Appealing an FDA PMTA Denial Order - Is it Possible?
Updated: Jun 9
Did you submit a U.S. Food and Drug Administration (FDA) Premarket Tobacco Product
Applications (PMTA) and it has been denied? If so, you’re not alone.
For the thousands of brands selling millions of newly deemed tobacco products - mostly vapor products, referred to as electronic nicotine delivery systems, or “ENDS,” who managed to submit the required U.S. Food and Drug Administration (FDA) Premarket Tobacco Product Applications (PMTA) by the September 9 deadline last year, it likely came as a shock to learn that FDA has now taken action on upwards of 90% of applications only one year later by denying them an approval on the products. A majority of this was done through either the issuance of a Marketing Denial Order (MDO).
Indeed, small manufacturers were especially surprised to receive FDA notices of action, as they were said to be last in line for review, behind the industry’s biggest players. As of September 9, 2021, FDA has taken action on over 6 million ENDS products, including 132 MDOs covering almost one million individual flavored ENDS products.
What Does This Mean for the Vapor Industry?
So, what does this FDA action mean for the industry? If a company received an MDO, it means these products are now considered misbranded and subject to enforcement action
immediately. For a small handful of others who have not yet received any correspondence
from FDA, it is likely that those applications remain under review.
We caution our tobacco industry readers that, following FDA’s unexpected progress in
reviewing so many product applications, the Center for Tobacco Products issued a statement outlining its current policy that products on the market which have now received a notice of refuse-to-file or marketing denial orders will be among FDA’s highest enforcement priorities.
You Can Appeal This Decision
It is possible to submit an appeal to the FDA’s decision. Despite these discouraging
developments, affected businesses should not simply toss their FDA notices (and businesses) in the dust bin – depending on FDA’s stated reasoning, adverse agency decisions, such as marketing denial orders, can be appealed through a written request to the FDA.
Each company must submit their own request. In it, you must provide your arguments as to
why the reasoning by the FDA which denied your PMTA is disputed by you. It must be a well reasoned and well organized document. In addition, where you think it would be helpful, a meeting request to the FDA may be made for further discussion.
Are you interested in learning more about the appeals process for your company’s denied
Ready to Learn More About CBP, OFAC,
BIS, and FDA? - for free! Details below.
We have dozens (literally!) of videos in our educational library on our You Tube channel related to importing, exporting, US Customs, BIS, OFAC, FDA, NFTs, and so much more. Subscribe to our channel now to stay up to date on the latest on these topics!
Our law firm helps growing companies who import and export comply with government regulations. We love what we do and we take our oath of confidentiality over your matters very seriously. How much? Watch this video to learn about it. CLICK HERE
Wondering "why should you have an attorney on your side?" Click here to watch one of our attorneys, Susan Steinman, break down the critical benefits as to why you want to have one on your side - whether you hire us to help you or another law firm.
Have questions? We are determined to help you.
We listen carefully to clients to ensure our understanding of the legal issues at hand, their factual context, and any limitations that might impact a chosen strategy. Feel free to connect with us using the contact form at the bottom of the Home page or send us an email at email@example.com.