Here is a Wall Street Journal article I found about the FDA's regulations to be released on Thursday...
E-Cigarettes Face First Regulations - WSJ.com
E-Cigarettes Face First Regulations - WSJ.com
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Wall Street Journal Article about FDA regulations to be relased Thursday 4/23/14
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If this is true then this one statement will be the death nail to ecigs:
"One of the biggest new requirements is that e-cigarette makers will need to apply to the FDA within two years to keep existing products on the market. The agency then will rule on applications roughly as it does on other tobacco products."
Then they will come after the flavors also. This will hand the vaping business back to their friends at BT.
"One of the biggest new requirements is that e-cigarette makers will need to apply to the FDA within two years to keep existing products on the market. The agency then will rule on applications roughly as it does on other tobacco products."
Then they will come after the flavors also. This will hand the vaping business back to their friends at BT.
The only thing that concerning to me, requiring makers to gain FDA approval for their products, what hoops will their force on them other than the article talks about.
"Banned from distributing free samples", doesn't sound legally right, have to see if this will be challenged in court(we're see if big tobacco steps in with their money) after all many companies give away samples..
IMO: All the other requirements are reasonable and I do like the part "makers will be required to disclose the chemicals used in the devices".
"Banned from distributing free samples", doesn't sound legally right, have to see if this will be challenged in court(we're see if big tobacco steps in with their money) after all many companies give away samples..
IMO: All the other requirements are reasonable and I do like the part "makers will be required to disclose the chemicals used in the devices".
E-Cigarettes Face First Regulations - WSJ.com
It's not as bad as we have feared. FDA To make an announcement tomorrow. Basically they have punted. Not exactly an example of "profiles in courage" But at least it looks like the unelected bureaucrats actually acknowledge the truth and have to care about their citizens health.
It's not as bad as we have feared. FDA To make an announcement tomorrow. Basically they have punted. Not exactly an example of "profiles in courage" But at least it looks like the unelected bureaucrats actually acknowledge the truth and have to care about their citizens health.
"One of the biggest new requirements is that e-cigarette makers will need to apply to the FDA within two years to keep existing products on the market. The agency then will rule on applications roughly as it does on other tobacco products."
If you don't think this is a bad thing, you don't know much about how the FDA operates.
If you don't think this is a bad thing, you don't know much about how the FDA operates.
Actually, if the interpretation is correct, its way better than I thought it would be. They did leave the door open on flavorings though but, based on the tone re ecigs as a means of stamping out smoking, I think that might just be to appease the ANTZ. I'm, personally, breathing a sigh of relief just at not bringing under the stricter tobacco regs banning net sales... I guess that means it will they won't be under the Family umbrella. Of course, that doesn't mean locals won't especially here with reservations competing.
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This looks pragmatic on its surface, but the thing about FDA approval reeks of a backdoor ban. The FDA does not approve products that pose a financial threat to the pharmaceutical industry.
Does anyone happen to know if there's a similar restriction against giving away free samples of nicotine gum/lozenges/etc.? If there isn't, then I'd fully expect this provision to be struck down by the courts.
There's another article here that's a touch different:
http://www.nytimes.
com/2014/04/24/health/fda-will-propose-new-regulations-for-e-cigarettes.html?_r=0
http://www.nytimes.
com/2014/04/24/health/fda-will-propose-new-regulations-for-e-cigarettes.html?_r=0
Another question that needs to be asked: What about manufacturers/suppliers that only sell PVs and replacement hardware? Does every rig and component have to be submitted for FDA approval, or is this just for cigalikes and liquids? If the hardware does have to be submitted for approval, what qualifies a food and drug agency to decide if an electrical device and its components are suitable for public sale?
If you don't think this is a good thing, you don't understand how politics work. A lot can change in 2 years. Today's Bonapartist could be tomorrow's victim of the guillotine. Bonaparte may be exiled to the island of Elba. It all depends on who is in charge at the time.
If that's in there, the lawsuit will be fast, hard, and quickly won. The FDA doesn't have any regulatory power over batteries, wire, microchips, or metal tubes unless they're listed as medical equipment. Since these aren't, and any attempt to do so will also be met with a lawsuit (backed up by previous decision), I don't expect they'll be dumb enough to try.
It sounds a bit like the standard 2 year delay, plus the time for the lawsuits, which should be considerable.
Still, it makes me glad I DIY and have plenty of base in the freezer.
Still, it makes me glad I DIY and have plenty of base in the freezer.
Well I read the NYT article and I'm still not filling warm and fuzzy. Everything still points to BT getting the vapor business.
And therein lies the problem. An agency that's supposed to be about public health and consumer protection is driven 100% by politics, and by protecting the financial interests of its paymasters in the pharmaceutical industry.
This is terrible. Another 2 years of 'vaping will be banned next week' threads, all the while nothing will happen that will affect how anyone of legal age vapes...
You mean the cigalike business. There's no way they can construct a regulatory framework that will stamp out the PV business. They'll just wind up playing Whack-a-Mole for however many years until they finally give up.
Is the two year window rolling? If so, what you say is completely true--just change a minor design bit, resubmit, and keep selling it for another two years.
If it's only an initial honeymoon period, then no--new devices may require approval before sale.
Mostly, I expect restrictions on nicotine. It's the only thing that's under the FDA's umbrella here.
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