In the past two months, the U.S. Food and Drug Administration (FDA) has issued two marketing authorization orders, one for four menthol cartridges of the NJOY brand and the other for seven e-cigarette products (batteries and cartridges) of the VUSE brand. The approval of the PMTA application for e-cigarettes after a year has allowed U.S. e-cigarette practitioners to see some positive results, and has once again made the PMTA application system a headline in the e-cigarette industry.
As we all know, if you want to legally sell new tobacco products in the United States, you must apply for PMTA, including atomized electronic cigarettes, heated tobacco products, nicotine bags, etc. For the US FDA, PMTA is an "effective" mechanism to control tobacco products; but for tobacco manufacturers (brands), sellers and other practitioners, it is "difficult to pass the PMTA application" because this "pass document" is too heavy .
In this article, we will unveil the mystery of PMTA application for readers and provide research materials and diverse perspectives.
1. The past and present of PMTA application PMTA is the abbreviation of "Premarket Tobacco Product Applications", which literally means "pre-market tobacco
product application". This product review system began in 2016 and has only been officially implemented for 5 or 6 years.
In 2016, the FDA issued regulations to include all electronic vaping products in the scope of tobacco products, and began to legally regulate new tobacco products, making a series of regulations on the production, import, packaging, labeling, advertising, promotion, and sales of new tobacco products.
In 2019, the FDA officially released the PMTA guidance document for e-cigarettes, which refers to e-cigarettes as electronic nicotine delivery systems (ENDS). According to the guidance document, ENDS manufacturers or importers must prove to the FDA that the marketing of new tobacco products will be suitable for protecting public health.
In 2021, the FDA released the final version of the PMTA guidance "Premarket Application and Recordkeeping Requirements for Tobacco", which will take effect on November 4, 2021. The final rule on PMTA specifies the content and format requirements of PMTA and requires manufacturers to keep records to ensure that their tobacco products are legally sold.
Since 2022, the FDA has successively issued marketing authorization orders (MGOs) involving e-cigarettes. These products are considered to have passed the PMTA application. However, the number of authorized products is just a drop in the ocean compared to the number of applications.
According to the FDA's official website, a total of 26 million PMTA applications were received before March 2023, of which more than 99% of PMTA applications have been decided, with rejection letters, rejection letters or marketing rejection orders issued for millions of products. The final review deadline has also been repeatedly delayed, from 2023 to 2024 and has not yet been completed.
As of July 2024, the FDA has authorized a total of 34 e-cigarette products and devices. These are the only e-cigarette products that can currently be legally marketed and sold in the United States, and any manufacture, import, sale, or distribution of e-cigarettes without the required pre-market authorization may be investigated and prosecuted by law enforcement.
2. PMTA review content and process
The FDA defines the original intention of setting up PMTA as protecting the public interest. Whether the information submitted in the PMTA is sufficient to prove that the product is appropriate for protecting public health when considering the risks and benefits of the entire population. Specifically, it means that the applicant provides evidence that these tobacco-flavored products may bring benefits to adults who smoke that are sufficient to offset the risks of the product, including the risks to teenagers.
Therefore, PMTA application mainly considers the following:
1) The risks and benefits to the entire population, including people who use the new tobacco product as well as non-users ;
2) Whether people who currently use any tobacco product would be more or less likely to stop using the products they currently use if the new tobacco product becomes available;
3) Whether people who currently do not use any tobacco product would be more or less likely to start using the product if the new tobacco product becomes available;
4) Whether the methods, equipment and control measures used to manufacture, process and package new tobacco products are harmful to health.
PMTA applications involve all new tobacco products. Taking e-cigarettes as an example, all parts and complete machines are within the reporting scope, such as e-liquids, smoking devices, sets and related accessories and parts.
According to the template requirements, the PMTA report must include seven modules, namely administrative information, summary, product description and manufacturing, non-clinical, clinical - the impact of the product on individual health, clinical - the impact of the product on group health and environmental impact.
After PMTA enters the review process, it can be roughly divided into 5 stages and 6 processes, namely pre-submission meeting, acceptance review, filing/record review, review of application, action/ruling and post-marketing requirements.
On the surface, the content of PMTA application is clear and the review process is standardized, but in practice it is still quite cumbersome and requires a lot of laboratory testing and experiments. Testing a product requires dozens of experiments, costing hundreds of thousands or even tens of millions of dollars in financial costs and thousands of hours of time.
Therefore, PMTA application has become a "game" for big brands and big companies to a certain extent, which can be seen from the ownership of the 34 authorized products. Only three brands, VUSE, NJOY and Logic, have been authorized, all of which are brands of international tobacco giants. Of course, these three brands cannot do without the support of Chinese supply chain companies, such as Smoore International.
In contrast, small and medium-sized brands cannot afford the high costs and lack laboratories, testing instruments and other hardware. For example, it is difficult for companies to conduct e-liquid composition testing and physical and mechanical performance testing on their own and they need to seek cooperation from third parties. Some companies claim to have invested hundreds of millions of yuan in PMTA applications for aerosol liquids, but have not yet seen an announcement of FDA authorization.
3. What will happen if you fail to pass PMTA?
As mentioned above, only 34 products have passed PMTA, and there are still a large number of products that have submitted applications but have not yet been reviewed, or have passed the initial review and entered the next round of review. For these products, the FDA will issue an application tracking number (STN number) according to the declaration sequence to help e-cigarette products clear customs smoothly when they are declared in the United States.
As the work of all parties deepens, the STN number cannot guarantee that a product will stay in the US market permanently and legally. Only obtaining an MGO (Marketing Authorization Order) is a real permanent solution. The STN number only guarantees that the product can be cleared smoothly when entering the US, but it will not play a role in future registration bills.
Currently, the PMTA registration bills in various states are being promoted in full swing. A PMTA whitelist will be established on a state-by-state basis to manage companies and products and to check non-PMTA products. In the future, comprehensive supervision will be implemented at both the federal (FDA) and state levels, and there is really not much time left for unauthorized products.
The FDA also has a variety of means to deal with unauthorized products on the market, usually taking actions such as warning letters, civil penalty complaints and bans, and the administrative effectiveness is gradually increasing. Recently, the number of warning letters and MDO information issued by the FDA has been increasing, and the enforcement efforts have been intensified and tightened. It is reported that the current enforcement focus of the FDA is on products that have obtained a marketing denial order (MDO) and have not yet submitted a PMTA application.
However, special attention is given to big brands, large companies or companies with high market share.
In view of this, it is recommended that companies with business in the United States should actively apply for PMTA to show the FDA their proactive compliance stance. Even if it has not been approved, the FDA will most likely ask the company to cooperate with supervision and maintain sales. If you receive a warning letter or a ban without applying, if you want to enter the US market again, you need to completely obtain MGO through PMTA, which basically means you are withdrawing from the US market.
In addition, Chinese supply chain companies should not pin their hopes on OEM for big brands. If big brands and big companies want to change OEMs, there is a lot of room for choice, and this operation is not complicated in the PMTA system. OEMs that lack core competitiveness will only have one option in the future: "involution".
In short, applying through PMTA is the only legal way to enter the US market in the future. As the final effective date is approaching, the US e-cigarette market will face a completely new regulatory environment. Before that, it will be the last fight for e-cigarette companies and brands.
Shenzhen Niimoo Innovative Technology Co., Ltd