FDA proposal posted: CASAA, Vapers, Vendors… time to act.

Do not waste time.

The FDA released their proposal for regulation today and it’s… long. It’s not as bad as it could have been, but it does have a lot of language in it that can be construed as very scary in the long term. It’s not the end of vaping as we know it or anything like that, but the foundational nature of some of these proposals can put quite a bit of power into the FDAs hands with a lot of blanket regulations that will create a very hostile environment for innovation and development or just continuing our business.

Some of these proposals are excellent. Federal rulings on age restriction means individual states are less likely to create their own regulations, driven by “Won’t some one think of the children” but used to sneak other rules into play.

What we, the vaping community need to do is respond. That is what this is about, they spell out methods of reply in the document (linked below) and I think it is imperative that we all do so. More than anything, vendors and manufacturers need to be responding and above that, CASAA and our other organizations need to put together a VERY thorough response, post it publicly and allow the consumers and vendors to use it as a reference document in our communications and feedback to the FDA. I would recommend that get done within a week.

Important notes from the current proposal that you need to think about.

1. “accessories” vs “tobacco products”. Currently, as it’s stated, not just the juice, but also anything used in the consumption of the “tobacco product” is set to be regulated by the FDA. This may or may not include essentially ‘anything’ we have outside of carrying cases and stands. Because of the wording, there are grounds to consider mods, PVs, batteries (marketed for vaporizers), atomizers, RDAs, RBAs, cartomizers, Kanthal, wicking material, even drip tips, all part of the body of product that they have the right to regulate. This means, if you develop a new mechanical mod or RBA, it may have to go through the full approval process just like a pack of cigarettes.

my personal thoughts on this one: Juice should be regulated. Prebuilt or self contained atomizers (i.e. the coil and wick material are already assembled, think cartos, evod replacement heads, etc) should be regulated. “DIY” atomizers should NOT be regulated. This includes RBAs, RTAs, etc. The “tank” of a clearomizer or carto tanks should not be included. Power supplies (i.e. mods, pvs, mechs, whatever you want to call them) should not be regulated. My reasoning for the parts that SHOULD be regulated is that those have the greatest potential for negative health impact if processed, assembled, or otherwise handled improperly during manufacture and development. The other products have a much lower potential impact on the users health and by over regulating them we will stifle innovation and grind the current explosion of development in the community to a halt.

2. The document is obviously based on “Cigarette” style E-cigarettes. I believe this has caused a lot of ambiguity and odd wording that can potentially screw those of us that are using more advanced product. “cartridge” as a term isn’t really a commonplace thing in the vaping world, is a clearomizer a cartridge or just the head? Is an RBA a cartridge? Is a bundle of wick material considered a tobacco product now?… We need to more clearly define categories of the various parts of our devices and express to them that they are being extremely limiting in scope with their definitions.

3. Even “products containing 0 nicotine” can be considered tobacco products and could require labeling saying “derived from tobacco” etc. This means, even if you pull back to 0 nic and want to vape still, it’s possible that the devices you’d use for it will be regulated and restricted and sold as tobacco products. If the device has a battery, metal tube, some stainless mesh, kanthal wire, and a liquid comprised of the same ingredients you might find in a bottle of juice in the cooler section of the gas station, it should NOT be considered a tobacco product. This all pans back to the definitions of accessories and tobacco products. I can’t emphasize this enough.

4. Flavors: They are setting the ground work to eliminate flavors. The argument has been put out there a million ways, I don’t think I need to expand on that more.

5. “Quitting” in multiple places in this document they say that there is no proof that people have quit smoking or that vaping is an effective method of quitting smoking. I believe they are basing this on the concept of using vaping as a cessation device with the intent of completely quitting NICOTINE not just “Smoking” or tobacco use. Nicotine does NOT equal tobacco. The goal of (I believe) most vapers, is to switch to vaping instead of simply quitting all together. If you write, you should make a note of the last time you used a combustable tobacco product and highlight any health improvements you’ve experienced since switching. They need to be made aware that vaping isn’t being used by the majority of people like a patch or pack of nicotine gum. yes, some people are doing that, but most of us are just trying to reduce our dependance and reduce the negative health impacts our addiction has. They openly admit that the toxins found in vapor are dramatically lower than in traditional tobacco. That should be an endorsement of Vaping as a harm reduction practice and they should stop focusing on vaping as a potential cessation practice.

Those are my primary highlights. Here’s the link to the actual proposal.

http://www.ofr.gov/(S(axtmtr20nu1bl20q4r3shcjt))/OFRUpload/OFRData/2014-09491_PI.pdf

Go, read, reply. Stand up for what you believe it. give them the appropriate information. And CASAA et al, help us… translate this stuff for the masses in language they understand. I’ll be posting breakdowns of various bits and pieces as I have time but I’m also going to be drafting my own responses to the FDA from my own position as a vendor, manufacturer, and product developer. THIS is the time to act, don’t just complain on the internets to each other, take that energy and let the FDA know how you feel and how you believe it should be.