• Deanna Clark-Esposito

Appealing an FDA PMTA Denial Order - Is it Possible?

Updated: Sep 15, 2021

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

PMTAs? If so, contact us at 917-546-6997 or via email at contact@clarkespositolaw.com to

schedule a paid consultation. In addition, we may be offering a webinar on this topic in the

future, so be sure to join our newsletter on our website www.clarkespositolaw.com, and follow us on Instagram @clarkespositolawfirm and on Facebook where we will be sure to post updates on any upcoming industry events.