How Can Vaping Devices Enter the U.S. Market Without Falling Into FDA Application Pitfalls? (Save Th

What is the FDA?

The FDA stands for the U.S. Food and Drug Administration, an international authority on medical review, authorized by the U.S. Congress and the federal government, responsible for the highest enforcement of food and drug management.
 
The FDA is a government health regulatory agency composed of professionals such as doctors, lawyers, microbiologists, pharmacologists, chemists, and statisticians dedicated to protecting, promoting, and improving public health.

Foods, drugs, cosmetics, and medical devices certified by the FDA are ensured to be safe and effective for human use. In the U.S. and nearly a hundred other countries, only materials, devices, and technologies approved by the FDA can be commercially applied in clinical settings.

It is worth noting that on June 22, 2009, the U.S. passed the Family Smoking Prevention and Tobacco Control Act, which first granted the FDA the authority to regulate traditional tobacco products. On May 10, 2016, the FDA issued the Deeming Regulation, which took effect on August 8, 2016, officially bringing e-cigarettes under the regulation of tobacco products. The FDA can legally regulate e-cigarettes, including components and parts, but not accessories.

This means that if Chinese e-cigarette products want to export to the U.S. market, they must go through the Premarket Tobacco Application (PMTA). However, the PMTA approval process is extensive and complex; for example, IQOS took two years to obtain approval, while JUUL, the world's largest e-cigarette brand, has yet to pass its application.

To help Chinese e-cigarette companies understand the FDA application process and find ways to expedite approval, on August 2, a technical seminar for the Guangdong e-cigarette shared laboratory was held, organized by Tianjian Testing. They invited Dr. Zhang Ruijin, a consultant from the Taiwan Health Department, a professor at Tsinghua University, and an FDA consultant, along with technical experts, manufacturers, and key technical personnel from the e-cigarette industry to discuss FDA-related issues and help everyone avoid the "pits" of the FDA application process.
 
There is no such thing as a "designated laboratory" by the FDA

The FDA is an enforcement agency, not a service agency. Therefore, the FDA does not have public service certification agencies or laboratories, nor does it have so-called "designated laboratories." As a federal enforcement agency, the FDA cannot engage in activities that involve being both the referee and the player.

The FDA will only recognize the GMP quality of service testing laboratories and issue certificates to qualified ones, but it will not "designate" or recommend specific testing institutions to the public. Companies only need to provide various test reports to the FDA to prove the safety of their products, and FDA experts will carefully assess the authority of the institutions and the authenticity of the reports. However, so far, no testing company can test all the items that require FDA certification.
 
No need to test all items required by the FDA

Although there is still limited testing data for e-cigarettes, unlike traditional tobacco products that have accumulated a lot of testing data and reports for reference, currently, no e-cigarette company has passed the PMTA, and even JUUL, which is prevalent in the U.S. market, has not yet passed the PMTA and is even facing removal from the market.

However, experts suggest that manufacturers do not need to conduct all tests; some data can be substantiated through literature and past relevant data. This not only saves testing costs but also significantly reduces time costs.

For example, to prove the healthiness of e-cigarettes, comparisons can be made with traditional tobacco, for which there is ample testing data available, eliminating the need for new tests.

It is important to note that when providing evidence, e-cigarette companies must submit direct evidence and avoid submitting bridging evidence (i.e., indirect evidence). If the FDA receives bridging evidence, it will need to submit it to the scientific committee for comprehensive review, which will consume a lot of time.
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Any CNAS-certified testing institution is qualified to provide direct evidence, such as Tianjian Testing Service, which has such qualifications. However, relying on a single laboratory cannot provide all testing certifications; collaboration with other laboratories is necessary for greater effectiveness.
 
E-cigarette products without FDA certification can still be sold

Compared to the EU, Japan, and South Korea, the U.S. market is relatively open. Even without FDA certification, e-cigarette products can still be sold in the market until your PMTA is rejected. However, once the PMTA is rejected, the product must be removed from the shelves.
 
Two possible reasons for e-cigarette products being removed from the market

Generally, e-cigarette products are removed from the U.S. market for two reasons: 1. Failure to submit the PMTA application within the specified time. 2. After submission, the PMTA application is not approved by the FDA.
 
It is essential to prove that e-cigarette products will not be sold to minors

The FDA places great importance on the question of whether "protecting public health is beneficial." Therefore, e-cigarette testing reports must include studies and surveys on issues such as whether the likelihood of existing smokers quitting will increase or decrease, whether non-smokers are more likely to start using the product, and whether the likelihood of existing users switching to higher-risk products will increase or decrease.

Here’s a tip: If you include restrictions in your application report, such as "we do not wish to sell to minors under 18" or "prohibit sales in middle schools," it will be easier to gain FDA approval.
 
The FDA will complete the review within 180 days

After a company submits a PMTA application, the FDA will complete the review and respond within 180 days. During the review period, if the FDA finds defects in the materials, the applicant will be required to continue supplementing the materials. At this time, the 180-day review period will be paused until the materials are fully resubmitted. If the application is rejected, the PMTA process stops, and the company must wait 2-3 years to reapply.

Conclusion

In summary, getting e-cigarettes into the U.S. market and obtaining FDA approval is a time-consuming, labor-intensive, and costly process, but it is something that e-cigarette companies must undertake.

It is reported that IQOS took four to five years from preparation to application to obtain PMTA approval, and JUUL has been applying but has yet to pass. Additionally, the deadline for submitting PMTA for e-cigarette products was August 8, 2021, so companies in need should prepare their applications as soon as possible.

The U.S. is a highly regulated society, and everyone must follow the rules to avoid future troubles. Violating regulations can lead to endless problems. Meanwhile, Tianjian Testing is also collaborating with various parties to find more ways to help e-cigarette companies successfully enter the U.S. market, so let’s wait and see.