FDA may soon propose regulation that could ban many/most e-cigarette products, eliminate many/most companies

[Vocalek]

Our argument against the FDA expanding the products they cover is essentially the same argument as used against the DOT considering vapor to be smoke: The executive branch is exceeding the authority given to the agency via the law passed by Congress and signed by the President. If Congress had intended for cigars and other products to be covered, they would have been named.

 

[Bill Godshall]

Another news article about cigar smokers (and cigar companies) opposing potential FDA proposed regulation to apply Chapter IX of the FSPTCA to cigars.
Cigar smokers resist possible FDA rules | Reuters

And once again, Matt Myers is lying to the news media.

"The reason Congress gave FDA authority is so that the decisions would be made based on facts and science, and not political muscle," said Matt Myers, president of the Campaign for tobacco-Free Kids.

 

[Retriever]

Wow, just reading through this thread sends shivers up my back! Why does everything that is good have to be regulated? ECF and ecigs have helped so many, including myself, I just don't know what I will do if they are banned. I guess it will be back to the analogs.

Speaking of analogs, I was thinking: If baby cribs killed as many babies as analogs kill adults every year, would they still be on the market? NO! Of course not. Thank you CASAA for all you do. I will help out where I can.

 

[sqirl1]

pigelty wrote



While it would be nice to have several million dollars to spend on future e-cigarette research, none of those expensive and time consuming studies (cited by pigelty) are necessary to demonstrate that e-cigarettes are far less hazardous than cigarettes. The problem is that FDA (and its contracted IOM committee) and all other e-cigarette prohibitionist have repeated that (and similar) lies (i.e. that millions of dollars of more research is needed) so many times that increasingly more e-cigarette consumers (including Cool Breeze and pigelty) appear to believe it, and are now repeating it here on ECF.

Murray Laugesen's first scientific evidence on e-cigarettes in 2007/2008 conclusively documented that e-cigarettes are exponentially less hazardous than smoking cigarettes, and dozens of subsequent studies and laboratory reports (including two done by FDA) have confirmed (without any scientific doubt) that e-cigarettes are exponentially less hazardous than cigarettes.

sqirl1 wrote



The only people who might be able to answer the first question are FDA Commissioner Margaret Hamburg, DHHS Secratery Kathleen Sabelious and perhaps some White House staff, and it appears that they've already delayed proposing the new regulation since October. My goal (which should be shared by everyone on this forum) is to convince those folks to change their mind and scrap the regulation instead of proposing it (which requires publishing in the Federal Register).

Ever since April 25 (when the FDA stated its intent to propose/approve a regulation to apply Chapter IX to e-cigs and other unregulated tobacco products), I've been working to prevent the FDA from proposing this type of regulation.

Yeah I think at this point we need to focus on stalling until a new president gets elected, this is clearly a partisan issue and if obama loses this election we are home free if new regulations don't go through before then. unless of course Ron Paul gets elected, in which case the FDA will either be dissolved or completely stripped of about 90% of it's power and we won't have anything to worry about either way.

 

[Nicko]

Yeah I think at this point we need to focus on stalling until a new president gets elected, this is clearly a partisan issue and if obama loses this election we are home free if new regulations don't go through before then. unless of course Ron Paul gets elected, in which case the FDA will either be dissolved or completely stripped of about 90% of it's power and we won't have anything to worry about either way.

I agree. With Ron Paul as president, liberty will be more than just a concept, it will be a reality.

 

[hlk]

I wonder if the tobacco companies are secretly behind the scenes here applying pressure to certain politicians.
After all, all these products do affect their bottom line.

It's stunning that the FDA police are even considering alternative products that are clearly not as hazardous to ones health vs what we know tobacco can do.

Typical overeaching government at hand... Somehow we need to make a lot of noise and fight this the best we can.

 

[rothenbj]

Another news article about cigar smokers (and cigar companies) opposing potential FDA proposed regulation to apply Chapter IX of the FSPTCA to cigars.
Cigar smokers resist possible FDA rules | Reuters

And once again, Matt Myers is lying to the news media.

"The reason Congress gave FDA authority is so that the decisions would be made based on facts and science, and not political muscle," said Matt Myers, president of the Campaign for Tobacco-Free Kids.

I don't see that as a lie, I believe that was the reason that Congress gave the FDA the authority. Unfortunately, people like Matt Myers and members of the FDA are using political muscle rather facts and science to promulgate restrictive regulations that will protect both the cigarette and pharma industries.

 

[Uma]

any other news yet?

 

[Traver]

I agree. With Ron Paul as president, liberty will be more than just a concept, it will be a reality.

And Big pharma and the antis will just give up.

 

[sqirl1]

And Big pharma and the antis will just give up.

oh no they won't give up but under his policies they won't be able to actually DO anything.... if E-cigs are left as they are now, BP is going to see major profit loss over the years, and the more money they lose, the more power they lose. If we can keep this from going through, BP is going to have to follow the rules of the free market just like everybody else

 

[Uncle Willie]

I guess I don't understand the anti FDA sentiment that always threads it's way thru the forum .. if not regulation / standards.. then what .. ?? How do we know what we are using is, in fact, what it's supposed to be .. ??

Seems to me, that in the scheme of things, the FDA does more good than bad ..

The industry is apparently not willing to take steps on it's own ..

 

[mostlyclassics]

Uncle Willie, you might want to review the FDA's actions a few years ago and the curriculae vitae of the loose cannons pulling the strings at the FDA these days. There are threads on these matters here.

No one here is being in the least bit "anti FDA." Rather, the discussion is about realistic strategies to take, given the FDA's history of dealing with vaping and vapers in the past.

What everyone here is afraid of is the FDA banning vaping supplies until the whole matter is "studied" to their satisfaction, which could take decades and multiple millions of dollars. And if no one can come up with the huge bucks to conduct studies to the FDA's standards (which they will set), then tough luck, you vapers. Wear a patch or chew Nicorette.

In the best of all possible worlds, I too would welcome sensible regulation. But we're not going to get that with the current FDA crew, at least not based on their sorry history to date.

 

[DC2]

I guess I don't understand the anti FDA sentiment that always threads it's way thru the forum ...

Well, I'll explain it from my position...

I watched the FDA try to remove electronic cigarettes from the market until they were stopped by the judicial branch.
I watched the FDA put forward a press release that was clearly designed to sway public opinion against electronic cigarettes.
I watched the FDA put together a Tobacco Scientific Advisory Committee that is significantly biased towards Big Pharma.

Now I am watching what appears to me to be an FDA that is preparing to ban online sales of electronic cigarettes.
On that last one I can only hope and pray that I am wrong about what it looks like they are planning to do.

Eventually I expect the FDA to ensure that only tamper-proof pre-filled cartridges are available for public consumption.

I am all for thoughtful, reasonable, scientific-based regulation of electronic cigarettes.
I am entirely skeptical that the FDA has that goal on their agenda.

 

[Traver]

oh no they won't give up but under his policies they won't be able to actually DO anything.... if E-cigs are left as they are now, BP is going to see major profit loss over the years, and the more money they lose, the more power they lose. If we can keep this from going through, BP is going to have to follow the rules of the free market just like everybody else

Under Ron Pauls philosophy there would be a huge transfer of power from the government to the fortune five hundred. BP will not get weaker they will gain power and pass a new more stringent law. Any way this is all fantasy, it's not going to happen. Even if by some miracle Ron paul becomes president he's not going to be a dictator not much is going to change.

We have to deal with things as they are not as we would like them to be.

 

[Uncle Willie]

Well, I'll explain it from my position...

I watched the FDA try to remove electronic cigarettes from the market until they were stopped by the judicial branch.
I watched the FDA put forward a press release that was clearly designed to sway public opinion against electronic cigarettes.
I watched the FDA put together a Tobacco Scientific Advisory Committee that is significantly biased towards Big Pharma.

Now I am watching what appears to me to be an FDA that is preparing to ban online sales of electronic cigarettes.
On that last one I can only hope and pray that I am wrong about what it looks like they are planning to do.

Eventually I expect the FDA to ensure that only tamper-proof pre-filled cartridges are available for public consumption.

I am all for thoughtful, reasonable, scientific-based regulation of electronic cigarettes.
I am entirely skeptical that the FDA has that goal on their agenda.

I fully understand .. my point is if the industry cannot or will not self regulate .. there is no hope of avoiding Gov step in .. and I would like to see some degree of standards / disclosure from the makers, which we don't get .. I don't like the idea of the FDA, however, from a straight product / liquid standpoint, the industry, as I see it, is doing little to nothing to establish credibility ...

 

[Brewlady]

I guess I don't understand the anti FDA sentiment that always threads it's way thru the forum .. if not regulation / standards.. then what .. ?? How do we know what we are using is, in fact, what it's supposed to be .. ??

Seems to me, that in the scheme of things, the FDA does more good than bad.

Yup, that's what I always thought. Then I started vaping. When I learned that the FDA was trying to block the import of e-cigs, I started researching. And the more I learned, the madder I got.

I took this book out at my local library.

Amazon.com: Over Dose (9781585423705): Jay S. Cohen: Books

If you want to know why I am thoroughly disgusted with the FDA, read this book. It's a quick read, and should be required reading for every physician that ever picks up a prescription pad (ok, I'm dating myself), transmits a prescription electronically to your pharmacy of choice, and for every adult who has ever popped a prescription pill.

 

[throatkick]

I guess I don't understand the anti FDA sentiment that always threads it's way thru the forum .. .

Hi. Let me explain the sentiment in an overly-simplistic way.

I used to smoke. I watched my health deteriorate and the prices of cigarettes go higher and higher because of taxes. I tried every government sanctioned cessation method under the sun and they all did absolutely nothing. I found vaping. I feel 10x better and spend much less. The government did not do this for me. Now, they want to restrict the vendors I can choose from and they will apply a hefty tax and a bunch of regulations/restrictions in order to do so. No thank you!!

I realize this is an overly simplistic synopsis of the situation but it does not make it inaccurate.

EDIT: I must add that they have already lied by omission concerning e-cigarettes. This is just one of their weasel-like methods to get attention and make everyone feel like regulation is more necessary than it actually is. Other countries have outright banned the sale of e-cigarettes while the sale of regular cigarettes continues. What does this tell you about their motivation?

EDIT2: Assuming the FDA came in and regulated e-liquid, for reason A, B, C or D, how much would that really cost? They could spot check vendors, order online and test the liquid they received etc. In any case, it could be done with a minimal budget. I would gladly pay a 10 cent tax per bottle to have that done. Do you really think this is what is going to happen? We all know they are already trying to ban internet sales. It will become political, they will say "it is to protect the children", governors, mayors, senators yada yada, and before you know it, you will have a choice of 5-10 mega vaping companies for supplies at 20x the current prices. Then and only then will you be "safe"

 

[Bootsand]

Nicotine lozenges as 'tobacco candy?' those things taste terrible! Horrific! If I tried one as a child, I would probably vomit.

Anyway, it looks like its time to stock up. As soon as I get some spare cash, I'm going to buy another bulk order of atomizers off alibaba, and place another large nic juice order from my my fav DIY vendor. Just in case the vaping apocalypse happens

And I'm pretty strapped for cash right now... but better to stock up than be screwed later on!

 

[wfx]

completely agree with these posts today. I have no problem with sensible regulation for safety and efficacy. Most users welcome it and so will reputable vendors.

I just don't see the FDA taking that tack here. fascinating how this issue reorganizes the typical political balance. take a look at the positions of folks on both sides of the issue on both sides of the aisle. you can see who are the ones really analyzing the issue and who are just making the same arguments from ten years ago.

 

[Vocalek]

Uncle Willie, have you read the FDA's reply to the petition that was filed at the White House? http://www.e-cigarette-forum.com/forum/legislation-news/249012-reply-fda.html

Have you read the IOM's report on the scientific studies that should be completed before any product can claim to be reduced-risk when compared to smoking? http://www.e-cigarette-forum.com/fo...ied-risk-tobacco-products-released-today.html

Reasonable regulations and standards are one thing, but "clinical studies" implies having e-cigarettes jump through the same hoops that medications must jump through. Are you OK with all products being removed from the market for 10 years while each product conducts animal studies, Phase I, Phase II, and Phase III clinical trials? But wait, that just won't happen because none of the companies that make or sell these products have a spare half a billion dollars sitting around. So are you OK with e-cigarettes being "regulated" totally off the market?

Aggregating across phases, we find that the out-of-pocket clinical period cost per approved new drug is US$ 282 million and the capitalized clinical period cost per approved new drug is US$ 467 million. These costs are more than four-fold higher than those we found in our previous study.

http://www.cptech.org/ip/health/econ/dimasi2003.pdf

Now these estimates were published in 2003.

The leadership at the FDA's Tobacco Program has not shown any indication whatsoever that it believes in the concept of Tobacco Harm Reduction and/or that e-cigarettes show promise. In his reply to the petition, Dr. Deyton advised e-cigarette users to participate in the Great American Smokeout.

Yup, that worked so well for us in the past.

Can you point to one thing spoken by or written by anyone who works for the FDA that gives you the idea that they plan to require reasonable regulations? To me, reasonable regulations would be batch testing of liquid, complete and correct labeling (including poison warnings), and the option for child-proof caps.

What they should do and what they can do are two different things. There is a clause in the Tobacco Control act that states no new tobacco products can be introduced after 2007. This means that the FDA could a) claim that there were zero electronic cigarettes being sold before the cut-off, or b) select one product that was on that market then and then require a lot of proof that anything introduced after that is "substantially equivalent". If they went with Option a, all e-cigarettes would be banned. If they went with Option b, we would be left with the Ruyan R4081--an underpowered e-cig with batteries that go dead in about half a day and with tobacco flavored liquid at a maximum strength of 16 mg (1.6%).

How many of the FDA TPSAC meetings have you watched? Have you heard the questions being asked by the members of the Tobacco Products Scientific Advisory Committee? The bias of some of the members of that committee is very obvious.

So how would you suggest we make sure that regulations are actually in the best interest of the million or so former smokers who need these products to be kept available and effective, and to keep them available and effective for as many of the 45 million or so current smokers who might be persuaded to switch to something less hazardous?