Wednesday, May 11, 2016
FDA’s New Deeming Regulations: How Does It Affect Us?
The FDA Deeming Regulations will have little to no impact on the consumer for the next 30-90 days (until August 5, 2016). New products will be allowed to be introduced into the market and shops can continue to sell its inventory.
However after this grace period and for up to 2 years from the publication date (May 10, 2018), manufacturers and anyone else who makes e-cigs, e-liquid, accessories and other advanced vaping products/components will need to submit a Premarket Tobacco Product Application (PMTA) for each and every SKU, variation, and nic level of products they produce. This process is estimated to cost anywhere from $200,000 to over 1 million dollars per application. A small juice company making 5 flavors in a line, would have to submit a minimum of 20 different applications potentially at the price tag of 20 MILLION DOLLARS!
During this time, consumers will start to see an industry freeze. There will be a significant decline of available products, particularly e-liquids. Shops will no longer be able to build an RDA or offer samples of liquid with nicotine. Most small businesses will go out of business. The rest may be subject to higher taxes, licenses, and fees. Online sales may also be prohibited.
After 2 years and up to 3 years (May 10, 2019), manufacturers must have started the costly PMTA process and/or been approved for a product to be on the market. Any products that have not gone through the process, or are rejected, will be prohibited to sell and manufacture as of this date. Based on the 2007 product technology date the FDA is using (predicate date), if this ban would go into effect today, 99% of the products on the market currently will be considered illegal. Any product not approved by this date will be off the market.
To shop owners and other small businesses, this is a HUGE win for Big Tobacco and a death blow for our industry. In less than 2 years, the vape world as you know it will be decimated. No longer will you be able to sample a huge variety of e-liquids, no longer will you be able to get a vaping device that works for you and helps millions of people quit smoking cigarettes every day. Shops will close, products will disappear and the industry will be forced into an illicit black market.
As consumers and owners, we have 2 options at the moment. We can respond through legislation or litigation. And we need to utilize our lobbyist and advocates for both. But there are also things we can do to help.
Our first step is to help get HR 2058 passed. This will change the predicate date to something closer to today and will continue to allow the 99% of all products on the market after February 2007 to be sold and manufactured. Any new products brought to market would be subject to PMTA. This is our first defense and one that would immediately right the course. If you click THIS LINK, you can send a pre-drafted letter to your senators and congressmen in your area, or you can draft the email yourself. It literally takes 2 minutes of time.
We could also litigate and get these regulations tied up in court for years. We could sue saying the FDA doesn’t have the authority to regulate e-cigarettes, etc. This is definitely an expensive option as well, but still less expensive than the PMTA fees.
There are still many questions that need to be answered and information is being sorted and understood further on a daily basis. I encourage everyone to please do your own research as well and continue telling your story to your congressmen and senators. As a community we have a lot of fight in us and if we stay strong, united, and respectful, we may be able to get these rules turned back into our favor.
Here are some valuable links if you would like to get involved in the fight: