Turning Point Brands, a vape company that recently filed a court petition against the Food and Drug Administration, has received a letter dated October 7, 2021, from the FDA rescinding the previously issued marketing denial order.
Turning Point Brands is a huge company, with brands including Zig-Zag, Solace, and Nu-X. They also operate the online vape shops Direct Vapor, VaporFi, and Vapor Beast.
While the reversal of this order has only taken place to allow further review, it could offer a glimmer of hope for vaping manufacturers and suppliers. The FDA gives several reasons for the reversal and as to their intentions going forward.
Reversals and Withdrawals: What the Letter Says
The letter from the FDA, sent to Turning Point Brands (TPB), states: –
“Upon further review of the administrative record, FDA found relevant information that was not adequately assessed”.
The FDA goes on to further elaborate on the information that was overlooked.
Specifically, they admit that TPB’s applications did, in fact, contain randomized controlled trials comparing tobacco-flavored products to flavored products, alongside surveys detailing who was most likely to use their products.
On September 14, 2021, TBP was issued a Marketing Denial Order (MDO), which previously prevented them from producing or selling any product for which they had submitted an application. The FDA cited that most denied the right to market their products ‘…lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”
TPB protested most strongly to this marketing denial order; the news on their website stated the following: –
“The PMTA denied by this MDO included an in-depth toxicological review, a clinical study, and studies on patterns and likelihood of use.
We believe the data demonstrated that TPB products do not appeal to never users, youth, or former users and that a significant majority of users of TPB products had completely ceased using combustible cigarettes.
The scientific literature on lower-risk nicotine delivery systems shows that these products can significantly improve public health by providing alternatives that are much less harmful than combustible cigarettes.”
Many manufacturers have been issued MDO’s based on the apparent lack of “sufficient evidence”. However, it remains to be seen whether other applications filed by manufacturers contain studies and data similar to the above.
The heartening thing for the vaping industry is that while the FDA’s review is taking place, they have signaled that they will not be initiating any enforcement action against TPB, meaning that at present, they can now continue to market their products.
As a result of the letter, Turning Point Brands has withdrawn its appeal.
A Good News Story?
The rescinding of an MDO could be met with mixed responses. In the short term, it is somewhat of a good news story. It is the first instance of the FDA admitting oversight and failing to properly consider all available evidence.
However, it must be remembered that this reversal only comes while the FDA reviews the already submitted evidence. Following its review, there could be a possibility that they reach the same outcome that TPB previously described as “arbitrary and capricious”.
What are the potential reasons for the oversight in the first place?
The FDA has been under significant pressure from both sides of the vaping debate. With over a million products removed as a result of MDO’s, forming 98% of applications, the FDA, on the face of it, does seem to have reached rushed decisions. Especially considering that they were criticized for missing their own deadline.
It should be noted, however, that they did find the time to thoroughly review and approve products supplied by R.J. Reynolds, a major tobacco manufacturer, and producer of a closed pod system that comes second to Juul in terms of popularity.
The good news is that other vaping manufacturers are following suit. It is hoped that they too could be granted a stay of execution in the short term and possibly a reprieve in the long term. Whether this is wishful thinking or genuine hope remains to be seen.