FDA Bill Godshall commentary on FDA deeming proposals
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Very informative, albeit a bit premature. Mr. Godshall appears to believe that these proposals would decimate the vaping industry as we know it, but the deeming proposals aren't regulations just yet, and we have plenty of time to get our point across.
I do like this bit here:
"Instead of proposing, and instead of issuing a final rule for the deeming regulation, the FDA should complete the tasks mandated by Congress in the TCA, and should begin to truthfully informing smokers and the public that all smokefree tobacco and nicotine products are far less hazardous alternatives to cigarettes."
While halting the issuance of a final rule is most likely not in the cards, I do think the FDA is earnest about the discovery proceedings it outlined in its proposal regarding the health and safety of vaping. The numerous health studies and testimonials will come into play heavily during these next 75+ days as we make our case. We're in for a rough ride, but I choose to remain hopeful that logic will outlast.
I do like this bit here:
"Instead of proposing, and instead of issuing a final rule for the deeming regulation, the FDA should complete the tasks mandated by Congress in the TCA, and should begin to truthfully informing smokers and the public that all smokefree tobacco and nicotine products are far less hazardous alternatives to cigarettes."
While halting the issuance of a final rule is most likely not in the cards, I do think the FDA is earnest about the discovery proceedings it outlined in its proposal regarding the health and safety of vaping. The numerous health studies and testimonials will come into play heavily during these next 75+ days as we make our case. We're in for a rough ride, but I choose to remain hopeful that logic will outlast.
Thanks for the posting Roly - I'd lost track of Bill's update page. At the very least, it's a good thing that we now have something to work with.
in my reading i fail to see how hardware that doesnt have pre-installed nicotine in it is affected
i admittedly haven't read the entire thing
i admittedly haven't read the entire thing
It defines the components used to consume the nicotine/tobacco as a part of the 'tobacco product', minus raw materials used in its construction. That covers mods/toppers/etc.
agreed... and in my conversation with an AP reporter, after he took part in the Media call this morning, he specifically said that the FDA stated they have no authority to regulate devices or products that do not contain nicotine.
Which as the reporter stated to is why they don't regulate lighters or cigar cutters, etc.
Completely reject? Unrealistic, and not something I can do.
Point in fact, I approve of banning sale to under-18 year olds. While some will still get their hands on them, there's no sense making it easier for them to consume a neurologically active substance.
I don't think any hardware regulations are going to fly in court, and it strengthens our argument to let the FDA fall over its feet on that.
Health claims? We already operate under that stricture, and a health claim would firmly place the e-cigarette in the medical device territory. Opposing this regulation is foolish for that reason as we want no implication of medical devices around these, the fetters on those are far more strict.
There's more, but that's enough.
Point in fact, I approve of banning sale to under-18 year olds. While some will still get their hands on them, there's no sense making it easier for them to consume a neurologically active substance.
I don't think any hardware regulations are going to fly in court, and it strengthens our argument to let the FDA fall over its feet on that.
Health claims? We already operate under that stricture, and a health claim would firmly place the e-cigarette in the medical device territory. Opposing this regulation is foolish for that reason as we want no implication of medical devices around these, the fetters on those are far more strict.
There's more, but that's enough.
Mmm, not exactly. Lighters and cigar cutters are defined as 'accessories', so they're not regulated. Actual components of the products, such as filters, papers, tubes, pouches, etc are. They're wanting to fold vaping devices into that existing definition.
One thing I should mention is this:
"In addition, FDA considers accessories to be those items that may be used in the storage or personal possession of a proposed deemed product."
That wording could be used to argue that a tank only stores the liquid, and only the coil/atomizer is actually involved in the consumption of the product. Something tells me they will clarify that before the final ruling.
Lol.. they're looking for your (our) "help" in defining what components should be regulated (banned)..
The one thing I took away from scanning the 200+ pages of spew they published was that:
addictive = evil, even if the addiction isn't harmful
protecting "children" from smoking trumps the rights of 50 million smokers who might want to quit..
no matter how many studies show e-cig users quit smoking, FDA will continue to (lie) and state that data is "unsupported"
And just enough paragraphs of the other side to pretend they're coming to a reasoned and balanced decision..
The only part I agree with is 18+.
But the only specific ecig "tobacco product" mentioned were refill cartridges and it could be argued that if it isn't pre-filledwith nicotine then it's not a tobacco product. And the FDA itself mentioned that e-cigs may be grandfathered in. But they are trying hard so they are included.
I wish they had made a separate regulation proposal for ecigs because this general lump in with other tobacco products just kind of sucks.
Its going to lead to more synthetic nicotine being used because the way it is written is that only products derived from tobacco leaf need to carry a warning. And it is going to stop or black market small businesses entering into the industry.
We should all stop using e-cigarette and adopt personal vaporizer because anything associated with cigarettes or tobacco are socially demonized now.
But the only specific ecig "tobacco product" mentioned were refill cartridges and it could be argued that if it isn't pre-filledwith nicotine then it's not a tobacco product. And the FDA itself mentioned that e-cigs may be grandfathered in. But they are trying hard so they are included.
I wish they had made a separate regulation proposal for ecigs because this general lump in with other tobacco products just kind of sucks.
Its going to lead to more synthetic nicotine being used because the way it is written is that only products derived from tobacco leaf need to carry a warning. And it is going to stop or black market small businesses entering into the industry.
We should all stop using e-cigarette and adopt personal vaporizer because anything associated with cigarettes or tobacco are socially demonized now.
I still don't see how they can include a battery, a metal tube, attached to another metal, glass or plastic tube with some wire and wick as a tobacco product when they can be used to vaporize almost anything.
My feelings are that the FDA will pass enough regulation and such that a "sin" tax can be added like they did with cigarettes. Remember when there was only sales tax on a pack? If they can rule them as a tobacco product then they can open the door to the heavy taxation. That is still a gray area however. I can pack all kinds of tobacco in my tanks and nothing will happen.
how can they say that this would protect the children, what the children will do if they have to and have it set in their mind is just pick up a real cig instead anyway. Adults like flavored things... take for example alcohol. all kinds of flavored alcohols but kids havnt dramatically increased usage because of that. some are going to go after nic/alcohol no matter what. some are not its how its always been. This flavoring thing to save the kids is outrageous I could see it better if they said we want to make sure whats in the flavors is safe but it seems that doesn't really matter I guess just that the children are not tempted by grape flavors ... which will lead them to smoke real cigs? that's pathetic as most who start vaping never want to see a cig again. "most" a large percentage anyway, I don't even like the smell of cigarette smoke anymore it smells bad to me now.
edit: a thought occurs to me, this may be off topic but it is very much related. in the 1800s when electricity was first being developed JP morgan and Thomas Edison were making money on lighting homes and citys with light bulbs. Rockafeller, leading the kerosene industry, at risk of loosing money due to the new industry made campaigns about electricity being extremely dangerous and how it could easily kill you and burn your house down. And was determined to destroy the industry even though it brought about a better change for the world. History continues to repeat itself as similar cases constantly have happened. (just watching some random history show :/) .. just had to say something about it because so much irony in whats still happening with oil, tobacco, ect
edit: a thought occurs to me, this may be off topic but it is very much related. in the 1800s when electricity was first being developed JP morgan and Thomas Edison were making money on lighting homes and citys with light bulbs. Rockafeller, leading the kerosene industry, at risk of loosing money due to the new industry made campaigns about electricity being extremely dangerous and how it could easily kill you and burn your house down. And was determined to destroy the industry even though it brought about a better change for the world. History continues to repeat itself as similar cases constantly have happened. (just watching some random history show :/) .. just had to say something about it because so much irony in whats still happening with oil, tobacco, ect
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AMEN! Call me a pessimist but they are out to get us.And they will. They have degrees in lying.
So... if equipment is included, then when I buy a 18650 battery for my mod is the vendor going to ask me what am I going to use it for? If I say for a flashlight, they'll quote me one price; if I say for an ecig, they'll quote me a higher price. Guess what my answer will be!
Don't see how they can enforce this. But then again, I think we're giving the legislators too much credit thinking they can grasp the concept of ecigs as a whole. All they see are the cigalikes and in their limited thinking they think they're covering all ecigs.
I'm going to sign off and watch Vikings. At least in that world, you know what's going to happen. Bye.
Don't see how they can enforce this. But then again, I think we're giving the legislators too much credit thinking they can grasp the concept of ecigs as a whole. All they see are the cigalikes and in their limited thinking they think they're covering all ecigs.
I'm going to sign off and watch Vikings. At least in that world, you know what's going to happen. Bye.
That is exactly what they are looking for. $$$$$$$
They don't give a hoot about our health because if they did they would read Dr. Michael Seigel and Bill Godshall and CASAA's report on "second hand vape". But NOOOOOO they have to protect the children. I want to vomit.
They don't give a hoot about our health because if they did they would read Dr. Michael Seigel and Bill Godshall and CASAA's report on "second hand vape". But NOOOOOO they have to protect the children. I want to vomit.
I have not read it yet but will tomorrow. What do they say about flavorless liquid nicotine?
As little as possible. they were very vague as they were with most things. Leaving the door wide open IMO
I do not feel that it is going to turn out well at all.
Bill has presented a worst-case scenario although things may not work out so badly, at first anyway - only time will tell.
He has a good reason for taking that line because the FDA's job is to remove ecigs from the market. If you remember, they did everything they possibly could to do so in 2010, when they seized every import they could locate and attempted to shut the ecig trade down in several ways including enforcement of medical licensing. It should be noted that the FDA doesn't work for public health, it is the legal arm of the pharmaceutical industry and will do everything it can to protect that industry and at any cost. In order to do that, it must protect smoking, since pharmaceutical industry revenues in this area depend on smoking.
However the FDA is under pressure from others and cannot simply ban ecigs, which is what it most certainly wants to do. It can only implement measures that will survive legal challenge. Therefore, we can see fairly easily what it needs to do: start out with what look like reasonable regulations, using the wedge principle, and then gradually tighten the screws. This will become easer to accomplish over time as small ecig businesses can be eliminated first (by fee structures and research costs that they cannot comply with), followed by larger players, leaving just the largest ecig firms and the tobacco giants standing.
The FDA only want to deal with a few large pharmaceutical and cigarette corporations - they certainly don't want the aggravation of having to deal with hundreds (or even thousands) of small businesses. This is not their operational model and in fact it is an impossible scenario for them; dealing with the paperwork from a few cigarette companies is an enormous task that they have a huge backlog with. If for no other reason, they need to cut the workload down by eliminating all the smaller businesses, an easy task when they control the regulations; fees charged for registering, and the cost of research and documentation, will easily accomplish that. Small businesses can't afford the hundreds of thousands of dollars that will soon enough become standard; eventually, costs will rise into the millions as that is how federal regulation works.
It is highly unlikely that implementation of any regulations will be sudden or perhaps even onerous. Their method will be to ramp things up slowly in order to gradually build an enforcement structure and to avoid legal challenges that will delay their task. The FDA's ideal picture of the ecig industry in ten years' time is that it will be owned by large cigarette corporations and a couple of large independents such as NJoy. They cannot now legally eliminate ecigs, but they can make it impossible for anyone except giant businesses selling simple old-tech models to sell in the legal market. Everything else will need to go black market eventually, since it will cost millions to introduce a new product to the legal market and there will be a timelag of years for the permissions.
This situation will persist until there are so many millions of vapers that federal law can be introduced to restrict the FDA's power, and that won't happen any time soon; at least twenty years. Until then, there are a million small battles to fight.
He has a good reason for taking that line because the FDA's job is to remove ecigs from the market. If you remember, they did everything they possibly could to do so in 2010, when they seized every import they could locate and attempted to shut the ecig trade down in several ways including enforcement of medical licensing. It should be noted that the FDA doesn't work for public health, it is the legal arm of the pharmaceutical industry and will do everything it can to protect that industry and at any cost. In order to do that, it must protect smoking, since pharmaceutical industry revenues in this area depend on smoking.
However the FDA is under pressure from others and cannot simply ban ecigs, which is what it most certainly wants to do. It can only implement measures that will survive legal challenge. Therefore, we can see fairly easily what it needs to do: start out with what look like reasonable regulations, using the wedge principle, and then gradually tighten the screws. This will become easer to accomplish over time as small ecig businesses can be eliminated first (by fee structures and research costs that they cannot comply with), followed by larger players, leaving just the largest ecig firms and the tobacco giants standing.
The FDA only want to deal with a few large pharmaceutical and cigarette corporations - they certainly don't want the aggravation of having to deal with hundreds (or even thousands) of small businesses. This is not their operational model and in fact it is an impossible scenario for them; dealing with the paperwork from a few cigarette companies is an enormous task that they have a huge backlog with. If for no other reason, they need to cut the workload down by eliminating all the smaller businesses, an easy task when they control the regulations; fees charged for registering, and the cost of research and documentation, will easily accomplish that. Small businesses can't afford the hundreds of thousands of dollars that will soon enough become standard; eventually, costs will rise into the millions as that is how federal regulation works.
It is highly unlikely that implementation of any regulations will be sudden or perhaps even onerous. Their method will be to ramp things up slowly in order to gradually build an enforcement structure and to avoid legal challenges that will delay their task. The FDA's ideal picture of the ecig industry in ten years' time is that it will be owned by large cigarette corporations and a couple of large independents such as NJoy. They cannot now legally eliminate ecigs, but they can make it impossible for anyone except giant businesses selling simple old-tech models to sell in the legal market. Everything else will need to go black market eventually, since it will cost millions to introduce a new product to the legal market and there will be a timelag of years for the permissions.
This situation will persist until there are so many millions of vapers that federal law can be introduced to restrict the FDA's power, and that won't happen any time soon; at least twenty years. Until then, there are a million small battles to fight.
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