The biggest event that might change the vape market in USA should be the PMTA. Even though you might not have to personally deal with it, most US vapers have at least heard of the PMTA. But what actually is it? How will it change your vaping business or vaping life? What should we do to keep your business? If you are a vape brand owner, a vape business owner or a single vaper, here are everything you need to know about the PMTA.
1. Background of PMTA
In May 2016, the FDA passed a “deeming rule.” This deeming rule stated that vape manufacturers would adopt the application process that cigarette and smokeless tobacco manufacturers go through before releasing a product. This application — the Pre-Market Tobacco Application (PMTA) — is part of a process in which the FDA reviews products before they can release them to the general public for sale.
The point of this application is to give the FDA an opportunity to approve or deny a product based on:
- Risk and benefit to the general public
- If the proposed product prevents use of a current tobacco product
- If the proposed product might persuade non-tobacco users to try it
- Manufacturing procedures
- And more unlisted
It is a long and expensive process to gather all the necessary products that has priced out many vape manufacturers already.
2. Who Need to Submit PMTA to FDA?
For all vape brands/manufacturers who want to sell their products in US market, PMTA is required. For end users and business owners, like vape store or vape distributor, submiiting PMTA is not your job.
3. Which Products should Submit PMTA?
If you’re wondering whether products already on the market need to file a PMTA application, they do. At the time of the ruling, the FDA set a deadline for August 8, 2018. That deadline gave manufacturers two years to gather all upporting documents and submit for all products released to the market after August 8, 2016.
For hardware products, manufacturers can just submit 1 application to FDA regardless of its product colors;
While for eliquid products, manufacturers need to submit applications by SKU, that is to say, for a same flavor e-liquid, you need to submit different applications for 3mg nicotion, 6mg nicotine…
4. Deadline of PMTA Submission.
Actually the deadline of PMTA submission has changed several times, right now, the confirmed deadline is: 9th Sept, 2020.
5. How Much Will it Cost?
The PMTA process was never really intended to be easy. The goal, more than anything, was to make it difficult for vaping companies to bring new products to market. It’s estimated that each PMTA will cost $466,563 averagely. That is for every product you want to keep on the market, including different e-juice flavors and nicotine levels. The actual cost might also be even higher than this, depending on the amount of original research and analysis is needed to support the application.
6. How Will it Affect Business Owners?
The deadline is coming up quickly for manufacturers, and I believe business owners have felt the effects of the new process. Changes will happen rapidly, so it’s important to know what to expect.
- You may get fined for selling FDA unapproved products;
- So it is very important to get to know which products are able to sell after the PMTA deadline and stock them a good quantity;
- Selling out those FDA unapproved products quickly;
- Keep a close contact with your suppliers/manufacturers to get the lastest updates
7. How Will it Affect Vapers?
Significant changes will happen after the PMTA deadline for sure. Vapers may not be able to find coils or even drip tips for their favorite devices at local vape shops. Get prepared for below potential changes:
- Your favorite brands might disappear. The PMTA cost and required files will block many small brands to enter the market.
- You may not be able to buy your favorite products in US. Manufacturers will not submit PMTA applications for every product.
- You may see changes in packaging. This is a part of the marketing requirement for the PMTA.
8. Suggestions for Vapers
Here are 2 suggestions for vapers to meet the potensial changes:
- Stock some of your favorate products ASAP, especially the replacement coils/empty pods and the e-liquid. If you want to do this, you can contact HealthCabin to get a bulk price to save more.
- Buy vape products online or abroad after the deadline.
9. Will the PMTA Kill Vaping?
Absolutely NO! For anyone involved in this industry, please don’t get too down about the future of vaping. While there are tough times ahead, enough independent companies like VOOPOO, SMOK are going through the PMTA process that you will still be able to get quality vaping products. The world of vaping may get smaller, but it won’t disappear entirely.
10. What Helps Can You Expect from HealthCabin?
As always, HealthCabin is happy to help all of our partners to grow their businesses. For the PMTA, here is a list we can do for you:
- Update you the lastest info/products related to PMTA;
- We are able to talk to all of our manufacturers directly, so we can send your requirements/feedbacks to those manufacturers.
- Offer the best product price, best shipping options and best service as usual.
The PMTA will affect the whole market and change the industry, the world of vaping may get smaller, but it won’t disappear entirely. For anyone involved, please get ready for the change.