Information on the new FDA regulations
I know that many of you are wondering what will happen to the vaping industry since the new FDA deeming regulations were released earlier this month. We have received a lot of calls and questions. After reviewing the documents and discussing them with the Smoke Free Alternatives Trade Association, here is the gist for our customers.
First, we will not be closing our doors in August, just to get that out of the way. These regulations, which go into effect August 8th, 2016, implement three major things right away. 1-we do not sell to minors, 2- we do not operate vending machines that could be accessed by minors, and 3-that we do not give away free samples. We may be able to give away samples in 0mg, but we are all still debating the sample regulation. I believe that included with a purchase, this would not apply. The gist of that bit of legislation seems geared toward giving away free samples at trade shows, conventions, and by direct mail to people who are not current customers. It is my belief that a free small flavor sample with a purchase by an adult customer is not an issue, but the lawyers are still chewing on it, as there are no precedents.
The BIG problem is the regulations that any e-liquid, flavor, battery, clearomizer, etc. that was manufactured after February 2007 be subjected to a pre-approval application. These applications cost anywhere from $300,000-$1,000,000. This would put basically the entire industry out of business. Products that are on the market as of August 8th, 2016 will be required to submit an application within 24 months of that date, so 2018. These applications require a great deal of research and testing and take time.
Support HR 2058, the FDA Deeming Authority Clarification Act of 2015. We support this bill and you need to as well! Email your congressional representatives to support it. This bill changes the pre-approval date from 2007 to the date of the official regulations, August 8th, 2016. Tell them your stories about how you quit smoking using vaping products and how it changed your life.
Products introduced after that date would require this expensive process. However, it gives us some breathing room and allows our current products to stay on the market while we continue to fight.
Does this mean that the products will not have to undergo an FDA-approval process? No…but the process needs to be simpler and much more streamlined. The FDA should give us their list of banned ingredients, and we should submit our proof of testing that the juice does not contain them and leave it at that. That would be similar to how supplements and over the counter vitamins are regulated. We are fighting to create new legislation and legal designations that would allow this, but we need time.
Economically, this is going to hamstring the industry by nearly eliminating new flavors and innovation, but at least we will still have an industry. If HR 2058 does not pass, you can expect nearly all of your vaping choices to be taken away within 2-3 years.