Manufacturers 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 2017 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.
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 vaping.com, 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, CASAA, as well as engage with industry allies like Representatives Tom Cole (R-OK) and Ron Johnson (R-WI). The vape industry remains under a microscope and it is crucial to continue down the path of compliance, implementing increasingly responsible business practices and as many aspects of the regulations as possible, while researching and preparing for the rest. SVBS
Sheerlie Ryngler is the Director of Operations and Creative Director for Vape Organics, the first certified organic e-liquid line. A native of Los Angeles, Sheerlie has traveled extensively, receiving her BA in International Relations and MA in Conflict Resolution. She has been a passionate activist for a number of causes around the world; for almost two years Sheerlie has focused her attention on the vape industry and believes that standards of excellence and commitment to progress are crucial to ensuring its continued success. You may contact Sheerlie at [email protected] or visit her website at www.pureorganicvapors.com.