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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. A significant number of applications received a Refuse-To-File (RTF) or Marketing Denial Order (MDO).
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.
For whom questions remain - we encourage you to contact us for assistance.
Appealing an FDA PMTA Marketing Denial Order (MDO) - Is It Possible?
Sep 15, 2021
Deanna: Hi, my name is Deanna Clark and I'm with the Clark-Esposito Law Firm, P.C. I'm here to talk to you about a very important issue facing the vapor industry today. Have you received a Marketing Denial Order (MDO)? If so, you should know you're not alone. In fact, as of September 9th, 2021, the FDA has acted on over 6 million electronic nicotine delivery systems, or ENDS, which could be a combination of either liquids or devices, supposedly tools, et cetera. So what's the result of receiving and Marketing Denial Order? Well, for starters, the products are considered misbranded, and that means you're no longer able to actually sell those products, whether in your physical store or online. In the event you continue to do so, you could be subject to enforcement by the FDA and other agencies. And let's not forget this action by the FDA in issuing all of these Marketing Denial Orders, otherwise known as MDOs has significantly impacted the vapor industry.
Deanna: Vapor products are referred to by the FDA as "ENDS", Electronic Nicotine Delivery Systems. And the impact on the ENDS industry is just phenomenal. So what kind of enforcement am I even talking about? Well, of course there's FDA enforcement, so that could be the issuance of civil monetary penalties. It could be that a seizure occurs of your products, that is agents come in and take the goods off of your shelves. It can also be subject to injunction. It's important to remember, however, that while the FDA is one agency with enforcement authority, you could be subject to other state agencies who are coming after you too. And I only say this because we've seen this happen with other clients of ours, whether it's their state's Consumer Product Safety Commission who comes in and seizes goods, or whether it's even the health department we've seen come in and sees, or rather not see as goods, but come in and issue notices and generally disrupts business.
Deanna: Keep in mind the state Attorney General's offices also have gotten involved. Sometimes they come to a place of business. Sometimes they simply reach out and say, “Hey, we're thinking about starting an investigation. Can you come talk to us?” So whatever the case may be, it's important you understand that it's not just the FDA who could be looking at you in terms of, “Hey, is your company doing something wrong?” So in relation to this FDA action and these MDOs, you should know that there is a way to appeal that decision. So what's involved? For starters, each company must submit its own submission appealing the FDA decision, that is you don't want to send something in combined with other companies, you want to send in your own submission. Next, you want to address arguments, refuting FDA's basis for your denial. It can't just be sort of this thing where you're complaining about how “It's unfair...
Deanna: ...The government sucks.” You need to use some rational basis behind what you're submitting to them. And thirdly, you need to submit it to the right office, right? You want to make sure it gets to the right people within the right time frame. We know from our own clients how frightened owners of vapor companies are right now, whether you're a manufacturer or distributor or retailer, we know that whether it's something you're making and selling or third-party products who, you know, or have reason to know, probably, you know, shouldn't be selling their products anymore. And so what does that mean for your business? We get how scared you are. And we know that because we've talked to our clients who are in a similar situation, we can help you understand your options. If you're facing this predicament, contact us. Our telephone number is (917) 546-6997. And our email is contact@clarkespositolaw.com. Reach out to us to schedule a consultation. We're determined to help you
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