What happened to all the fear mongering and paranoia? Zero hour has passed and the FDA hasn't kicked down my door and confiscated my e-cig and e-nic. How will some of the vendors who rely on stockpilers stay in business?
FDA issues Brief Summary of Not Substantially Equivalent Determinations delineating why deeming reg would ban all e-cigs
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"Zero Hour", as you call it, was established by the FDA and is not a hard deadline. E-cigs aren't at the top of their list; they'll get to it when they get to it (they have submitted their ideas for review, BTW).
It ain't over, not by a long shot.
Here's an english translation; http://www.e-cigarette-forum.com/fo...bacco-regulation-conference.html#post11145035
It appears that regulations may already be in the hands of OMB for approval. Then it'll go back to the FDA for final tweaking.
Note to self
Next time we hear of an FDA deadline ...
ask if it's a "Hard" deadline or just an FDA rattling saber deadline.
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It's a big waiting game because everyone [in the tobacco industry] is trying to figure out what the hell they are going to put out. The regs are sitting at the OMB, they are doing their due diligence and they're behind because of the shutdown, said one Republican lobbyist representing electronic cigarettes.
The draft rules were expected out by the end of October, but the OMB has until the end of December to finish its review. That deadline could be extended into next year.
E-cigarette makers ramp up lobbying efforts | TheHill
The draft rules were expected out by the end of October, but the OMB has until the end of December to finish its review. That deadline could be extended into next year.
E-cigarette makers ramp up lobbying efforts | TheHill
Wiki OMB
"The Office of Management and Budget (OMB) is the largest office within the Executive Office of the President of the United States (EOP). The Director of the OMB is a member of the President's Cabinet. The main function of the OMB is to assist the President to prepare the budget. The OMB also measures the quality of agency programs, policies, and procedures and to see if they comply with the President's policies."
Mmmm ... Obama's FDA
I'm sure the OMB would ask Obama if they have any doubts if he might not agree
with the FDA's proposed regulations ... so Obama wouldn't have to say
he only heard about what his administration was doing ... in the news ... Again.
(sarcasm)
By the way ... Did the White House ever respond to our last petition ?
Rhetorical question
"The Office of Management and Budget (OMB) is the largest office within the Executive Office of the President of the United States (EOP). The Director of the OMB is a member of the President's Cabinet. The main function of the OMB is to assist the President to prepare the budget. The OMB also measures the quality of agency programs, policies, and procedures and to see if they comply with the President's policies."
Mmmm ... Obama's FDA
I'm sure the OMB would ask Obama if they have any doubts if he might not agree
with the FDA's proposed regulations ... so Obama wouldn't have to say
he only heard about what his administration was doing ... in the news ... Again.
(sarcasm)
By the way ... Did the White House ever respond to our last petition ?
Rhetorical question
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As a flavor distribut6or, concentrated flavors are already FDA approved in most every country but China and India. I deal with US customs weekly ABOUT EVERY FLAVOR ORSER.
Well, I'm glad your not a physician writing out patient prescriptions
(I'm kidding I'm kidding)
Rumor on the hill is definitely that the regulations are currently at OMB, and then they will have to make their way over to Health and Safety. SFATA (Smoke Free Alternatives Trade Association) gathered 30 of their members in DC earlier this week to meet with the offices of their representatives and senators. Their message in a nutshell? The industry needs regulation, but not be shoehorned into rules that don't fit, and trying to include e-cigarettes into the tobacco act is like trying to put a square peg into a round hole. Fortuitously enough, one of the congress members SFATA came in contact with was someone within Health and Safety, and they were very interested to hear that the FDA wasn't being totally truthful.
Something I took away from the SFATA meetings for us as consumers (I attended in support of a friend of mine who is a member) is to keep writing your representatives and senators. Even if it doesn't reach the intended person, for each letter that they receive one of their staffers has to sit down and form a reply plus log that exchange into the books. If a pattern forms it will get noticed. Also, for anyone capable of it, make an appointment and visit your representative. From the mouths of paid lobbyists we heard that it's a thousand times more powerful than hiring a lobbyist to do it for you. A hired gun is easy enough to dismiss, but they are required to pay attention to you as their constituent. And again, it goes into the books plus a report is made to that house member if it was a staffer that met with you.
Something I took away from the SFATA meetings for us as consumers (I attended in support of a friend of mine who is a member) is to keep writing your representatives and senators. Even if it doesn't reach the intended person, for each letter that they receive one of their staffers has to sit down and form a reply plus log that exchange into the books. If a pattern forms it will get noticed. Also, for anyone capable of it, make an appointment and visit your representative. From the mouths of paid lobbyists we heard that it's a thousand times more powerful than hiring a lobbyist to do it for you. A hired gun is easy enough to dismiss, but they are required to pay attention to you as their constituent. And again, it goes into the books plus a report is made to that house member if it was a staffer that met with you.
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You are correct randyith. However, while the extensive field of flavors and fragrances (organoleptics), either as natural products or via chemical synthesis is regulated and approved for the food, cosmetics, health consumer products etc, I am not aware of any regulatory agency either in the US or abroad which has approved these generally for inhalation. Ominously, the EP has recently agreed to ban all flavored and menthol tobacco, AND has submitted ecig to regulations under their tobacco products directive i.e., heavily regulated as tobacco products
The state of regulations in the EU and the US against ecig is confusingly maddening. Both anti-tobacco (make this anti-nicotine now) zealots and a heavy-handed bureaucracy are salivating over the prospect of suppressing the ecig industry, accused indiscriminately of prostitution with big tobacco, and of imposing parasitic taxation to the same industry which offers a significant alternative to ex-smokers who are unconvinced of pharmacotherapy (Zyban, Wellbutrin, Chantix) and its adverse events. While the recent EP proposal will regulate ecig as tobacco products rather than as medical devices (good news for now, although regulation of ecig as medical devices will eventually be imposed), tobacco products (ergo ecig) will now suffer additional pressures, e.g., flavored tobacco and menthol will be phased out altogether (3 yr for flavors; 5 yr for menthol). Ecig which do not comply with this directive will be tolerated on the market for 36 months. Vapers will experience death by a thousand cuts.
This has occurred to me regarding our Food and Drug Administration. Were initial regulations seemingly light, time could work in an erosive manner against that.
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OMB's two biggest concerns are probably preventing the Justice Dept from losing another lawsuit filed against FDA, and preventing Obama's approval ratings from further declining below their all time low of 39% this week.
As such, OMB may not allow FDA to propose the deeming reg.
As such, OMB may not allow FDA to propose the deeming reg.
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anything federal is bound to be a manure party for lack of better terms. no decision by these clucks could potentiate something like banning sales of devices/mods or eliquid could it?
It's heartening to hear that there are ways to break through the big money corproate shield.
I think it would be the same process independent of the elected president, no matter which side of the aisle they were on.
You are probably correct. BUT, I suspect this administration's staff, HHS staff and most of the political appointees in federal government today are anti-nic. When people become fanatical in their beliefs, like most anti smokers are, nothing gets through to them. To them nic is so bad it probably should not even be allowed for use as an insecticide.
I imagine there are some that think nicotine is evil, given that I know such people exist.
But many of the ANTZ and legislators only think nicotine is evil if it is not approved by Big Pharma.
If you know what I mean.
Just sayin...
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