It’s a month since the PMTA deadline of September 9th has passed. We’ve seen which companies have submitted.
But… what exactly happens to a PMTA once the FDA receives it? Why are there companies saying they’ve moved onto the “second round” of PMTA and are on the final stage? What does that even mean?
There are six stages, or rounds, to the PMTA process. The FDA refers to them as the Pre Submission Meeting, Acceptance, Filing, Review, Action, and Postmarket Reporting. The FDA has also released a simplified set of phases that consist of Acceptance, Notification or Filing, Review, and Action.
To begin the PMTA process, there is an in-person meeting between the applicant and the FDA where they talk about the products they want to submit for the PMTA.
This is where the FDA looks at the application and agrees that it is a tobacco product, and that the application meets the more basic standards. If the FDA agrees it is a tobacco product and the application isn’t terrible, the company receives an acceptance letter. If the application does not meet the FDA’s standards, the company receives an RTA (refusal to accept) letter.
This is the stage a lot of companies are on or have gotten through, and why companies say “they received an acceptance” instead of simply saying they submitted a PMTA. Acceptance of the application is one step further along in the process than just sending it to the FDA.
Filing is another stage of application checking. The FDA verifies that the application has all the information they need to start making decisions about the product. At the end, companies either receive a filing letter, which means they have made it to the review stage, or a RTF (refusal to file) letter.
This is what companies meant when they said they have moved past the second round of PMTA and onto the final stage. Although the review stage is not the final stage, it is the last hurdle for an application before a company is authorized to sell.
The review stage is when the FDA looks at all the evidence submitted and decides whether or not the product should be sold.
At this stage, the FDA may want more information and send the company a deficiency order, which asks the company to provide them with more information. Another action they may take is to send out an environmental information request letter. An environmental information request letter means they want to let companies sell it, but the company has to provide information about environmental considerations before they authorize it.
This is the step where the FDA either puts out a market order that allows the product to be sold, or they do not allow it to be sold.
Even if a company gets a marketing order, the FDA can still withdraw or temporarily suspend permission if a product shows signs of being problematic. Companies will still have to maintain records and report to the FDA after approval.
Yes, the PMTA is a long process, and there are a lot of applications. Many companies submitted PMTAs to meet the September 9th deadline.
"Although we do not know how many applications will be submitted by the September deadline, we do know that there are over 400 million deemed products listed with FDA. Even if applications are submitted for only a portion of those products, the likelihood of FDA reviewing all of these applications during the one-year review period is low given that this would be an unprecedented number of applications and several orders of magnitude greater than anything the Agency has experienced. "
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