HOW SYNTHETIC NICOTINE LAW APPLIES TO VAPORS
On March 11, 2022, Congress voted 68-31 to pass the omnibus spending bill, which, in general, set $1.5 trillion to fund various government projects through this fiscal year - ending in September 2022. One of these projects included the nicotine law, i.e., amendments to some sections of the Federal Food, Drug, and Cosmetic Act (FDCA).
This language was passed into law when President Joe Biden signed the bill on March 15, 2022. With the new provisions, the Food and Drug Administration (FDA) was granted access to oversee and regulate nicotine made in labs, i.e., synthetic nicotine, including any other type of nicotine not derived from tobacco.
Under the new regulations, all companies that once avoided the FDA approval of their products containing synthetic nicotine will now be obliged to go through the same vetting process as companies that manufacture tobacco-based products.
In January 2020, the FDA issued a policy that prioritized enforcement against certain Electronic Nicotine Delivery Systems (ENDS) products. This was mainly aimed at flavored ENDS - except tobacco or menthol flavors - and brands specifically targeting minors.
The goal was to set a boundary for the vaping craze among America's youth. For the same reason, the policy banned all manufacturing, distribution, and sale of unauthorized flavored ENDS.
As a result of this effort, the FDA issued several warning letters, asking corporations to refrain from creating and/or removing flavored e-liquid and e-cigarettes from their offering, mainly because they do not have the needed authorization.
This move applied to some of the most prominent companies, like Cool Clouds Distribution Inc. - also known as Puff Bar - Vape Deal LLC, HQD Tech USA LLC, and more.
In the case of Puff Bar, the company chose to use an apparent loophole in the law at the time. Namely, the FDCA stated that tobacco products only include goods made or derived from tobacco intended for human consumption. Considering that lab-made nicotine does not originate from tobacco, it was a clear way out for all corporations working in this area.
Therefore, Puff Bar seized all production of their disposable, plant-based nicotine products and fully turned to synthetic nicotine. This was above FDA's reach, allowing many corporations to take advantage of this legislation gap.
The New Amendments
The vaping market has steadily increased in recent years, bringing the need to set this matter within legal frames. Adding more to the issue was that many companies were evading the FDA's effort to address and mend the aforementioned loophole.
That said, the new bill put all problems to rest, clearly bringing synthetic nicotine to the level of tobacco-based products.
The first and most important change enforced in the amendments is the need to provide a clear definition of what tobacco products are. The law stated that this was "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product…" (21 U.S.C. 321(RR)). Now, the most recent amendments added the "or containing nicotine from any source" right after "from tobacco" to the provision.
To clarify any misconceptions, the bill added," 'tobacco product' does not mean an article that is a food under paragraph (f), if such article contains no nicotine…."
This undoubtedly settled the matter of whether companies can evade the law by closing the preexisting gap.
The bill was passed on March 15, 2022 (enactment date) and is expected to enter into force 30 days since the enactment, meaning on April 15, 2022 (effective date).
All companies that made products from any other type of nicotine that is not tobacco, and were marketed as such up to the enactment date, will be given 30 additional days to submit a premarket tobacco product application (PMTA). They can remain on the market until May 14, 2022 (PMTA deadline).
If companies file for a PMTA, the new amendments state that they will have an additional 90 days to keep their product on the market, i.e., until July 13, 2022. Following this date, any corporation that has not received authorization from the FDA must cease such products from its sale lines.
One exception of this additional 90-day rule concerns products previously denied the application, refused to apply, or withdrew an order. In other words, if a product used plant-based or lab-made nicotine but was subjected to Refuse-to-File (RTF), Refuse-to-Accept (RTA), or Marketing Denial Order (MDO) by the Secretary of Health and Human Services, it must be pulled off the market after the effective date.
Simply put, all plant-based nicotine product manufacturers who have previously been denied authorization and thus moved on to manufacturing synthetic nicotine will not be given another chance to file for a PMTA.
Finally, the amendments state that tobacco products that fall into these new changes will be all subject to the requirements set in the regulations applicable to tobacco products.
This includes the Tobacco Control Act (TCA) and all its demands, such as labels, ingredient listing, etc.
To recap, these are the dates of essence to bear in mind:
1.March 15, 2022 - the date when the bill was signed;
2.April 15, 2022 - enactment date, i.e., the day when the bill will come into force;
3.May 14, 2022 - deadline for submitting PMTA;
4.July 13, 2022 - deadline by which the FDA decides on the submitted PMTAs, i.e., the deadline deciding if unauthorized synthetic nicotine products can remain on the market.
What Should Shop Owners, Retails and Companies Do Next
Considering the number of companies affected by this regulation, including online vape shops, many have been guessing the next course of action.
By the bill alone, it can be concluded that all synthetic-based nicotine products will be banned from the market by July 14, 2022, if they do not receive authorization from the FDA in the meantime.
All companies that created synthetic nicotine products and were previously unregulated by the rules of the FDCA are now required to file for a PMTA before the deadline on May 14, 2022.
Following this date, they can continue with the sales of their products until the FDA decides whether their goods comply with all legislation - to be carried out no later than July 13, 2022.
Filling for a PMTA is simple and can be done online via FDA's website.
All retailers and manufacturers should consider that their nicotine products now fall under the procedures and requirements stated in both TCA and FDCA.