It’s been a month that has passed since the PMTA deadline of September 9th is over. We’ve seen the companies that have submitted their applications.
However… What happens to a PMTA after the FDA gets it? Why do some companies say they’ve entered”the “second round” of PMTA and are at the “final” stage? What is that actually referring to?
There are six phases (or rounds) in each game of the PMTA process. The FDA calls them”Pre Submission Meeting, Acceptance, Filing Review, Action as well as Postmarket Reporting. In addition, the FDA has also published an easier sequence of phases, which consists of Notification, Acceptance or Filing Review, and Action.
PRESUBMISSION MEETINGS
In order to begin the PMTA procedure, there’s an in-person meeting with the applicant and FDA to discuss the products they wish to submit for PMTA.
ACCEPTANCE
The FDA examines the application and determines it’s a tobacco-based product and that the application is in line with basic requirements. If the FDA believes that the product is a tobacco product and the application doesn’t look bad, the company will receive an acknowledgment letter. If the product does not conform to the standards of the FDA, The company will receive the RTA (refusal to approve) letter.
This is the phase that a majority of businesses are currently on or have made it through, which is why many companies claim “they received an acceptance” instead of saying that they have submitted a PMTA. The acceptance of the application is a step higher to the next step, and not just forwarding it off to the FDA.
FILING
Filing is a different stage of screening the application. The FDA ensures that the application is complete with all the data it requires to decide on the product. In the end, companies are issued either a filing notice that indicates they’ve reached the review phase or an RTF (refusal to apply) letter.
That’s what they meant when they claimed that they had passed the second stage of PMTA and into the next scene. While the review stage isn’t the end of the road, it is the final step to pass before a business is legally able to sell its products.
REVIEW
The review phase is the time when the FDA examines all the evidence provided and decides if the product is suitable for sale.
At this point at this point, the FDA could want to know more and may send an order of deficiency that asks the business to supply them with additional details. Another step they could take is to send the environmental request. A request for environmental information indicates that they wish to allow companies to sell the product. However, the company needs to give information on environmental concerns before they approve it.
ACTION
This is the stage in which the FDA either issues an order for market access that permits products to be offered for sale, or they deny the product for sale.
POSTMARKET REPORTING
Even if a business receives an order to market, however, the FDA could still decide to withdraw or temporarily revoke approval when a product is found to show evidence of being unsuitable. The company will have to keep track of its records and provide reports to the FDA upon approval.
Yes, there is a problem. The PMTA is a long-winded procedure, and there are many applications. Numerous companies have submitted PMTAs in time for the deadline of September 9th.
“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. “
In the next year, there will be problems with the products that are on the market. In the meantime, be aware of the latest vape news and laws that protect the rights of vapers.
