In Part 1, we took at look at the very beginning of the FDA’s war on electronic cigarettes, which dates as far back as 2008 when the FDA rejected the very first application from an e-cig manufacturer attempting to register products, then began seizing an blocking e-cig shipments in 2009. Now we’ll take a look at the FDA’s involvement in the vaping industry after officially announcing the proposal for Deeming Regulations, which would extend the FDA’s authority over tobacco products to include vapor products.
FDA’s Involvement in Vaping Industry Continues
In April 2014, the FDA submitted a press release citing an official proposal to extend authority over additional tobacco products, including vapor products. By the end of the year, the FDA’s Center for Tobacco Products (CTP) began holding workshops to “gather scientific information and stimulate discussion among scientists about electronic cigarettes”.
Related: FDA Workshops for E-Cig Regulations
The FDA and E-Cigs in 2015
In March of 2015, the FDA began the second set of workshops on e-cig regulations. One month later, Representative Tom Cole introduced HR 2058, legislation that would change the FDA’s predicate date for vapor products on the market prior to February 17, 2007 to be grandfathered into the Deeming Regulations.
By October of 2015, the FDA’s Deeming Regulations reached the OMB, the White House’s Office of Management and Budget, to be reviewed.
The FDA and E-Cigs 2016: Deeming Regulations Become Reality
In early 2016, the OMB had finished reviewing the FDA’s Deeming Regulations and apparently deleted part of the FDA’s planned policy, as well as the rationale for the policy, which would have removed flavored e-cigarettes from the market.
On April 19, the House Appropriations Committee held the Agricultural and Rural Development Appropriations bill hearing to vote on proposed legislation within the Fiscal Year 2017 Agriculture Appropriations Bill, which included a cosponsored amendment by Rep Tom Cole and Rep Sanford Bishop now commonly referred to as the “Cole/Bishop Amendment”. Separate from the HR 2058 bill introduced by Tom Cole in 2015, the Cole/Bishop Amendment included language that would amend parts of the FDA’s proposed regulations, including changing the predicate date from February 15, 2007 to the effective date of the FDA Deeming Regulations. The amendment passed the House by a 31-19 vote.
May 5th, 2016: “D” Day
On May 5th, 2016, the FDA issued an early release (by 5 days) of its final ruling for deeming regulations, and by May 10th, the final ruling had been published in the US Federal Register with the official effective date of August 8, 2016. That very same day, the first of three lawsuits challenging the FDA’s regulations was filed in the D.C. District Court.
In the meantime, e-cig manufacturers, vape shop owners and vaping advocacy groups continue the scramble to make sense of the 499 pages worth of regulations, which Tobacco Control Expert Dr. Michael Siegel referred as “a disaster for public health” in his blog posted ninety minutes after the early release. In his blog, Siegel documented his initial reaction to the regulations, along with a breakdown of the onerous requirements the regulations entail.
What Do E-Cig Companies and Vape Shop Owners Do Now?
This is a question we have been trying to answer with the help of key leaders in the fields of Tobacco Harm Reduction and Vaping Advocacy with the continuation of “E-Cigs DeMISTified”, a webinar series dedicated to informing and educating the public on the science and regulations of electronic cigarettes. During the first three installments of the webinar series following the release of the Deeming Regulations, our guest speakers received tons of questions from viewers, many of which went unanswered due to time constraints. We have been hard at work in finding the answers to these questions and will be providing the answers in the continuation of this blog series.