FDA Sen Johnson (R-Wis) demands answers from FDA RE deeming
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Overall, I feel the FDA rules will be relaxed from its current form, with the lawsuits, Congressional action, etc...A lot can happen in two years and while it's worrying, I think we don't have to go back to smoking anytime soon (even for those who didn't hoard).
I think we all HOPE that you're right, but I don't think that will happen unless someone MAKES it happen. I'm not going to count on it either.
I'd like to see relaxation on the current devices that are being required for testing. Meeting UL safety requirements should be enough. I'd like to know what's in my juice, but it's not necessary to test the same flavor multiple times just because it's a different nicotine level.
If the FDA is so curious about testing, then let them receive one of each and do it at their own cost. I'll bet that they could obtain sufficient information for far less than $300K per sample.
So... do you really want to trust the FDA labs testing results?
Those could be countered with private lab testing. My point was directed at the FDA's requirement for individual testing of each juice and each nic level of that flavor. That's a little like testing each square foot of dirt in your yard for fertilizer needs instead of just taking a few representative samples and mixing them into a single sample for testing.
As long as juice contains FDA approved flavoring, FDA/EPA approved PG and VG, and medically approved nicotine, there shouldn't be an issue. The standard mix is changed by changing flavorings, so there's no reason to submit all juices to exhaustive testing provided that the only difference is in the FDA approved flavoring used.
It's all a farce to break the back of the Ecig industry and sell more tobacco cigarettes. Congress knows that and should challenge the FDA's Gestapo tactics toward Ecigs, IMO.
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You have to remember that the fda doesn't approach this like we would. There really is no toxicological reason to test each nic level. The real "testing" would be the psych studies, is 12mg more or less addicting than 18mg(neither is), or will 6mg result in someone continuing to use the product who would have otherwise quit while using 24mg. None of it makes sense in the real world.
And on a happier note, I just saw this:
Bring on the handcuffs!
I love Senator Johnson!
He is the best!!!
1. There is no reason why every juice vendor should have to establish that vaping each of his/her eLiquids is generally safe. If you bake cookies and market them to a local food store, do you have to do clinical studies to prove cookies are generally safe and "are a public benefit"? But that is a moot point because...
2. Most importantly, the TCA was not meant to be fair. It was meant to eliminate any future "tobacco products" that were not grandfathered. So the issue is not the fairness of the PMTA process, the issue is that the law was expressly written to prevent something like the vaping industry from ever getting off the ground. That is the fault of Congress, which basically decreed that no more new products made from nicotine would be sold as general consumer products, even if they are 1000% safer than cigs. Congress needs to fix this.
And it could play into their 'dual use' argument.... people start out higher, and go lower - sometimes rather quickly..... but eventually (not all cases, of course).
HR2058 is our best bet, IMO. It provides for grandfathering products now on the market without further testing.
The FDA could do that with a survey monitoring program and save everyone a lot of money.
I think vapers find a level that's satisfying early on and hang there for a while. Some move down over time and some stay at high levels.
The FDA could ask for volunteers to enter a test that monitored nic level used by vapers. The truth is that many if not most vapers have titrated downward from 24mg to much lower levels and found that lower nic levels are equally satisfying. True, some of that is a result of high wattage cloud makers.
I was a 24mg/ml vaper from 2010 until a couple of years ago. Now I'm at 3mg and finding it just fine. When I try 0mg juice all the nic bite is gone and it's boring, so I stay at 3mg.
There are definitely much better and more rational ways to go about regulating these products than what the few proposes. In all honesty, nic level of the liquid is somewhat meaningless since as you point out, much depends on the delivery system. On top of that, nic level isn't really anything to be concerned about. The body is remarkably good at self regulating nic intake. Of course, the fda doesn't see it that way.
The same gasoline put into different vehicles produces varying levels of exhaust components. Juices vaped in different types of atomizers at different wattages vary, also.
Yes, the FDA is searching for ways to level the playing field for BT, IMO. Gotta keep up the revenue for paying out the MSA.
Is there such a thing as a cookie that is a public benefit? What does "public benefit" even mean? How is tobacco a public benefit? But I guess tobacco slithered by having to meet that requirement. I could begin an endless list of consumer items that are in no way a public benefit and another of items that are actually a public harm. Why don't they have to prove themselves?
This, IMO, is where the Conversation should Always be turned Back To.
e-Cigarettes are Harm Reduction over Smoking. Credible Science is showing that. So if Cigarettes are going to be Allowed to be Sold in this Country, why wouldn't e-Cigarettes be seen, at worse, as a Lesser Evil?
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