With the implementation of the much-feared PreMarket Tobacco Application (PMTA) guideline on September 9th, there is still a bit of grey area for many vape retailers.
The global e-cigarettes market is expected to grow to a worth of USD 67.31 billion by 2027. As with any other product with unspecified potential risks, FDA is all set to scrutinize the vape industry critically. Both, the new entrants and established manufacturers, would have to re-align their production process per GMP guidelines. Even though the PMTA deadline period has passed, many retailers and producers aren’t fully aware of the risk management requirements.
If you are looking forward to a successful vape product launch by staying compliant with the FDA regulations, you need to know about PMTA in more detail.
An Introduction to the PMTA Modules
A court required all the tobacco-deemed product manufacturers to receive a PMTA authorization before they can engage in any business activities in the US. So, what do the convenience store retailers and certified distributors need to know about it?
The initial date of implementation of the PMTA process was set for May 12th. Due to complications related to the COVID-19 pandemic, many manufacturers failed to make preparations within that period. This is the reason they requested the FDA to extend the deadline. So, the US District Court permitted to delay the deadline to September 9th, 2020.
There are 7 distinct modules on which the entire PMTA is based. All the vape retailers need to know about them don’t want to get blacklisted in the legal US market.
Module 1: This module is concerned with administrative data, marketing outline, and product-specific details.
Module 2: This section should provide an integrated summary regarding the data taken from Module 3 to Module 7. Also, it should have a detailed summary of the target market for the proposed tobacco product.
Module 3: This section addresses product shelf life and Harmful and Potentially Harmful Constituents (HPHCs) data.
Module 4: This module includes the nonclinical impact of the product, such as ingredients and HPHCs.
Module 5: This section is mainly directed towards clinical abuse liability, the addictiveness of the product, and risks associated with the misuse.
Module 6: This module looks at health risks associated with the use of the proposed product using population modeling. It also gives details about post-market surveillance and research plan.
Module 7: This model contains an environmental impact assessment. Also, it tells about the mitigation procedures that can help minimize those negative environmental effects.
Who Should File a PMTA?
If you manufacture electronic nicotine delivery systems (ENDS) that are deemed “new tobacco products”, then you will have to apply for a PMTA.
A new tobacco product is:
- A tobacco product that was not officially sold in the US as of February 15, 2007.
- A tobacco product that went through any modification after February 15, 2007. Some examples of alterations in the product include a change in its design, part, or any component, or the nicotine percentage by volume.
There is also another facet to this regulation: grandfathered tobacco products. This refers to products that were officially released on the exact date of February 15th, 2007. For these products, the manufacturers don’t have to wait for an authorization certificate before they can sell them in the legal market.
The vape producers also have to take this into account that this rule is not only applied for the manufacturing of electronic cigs but also e-juices. You can get your entire product line of different vape flavors approved by the FDA in a single PMTA file.
What Does a PMTA Submission Include?
There is a ton of legal jargon involved when it comes to submitting for your PMTA approval.
The main guidelines for FDA authorization for ENDS are mentioned below:
Under the Tobacco Control Act, the certified manufacturers should be able to show a net benefit that the public can avail of using their products.
This means you would be required to come up with convincing evidence that your electronic cigs would help promote smoking cessation. You would also have to apply for lab tests that would find out the potential health risk of using those alternate smoking products.
This health research should also include the implications of these new tobacco products on non-users’ health and wellbeing. In most cases, you would have to run your vape devices through lab tests. Once they are deemed safe for public use, you would have high chances of being approved.
Complete Statement of Ingredients and Components
The manufactures are required to come up with a detailed list of all the additives and ingredients used in vape juices.
Similarly, for vape pods mods and pens, you would have to mention all the parts that are uniquely identified within a unit. Also, the manufacturers have to ensure that they mention accurate readings related to volume and capacity.
Product and Label Samples
Each product sample you submit should be accompanied by a related cover letter that includes all the product details.
In the cover letter, you would have to include various shipping-related guidelines, such as shelf life and recommended storage criteria. This would ensure smooth processing and inspection of your product.
Upon receiving your samples, the FDA holds its right to perform further testing on its own. So, you should send a sufficient number of samples that can undergo the trial phase within a lab.
Most vape manufacturers and distributors have spent a fortune in this business given its future potential and growth projections.
With the implementation of rules like the PMTA, all the stakeholders are willing to go to any length to break any unjust law. The coming months would act as key indicators of how electronic vape devices and nicotine juices go through the FDA approval process.
The good news for vape manufactures is that these rigorous testing obligations might further strengthen the brand image and legal paperwork. We are all set to enter the new era of vaping starting from September 10 onwards. Vladdin have submitted our Vladdin Chopin, Vladdin Vantage, Vladdin X to PMTA review, our submission documents has been successfully received by FDA.