SBA requests additional year for PMTA related sales

FDA Finally Publishes Submitted PMTA List

A section of the SBA (U.S. Small Business Administration) has sent a letter to the FDA requesting that they delay enforcement on products that have submitted PMTA forms for another year.

To review, the FDA has announced that it will prioritize PMTA applications from products with a larger portion of the market share. While that approach means they will be able to regulate more of the market with fewer applications processed, that also means smaller products will have to wait longer in order for their PMTA application to be reviewed.

However, that also means that the smaller businesses who cannot endure a period without sales will have to wait the longest for the possibility of selling again. This issue is mentioned in the SBA’s letter to the FDA:

“Conversely, larger ENDS manufacturers often are diversified with multiple product lines and revenue streams and could afford for their ENDS products to be temporarily removed from the marketplace until their PMTAs are approved.”

The letter also states that 90% of tobacco stores, which would likely include vape stores, are classified as small businesses and will likely be affected or closed permanently as a result of enforcement before PMTAs have finished being processed.

Though it is nice to have an official request from an entity that attempts to advocate for smaller businesses, it is still unlikely that there will be an extension. The FDA has already signaled that they expect legal complications to arise if they try to extend the PMTA grace period for another year. The FDA has also recently sent out clarifications that there will not be another year of sales for products that have submitted PMTA applications.

References:

June 7, 2021 VIA ELECTRONIC SUBMISSION The Honorable Janet Woodcock, MD Acting Commissioner US Food and Drug Administration

SBA Urges Another Year of Sales for PMTA-Submitted Products