With all the news related to the FDA’s recent enforcement action against flavored cartridges, their PMTA enforcement initiatives have flown under the radar. As the FDA PMTA deadline approaches, however, that’s about to change and some of your favorite brands may be affected. As with other recent FDA actions regarding vaping, it has been a long and twisting journey to get to this point, but we’ve reached a point where some certainty about the process is starting to coalesce. Let’s take a look at how we got here.
Premarket Tobacco Application
The FDA has alternated between being slow to move when it comes to regulating vaping and moving extremely fast with often reactionary policies. The Premarket Tobacco Application (PMTA) was designed to give the FDA a way to review any new tobacco product before it hits the shelves in US stores. Originally, this applied only to products like cigarettes and smokeless tobacco.
In May of 2016, however, the FDA finalized a “deeming” rule. This rule stated that the PMTA guidelines would not only cover their traditional markets but also the burgeoning new industry of e-cigarettes and vapes. Under this deeming, any product produced after August 8, 2016, would need to file a PMTA before it was available for sale. This would, ostensibly, give the FDA the ability to verify its relative safety, the ingredients involved, and its marketing practices.
The deeming didn’t stop there, however. Products already on the market and in production or distribution would also need to file a PMTA by an FDA deadline. This deadline was extended out several times before a lawsuit was filed by anti-vaping groups seeking to force the FDA to immediately demand PMTAs for vaping products to be sold.
In the lawsuit, anti-vaping lawyers argued that the FDA had not allowed a sufficient comment period before extending the deadlines, therefore any product without an application in process should be taken off the market and the FDA should immediately start demanding and processing application paperwork from manufacturers. This would have done severe damage to the industry, as, at this time, the FDA had no official guidance documents for e-cig or vape manufacturers to follow when it came to the PMTA.
The FDA, on its part, argued that rushing the process could be potentially disastrous. WIthout allowing sufficient time to review applications, the risk of potentially harmful products or those markets contrary to guidelines was too high. Although it also argued that industry leaders who asked to keep the extended deadlines could always call for assistance in lieu of published final guidelines and that these manufacturers had had sufficient time and possessed sufficient resources to begin the PMTA process earlier than the initial extensions.
In the end, the judge took a middle-ground approach, while the anti-vaping plaintiffs were correct that notice for public comment should have been given, the FDA had made a compelling case for an extended timeline. The judge set a May 11, 2020, FDA PMTA deadline. This allowed time for tardy manufacturers to get their documentation ready with the help of the FDA, the FDA to finalize its PMTA guidance, and both sides the ability to gather the resources needed to offer full compliance.
As The Deadline Approaches
While the judge may have felt manufacturers had the time and money to begin the process, not all manufacturers felt the same. We won’t know for sure if anyone is left out in the cold from either not having their paperwork filed or having it deemed insufficient until the deadline approaches. It’s important to note that while the application is in processing, companies are allowed to market and sell their products as they have been, so the number one priority for any manufacturers struggling to gather their compliance documents at this late date is to get their PMTA filed with the FDA.
What Is Entailed In The Application
For the application, the manufacturer has to gather certain information and documentation for FDA review.
- Marketed In A Manner Appropriate For Public Health - Manufacturers must demonstrate that they are going to market their products in a way that is most beneficial and least harmful to the population as a whole.
- Show That The Product Should Either Be Grandfathered Or Has A Previous Related PMTA - To avoid a more extensive research process, manufacturers must prove their products were on the market by the time the deeming rule was passed, are significantly equivalent to products on the market then, or similar to products that already have a PMTA in effect.
- Prove That They Avoid Certain Dangerous Ingredients - As we learned with the recent vaping illness epidemic related to illegal THC vapes, what you put in your liquids matters. Manufacturers must prove that their products do not contain ingredients that have been deemed dangerous.
If your favorite manufacturer doesn’t get their paperwork filed, then their product is likely to be deemed by the FDA as unable to be sold in the United States. While the process to rectify this would hopefully be as simple as filing the application, they would be bumped to the back of the line and the FDA has not issued a clear stance on submissions made after the deadline.
We’ll be watching the regulatory environment closely as the FDA PMTA deadline approaches, and we’ll make sure you know about any new PMTA developments that may affect your vaping. Keep an eye on the Elevated Vaping blog to stay informed about the latest vape gear, flavors, and regulatory initiatives.