PMTA is a marketing authorization application that all vape manufacturers must obtain before they can launch new vape products. However, as you will see, obtaining permission is extremely difficult. Once you have properly submitted your application, it may take up to 180 days for the FDA to respond. And every new product must have this approval. If a company wants to sell 30 products, it must submit and successfully submit 30 PMTAs.
Let’s start over. The Family Smoking Prevention and Tobacco Control Act (TCA) went into effect on June 22, 2009. The act empowers the U.S. Food and Drug Administration (FDA). Regulates the manufacture, distribution, and marketing of tobacco products in the United States.
Among other things, it mandates the introduction or modification of any TCA-regulated tobacco product on the market after February 15, 2007. It must be approved by the FDA before it can be marketed.
The TCA announced that any product derived from tobacco is now a tobacco product under federal law. Although the TCA requirements initially only applied to cigarettes, rolling tobacco, roll-your-own tobacco and smokeless tobacco. The bill also gives FDA discretion to determine which other tobacco products will be subject to federal regulations.
As a result, the FDA issued a “deeming rule” in May 2016, formally extending the TCA requirement to electronic nicotine delivery systems (ENDS). Among other things, e-liquids meet the legally prescribed definition of a tobacco product.
What exactly are PMTAs?
PMTA is the abbreviation of PremarketTobaccoApplication. The process began with the passage of the Family Smoking Prevention and Tobacco Control Act in 2009. Any new tobacco product must receive a marketing order from the U.S. Food and Drug Administration (FDA).
Under the Tobacco Control Act, a new tobacco product is any product that was not on the market on February 15, 2007. FDA issued a “presumption rule” on May 10, 2016. It states that vaping products will be regulated as tobacco products in the United States. As such, vaping products will be governed by the Tobacco Control Act.
In 2007, there were no e-cigarette products on the U.S. market. As a result, every vaping product sold in the United States has not been approved.
We consider each device, can, coil, flavor, and nicotine strength of each e-liquid to be a separate product in accordance with U.S. e-cigarette policy regulations. Beyond that, it needs its own marketing order. To continue selling vaping products in the United States, manufacturers must submit a PMTA.
On the other hand, the legal compliance system for vaping products in the United States does not seem to be any different from ours here. After all, e-liquid manufacturers in the UK must register their products before they can sell them. It should carry out emissions testing with the relevant authorities.
On the other hand, we confirm that the compliance process for new e-liquids in the UK is fairly fair and reasonable for small businesses. On the other hand, the PMTA process, according to FDA estimates, costs as much as $117,000-466,000 to generate PMTA for a single product. Creating a PMTA for even the most basic line of e-liquids can cost millions of dollars for each product.
FDA and PMTA E-cigarette Product Rules
As part of the “presumptive rule,” FDA set an August 8, 2018, deadline for manufacturers to submit premarket authorization applications for new tobacco products. It applies to products listed on August 8, 2016. In addition, we cannot sell products that are not on the market as of this date without FDA marketing approval.
The FDA proposed in May 2017 to extend the submission deadline by three months. The agency then announced in July 2017 that it intended to further extend the deadline. Suitable for combustible products such as cigars and non-combustible products such as electronic cigarettes. FDA released a draft compliance policy in March 2019. It moved the enforcement date of flavored ENDS to August 8, 2021.
Two years later, the U.S. District Court for the District of Maryland ordered the FDA. It requires manufacturers to submit premarket applications for any newly designated tobacco products. The court also granted the FDA a one-year grace period to allow the products to market. If people can submit applications by the May 12 deadline, it could become widely available in the marketplace. Even so, FDA has the authority to enforce the premarket review provisions prior to the submission date and within a one-year grace period.
FDA began prioritizing enforcement of flavored ENDS in February 2020. Flavor cartridge ENDS products are different from tobacco or mint flavored ENDS products. These products have not received FDA premarket approval; we cannot sell these products in the United States.
Given the extraordinary circumstances surrounding the COVID-19 pandemic, the FDA requested a 120-day extension to the PMTA deadline. On April 22, 2020, the court granted FDA’s request and extended the original deadline to September 9, 2020.
By September 9, 2020, any product that has not received premarket authorization cannot be launched in the United States. Submitted products can usually remain on the market for one year if the manufacturer applies by the deadline. FDA may choose to exercise enforcement discretion even after a PMTA has been submitted. During that time, it takes negative action against such products.
PMTA and Electronic Cigarette Industry
When the United States began the era of comprehensive government regulation of e-cigarettes in 2020, great changes have taken place in the e-cigarette industry. There’s also a good chance you don’t pay much attention to the news and think that what’s happening in the US has little effect on vaping in the UK PMTA vaping has a lot of positive impact on the vaping market.
However, it would be incorrect to view the vaping industry sector as a collection of separate entities existing only in their respective countries. This is especially true in the United States, which has the largest market for vaping products in the world. Events affecting the U.S. vaping industry have global ramifications.
The impact of the US incident on the UK e-cigarette industry
Just look at the vaping-related lung injuries that spread across the country last year for an example of the possible knock-on effects of the U.S. vaping incident. Although the disease has afflicted more than 2,700 people, it is due to illicit smoking of marijuana products.
In addition, many American media outlets only use the term “vaping” when reporting on the disease. They failed to explain the difference between marijuana vaping and nicotine vaping. Due to the panic that ensued, some vapers stopped vaping and started smoking again.
An additive called vitamin E acetate contributed to the outbreak of lung disease. We use this additive in millions of low-quality, illegal cannabis e-liquid pods. It makes it seem more effective than they are. Although no outbreaks have occurred in the region. Smokers read the news reports, and many decided they shouldn’t switch to vaping.
Public Health England was forced to issue a press release due to irresponsible news coverage in the US. Reassure the public that EVALI has nothing to do with nicotine e-liquid. It states that if smokers are unable or unwilling to stop using nicotine, they should absolutely switch to e-cigarettes.
The EVALI outbreak is just one example of how events in the vaping industry are having an impact on the rest of the world. However, the September 9 PMTA deadline kicked off changes that could have larger long-term effects.
How will the US PMTA deadline affect the UK e-cigarette industry?
So, how will the US PMTA deadline affect the UK vaping industry? At first, the deadline seemed to have little effect. That sucks for the small vaping businesses in America, but what does it have to do with us?
To answer this question, you have to consider the whole situation. The United States remains the world’s largest market for vaping products. But most of our e-liquids come from the UK. In addition to this, we also get a large amount of e-liquid from American manufacturers. There will be changes in the future, and we can see changes in them. In the innovation of new products of e-liquid, the United States is no longer in the leading position.
The PMTA deadline will have an impact on vaping consumers in the UK, as it will result in fewer e-liquids being made in the UK. Many e-liquid companies in the United States have closed down. Other companies have also only submitted PMTAs for some of their e-juice flavors and stopped supplying others. It is possible that the company will no longer produce e-liquids. Products that are still available in the UK are second-hand, and if once gone, they’re gone.
Advantages of PMTA in the UK e-cigarette market
The PMTA deadline cements the UK’s position as the world’s second largest vaping market when it comes to the development of new vaping hardware. With new hardware designs, the Chinese manufacturer is unlikely to cater to the preferences of the American vaping community.
Other than that, there is no point in developing a product for the US market unless you intend to file a PMTA for that product. You cannot legally sell products in the US unless you do this.
You can already see evidence of this change when you look at the latest products displayed on the websites of Chinese vape manufacturers. The page for the new product suddenly uses the British spelling instead of the US spelling. TPD-compliant product versions are becoming increasingly prominent in stock photography.
It’s also possible that manufacturers will focus more on optimizing the performance of their TPD-compliant products in the future, rather than simply cramming existing coils into 2ml housings as an afterthought.
The PMTA deadline is not good for the US vaping community. It limits the product choices available to U.S. vapers and ensures that only large companies with deep pockets will be able to sell vaping products in the U.S. in the future.
For us, the PMTA deadline is a good thing because it means UK vapers will have a greater influence on the global vaping industry than ever before. UK vapers will be the biggest buyers of the latest vaping hardware and manufacturers. They have no choice but to design and release new products in response to the needs and desires of the vaping community.