When is the FDA thing going down?

[Racehorse]

Rough estimates of ecigarette sales......$500 million in annual sales.....

When Lorilard bought Blu Ecigs, Blu's was showing $30 million in revenue ...

Do you realize the huge TEAMS of legal and bean counting analysts a company of this size employs to do research? Lorillard says e-cigarette sales have been doubling every year and is betting the product will grow more quickly than other smokeless alternatives.

The Big Boys don't make bets like this if they think they have a bad poker hand. They just don't. Murray Kessler doesn't make $3.2 million a year in salary and bonuses as CEO because he's a dumb .... You think he's going to go down in flames?

That's why I don't buy into the hysteria. I read Forbes, try to figure out who is doing what and why.

By the way, Kessler's daughter is an extremely talented young lady and was selected to be on U.S. Olympic Team for show jumping and placed 6th. Very talented at a very young age. As a matter of fact, both Mr. Kessler and his wife are competitive riders as well, so I knew something about them since I follow the "horse thing".

Best thing the ecig bus can do, and should have been doing all along, is mount up enough studies and research to show it isn't hazardous to health. I guess I'm left wondering why, in an industry that has $500 million in sales last year (and to be honest, I think that is a very CONSERVATIVE figure, it's way more than that) , can't seem to pummel and absolutely drown the FDA reveiwers (who are already under-staffed and overwhelmed) with enough research to tilt the wheel. Seems to me the $$ is there?

As a vaper, I'm already spending enough on products, and asking me for $$ for research is like the cigarette companies asking their customers for $$ for THEIR research. Their customers DO support the reseach, by buying the products.

Now, to be honest, who are the "fall guys" going to be if there is ever research that shows ecigs are harmful to people, esp. young people who may be starting to use them? I really can't blame the FDA in a lot of ways. I don't want to see our children take up smoking but I also don't want them to take up something else that might harm them. This is why PROVING is necessary. The more the better.

When I say fall guys, I mean, who in this industry is going to pay (like big tobacco did) for the fallout IF something happened? Let's say 20 years down the road? My thoughts right now is that all you will see is a bunch of "404 not found" internet sites. You NEED to have the big guns getting into this industry. As a cottage industry, *vaping* just doesn't have the power, the pull, the resources, or the $ for studies, etc.

And yes, the more mainstream something is, the more it can expect regulation. That is going to be true in the U.S. or anywhere else for that matter. If enough people inbibe or inhale a substance, or pick up a habit or hobby, expect it to be looked into. That is just the way it is. People hate OSHA too, but the number of people cutting their hands off in machines, and buildings blowing up, is way less than it used to be 3 decades ago, due to safety regs. Big Corporate is NOT going to institute safety measures if that means profits can go to the CEOS, that's just capitalism folks. So, as much as some of you seem to hate the government, I'm glad they're there.

I think the reason is all the guys I know work in *dangerous* industries, I'm glad to know they are a little safer. I know Big Oil isn't going to care if some young diver gets his hands blown off welding a pipeline underwater. They just don't...it's just a $ number in their actuaries accounting sheet....something to get paid and over and done with. I know insurance companies and bean counters and how it all works.

 

[cashley]

There was 2 things in today's headlines that bear some watching. The first being that the FDA has asked for a budget increase for help with regulation. They cite a few areas in which they need to spend that money and among them is monitoring ingredients and products in china.( also listed was for the White Oak Consolidation but I found that alarming for a whole different host of reason).I honestly don't think they need more money period but that is neither here nor there, it is simply in our best interest for them not to have more money to go regulating us and our Chinese imports.I plan on writing to my representatives and citing budget concerns ( I wont be lying ) insist that they deny that request.
The second I actually like and its in Obama's new budget and concerns Obama wanting to raise taxes on smokes by 94 cents.I wonder how many smokers already walking a very thin line with their smoking budget are even now looking just a bit harder at alternatives and how many will give that njoy or that blu a another hard look when they walk in the store. This can help grow our numbers and as we know there is strength in numbers. Regardless of your political position on the tax is the mere mention of another dollar intake can end up helping us.

 

[StormFinch]

Rough estimates of ecigarette sales......$500 million in annual sales.....

When Lorilard bought Blu Ecigs, Blu's was showing $30 million in revenue ...

Do you realize the huge TEAMS of legal and bean counting analysts a company of this size employs to do research? Lorillard says e-cigarette sales have been doubling every year and is betting the product will grow more quickly than other smokeless alternatives.

The Big Boys don't make bets like this if they think they have a bad poker hand. They just don't. Murray Kessler doesn't make $3.2 million a year in salary and bonuses as CEO because he's a dumb .... You think he's going to go down in flames?

Respectfully snipped for brevity...

You do realize that Blu, along with RJR's Vuze and others, have basically the same form factor on their e-cigs as what was being vaped pre-2007, correct? Although the e-Go style is the biggest go to battery after people outgrow their cigalikes, these companies keep churning out cheap starter kits with throw away carts, and I believe there's a reason for that. I'd bet you dollars to doughnuts that the FDA has given them a hint of what's coming and they're planning on filling the empty spots in the market left by anything that was designed after 07, which along with bottled juice, is what the FDA is eyeballing. It's just like when several "mainstream" starter kit companies dropped every flavor they had short of tobacco and menthol a couple of years ago. Yeah, they're not stupid, but they would applaud a de facto ban on the current breed of mass produced batteries, because then they're the only player left on the field... legally at least.

 

[Racehorse]

You do realize that Blu, along with RJR's Vuze and others, have basically the same form factor on their e-cigs as what was being vaped pre-2007, correct?

Storm, yes, I do realize that.

None of this is about form factor of ecigs pre-2007, though. Its about cigarette companies, selling products that are KNOWN TO KILL PEOPLE, coming out with new, more varied, cool-named, flavored, rolled lightable tobacco products every year, because that is the ONLY way they can snare and snag new customers....young people.....and get them "hooked" on killer products.

The problem is that ecigs haven't been properly detached/delineated from this grouping. But it's never been about targetting the "form factor" of ecigs.

I can't parse thru every word and sentence in these topics, but I will come out and say, there seems to be a lot of conjecture here. I'm all for being prepared.....I'm just not about expending a lot of energy before a race. Racehorses that get worked up before a race don't win races. Winners save their focus and energy and unleash it DURING the race.

In today's internet world, all I seem to get now are blasts of words words words telling me how I should be getting hysterical about stuff. I received no less than SIX telephone calls this week from some kind of political focus groups telling me about stuff I should be "worrying about", blah blah blah blah blah. I'm sure I'm not the only one who has trouble separating actual activism from public relations these days. (Its no different in dog rescue, which I am involved in. There are groups like PETA and HSUS who mostly engage in public relations....then there is the ASPCA who are actually out there, in the flesh, helping actual abused dogs and rescuing them. Huge idealogical arguments about which is a better kind of group, and I'm so tired of it. )

I'm just not a "the sky is falling" kind of person. Everyone has a different way of assimilating and synthesizing information, and then ultimately deciding "what to do with it" i,e. how best to put it to use, using what talents are theirs to work their magic.

A drop of water can slowly wear away a rock over time. A typhoon can move the rocks miles away in moments.

Each of us can be either kind of water......both are efficient in their power.

I'm not sure what is required of me here, but I suspect I will go about this in my own way, regardless of how many words I am pummelled with. Wisdom has many faces and means. For me, mass hysteria doesn't fit into my running style.

 

[kristin]

. Its about cigarette companies...coming out with new, more varied, cool-named, flavored, rolled lightable tobacco products every year, because that is the ONLY way they can snare and snag new customers....young people.....and get them "hooked" on killer products.

The problem is that ecigs haven't been properly detached/delineated from this grouping. But it's never been about targetting the "form factor" of ecigs.

I can't parse thru every word and sentence in these topics, but I will come out and say, there seems to be a lot of conjecture here. I'm all for being prepared.....I'm just not about expending a lot of energy before a race. Racehorses that get worked up before a race don't win races. Winners save their focus and energy and unleash it DURING the race.

First, while I agree with not getting too worked up "before the race," it is worth mentioning that a lot of people won't even show up for the race if they don't even know about it. So a lot of us keep talking about it not to get people expending energy with conjecture but to raise awareness and get people to the race in the first place. Its just human nature to start hedging bets about the possible outcome of races.

Second, those first two sentences of your post that I quoted above are pure ANTZ rhetoric that people need to stop buying into. That same myth is being used against e-cigarettes and as long as we keep supporting ANTZ lies by repeating them as fact, we only hurt ourselves. People need to unbrainwash themselves of all of the BS lies and stigma that ANTZ put out about tobacco and nicotine if we are ever to gain acceptance of e-cigarettes and other smoke-free alternatives. E-cigarettes will NEVER be "detached" from tobacco so long as they contain nicotine and are used as something other than a treatment to get off nicotine. ANTZ have a fundamental hatred for anything that is tobacco or nicotine related. So social acceptance of e-cigs hinges on social acceptance of smokefree tobacco and nicotine as a low risk product and that will only happen once the ANTZ lies about tobacco and nicotine are exposed and people can get over their irrational hatred of the tobacco industry.

 

[kristin]

Are you saying that a battery holder and an empty tank can be considered a nicotine product? I don't see how.

Pre-filled cartridges and nic liquid yes, I understand how those fall under FDA regulation

The FDA regulates hospital baby cribs. Are you saying there is no way it will use its power and issue regulations for the equipment designed to deliver the "toxic and addictive substance" it already will be regulating? Unless a company wants to hide what it is making by not mentioning its intended use, I absolutely think the FDA can regulate it in some fashion if it wanted to.

But that isn't the point I was making. How many companies sell popular products like ego's without also selling the liquid and pre-filled cartos too? What if they could no longer sell bottles of refill liquid? What if all kits could only be blu-style devices? It would basically eliminate the chances of mods and refill liquid companies going mainstream by forcing them into hiding from the huge potential market or out of business altogether. Like I've said already, if you have the knowledge to DIY you're golden. But the FDA limiting companies that want to sell to the millions of smokers who have never tried an ecig to prefilled cartos on weak stick batteries with 4 mg tobacco-flavored liquid would kill the influx of new customers to the mod, tank, bigger battery makers and boutique liquid companies, because those would remain "unapproved" and couldn't advertise intended use without running afoul of the FDA.

The people who go to forums like this represent only a tiny portion of ecig users and even less of the number of smokers out there who would find a blu isn't enough and just go back to smoking. Of course, I'm looking at ramifications beyond my own personal gain or loss.

 

[Ferrel1134]

I choosing to enjoy my vaping today. If big bad scary govt regulates then they do. Why waste brain power and give in to what ifs. There is nothing I can do but educate where I can and support my fav vendors. I don't want to think my provari will starve in the near future. I also don't want to freak out that I just now found a system that actually got me smoke free for the first time in 17 years. Fear is the mind killer. The FDA is trying in my head to scare us back in line. And just for today I won't let them.

 

[Berylanna]

There was 2 things in today's headlines that bear some watching. The first being that the FDA has asked for a budget increase for help with regulation. They cite a few areas in which they need to spend that money and among them is monitoring ingredients and products in china.( also listed was for the White Oak Consolidation but I found that alarming for a whole different host of reason).I honestly don't think they need more money period but that is neither here nor there, it is simply in our best interest for them not to have more money to go regulating us and our Chinese imports.I plan on writing to my representatives and citing budget concerns ( I wont be lying ) insist that they deny that request.

NO, we should ell them to APPROVE the request with OUR conditions!

IMO this is a golden opportunity and we should get right on it. The FDA is under heavy pressure to find out why Chinese dog treats are killing dogs in the U.S. They've been doing analysis and running all over China looking at factories for months and haven't found the cause.

The FDA was ORIGINALLY founded because of many U.S. deaths caused by American counterfeit glycerin, diethylene glycol. They are still really worried that China makes no distinction between industrial glycerin vs. pharmaceutical or even food grade, and are lobbying in China very heavily to PLEASE create standards for TWO grades of glycerine.

So we should lobby to YES, give them the money for that, WITH A RIDER to not criminlnalize e-cig things. They can have two tiers here, also: FDA-approved vaping products that can make health claims and unapproved products that cannot make health claims.

And they should make a rule that glycerine in ANY ecigs must come from a country that has a food-grade glycerine.

The best time to get something we want from the FDA is when there is something THEY want from us.

I think this should be a call-to-action.

 

[Berylanna]

The FDA regulates hospital baby cribs. Are you saying there is no way it will use its power and issue regulations for the equipment designed to deliver the "toxic and addictive substance" it already will be regulating? Unless a company wants to hide what it is making by not mentioning its intended use, I absolutely think the FDA can regulate it in some fashion if it wanted to.

I had hoped someone would post a link about this but, not seeing one, I did some surfing. Queries about recalls of baby cribs do NOT lead back to the FDA, they lead to the Consumer Product Safety Commission, cpsc.gov

I think the CPSC has authority over just about anything that isn't Food or Drugs (FDA), or Alcohol, Tobacco or Firearms(ATF, which is fast losing their 'T') , or Transportation (NTSB?) or flight (FAA) or financial (multiples)

THAT is what I was getting at regarding the claim that "e-cigarettes are TOTALLY unregulated." I was hoping someone already knew what the regulatory power is, because I think we regulate things WITHOUT needing to pre-approve them. I suspect ecigs are ALREADY regulated by the someone -- probably CPSC by definition -- and the FDA is trying to take them over by "Deeming"

We need to be able to say who CURRENTLY regulates e-cigs -- I believe the CPSC doesn't get involved unless there is an important product defect that the manufacturer doesn't find and fix first -- BUT that doesn't mean things are unregulated!!!! It just means they aren't dangerous-enough for the CPSC to have taken action! (I think......)

 

[kristin]

The FDA regulates HOSPITAL baby cribs, not home baby cribs. In a hospital, they must be considered medical equipment.

 

[kristin]

The FDA regulates things meant to be consumed or used on the body in some way - cosmetics, drugs or foods that could make people sick. E-cigarettes are a way of consuming nicotine. That clearly falls under the FDA jurisdiction.

See: How do the activities of USDA?s Food Safety Inspection Service differ from the activities of FDA?s Center for Food Safety and Applied Nutrition?

As I mentioned in the other thread, the FDA does regulate ALL nicotine products, including e-cigarettes. E-cigarette ingredients ARE regulated already, however, the FDA just has not issued specific guidelines on the manufacture and marketing of those ingredients mixed together for intended use (inhalation) yet. It IS regulating them though - as seen by the cease and desist letters companies who market them as smoking cessation devices have received. Some companies have been inspected and even issued warning letters for GMPs (good manufacturing practices) by OSHA. So, e-cigarettes are NOT going completely unmonitored.

 

[cashley]

NO, we should ell them to APPROVE the request with OUR conditions!

IMO this is a golden opportunity and we should get right on it. The FDA is under heavy pressure to find out why Chinese dog treats are killing dogs in the U.S. They've been doing analysis and running all over China looking at factories for months and haven't found the cause.

The FDA was ORIGINALLY founded because of many U.S. deaths caused by American counterfeit glycerin, diethylene glycol. They are still really worried that China makes no distinction between industrial glycerin vs. pharmaceutical or even food grade, and are lobbying in China very heavily to PLEASE create standards for TWO grades of glycerine.

So we should lobby to YES, give them the money for that, WITH A RIDER to not criminlnalize e-cig things. They can have two tiers here, also: FDA-approved vaping products that can make health claims and unapproved products that cannot make health claims.

And they should make a rule that glycerine in ANY ecigs must come from a country that has a food-grade glycerine.

The best time to get something we want from the FDA is when there is something THEY want from us.

I think this should be a call-to-action.

I understand what you are saying and I like the theory however not knowing where my representatives stand on the vaping issue I feel more comfortable calling it budget worries for this specific letter, I have already addressed vaping issue in a separate letter , it’s not like it’s going to go to vote so we the actual people paying for it can vote yes or no and give any set of conditions. In my opinion I feel more comfortable simply asking for a straight denial........The FDA can take the money they are spending trying to regulate vaping and use that for dog food and such they want/need to fix. I buy my pg and vg through a US supplier and I know they test their liquids and for now I feel that’s best. People opinions may very but I am not a fan of the FDA in the first place and yes I have heard the many arguments for and against them but what it comes down to it to me........ I may support them if all they did was quality check and stayed out of telling other people what to do business....If I want to vape instead of smoke regardless of how they feel about the safely I reserve the right to make that choice....If I want to drink raw milk instead of mutated milk I also reserve that right and if I want to take ephedra in the recommended dose because it works for me regardless of the fact that some people who could/would not follow instructions ended up getting themselves in trouble or worse I reserve that right. So no as the fda stands now I do not want them to have any more funds to do any more. I want them to use the funds they have to check what they need to check and leave the decisions to us….Grown adults responsible for our choices. I choose to vape and if there are repercussions down the road I accept responsibility for them. I would rather take my chance doing what I feel is best rather than have the someone else who claims to know what is best make any decision for me. I will urge them to deny any and all additional funding for the fda for as long as they try to force their beliefs and ideas on me.

I was playing nice there in responding with the assumption they are passing legislation they do actually believe is best for us and not just a way for them to fill their pockets, I don’t really believe they are even trying to act in our best interest but even if I am wrong and they are it changes nothing imho)

 

[tj99959]

Sometimes I feel like I need to step back and do a reality check. I don't want to be using liquids with DG in it. I don't want to be using batteries that might explode in my face, guess I could add to that list Ad infinitum.

So why wouldn't I want proper regulation and oversight?

 

[kristin]

Good question. But what is "proper regulation and oversight?"

Most people don't even realize that lithium batteries aren't "regulated" beyond the DOT rules on how they can be transported. UL certification is not a requirement for electronics. There are already regulations on how much DEG is allowable in products. GMPs already exist to regulate manufacturing standards to keep them clean and sanitary. OSHA already has rules for employee safety while handling potentially toxic materials. Any company manufacturing and selling consumable products to the U.S. public are automatically subject to these existing regulations, including e-cigarette companies.

What additional regulations would you want the FDA to apply to e-cigarettes that don't already exist for consumable products?

 

[potholerepairman]

Good question. But what is "proper regulation and oversight?"

Most people don't even realize that lithium batteries aren't "regulated" beyond the DOT rules on how they can be transported. There are already regulations on how much DEG is allowable in products. GMPs already exist to regulate manufacturing standards to keep them clean and sanitary. OSHA already has rules for employee safety while handling potentially toxic materials.

What additional regulations you would want the FDA to apply to e-cigarettes that don't already exist for consumable products?

hello and thanks Kristin, you have for the long haul brought knowledge and guidance in ways no one has.The fight is forever imo, and its a good fight that needs a worthy ....(cig) kicker.My grasp on how the issues will go involve reading your post, and guessing like most

 

[tj99959]

Good question. But what is "proper regulation and oversight?"

Most people don't even realize that lithium batteries aren't "regulated" beyond the DOT rules on how they can be transported. UL certification is not a requirement for electronics. There are already regulations on how much DEG is allowable in products. GMPs already exist to regulate manufacturing standards to keep them clean and sanitary. OSHA already has rules for employee safety while handling potentially toxic materials. Any company manufacturing and selling consumable products to the U.S. public are automatically subject to these existing regulations, including e-cigarette companies.

What additional regulations you would want the FDA to apply to e-cigarettes that don't already exist for consumable products?

Now we're getting somewhere, what additional regulations and/or oversight should we be wanting to insure our safety and health. IMO we do have a need for spending more time discussing what we do want instead of what we don't want. And, 'head in sand' is not a good option.

 

[Vapor Vinny]

The second I actually like and its in Obama's new budget and concerns Obama wanting to raise taxes on smokes by 94 cents.I wonder how many smokers already walking a very thin line with their smoking budget are even now looking just a bit harder at alternatives and how many will give that njoy or that blu a another hard look when they walk in the store. This can help grow our numbers and as we know there is strength in numbers. Regardless of your political position on the tax is the mere mention of another dollar intake can end up helping us.

What? Are you figuring the ejuice won't be taxed like analogs? And make them a $6 dollar a day habit? Then you are figuring wrong.

 

[kristin]

I forgot to mention that the FDA also already requires consumables under its jurisdiction (which includes nicotine products) to have ingredients listed and poison warnings (if applicable) on the labels.

So, here are the regulations that are already covered by current regulations for e-cigarettes:

1) Ingredients listed on labels
2) Poison warnings on labels
3) Clean and sanitary manufacturing facilities and handling procedures
4) Maximum level of DEG that may be found in products made with PG
5) Safety standards for employees

Electronics and batteries of all kinds are not currently regulated, so that would include e-cigarette electronics. However, consumers who are concerned could buy only UL certified devices.

As far as the possibility of other impurities and poisons being added to e-liquid, it's probably fair to say that would be handled the same way the FDA handles other contaminated consumable products. If a company's products are found to have caused harm, the FDA will shut down the company responsible until the issue is fixed. As far as I know, putting or allowing poisonous things in consumable products is already prohibited and the only way the FDA and other government bodies handle this is responding to complaints.

All of the above is good enough for me, personally. I see no need for restricting flavors, prohibiting refill bottles or lowering the nicotine levels below that which are currently being sold. If the FDA wants to restrict nicotine levels higher than what is currently being sold, I have no problem with that, either. No one is selling it anyhow. As long as I know what is in the liquid per an accurate label and that it is being made in a clean and safe environment, I'm fine with current regulations.

 

[Berylanna]

Good question. But what is "proper regulation and oversight?"
Most people don't even realize that lithium batteries aren't "regulated" beyond the DOT rules on how they can be transported. UL certification is not a requirement for electronics. There are already regulations on how much DEG is allowable in products. GMPs already exist to regulate manufacturing standards to keep them clean and sanitary. OSHA already has rules for employee safety while handling potentially toxic materials. Any company manufacturing and selling consumable products to the U.S. public are automatically subject to these existing regulations, including e-cigarette companies.

What additional regulations would you want the FDA to apply to e-cigarettes that don't already exist for consumable products?

For starters, although SAFETY might be a requirement, for reduced-harm, EFFICACY is inappropriate. These are not drugs. The extra expense of proving efficacy is wasted anyway because this product requires drastically different setups and flavors PER PERSON.

As long as they are at least 50% safer than tobacco, I think they should be allowed to make health claims and not worry about efficacy of quitting -- the proof is in the pudding.

Also, a reduced-harm device or eliquid should NOT have to be proven on a per-product, per-flavor basis. There should be a PRESUMPTION of equivalency, out of the gate, that would require a DRASTIC change before new testing is required for safety. For instance, "Pluming" tobacco would be drastically different from using e-liquid and could require its own safety testing.

And, third, pre-approval devices and eliquids should be consumer products that cannot make health claims but are not criminalized. Not sure how that can be done, maybe by "deeming" them to be reduced-harm products (which would subject them to initial approval but the intial approval would be time-consuming and expensive" instead of "tobacco products" (because Congress made it clear that the FDA should never allow new flavors of tobacco products.)

We need a lawyer.

 

[Ferrel1134]

We need a lawyer.

I second that.