PMTA Grace Period Not Extended

Some small vape manufacturers are being contacted by the FDA stating that they have an additional year to sell their products. These messages started being sent seven months into the one-year grace period companies received after the PMTA deadline. Given the timing of the message, and the growing worries that the FDA will not finish processing applications in time, it was reasonable to assume the FDA was giving manufacturers an extra year in addition to the original grace period.

After some confusion, the FDA has clarified that there will be no additional extension. Rather, they are attempting to confirm acceptance of PMTA applications before September 9th, 2021 with an outdated script.

The number of PMTA submissions took the FDA by surprise. Not only did they state they received more PMTA submissions than expected, they have been forced to prioritize products with a higher market share because they admitted it was unlikely they would finish processing applications before the end of the one-year grace period.

To help process the applications faster, temporary workers were trained and hired to help deal with the workload. But hiring and training temporary workers takes time. Time passed, and small, manufacturers that were not prioritized have finally been contacted. The FDA is not being overtly anti-vape. The FDA underestimated how complicated and time-consuming their own PMTA approval process would have to be, and fell behind on their own deadlines as a result.

Consumers and shops still do not have a list of vape products that are allowed to be sold in the one-year grace period. At this rate, two thirds of the grace period will have passed and shops still have to rely on the company’s word for filing - and it is the shops that risk getting targeted by the FDA if they are selling unapproved vapor products.

The FDA is trying to contact every company before September 9th, 2021. However, given the amount of time that has gone by, its outdated scripts and temporary employees that cannot answer clarifying questions may be confusing more manufacturers than they reassure.

Since vapor products with the largest market share will get priority, smaller manufacturers with the least ability to survive a period without being able to sell will be the last to know the outcome of their applications. Although there is growing concern about what will happen to unprocessed applications once the grace period expires, the FDA has not stated what will happen after that point. Hopefully, the FDA decides before then. Otherwise, the FDA may find themselves wasting time and manpower going through applications for many companies that were forced to stop selling and go out of business.

References:

PMTA Confusion Update: FDA "Clarifies" One-Year Sales Extension