CASAA Call to Action: During the last few days the Tobacco Vapor Electronic Cigarette Association (TVECA) has released two leaked “draft” documents which they claim are recent drafts of the Final Rule. The Deeming is currently in the final two stages before it becomes the law of the land. The Final Rule is on the desk of the OMB and this may take up to 90 days or more for them to complete their review and then the last step is a review by Congress. I’m reasonably certain that these “leaked” documents are authentic since they were released by a well known and supported trade group.
The first leaked document is titled “Draft T.O.C. of the Deeming Regulations“. This document contains a troubling reference to flavors and B and M’s. Please remember that it’s only a Table of Contents so the gory details are not included in this document. The real shockers are found in the second leaked document titled “Guidance for Industry/Draft Guidance” Fasten your seat belts and grip your mouse firmly while I dive down into the gory details of this document. Please study this section which pertains to B and M’s:
Here is a quick summary of the above text. Almost all B&M’s will vanish. This is a tragedy. People who currently smoke will face huge obstacles in switching to ecigs. That’s criminal. A death sentence if you will. People will loose their jobs and the only way to embrace vaping will be those ecig sticks sold at gas stations and convenience stores or deal with BT. “House Blends” for ejuice are a huge source of revenue for a shop. This also generates return visits for more sales. Many shops also provide “builds” for toppers. The customer buys a topper and the shop will build the coil and wick. The critical revenue source is the sale of the topper. Customers continue to return for new builds which generate more sales opportunities. If a shop wishes to engage in the sale or distribution of the issues noted above they must obtain Premarket approval from the FDA. This is a very costly (300K or more per item) plus mountains of paper work and huge amounts of time. Vegas has both large shops and small shops. I don’t know any of these shops which could afford this expensive procedure and I doubt any shop in the US could afford this expense. Please remember, if my shop offers 30 flavors in 4 different NIC strengths then every one of these mixes must comply with the FDA rules. Due the math, that’s potentially millions of dollars in expenses for the shop. The same holds true for toppers or any other item noted abover. Think you are clever and will only sell pre-mixed flavors (not finished ejuice) and send the customer someplace else for the NIC. That’s not going to work either.. Next, lets take a look at what products are covered in the following screen capture:
Here is a quick summary of the above text. Almost everything used in vaping will require the very expensive FDA Premarket approval. It’s also important to remember that the FDA has “enforcement discretion” and vapers may also be subject to “Medical Device” regulatory enforcement. If a given component doesn’t fit into the Tobacco Control Act then it’s regulated as a medical device. The net affect is that only a very small number of companies can afford the very expensive premarket approval from the FDA. Premarket approval is also a defacto ban on innovation. Modify the style of a topper or mod, invent a new topper or mod, change the formula for a ejuice mix, and these actions will all trigger the requirement for a new premarket approval. Essentially BT and perhaps a few large players in the Vaping industry such as VaporShark will survive. Think your going to China for your vape gear? Customs procedure in concert with the FDA may lead to embargoes.
Finally, embrace activism today! It’s never to late! Get off the couch and if your head was in the sand then please face reality. Will the FDA obliterate vaping tomorrow? Nope. My ballpark guess is the final FDA regulations (the final rule) will become the law of the land (the effective date) in the first or second quarter of 2016. Then the compliance date would be 24 months after the effective date of the final rule. All products (99.9%) remaining on the market past the compliance date would need to comply with these FDA premarket approval requirements. Some have referred to the 24 month period as a “grace period”. In reality, the 24 month compliance date is more about the time necessary for the FDA to create the necessary infrastructure for aggressive enforcement actions. Certainly the “Black Market” will flourish but that’s a subject for another post. Given the draconian nature of these provisions, the FDA will definitely get sued by Vaping trade groups and perhaps others. The effective date of the final rule will create “panic” in the marketplace so my advice is “Better safe than sorry” so start today to prepare for the worst possible outcome. Become a “hoarder” consistent with your budget. Make friends with a DIY geek or try it yourself. It’s not that hard. . Although this posts deals with “leaked documents”, I would not expect the Final Rule to differ in any significant fashion from these leaked documents. That’s my best guess. ECF has a great thread on these issues started by the founder, SJ/Oliver Kershaw. I encourage you to read it, participate, and reach your own conclusions. You may also wish to read E-cig firms steel for legal battle which provides some backround on these “leaks” and reactions from opponents of vaping. TVECA has promised to release more leaked documents. If and when they do, I plan to cover these in additional posts.
10/31/15: Edited for clarity and deployed the following banner on ECF:
11/4/15 Update: You can read my latest post about TVECA and the surrounding issues.