A division from the SBA (U.S. Small Business Administration) has written to the FDA in which they request that they hold off enforcement of products that have completed PMTA forms for a further year.
To look over the status of PMTA applications, the FDA has declared that it will give priority to PMTA applications for products that have a greater market share. Although this means they can control more markets with fewer applications being processed, it also means that smaller companies will need to wait longer for the PMTA request to be evaluated.
However, this is also a sign that smaller companies that cannot endure a prolonged period of no sales must wait longest for the chance to sell again. This is a point that’s addressed in the letter sent by the SBA 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 mentions that 90% of the tobacco stores, which could include vape shops, are categorized as small-scale enterprises and are likely to be closed or affected for good as a result of prosecution before PMTAs have completed processing.
Although it’s pleasing to receive the official approval of a body that tries to promote small-sized businesses, there won’t likely be a delay. It is worth noting that the FDA has already indicated that they are expecting legal problems to arise when they attempt to prolong an extension of the PMTA grace period by an additional year. It is also noted that the FDA has also issued clarifications that there is no chance of another year of sales for the products that have filed PMTA applications.