PMTA 101

If you vape, you may have heard of PMTA. Whether you’ve just started your vaping journey or have been vaping for many years, you probably have lots of questions about PMTA. We’re here to help.

What does PMTA stand for?

The acronym PMTA stands for Premarket Tobacco Product Application.

What is a Premarket Tobacco Product Application?

A PMTA is an application that a tobacco product manufacturer makes to the FDA when they have a new tobacco product that they want to sell (or market) inside the United States.

Sounds simple, right?

But I’ve been using my vape for years, it’s not a new product.

There’s a little bit of a history you need to know if you want to understand the current situation with PMTA.

A Brief History of Vaping

Noncombustible tobacco products have been around for decades. For example, the Favor cigarette was introduced in 1986 as an alternative nicotine-containing tobacco product. It looked like a cigarette, and consisted of a hollow polymer tube with a nicotine-saturated plug at the far end, which provided nicotine as the user inhaled. There were other, similar products sold throughout the late 20th century.

E-cigarettes as we recognize them today were invented in 2003. A Chinese pharmacist named Hon Lik patented an electronic cigarette and began marketing and selling the product in China in 2004, under the name Ruyan. You might be familiar with an e-liquid flavor profile called RY4 – this specific tobacco flavor profile was also introduced by Ruyan and is still popular today. Of course, contemporary e-liquid makers have their own formulas for making RY4 style flavors.

In the mid to late 2000s, Americans on the bleeding edge of this technology began using these early e-cigarettes. Ruyan and Janty were popular early brands, with more familiar names like Njoy and Joyetech becoming well-known in the online vapor communities in the late 2000s and early 2010s.

As e-cigarette use became more mainstream, the technology – both in the hardware and in e-liquid development and manufacture – associated with vaping advanced rapidly, and new products were released almost daily. Right now there are hundreds of hardware options and thousands of e-liquid flavors available.

A Brief History of Tobacco Regulations

While there is a lot of interesting information about tobacco production and regulation in America starting before we were even an independent nation, we will cover only the topics specifically relevant to vapor product regulations.

In 2009, the Family Smoking Prevention and Tobacco Control Act was passed by the U.S. Congress. This federal statute gives the Food and Drug Administration (FDA) the authority to regulate the manufacturing, distribution, and marketing of tobacco products.

While there are lots of regulations contained in the Tobacco Control Act, the one relevant to PMTA is that tobacco manufacturers are required to seek FDA approval for new tobacco products.

This approval is managed through the Premarket Tobacco Product Application (PMTA) process.

So why is this an issue now? Shouldn’t this all have been addressed in 2009?

When e-cigarettes were being marketed and sold in the US in the mid-2000s up until the mid-2010s, they were not considered tobacco products, so the manufacturers of those products didn’t submit Premarket Tobacco Product Applications for any products.

That all changed in 2016.

In June of 2016, the FDA passed a new tobacco rule, commonly known in the vape community as the FDA Deeming Regulations. Prior to this rule, the FDA was regulating cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco (chewing tobacco).

The Deeming Regulations of 2016 extended the definition of a tobacco product to include hookah, e-cigarettes or ENDS, dissolvables, all cigars, pipe tobaccos, and nicotine gels.

This new rule “deeming” these products tobacco products gave the FDA the authority to regulate those products – and to require Premarket Tobacco Product Applications for any products not on the market (being sold in America) as of February 15, 2007.

On August 8th, 2016 the FDA Deeming Regulations went into effect, and all e-cigarette manufacturers had to stop producing new products. Any e-liquid or e-cigarette that had been marketed (sold) prior to August 8th, 2016 could continue to be sold, but no new products were permitted to be sold after that time without completing the PMTA process.

All those products available before August 8th, 2016 could still be sold in the US, but the manufacturers would still have to submit a PMTA and seek FDA approval for their products or stop selling their products by a certain date.

Between 2016 and now, the ‘end date’ for PMTA submission on existing products has moved several times. Currently, all new tobacco products (products that were invented or first sold after February 15, 2007) must have a PMTA submitted to the FDA by September 9, 2020. Products not actively seeking FDA approval, or approved by the FDA, won’t be available after that time.

What is the PMTA / FDA approval process like?

A PMTA provides scientific data about one specific tobacco product to the FDA so that the FDA can make sure that the product:

  • Provides a benefit to the population as a whole, including both people who use the product and people who do not
  • Is going to be something that people who currently use tobacco products will want to use instead of the products they are currently using
  • Is not going to entice non-tobacco users to begin using tobacco products
  • Is manufactured, processed and packed in a clean, responsible, and controlled manner

If the product submitted for approval meets these criteria, it should be approved for sale.

A Premarket Tobacco Product Application includes a huge amount of information, including a full ingredients list, a detailed description of the manufacturing process, samples, and scientific and clinical reports on product impact on individual and population health as well as environmental impact.

The PMTA must be submitted for each and every individual product available for sale. This makes it a massive undertaking for all tobacco products manufacturers, but is particularly onerous for smaller companies. For example, if a specific company has five flavors available in 0mg, 3mg, and 6mg nicotine strengths, that company would need to submit fifteen separate PMTAs – one for each individual flavor and nicotine strength!

One of the reasons there are so many e-liquid flavors available today was the comparatively low cost of entry to become an e-liquid manufacturer. The FDA Deeming Regulations and PMTA process makes the cost to become a manufacturer a lot higher. Many small manufacturers have consolidated or partnered with larger manufacturers, or will not continue to manufacture their products after September 9, 2020, because they do not have the resources to seek FDA approval for their products. 

How will PMTA affect me?

As a vaper, PMTA will directly affect you because the products you currently use may not be available after September 9, 2020. Only products that have had a PMTA submitted for approval, or that have been approved by the FDA, will remain available for sale legally.

That date may change, of course, depending on the court system – as with all legal issues, laws and court rulings have a huge impact on the ‘when’ and ‘how’ of these regulations being implemented.

While PMTA submission and FDA approval is an expensive process for tobacco product manufacturers, the products that are approved will be the most responsibly manufactured, trustworthy vape products available.

What products will be available?

It’s hard to say exactly what e-liquids and hardware will be available long-term. Many companies, including a large number of the e-liquids and hardware available at Giant Vapes, are submitting their products for FDA approval. We hope that all the items we stock will continue to be available, but that’s not likely.

We do plan to make PMTA information available to our customers as quickly as possible when we have it. We know at the time of writing that AVAIL Vapor flavors, BANTAM flavors, and a number of SMOK and Vaporesso hardware products are seeking FDA approval, for example, but as this process happens individually for each product and manufacturer, information isn’t always readily available.

What should I do if my favorite flavor isn’t in the PMTA process?

First, we recommend confirming with the manufacturer of your favorite product whether that flavor is going to have a PMTA submitted. If it’s not, contact our awesome customer service team at Giant Vapes and let us know what the profile of your favorite e-liquid is – we will do our best to recommend something similar that is going to be submitted for FDA approval. We can’t promise every product will be approved, but we will help where we can!

Still have questions? Leave us a comment below!

SOURCES:

https://www.cdc.gov/tobacco/data_statistics/sgr/e-cigarettes/pdfs/2016_SGR_Chap_1_508.pdf

https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications

https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-overview

https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/fdas-deeming-regulations-e-cigarettes-cigars-and-all-other-tobacco-products

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