The FDA has no authority to levy taxes. Only Congress can do that.
Now that they are being handed a definition of tobacco product do you seriously see congress, state and local governments not pouncing on the tax gravy train?
The FDA has no authority to levy taxes. Only Congress can do that.
[...] I believe that even if the FDA ultimately wishes us harm, it's a tactical error on their part to let the ecig market breathe for the next two years -- or even for the next few months. The longer the genie's out of the bottle, the better for all of us. [...] We know that our opponents in the faux-public-health lobby will do or say anything to promote their irrational crusade against so-called non-communicable diseases. We also know, from past history and from the FDA's own statements in the very proposal that is our topic du jour, that the authorities are not friendly to our cause; even now, the FDA refuses to acknowledge the vast bulk of the evidence in the ecig's favor. There are any number of battles to come, and although we have the truth on our side -- although I believe we will eventually win -- we do ourselves a disservice if we devalue our own efforts to effect that victory. [...]
I'm not really concerned about that paragraph as things stand now, because 1) it attempts to exert authority that's plainly outside the parameters of the agency's power, and 2) no judge, however scientifically illiterate, or vaping-naive, is going to accept the argument that a PV and its constituent parts have no conceivable purpose except the delivery of inhalable nicotine. The very existence of zero-nic liquid, and the sizeable market share it currently enjoys, renders this argument a non-starter.
DO we have hard numbers on how big the 0 nic industry is? I have never seen them from a credible source?
--Do I understand the proposed regulation correctly, that ecigs will require warning labels?
--It's still unclear to me whether hardware is regulated if it doesn't contain nicotine (or isn't derived from tobacco). Blank cartridges, atomizers, driptips, batteries, tanks...
Quote: "tubes, papers, pouches, AND FLAVORINGS are considered components" as they are intended to be used in the consumption...
The one question I have right now is; how will the FDA determine something can remain on the market or deny it?
The FDA is required to deny .... if the FDA finds that:
- The manufacturer has not shown that the product is appropriate for the protection of public health,
- the manufacturing methods, facilities, or controls do not conform to manufacturing regulations issued under section 906(e) of FD&C Act,
- the proposed labeling is false or misleading, or
- the manufacturer has not shown that the product complies with any tobacco product standard in effect under section 907 of the FD&C Act.
More vagueness:
How does one show that the product is appropriate for the protection of public health?
Haven't had time to look up the manufacturing regulations.
Their definitions of 'false or misleading labels' are very interesting reading all on their own.
I haven't found that the FDA has ever issued any tobacco product standard, so at least that should not have to be worried about.
I am not questioning you. I am just very confused about how these manufactures can even get their products approved unless someone "proves" that e cigs are not harmful. It seems like a lose/lose situation all around for e cig manufactures. How much more troublesome would be to get flavors approved.
I am not questioning you. I am just very confused about how these manufactures can even get their products approved unless someone "proves" that e cigs are not harmful. It seems like a lose/lose situation all around for e cig manufactures. How much more troublesome would be to get flavors approved.
Basically, they would have to have long-term testing, which of course is hard to do when your product isn't available for retail sale. The burden of proof, is on the manufacturer; otherwise it appears that the FDA will assume that it's just as bad for you as smoking. Except for "premium cigars,' which appear to have some special magical powers that make them not as bad.
Basically, they would have to have long-term testing, which of course is hard to do when your product isn't available for retail sale. The burden of proof, is on the manufacturer; otherwise it appears that the FDA will assume that it's just as bad for you as smoking. Except for "premium cigars,' which appear to have some special magical powers that make them not as bad.
The theoretical loophole is "substantial equivalency". A manufacturer has the opportunity to demonstrate, to the satisfaction of the FDA, that a product is substantially the same as an existing product.
The song remains the same:
I had a dream. Crazy dream.
Anything I wanted to know, any place I needed to go
Hear my song. People won't you listen now? Sing along.
You don't know what you're missing now.
Any little song that you know
Everything that's small has to grow.
And it has to grow!
California sunlight, sweet Calcutta rain
Honolulu Starbright - the song remains the same.
Sing out Hare Hare, dance the Hoochie Koo.
City lights are oh so bright, as we go sliding... sliding... sliding through.
(I don't think I have to attribute those lyrics![]()
My reading of it is that manufacturers will have 2 years to submit an application and their products can stay on the market while the application is being reviewed.
I don't believe any new products can be introduced after the rule is final without an application submitted and approved first. EDIT: Re-read the regs and you can still introduce new products in the first 2 years as long as you also submit an application and continue to keep selling until the application is reviewed. After 2 years, no new product can be put on the market without an approved application.
Have you seen the requirements for a new product application? None have ever been approved yet.
People are saying these regulations are good news because they didn't see any outright ban in the document, but the ban is this: Submit an application, we'll never approve it, de facto ban.