Whether you’re a vaping veteran or you just started to vape recently, it’s hard to miss — the laws around vaping have changed at an astonishing rate since the FDA first started to regulate e-liquid and e-cigarettes in 2016. State and local legislatures brought laws into effect regarding everything from taxes and licensing to minimum age and signature requirements. Most importantly, at the federal level, there has been a change to something that affects the entire vaping industry — the PMTA.
- What is a PMTA?
- PMTA Requirements
- When are they due?
- How much do they cost?
- How PMTAs will affect you
Read more to find out more about the PMTA process and how it affects vaping as we now know it.
What is a PMTA?
PMTA stands for premarket tobacco product application. Any new tobacco product on the US market after February 2007 — essentially 99% of all vapor products— are legally required to go through the premarket tobacco application process.
Domestic manufacturers and importers of e-liquid and hardware need to submit PMTAs for products not commercially on the US market as of Feb. 15, 2007. FDA considers vape shops who mix their own “house juice” as manufacturers; therefore, vape shops which produce their own e-liquid in-house would also need to submit PMTAs. FDA must approve a product’s PMTA in order for that product to be legally marketed and sold in the United States.
A PMTA must demonstrate that a new tobacco product is appropriate for the protection of the public health (APPH), taking into account the risks and benefits to the population as a whole, including users and non-users of tobacco products.
Here are some of the requirements of a PMTA (Note: This is not an exhaustive list, and while FDA has provided guidance on the content of applications, FDA may also request additional information as needed):
- Product Samples and Labeling- Submission of product samples in order to conduct testing and analysis. The content of labels will be analyzed for any warning statements, text or graphic elements intended to identify the product and minimize risks associated with its use.
- Scientific Studies and Analyses- Submission of full reports of information concerning the health effects of the product.
- Product Analyses and Manufacturing- Specific information pertaining to the manufacture of the new tobacco product, standard operating procedures (SOPs) for manufacturing the tobacco product, etc.
- Principles of Operation- Description of how a consumer operates the product, how consumers could adjust the performance or add or subtract ingredients, and examples of the other types of electronic nicotine delivery system (ENDS) products with which the product can be used.
- Product Use Patterns- How individual users consume the product, frequency of use, and trends in consumption over time, including use in conjunction with other tobacco products.
- Appeal, Consumer Perceptions and Intentions- Assessing how consumers perceive products and how this perception affects appeal to youth and young adults.
- Human Factors- Analyses of risks associated with “real world” use of the tobacco product, including normal use and foreseeable misuse.
Video about PMTAs
When are PMTAs due?
The due date for PMTAs has been modified four times. FDA initially ruled that manufacturers had two years to submit a PMTA (i.e. August 8, 2018), pushed it back to November 2018, and then extended the deadline to August 8, 2022. FDA later revised the PMTA deadline to 2021. Finally, after a U.S. District Court decision,the current due date to submit PMTAs to the FDA is May 12, 2020. Once an application is submitted, an applicant can continue to sell the product for one year or until the product is approved or denied (whichever comes first). Products which do not comply with these requirements may be subject to enforcement action.
How much does a PMTA cost?
Although submitting a PMTA is free, FDA has estimated the cost of compiling the data needed for a PMTA in the low to mid hundreds of thousands of dollars (around $117,000 to around $466,000). However, this may be a conservative estimate. The final cost of a PMTA may be much higher, especially since manufacturers need to conduct original research and testing to inform the application.
What’s the bottom line, and how does it affect me?
The PMTA is an important federal requirement that affects the products which can legally be sold after the deadline. The vaping landscape will soon change depending on what products are able to make it through this regulatory gateway.
At VapeWild, we are committed to working through the PMTA process. PMTA submission is very intensive, and in the meantime you may notice some changes in our products and website. To sum things up, we are taking steps to ensure the long term growth of our company and continue with our mission — to provide our customers with alternative options at an affordable price.
The information provided on this website does not, and is not intended to, constitute legal advice; instead, all information, content, and materials available on this site are for general informational purposes only. Information on this website may not constitute the most up-to-date legal or other information. This website contains links to other third-party websites. Such links are only for the convenience of the reader, user or browser; VapeWild and its members do not recommend or endorse the contents of the third-party sites. Readers of this website should contact their attorney to obtain advice with respect to any particular legal matter.
Posted by Tasha Silva - FDA Compliance Expert on Sep 5th 2019