PMTA Update: Marketing Denial Order (MDO) Crisis

The vape Industry in the USA is facing a crisis, but one that it can overcome. The U.S. Food and Drug Administration (FDA) has issued more than 946,000 Marketing Denial Orders (MDO) for flavoured ENDS (electronic nicotine delivery systems) products as a result of a legal limitation which meant that the FDA had to clear their desks of the vast majority of Premarket Tobacco Product Application (PMTA) applications.

Adact’s Chief Regulatory Officer, Damien Bové, provides more information…

The FDA has made a massive change to their PMTA evaluation process and dropped the deficiency stage, meaning applicants do not get an opportunity to update information in response to FDAs initial opinions. This fundamentally undermines many companies regulatory strategy.

Industry experts believe this change was forced through as the FDA was running out of time to review all submissions by 9 September 2021 and rejecting flavoured products could be seen as a legal way to kick out thousands of applications.

ADACT is taking advice from the American Vaping Association (AVA), Smoke-Free Alternatives Trade Association (SFATA), various lawyers and industry specialists. We will be advising a Freedom of Information request is submitted on how the applications have been reviewed which will be important evidence for any future legal challenges.

The long term plan
As legal challenges and appeals are implemented, your PMTAs will need to be kept up to date and ready for evaluation. The MDO crisis can be managed and overcome if the industry works together to get policy changed and we work within the FDA PMTA structure that will come out of this transition to obtain legal approved status. All companies may need to resubmit PMTAs over the next twelve months.

Synthetic nicotine
One potential solution is to use synthetic, non-tobacco derived nicotine as this will mean you are no longer selling tobacco products. The synthetic nicotine window is estimated to be open for 12-18 months and while it is not clear how the FDA will close it, many states are already considering a local ban. Group legal action against this is underway and after review, Adact may recommend joining these efforts in the near future.

Certified as synthetic
The looming issue with the synthetic nicotine strategy is proof, as many of the synthetic nicotines Adact independently tested have in fact been tobacco derived.

To combat this, we are able to test bulk nicotine or finished products in our ISO/IEC 17025 accredited laboratories and certify your synthetic nicotine. This proof can then be passed on to the FDA when challenged and companies that don’t prepare for this will face an uncertain future.

To arrange synthetic nicotine testing for your products, please call your US or UK representative.

Adact US – Call (786) 706-4316 or email [email protected]
ADACT in the UK – Call +44(0)1302 986 088 or email [email protected]