TFN Vape Law: What To Do or How To Proceed and What it Means for Vape Shops

Estimated 0 min read

Author: Andres RomanDecember 14, 2022

On March 15, 2022, the $1.5 trillion omnibus spending bill was signed into law by President Joe Biden. The bill, which allocated funds for the federal government and provided $13.6 billion dollars in aid to Ukraine, also included a provision that amended the definition of “tobacco product” to include all products made from synthetic nicotine, also known as tobacco-free nicotine (TFN). What does this mean for companies currently making these products and how should vape shops proceed? These questions and more are discussed in today’s blog.

Table of Contents:

Why Have TFN Products Been Included in the Definition of “Tobacco Products”?
When Does the Law Take Effect and What Does it Entail?
What Does the TFN Vape Law Mean for Vapers and Vape Shop Owners?
Conclusion

Why Have TFN Products Been Included in the Definition of “Tobacco Products”?

Until now, TFN vape products had operated in a legal gray area because the definition of a “tobacco product” only included products that used nicotine derived from the tobacco plant. There was no mention of products that used man-made nicotine, meaning that TFN and synthetic nicotine vape products could not be regulated by the FDA.

Because of this, many companies switched gears and started to create vape products that only used synthetic nicotine because they could be marketed and sold well and there was no need to submit Pre-Market Tobacco Applications (PMTAs).

It was only a matter of time before the FDA took notice and began to figure out the best way to bring these products under their control. This brings us to today, when TFN products have been added to the “tobacco product” definition of the law which gives regulation power to the FDA. Under the new law, the updated definition of a “tobacco product” found in the 2009 Tobacco Control Act will read as follows:

“The term ‘tobacco product’ means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).”

When Does the Law Take Effect and What Does it Entail?

The law will take effect on April 14, 2022. It states that any synthetic nicotine product on the market after April 14, 2022 can remain on the market an additional thirty days until May 14, 2022. After that date, manufacturers that wish to keep their products on the market must submit a PMTA with the FDA for every product that uses synthetic nicotine. Products that remain on the market after May 14, 2022 that do not submit a PMTA will be subjected to FDA enforcement. If a manufacturer successfully turns in a PMTA for their synthetic nicotine products, they may keep the product or products in the market for an additional 90 days, or until July 13, 2022. After July 13, 2022, any product that has not received market approval by the FDA must be taken off the market.

The law also states that manufacturers that created products that had previously received Marketing Denial Orders (MDOs) and only changed the type of nicotine used in these products to synthetic nicotine can only be marketed until April 14, 2022. However, new products with different names and ingredients that use synthetic nicotine can be introduced into the market but only until April 14, 2022, and these products can be used to submit PMTAs.

Aside from the FDA requirements, all synthetic nicotine products will also be subjected to every requirement that applies to tobacco products, this includes Tobacco Control Act requirements, which state that these products must submit ingredient listing, product listing, and label compliance, among many others.

What Does the TFN Vape Law Mean for Vapers and Vape Shop Owners?

For vapers, the TFN Vape Law means a limited choice of flavors and e-liquids, a gamble that could potentially convert former smokers back to smoking. For vape shops, it means more limitations on the type of products they can sell. For small independent manufacturers who have already received MDOs, it could mean the end of their business. And for vaping as a whole it means another obstacle to overcome.

Conclusion

While many believe this is devastating to the vaping industry, we believe hope still exists. We expect that many manufacturers won’t take this lying down and will instead seek to challenge this new synthetic nicotine law through legal means where some manufacturers have already found success reversing MDOs given by the FDA.