How will FDA regs effect new mod products
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That is not how any of this is set up. There are no fees per se. The FDA does not perform the testing. The cost associated with applying for approval is the research, analysis, and putting together a document that shows the product will not have a negative effect at the population level. An eLiquid would need to be tested in every open system device. But, there are no approved open system devices. Those devices would need approved eLiquid to prove their safty. CATCH22, only closed systems have any chance of approval.
Trunker, I can't always tell when you're making an attempt at humor.
In case you're serious, there is no contradiction. The first statement you quoted is preceded by "unless the legislation passes..." You left that part out. The second statement you quoted is preceded by "the legislation would allow," which you also left out. So, the only "contradiction" is that when different things happen you get different results.
I'm closing my eyes and wishing the FDA committee in the E-Cig approval department are all vapers and pass everything. No businesses (B&M or online) suffer, lose profits, all products stay, and that vaping will continue to lead to getting people off the stinkies. And that today's date is 8/7/15.
Do you part and sign the petition so maybe the Deeming Regulation will be thrown out. Don't just close your eyes and wish!
Sign the petition by clicking here.............
U.S. Senate, U.S. House of Representatives, President of the United States: Reject the FDA's Deeming of Vapor Products as Tobacco Products
Sign the petition by clicking here.............
U.S. Senate, U.S. House of Representatives, President of the United States: Reject the FDA's Deeming of Vapor Products as Tobacco Products
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Certainly it will help new products hitting tge market after tomorrow.
There are two routes in the FDA.
1 is the full PMTA route
2. Changing the predicate date they can use the route that prices the new product is equivalant to a device already grandfathered in.
It has passed. We're on the same side btw!
'when different things happen you get different results'. How insightful.
T
The benefits of federal regulation are vastly overrated--most notably so when they are imposed in a heavy-handed fashion, as they typically are and as we are now seeing with vaping products.
To your point, the United States government didn't start regulating automobile safety until the mid-60s. At that time, before regulation, the U.S. auto industry was the world leader in technological development and manufacturing. the U.S. had safer traffic than any country in the world. That's no longer the case. LINK Henry Ford had long ago made it possible for ordinary middle class people to afford a car. It's not hard to imagine how Ford would have fared with federal regulators constantly second guessing every nut and bolt of his car designs. He probably would have washed his hands of the whole endeavor and become a shoe manufacturer.
In the book which triggered the hysteria and outrage which let to the introduction of federal safety standards, Ralph Nader demonized the Corvair as "unsafe at any speed." As it turns out, it wasn't any more dangerous than other cars: In 1971, "This [NHTSA] review panel concluded that "the 1960–63 Corvair compares favorably with contemporary vehicles used in the tests [...] the handling and stability performance of the 1960–63 Corvair does not result in an abnormal potential for loss of control or rollover, and it is at least as good as the performance of some contemporary vehicles both foreign and domestic." LINK Woops! A little late to save the Corvair, which was one of the most advanced and innovative cars ever produced in this country.
My belief is that people ought to be able to drive what they like, vape what they like, smoke what they like and in fact do anything they like that fits in with life, liberty and the puberty of happiness.
T
T
Neither piece of legislation has passed. How did you get the idea that anything has passed?
Yes, we're definitely on the same side, which makes me wonder why you feel the need to make sarcastic remarks like "How insightful." No, not insightful. It's an attempt to explain with meticulous clarity and simplicity something which you seem to have trouble grasping--for what reason I can't imagine.
I never said that. Here it is again.
Here us what will happen if the grandfather date is changed.
All products on the market as of the predicate date can stay on the market with no PMTA.
How it will help new market is the new product is. They can prove that item #98474 is equivalent to item #35 that was grandfathered in on or before the predicate date. Much less time consuming, much less paper work, ABS much less expensive to be aporoved
Right. A new product might get approved as the substantial equivalent of an existing product. So far, the FDA has treated "substantial equivalent" to mean virtually identical, so significant innovations would be unlikely unless there's a dramatic shift in policy.
Apparently so, but I can't fathom why. Perhaps you could explain where the misunderstanding lies.
@Verb The fees I was talking about was fees paid per juice company per product if they want to pay to test their products. Not paid for by the FDA, they don't spend money (only time), only the juice company may or may not pay for it's testing, up to them to decide if they'll be successful, you could crap shoot and not pay and just get lucky and get approved too or you can pay and get your juice tested if you know what the FDA will look for. But I was merely replying in saying it could or might not cost as much, as I was replying to another person. And how the testing if performed; open system or closed, nobody actually really knows the testing procedure the FDA will undergo in said situation. I was already aware the fact there are no approved open systems approved at this time, unfortunate because I (most of us that use 510 atomizers) use open systems, not closed gas stations e-sticks. Only one approved atm, I've seen anyways was the Blu e-stick style closed system. Vaping in general isn't banned, but my adv is a Petri Dot Mod and Noisy Cricket, which are open systems. Way 2 different styles of vaping and devices. Either or, for people like me who's been vaping for 5+ years, getting our style devices/gear will be harder to get, or slower to come in to market. Those circumstances are also unknown as we have to still wait and see. For now, we can continue to do follow up on the CB amendment (or @SteveS45 petition signing), CASAA, or not blowing smoke, that's all we can do. My crossing fingers was just a light-hearted wishful thinking message since things here in this thread was getting a little "debatey".
@J.d. Roberts that isn't my petition it was started by @Lessifer and I am just doing my part to try and get the needed signatures.
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