FDA and vaping – ridiculous part 3

I just thought I would post this to ensure anyone reading this blog is up to speed. For any of my fellow vapers in the USA, you need to get active on this before big brother and big tobacco take your vaping away from you. For those of us in Canada, we need to keep a very close eye on Canadian regulations, as it is quite typical for Canada to follow the USA’s lead

WASHINGTON, April 28, 2014 /PRNewswire-USNewswire/ — Last week, the U.S. Food and Drug Administration (FDA) released its long-awaited draft regulations for electronic cigarettes (e-cigarettes) and other low-risk alternatives to smoking. The regulations offer little benefit, according to The Consumer Advocates for Smoke-free Alternatives Association (CASAA), the leading advocate for the current and future consumers of low-risk alternatives to smoking. However, CASAA believes that should the FDA finalize the rule in its current form, it will inflict devastating harm on consumers.

“This is a classic case of government imposing a ‘solution’ and then looking for a problem,” said CASAA President Julie Woessner, J.D. “The regulations do nothing to address real concerns, and instead are a slow-motion ban of the high quality e-cigarettes that have helped so many smokers quit. The rules would mostly require busy-work filings that impose huge costs with little apparent benefit.”

The proposed regulations are based on a faulty understanding of the science, reports CASAA Scientific Director, Dr. Carl V. Phillips. “FDA has cherry-picked the available evidence,” says Phillips, “blindly accepting any assertion that favors aggressive regulation and ignoring the overwhelming evidence about the harms that these regulations would cause.”

Although the regulations do not openly ban the refillable devices that are preferred by experienced users, they impose a costly registration and approval process that would effectively eliminate them. Such registrations offer minimal benefits, but ensure that only a few large companies who mass-produce small and disposable products would be able to afford the necessary filings. Additionally, while the regulations do not immediately ban the variety of popular flavors for e-cigarette liquid, they signal an intention to do so in the future.
“Our research and others’ shows that higher-quality hardware and appealing flavors are important for smoking cessation,” says Phillips. “Many former smokers report that they were always tempted to go back to smoking while using the smaller devices with imitation tobacco flavoring, but they quit smoking for good when they found better hardware and flavors that no longer reminded them of smoking.”

It is estimated that as many as a million American smokers have quit or substantially reduced their smoking thanks to e-cigarettes, and many are already making plans for a black market if these regulations take effect. Those smokers who are using e-cigarettes in a transition stage could easily return to smoking–and future potential switchers may never be able to make the transition–if the restrictions on high-quality products are imposed. Woessner, who quit smoking thanks to e-cigarettes, fears such impacts. “If I had been limited to only those products that would exist under this regulation, I would probably still be smoking.”

CASAA is preparing a response that will point out the flaws in the proposed regulations and is organizing its members and hundreds of thousand of other e-cigarette users in an attempt to persuade FDA about the harms this regulation would cause. Should that fail, it plans to fight the regulations in court.

CASAA is a 501(c)(4) nonprofit, public health, membership NGO. It does not represent the interests of industry. Donations are not tax-deductible as a charitable contribution.
Contact: Carl V Phillips, CASAA Scientific Director, 651-503-6746, cphillips@casaa.org.

FDA and vaping – ridiculous part 2

This is important to me as vaping has allowed me to give up cigarettes. Rather than my pack a day habit, I am now simply vaping. I haven’t had a cigarette since October, and all of my prior efforts to quit had been unsuccessful.

The proposed FDA regulations are going to insist that any vaping products, such  liquids must be reviewed and prior to  being allowed to be sold. The application fee is $2500 just to start, Then they also have to pay an additional $1500 per ingredient. Now some nicotine juice only contains as few as 4 or 5 ingredients, which means that the combined cost for the PMTA would be about $10,000 dollars. But that is misleading. That is for each juice, so if you manufacture 25 juices at 4 levels of nicotine, that is 100 applications, so a total of a million.

The exact rules are

1. Products that were already on the market as of February 2007 are grandfathered in and allowed to be sold without review, although the FDA could hypothetically order them off the market.

2. Products introduced between February 2007 and March 2011 are allowed on the market while under provisional review. Producers have had to submit applications, but they are allowed to continue selling while the FDA reviews them.

3. Since March 2011, all new products must receive FDA approval before being sold.

This will totally destroy the small vaping community, just leaving the big players (who are mostly owned by big tobacco companies now), as most, if not all current vaping products came into existance after the 2007 date, so that will put all of the current market under review.

If there was one shred of evidence that vaping was dangerous, I could look at this and say that it was for health reasons, but there isn’t. It is ludicrous that vaping is falling under the Tobacco Control Act. One interesting note is that the Tobacco Control Act was fully backed and negotiated by Philip Morris. They knew what they were doing. 

Not only that but the review process is a snail. It has been reviewing applications for four years on tobacco products, currently has more than 150 employees working on reviews, has received approximately 4,000 applications, and has managed to rule on only 34 of them. 


FDA and vaping – ridiculous

refillable vaporizer The FDA has come out with a draft regarding its position on vaping and it is now open to public commentary. I’m in Canada, so not directly affected, but where the US goes Canada seems to like to follow. The proposed FDA regulations are restrictive and very far-reaching and any vaper needs to take note and hopefully act.

The FDA seems to be grouping vaping under tobacco regulations, which is very silly, but I suppose as a lot of e-juice contains nicotine, there is a certain twisted logic. It is like grouping mouthwash under the liquor control board because they both contain alcohol. The draft regulations are a very long read, but there are three areas that stand out.

Age control – the FDA is looking to restrict vaping to 18 or older. To my mind, this is sensible and should move forward, although there is a great deal of evidence to support the position that banning something makes it even more attractive to those under the age of majority.

Warning labels – the FDA is proposing that e-liquids have warning labels on them. Again, this would seem sensible and I have even less objection to that than the age limits. Lets face it, a lot of e-liquid contains nicotine, which is addictive. That being said, so is caffeine and I don’t see coffee being similarly controlled.

The third area is the one that I have huge problems with. The FDA is proposing that all vaping gear and supplies needs approval before it is legal to sell them. This imposes a huge and probably unmanageable overhead on small manufacturers and sellers. This would hand the vaping world over to the large manufacturers, especially big tobacco, who already have to live under these restrictions. Most vaping gear consists of either batteries or units that contain coils to vaporize e-liquid. It is ridiculous to control these units – heck its like trying to control flashlights. As far as e-liquids are concerned, there is something to be said for a full statement of contents and potentially a ban on including certain products such as diacetyl which can be found in certain food flavorings, but approval – no – that is going way too far. That would mean that a small boutique e-liquid manufacturer would have to get approval for each and every liquid they create, for each mix of PG/VG, for each level of nicotine and for each flavor. That is something that would be completely unmanageable for a small outfit and would force them either underground or out of business.

Please watch this video – it does a good job of explaining what the FDA is proposing here

If there is any evidence that vaping is in any way dangerous to health, either to the vapers themselves or more specifically to those around them, then lets see that evidence and use that as the basis for sensible regulations. If I was suspicious, I would say that big corporate interests had significant input into these regulations with the intent of taking control of the vaping industry, and if these regulations proceed through as they are, then there is a pretty good chance that they will succeed.

For those of you that are vapers in the USA, or friends of people that have given up smoking by switching to vaping, you need to contact your congressman and tell them how much vaping has helped in your lives. This legislation must be stopped or heavily amended. It is just wrong that something that has helped me and thousands of others is going to be treated this way.


Fort Hood

forthoodThere has been another tragedy at a US Military Base, and again it is Fort Hood.

The soldier who killed three people at Fort Hood may have argued with another service member prior to the attack, and investigators believe his unstable mental health contributed to the rampage, authorities said Thursday. Spec, Ivan Antonio Lopez was a 34 year old military truck driver and Iraq war vet, who was being treated for anxiety and depression.

Now the effect of war on soldiers and the aftermath are a subject that needs looking into. If we send our young men and women into harms way, then there must be an obligation to deal with the outcomes. Whether this be physical scars or mental ones, needs must be met. Will it be possible to help everyone to the full extent they need? – no probably not, although a best effort is needed. What will be true, as in all things in life is that despite everyone’s best effort, people will fall through the cracks, and the best that can be done is to ensure those cracks are as narrow as possible..

The lesson to be learned here though is not that this is an ex-soldier, shooting military personnel on a military base. It is that he was using weapons that were not military issue. Weapons are very tightly controlled on a military base and only issued on an as needed basis. The military realizes that they are dangerous and does its best to keep them under control. This is not true in the world outside of the military. Guns are far too easy to obtain, and in this case, rather than a fist fight breaking out there was a mass shooting.

The NRA will have you believe that the answer to this is more guns not less. If everyone has a gun, then these mass shootings will not happen as people will be able to defend themselves.


Shootings will still happen. People will crack and make bad decisions and the fact that they have easy access to guns leads to those bad decisions being fatal rather than bruising.


War of words

russiantanksMoscow is pressing Nato to explain its plans to enhance its military presence in Eastern Europe, Russian Foreign Minister Sergei Lavrov has said.

“We not only expect answers, but answers… based fully on respect for the rules we agreed on,” he said.

Nato has said it will reinforce the alliance’s defences in Eastern Europe following Russia’s annexation of Crimea from Ukraine.

Nato has also halted all civilian and military co-operation with Russia.

Russia by all reports has massively built up its troop presence on the border with Ukraine, and has persistently refused to honor requests to reduce that presence. Now, when Nato is proposing some counter moves, which are based upon the nervousness of Nato members that are close to this region, Russia is demanding explanations.

Maybe, “well you are standing on the Ukraine border with 40,000 big clubs” would do.

Russia has proceeded with complete disregard to any international pressure to this point, so I would make the case that it was has a game plan that it is following. Whether that game plan is well thought out is up for debate, and how it  will play out depends on a lot of factors outside Russian control.

It has executed a force play on the ground, and is well into a media play to attempt to give those looking for excuses to look the other way a rationale for doing so. It is also blowing smoke out of every orifice.

It is attempting to destabilize an already unstable area for its own ends and hopefully the “excusnics” will get very little media play, but if past experience is anything to go by they will get far more coverage than they deserve.

Making Lemonade

CNN newsman Don Lemon

CNN newsman Don Lemon

Near the end of CNN’s special primetime report on Malaysia Airlines Flight 370 on Wednesday, anchor Don Lemon read a pair of tweets he received from viewers suggesting the plane’s disappearance could be the result of a “black hole,” Bermuda Triangle or an occurence akin to the television series “Lost.”

Lemon then turned to Mary Schiavo, former inspector general of the U.S. Department of Transportation, and said, “I know it’s preposterous, but is it preposterous, do you think, Mary?”

“It is,” Schiavo replied. “A small black hole would suck in our entire universe. So we know it’s not that. The Bermuda Triangle is often weather, and ‘Lost’ is a TV show.”

“Right,” Lemon said.

It is a bit scary that someone can be in public position with that complete lack of common sense. I know we can’t expect much from a talking head, but at least some attachment to a brain might be nice. If it wasn’t such a potentially tragic situation with the Malaysian Air plane, I would send him a tweet about it being sucked into a parallel dimension through a rift in time/space. That would make his head explode, which would be rating leading TV.

Statistics on education suspensions show racial differences

Black students are more likely to be suspended from U.S. public schools — even as tiny preschoolers. The racial disparities in American education, from access to high-level classes and experienced teachers to discipline, were highlighted in a report released Friday by the Education Department’s civil rights arm.

The suspensions — and disparities — begin at the earliest grades. Black children represent about 18 percent of children in preschool programs in schools, but they make up almost half of the preschoolers suspended more than once, the report said. Six percent of the nation’s districts with preschools reported suspending at least one preschool child.

Advocates long have said get-tough suspension and arrest policies in schools have contributed to a “school-to-prison” pipeline that snags minority students, but much of the emphasis has been on middle school and high school policies. This was the first time the department reported data on preschool discipline.

Earlier this year, the Obama administration issued guidance encouraging schools to abandon what it described as overly zealous discipline policies that send students to court instead of the principal’s office. But even before the announcement, school districts have been adjusting policies that disproportionately affect minority students. Overall, the data show that black students of all ages are suspended and expelled at a rate that’s three times higher than that of white children. Even as boys receive more than two-thirds of suspensions, black girls are suspended at higher rates than girls of any other race or most boys.

The data doesn’t explain why the disparities exist or why the students were suspended.

“It is clear that the United States has a great distance to go to meet our goal of providing opportunities for every student to succeed,” Education Secretary Arne Duncan said in a statement.

“This critical report shows that racial disparities in school discipline policies are not only well documented among older students, but actually begin during preschool,” Attorney General Eric Holder said. “Every data point represents a life impacted and a future potentially diverted or derailed. This administration is moving aggressively to disrupt the school-to-prison pipeline in order to ensure that all of our young people have equal educational opportunities.”

There are three interesting statements here – the first is

the data doesn’t explain why the disparities exist or why the students were suspended

. The other two are from the Education Secretary and the Attorney General who from their responses are making the case that this is solely due to racial bias.

Lets get more information and then we can act on facts not ideology

2nd amendment rights

I’ve been following the gun control debate in the US after the dreadful evens at Newton, which are just the latest in a long string of tragedies.

I also understand the enshrined right of the 2nd amendment being pretty sacred in a nation that was born through revolution.

What I don’t understand is why the NRA is actually capable of having any influence in the debate, based upon the complete nutbar pronouncements. Their solution to tragedies like Newton is to put armed guards in all schools. Gee – why don’t we simply give out handguns in grade 5 and have everyone armed. They also don’t seem to like the idea of background checks – they say that they don’t work, and that criminals don’t comply with  background checks. There is also resistance to banning high capacity magazines.

The NRA seems to be well funded, well connected and very able at influencing politicians. It is a shame that they can’t use this for something useful. Guns for hunting are one thing, but the remainder – assault weapons, handguns and automatic weapons of any kind simply don’t have a place in civilized society. How long is it going to take and how many innocents need to die before this is recognized?

Obama defends US wars as he accepts peace prize

Now isn’t that just so ironic.

Obama is receiving a Nobel Peace Prize just as he announces a troop surge in Afghanistan.

There seems to be a temporary blind spot for some US presidents.  It is like looking into the sun. For a while you cannot see clearly and everything is surrounded by a halo.

Kennedy had this working for him, and if you look at his record, he certainly wasn’t one of the greats. Obama has the same going for him at the moment, although plunging domestic approval ratings are indicating that the halo effect is wearing off.

On one hand I feel very sorry for President Obama, in that the expectations were so high at his Inauguration that no mere mortal would stand a chance at achieving them. On the other hand however I see that he is proceeding to throw away all of the high sounding words that got him elected and proceed with business as usual on the Hill. That is such a shame. The words are still there, but now they are starting to sound cliched.

I suspect that the report card on Mr Obama will read “Barak has limitless potential and is a very bright boy, but talks too much in class and doesn’t keep his promises”. That is such a shame, as the US really did need a fresh start and it isn’t happening.