As September 9 PMTA deadline looms, vapers stocking up on flavored e-juice
After extensive litigation and multiple deadline extensions by the U.S. Food and Drug Administration (FDA), the Fourth Circuit Court of Appeals finally ruled in mid-April that the PMTA process must proceed. A final four-month extension to September 9, 2020, was granted by the courts to allow the FDA enough time to get its ducks in a row. As the drop-dead date is now fast approaching, vaping enthusiasts are now stocking up on their favorite brands of e-liquids before they perhaps disappear from store shelves forever.
The PMTA (Pre-Market Tobacco Application) process is overly complex, uber-expensive, and does not guarantee an approval once the entire process is complete. Among other things, manufacturers of e-juice must submit scientific documentation proving that their products are safe for human consumption, a process which typically involves the hiring of professional experts and laboratories to conduct extensive research.
The coronavirus pandemic makes PMTA process even more tricky
Under normal circumstances, this would be an extremely daunting task. Most makers of e-juice products do not have the financial resources to conduct such detailed analysis, and even if they did, the FDA can approve or deny individual applications at-will. The agency is not even legally obligated to provide adequate reasoning for its decision.
Then there’s the nationwide chaos that has ensued since the outbreak of the coronavirus in the United States. A significant percentage of the research facilities and laboratories needed to compile the necessary scientific documentation that might cause the FDA to approve a PMTA has been closed in recent months due to the pandemic and social distancing concerns.
- Human studies have been largely suspended.
- Laboratories and research facilities have been closed, at least temporarily.
- Many of the scientists employed by individual research companies are now working from home, making contact and travel between vapor companies executives extremely challenging.
- As almost every nation on earth has now implemented some sort of travel ban against the United States, allocation of product deliveries from other nations has digressed to a snail’s pace.
- To make matters worse, many of the FDA officials responsible for approval of pre-market applications have been temporarily reassigned to other departments in an effort to combat the spread of the virus. This lack of internal infrastructure at the FDA will slow the approval process even further.
According to the FDA deeming regulations, any vapor products already on the market after November 8, 2016, must submit a PMTA prior to the September 9 deadline. Manufacturers must submit and pay for a PMTA for each individual product – including all pre-filled pod-styled vapes that including flavorings other than tobacco and menthol.
Related Article: New FDA e-cig regulations and the million-dollar PMTA process
For those products with a submitted application, they are granted another 12-months to stay on the market or until such time that the FDA approves or denies their associated PMTA. For manufacturers who choose to forego the submission of a pre-market application, their products must be pulled from store shelves and e-commerce sites immediately.
In January, Secretary of Health and Human Services Alex Azar had promised to “streamline” the PMTA process by focusing on a substantial reduction of both the exorbitant costs and the massive amounts of bureaucratic red tape involved. Unfortunately, any potential changes to the process have yet to be announced by the administration, and the PMTA deadline is now less than 30-days away.
Related Article: Is vaping doomed? New PMTA deadline may be just 4-months away
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