August 8, 2016 – Welcome to the New Era for Vaping
Today is the first day of an unknown era. Vaping in the good ‘ole US of A may never be the same again, and whether we are going to see the twilight of its golden age, or the dawn of something newer, bigger and better is still obscured by a big white cloud of vapor…
This past Friday, August 6th we released nearly one hundred new flavors in order to keep from violating the FDA’s regulation that no new tobacco products be placed on the market after 8/8 without a PMTA. We have also implemented age verification on our website and ended our exclusive pre-release sampling program in order to comply with the apparent inclusion of vapor flavorings as deemed “tobacco products.”
It is very clear from the updated publications on the FDA’s website, Q&A webinars held in July, and their direct correspondence with us that DIY ejuice will not emerge unscathed if things continue on the same course.
The FDA still has not given us a clear answer about the PMTA requirements for products like flavoring that 1) are not made or derived from tobacco and 2) cannot be used directly in an e-cigarette. There are specific exemptions for “raw” materials, but those only apply when flavors are sold B2B. The one thing that they have made clear however, is that if the intended use of a product even comes close to an e-cigarette, they will be exercising their mandate to regulate.
In the very recent “olden days” we liked to release our DIY flavors slowly and give people enough time to sample them before they were available publicly, but since our ability to offer free samples has also been regulated (whether that is constitutional should be examined by a judge experienced with the 1st amendment) and taken away by the FDA’s new rules.
We sent out our last box of freebies on Friday. It is a new era.
Changes will come to DIY as vendors encounter FDA enforcement aimed at manufacturing since bottling and labeling a DIY flavor after 8/8 is now considered tobacco product “manufacturing.” A lot of vendors who import bulk flavors and then rebottle them in the US are going to be constrained by this regulation. As it seems, even domestic re-bottlers will need to provide a masterfile of their own or register and assign their flavors to an existing one.
This leaves flavor vendors who do not intend to comply with FDA regulations in a very difficult predicament: the obligation to register their master files with the FDA Center for Tobacco Products so that commercial customers can file their PMTA’s, while not having an application of their own in for the sale of those same flavorings for DIY use.
We intend to fully comply with the deeming requirements in regards to both our commercial, and DIY products. The black market is simply not an option.
We have hundreds of customers that will be filing thousands of PMTAs of their own and they need our assistance to make their filings and they need us to maintain our good name and reputation with the regulators they are also working with.
Besides the right and wrong of it, the FDA is a formidable government agency with powerful enforcement resources to bear on anyone they chose to make an example of. A vendor can pretend that the intended use of multi-purpose flavoring is not ejuice, but for a legitimate business that does not deal in the black market, the specter of fines and possible jail time are going to separate the true intended use of flavorings made and packaged for vapor from multipurpose drops intended for beverage, candy and baking.
Over all, it is a disappointing situation that can only be fixed with better decisions being made by the people in charge. We need to educate them and they need to hear our voices.
If you want to keep mixing your own juice, then stop feeling like you have an unassailable refuge in DIY and realize that DIY could be taken away just like commercial ejuice. We urge you to call your congressman.
