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Appealing FDA's PMTA Marketing Denial Order (MDO): What You Need to Know

Find out if you are eligible for a U.S. Food and Drug Administration (FDA) appeal on your Premarket Tobacco Product Application (PMTA) Marketing Denial Order (MDO). Remember, there's no harm in appealing, and your application deserves a fair review. Know someone else who deserves an appeal? Share this video with them!

Did you and your company strictly follow all of the U.S. Food and Drug Administration's (FDA’s) rules and spend tens of thousands of dollars preparing a Premarket Tobacco Product Application (PMTA), only to find out a year, or even two years later, that FDA did not even review your PMTA before rubber-stamping it as denied and issuing you a Marketing Denial Order (MDO)?


A recent court decision has created an opportunity to appeal your denial to demand that FDA perform a real review of your PMTA as the agency said it would do in multiple guidance documents issued over the past several years. 


If you've landed on this article, it is most likely because FDA denied your PMTA. Our firm stands ready to assist you through a straightforward process aimed at gathering essential details to assess your eligibility for an appeal. Key information to include would be the products you've applied for and the dates of your PMTA submissions.


Before moving on to those steps, however, we should point out that if you have received a PMTA denial there is no down side to appealing. Your company is entitled to have your applications reviewed according to the rules that FDA had in place at the time you submitted your application. We would encourage you to take every step you can to make sure that happened, and if not, to make sure it happens now.


For those already in the process of appealing a PMTA denial, there is an opportunity to add new information to your pending appeal through supplemental filings. These additional submissions can incorporate new information that has come to light from recent court decisions, which can make your appeal stronger.

Ready to take the next step and explore your options? Our firm is here to assist you every step of the way. Click the button below to fill out our questionnaire, share your story, and schedule an introductory call. Let's work together to navigate this process effectively and ensure your PMTA receives the thorough review it deserves.

Know someone else who deserves an appeal? Share this article with them.

Have questions? Give our office a call today at (917) 546-6997, we would be happy to speak with you.

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