PMTA GRACE PERIOD NOT EXTENDED

A few small-scale vape producers have been contacted by the FDA, informing them that they will be given an additional year to market their products. These messages started to arrive seven months after the grace period of one year that companies received following when they missed the PMTA deadline. Based on the timing of the messages and the ever-growing concern that the FDA is not able to finish processing applications on time, it seemed plausible to conclude that the FDA gave companies an extra year in addition to the grace period originally granted.

After a bit of confusion following some confusion, the FDA has clarified there will not be a further extension. They are instead trying to verify the acceptance of PMTA applications prior to September 9, 20,21, using an old script.

The amount of PMTA submissions caught the FDA shock. Not only did they say that they were receiving higher numbers of PMTA submissions than anticipated, but They were also required to prioritize products with more market share, as they acknowledged that it was unlikely they could finish processing applications prior to the expiration of the grace period, which is one year.

In order to process applications quicker, temporary employees were hired and trained to handle the load. However, training and hiring temporary workers is a lengthy process. The time has passed, and the small manufacturing companies that were not prioritized have been finally contacted. The FDA does not appear to be blatantly anti-vape. The FDA did not realize how complex and long-winded its own PMTA approval process would need to be, and it fell behind in its deadlines for its approval.

The shops and the consumers still don’t have the list of products that are permitted to be sold during the grace period of one year. At this rate, that means two-thirds of this grace time has been completed, and shops will have to trust the word of the company to file a report – and it is the shops who are at risk of being snubbed by the FDA at the event that they sell vape products that the FDA does not approve.

The FDA is working to reach out to all companies by September 9, 2021. But, in light of the amount of time that has passed by, its outdated protocols and temporary employees who cannot answer clear questions could confuse manufacturers more than they are reassured.

The vapor products with the highest market share will have the upper hand, and smaller companies with the lowest chance of surviving an extended period without selling will not be informed of the results of their application. While there is a growing concern about what happens to applications that are not processed after the grace period ends, the FDA has not yet announced what happens after this point. It is hoped that the FDA decides prior to then. If not, it is possible that the FDA could end up in the process of wasting time and energy looking through the applications of many companies which were made to stop selling and cease business.

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