Implications of the FDA’s Deadline Postponement

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While 2017 is off to a tumultuous start for many, the vape industry finally has reason to be cautiously hopeful as: rumor has it a regulatory reform candidate will be instated as Commissioner of the FDA, analysts predict a more favorable approach to our industry with the Trump administration’s “regulatory reform agenda,” a fresh bill was introduced by Tom Cole (R-OK) and Sandford Bishop (D-GA) to change the predicate date, and very busy organizations like SFATA and CASAA are fighting the great fight for a worthy cause. In addition, the FDA’s deadline postponement is an appropriate and practical lens through which to analyze the potential shift.

Woman Holding Vape in Peace SkateboardManufacturers and importers of vapor products across the United States rejoiced on December 9, 2016 when, just weeks before the compliance date, the FDA announced that the deadline for vape companies to submit registration and product listings was postponed. Perhaps this decision wouldn’t be seen as signaling larger implications for the regulations if it weren’t extended by six months; in the face of such a sizable extension of the first actual submission in the compliance process, it’s worth exploring the potential implications of this decision.

In order to do so, it’s necessary to evaluate the possible factors that led to the postponement. It seems that the most urgent reason for this postponement stems from the FDA’s realization that the deadline was unenforceable in light of the agency’s own unpreparedness. According to SFATA’s federal lobbyist, Mike Hogan, the extension likely stems from the FDA’s lack of preparation for, and ability to respond to, the avalanche of inquiries from business owners attempting to register, as well as technical glitches in the software for form submission, and the very real possibility that the agency was not expecting the incredible volume of incoming and projected submissions.

If the agency tasked with regulating the vape industry was in fact unprepared, one implication of the extension is the possibility that subsequent deadlines may also be postponed. Already we have seen that the ingredients listing submission deadline was extended by six months for each tier, from February and August 2017 to August 2017 and February 2018 for standard and small manufacturers, respectively. If the agency does not take serious measures to ensure its preparation for the first wave of deadlines later this year, including updates to technical infrastructure and, potentially, personnel increases, the agency may once again find itself too inundated with registration and ingredient submissions to accept the next rounds of increasingly robust submissions.

Group of People Assembled with I Vape & Vote signs

Photo credit: @sfata

Aside from implications related to the FDA’s capacity to process and enforce the regulations, there are external forces at work that both may be influencing this postponement and highlighting greater implications for the the overall trajectory of the regulatory process. Of course, the regulation of the vape industry is not occurring within a vacuum but is affected by the wider political climate—to what extent remains to be seen. However, it is possible that the FDA postponed the deadline by such a long stretch in order to first evaluate the new administration’s approach to the deeming regulations; if so, this would indicate the potential for major revisions.  As highlighted by Peter Beckett on, while on the campaign trail president-elect Donald Trump asserted that 70 percent of federal regulations may be subject to elimination under his authority. However, Beckett also explains that the deeming regulations may have been passed just days too soon to qualify for a complete cancellation under the Congressional Review Act. Nonetheless, it is possible that there will be revisions, including a much-hoped for revisiting of a change to the predicate date. Finally, Jim O’Neill, the rumored front-runner candidate to take charge of the FDA under the Trump administration, has been called a “regulatory reformer” by ECigIntelligence and, according to Beckett, has close ties to people in the vape industry.

While it’s too early to make predictions, the fact that the FDA postponed the registration deadline by six whole months highlights potential implications that offer hope of changes to the deeming regulations. In the meanwhile, it’s crucial that our industry continues to support those organizations actively working to represent industry interests on the political level, including SFATA and CASAA, as well as engage with industry allies like Representatives Ron Johnson (R-WI), Tom Cole (R-OK), and Sandford Bishop (D-GA)—importantly, the latter two have recently introduced a fresh bill to change the predicate date. The vape industry remains under a microscope and it is crucial to continue down the path of compliance, implementing increasingly responsible business practices, vigilance when it comes to advocacy, and the demonstration of higher and higher industry standards.

A revised version of this article was written for, and originally appeared in, the January/February issue of Smoke and Vape Business Solutions.


Vape Community Alert: Urgent Calls to Action - Man with Megaphone

Current Calls to Action: 3 Phone Calls

SFATA is asking us to make 3 phone calls to our representatives, in order to help save our industry! Here’s what to do:

  1. Call both of your U.S. Senators asking that they include the House version of the Department of Agriculture Bill in the Fiscal Year 2017 spending bill;
  2. Call to urge your U.S. House of Representative to co-sponsor the Cole-Bishop bill (H.R. 1136), demonstrating support for this language to remain in the budget bill.

Mike Hogan, SFATA’s federal lobbyist, recently sent an in-depth and optimistic federal lobbyist update about the recent SFATA fly-in: “I have to say, we all detected a real shift in both understanding of our issues and willingness to prevent the calamity that the regulations will cause.”

Thank you, SFATA for being a tireless voice for the vape industry! If you are not already, please consider becoming a member of SFATA today.

P.S. ACTIVISM 101: Say thank you, too! Consider writing thank-you letters to Reps Cole and Bishop!

By | 2017-06-05T16:29:04+00:00 March 10th, 2017|Industry Information|0 Comments

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