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FDA misses filing deadline; Deeming regulations delayed

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Either by error or by choice, the U.S. Food and Drug Administration (FDA) has failed to meet two important filing deadlines, resulting in a six-month delay for certain sections of the FDA deeming regulations. While agency officials are remaining mum about the reasons for the lapse in filing, many in the vaping industry are speculating that a possible Trump reversal is in the immediate future.

Of course, this is all mere conjecture at this point. The more likely reason for the failure to file is simply poor management by the top brass. According to the FDA deeming regulations of May 5, manufacturers of e-cigs, e-liquids, and other related products had until December 31, 2016 to file with the FDA for products released before August 8, 2016.

This deadline is now delayed until June 30, 2017, but manufacturers of products released after the August 8 effective date must still comply with the FDA deeming regulations in their original state by the end of the year. It is all rather confusing but not unprecedented. A similar situation occurred during the rollout of the Obamacare Website in 2014.

Will Donald Trump overturn the FDA deeming regulations?

Like Obamacare, many political insiders suspect that the FDA grossly miscalculated the number of new Pre-Market Tobacco Applications (PMTA) that it would receive by the vaping industry, both in the United States and abroad. Even if an e-cig company is based in the UK or China, for example, it still must file a PMTA with the FDA and submit the million-dollar fees along with the perhaps mountains of scientific research related to their product.

The processing system used by the FDA to manage these PMTA requests is called the FDA Unified Registration and Listing System (FURLS), and it is the very same database used for decades by Big Tobacco. While it may have been perfectly efficient in the past, now it must also handle perhaps tens of thousands of new applications per month from the global vaping industry.

Does the FDA have sufficient manpower to handle such a massive influx of new work just days before the Trump Administration is about to officially take office? Or does Mitch Zeller, Director of the FDA’s Center for Tobacco Products and creator of the controversial FDA deeming regulations, simply see the proverbial writing on the wall? Will Donald Trump indeed overturn the FDA deeming regulations almost immediately come January 20?

Only time will tell.

The full update to the FDA deeming regulations can be found online.

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