processes, accelerate the listing of their products, and enter the huge US market. Therefore, this approval also provides some inspiration for Chinese companies, encouraging them to have a long-term vision to plan for the future.

 

2FIRSTS: Does this approval mark a new stage in the regulation of the e-cigarette industry?

 

Zheng Zhi: This approval is a good signal that PMTA, as the main standard for the regulation of the US e-cigarette market and products, will not be abolished. This also means that the United States will not adopt a one-size-fits-all regulatory approach and implement strict bans like some countries, but will use strict technical requirements as the standard for product listing.

 

In addition, more specifically, open products are not excluded. When the PMTA regulations were first established, open, disposable and closed products were all included. In recent years, some people have believed that open products and e-liquids may be excluded, but this approval shows that such concerns are unnecessary. This also indicates that PMTA is gradually stabilizing, and some small parameters may be improved in the future, but large product categories will not be affected.

 

As for the impact of political factors in the FDA's "7 points technology, 3 points politics", it involves differences between the two parties in the United States. The Democratic Party is generally negative about e-cigarettes, while the Republican Party is more supportive. It usually takes several years to improve regulatory policies, and how political factors such as annual elections will affect the regulatory attitude of the US e-cigarette industry needs to be observed.

 

2FIRSTS: What does this approval mean for other Chinese e-cigarette brands? What are the impacts? Do you have any suggestions for them?

 

Zheng Zhi: The direct impact of this product approval is that NJOY is manufactured by Chinese OEM factories, Heyuan and Smoore. These two companies have been inspected by the FDA before. According to FDA practice, factories that have been inspected and confirmed by the FDA will obtain review exemptions when producing products of the same category. Therefore, Heyuan and Smoore have gained significant benefits from this product approval: their OEM products have been approved by the FDA, which will make international tobacco brands more inclined to place orders with them, and it will be easier to pass PMTA based on their quality management level. At the same time, these manufacturers can also give full play to their advantages in quality management system and ODM services.

 

At present, the e-cigarette industry is still in a rapid development stage, with new functions, new technologies, and new materials emerging in an endless stream, and FDA regulations will be adjusted accordingly. We can see that the FDA has rapidly learned e-cigarette-related technologies in the past decade, hoping to shorten the approval time and improve clinical and toxicological standards. With the improvement of future standards, Chinese companies will face greater challenges in entering the market.

 

Therefore, I suggest that companies that are actively applying for PMTA should not give up their efforts and continue to seek approval; and companies that have not yet taken action should either speed up their pace to enter the market, or give up the pursuit of the US market and concentrate on being a foundry, or adjust their goals to small country markets and turn to OEM or ODM business.

 

2FIRSTS: In the future, what direction do you think FDA's supervision of the e-cigarette industry will develop in?

 

Zheng Zhi: FDA's supervision of the e-cigarette industry will tend to the standards of fields such as drugs and cosmetics, but this will take a long process. I expect that in the next 3-5 years, the PMTA system may be relatively complete, but it may take 7-8 years or even 10 years to reach the level of the pharmaceutical industry.

 

Unlike high-risk products such as drugs, the regulation of e-cigarettes may eventually be similar to cosmetics, some of which may be exempted from clinical trials, and at the same time, audit fees will be charged. The approval fee for a product may be between tens of thousands and hundreds of thousands of dollars. By raising the entry threshold, approval management is implemented. Therefore, when the FDA begins to charge PMTA review fees, it may mark that FDA's supervision of the e-cigarette industry is close to perfection.