On Friday, the U.S. Food and Drug Administration (FDA) missed its self-imposed deadline to submit clarifications to the FDA deeming regulations amid speculation of an imminent repeal by the Trump Administration. The original deadline of December 31, 2016 is being pushed back to June 30, 2017 for products manufactured prior to the August 8, 2016, giving the vaping industry a 6-month extension. Products released after the August 8 effective date must still register by the end of the year.
The FDA is not offering an official reason for the extension, but the change may be due to simply “poor planning.” The agency may have grossly underestimated the massive surge in new Pre-Market Tobacco Applications that would need processing by FDA officials, a technological problem reminiscent of the Obamacare website fiasco of 2014.
The agency’s processing system is named FURLS (FDA Unified Registration and Listing System), and it is somewhat antiquated. In fact, it’s the same system that Big Tobacco has been using for several years, but FURLS was never designed to manage thousands of new applications every day.
Will Trump repeal the FDA deeming regulations?
Others in the vaping industry are wondering if the recent FDA amendment is simply a stall tactic to delay work on the new deeming regulations until President-Elect Donald Trump officially takes office on January 20, 2017. Trump has been a vocal opponent of excessive government oversight favored by the Obama Administration and often implemented through the FDA.
Furthermore, news of the FDA extension comes just days after the announcement of Rep. Tom Price as Trump’s pick for Secretary of the Department of Health and Human Service, the cabinet position ultimately responsible for managing the FDA. Price has publicly stated on several occasions that he will actively pursue the repeal of Obamacare and other regulatory legislation imposed by President Obama via executive order. The FDA deeming regulations could be on the list.
FDA fails to deliver list of ‘toxic chemicals.”
Another reason for the extension might be that they FDA also missed another self-imposed deadline to provide the government with a detailed list of all toxic chemicals allegedly found in e-cigs. The vaping industry has long argued that this “list” doesn’t exist. It’s all been a complete and intentional misrepresentation of the facts in an attempt to discourage the use of e-cigs and vaping technology by the American Public.
The argument is that Mitch Zeller and his FDA cronies, who previously worked for the Big Pharma company GlaxoSmithKline before coming to the FDA, are secretly trying to bankrupt the U.S. vaping industry. If Zeller and the FDA are successful, then more traditional nicotine replacement therapies like “the patch” and Nicorette gum - products whose patents are held by GlaxoSmithKline and Big Pharma -can regain their previous stronghold on the marketplace.
Manufacturers should be careful not to interpret this latest extension as a sign that the FDA deeming regulations will ultimately be overturned by Donald Trump. Even if this were to occur, it is highly unlikely that Trump will reverse them immediately after taking office. The complete update to the compliance requirements for the FDA deeming regulations can be found online.
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