FDA-Vetted Vape Companies That Made a Comeback & Resumed Sales

Unfortunately, there have been many companies in the vape industry that have received Marketing Denial Orders (MDOs) or some sort of prohibition to continue selling their products. But the tide seems to be changing this new year as the Eleventh Circuit Court of Appeals granted four of these companies a judicial stay on their MDOs.

In other words:

These four companies are legally allowed to continue selling their products while the lawsuits they placed against the Food and Drug Administration (FDA) remain active. These four companies are Bidi Vapor, Diamond Vapor, Johnny Cooper, and Vapor Unlimited.

These active lawsuits came about after the FDA launched the Premarket Tobacco Product Application (PMTA); a process that all vape companies operating in the U.S. need to go through in order to gain approval for operation. This process includes a series of testing and manufacturing requirements that have put the vaping industry in check due to their compliance difficulties and high costs.

With the PMTA launched and in operation, dozens of vape companies decided to place lawsuits or take alternative legal action routes against the FDA. Not only because it implemented hurdles and additional obstacles to launch a product, but also because the wording in the PMTA process seemed quite ambiguous and left a lot of room for interpretation, which is not the best case scenario when it comes to law.

The exact wording was, “appropriate for the protection of public health”, which could be interpreted in a variety of ways. Over the past couple of years, people in the industry have come to understand it as “how likely a product is to help smokers transition to other forms of nicotine consumption.”

The main concerns from industry members and also main reasons for legal action were that the FDA was taking a long time to review and determine the validity of PMTAs filed by companies, delayed decision making, a lack of lines of communication, and a modus operandi of arbitrarily denying PMTAs. These at least are the concerns that some companies voiced.

In the specific case of Bidi Vapor, the company spent a couple of years structuring PMTAs, filing over 250,000 pages of information and a hefty sum of money that amounted to more than $6M according to court filings. Information in the company’s books demonstrated that their products provided substantial benefits in terms of a lower relative health risk when compared to smoking nicotine. 

This brings us back to the ambiguity behind a statement like “appropriate for the protection of public health” which is completely subject to interpretation. After the whole debacle, the FDA issued Bidi with an administrative stay in October 2021 that has allowed the manufacturer to sell and distribute its products legally.

For the time being:

The decision of the FDA on Bidi Vapor seems to open up avenues for the company itself and other vape industry manufacturers in terms of legal actions. For the time being, it also seems like the tide may be shifting in a more positive direction. However, only time will truly tell, but what is clear is that there is current ambiguity in the way PMTAs are addressed and we’re not the only ones noticing it.