Bend Over, Here It Comes Again
Posted on 07/09/2010 6:42:11 AM PDT by marktwain
In January a federal judge issued a preliminary injunction that blocked the Food and Drug Administration's attempt to ban electronic cigarettes, devices that deliver nicotine vapor without combustion products. Last
month the e-cigarette distributor NJOY filed a brief urging the U.S. Court of Appeals for the D.C. Circuit, which is scheduled to hear the case in September, to uphold the injunction, which has been stayed pending the FDA's appeal.
According to the legal interpretation the FDA is using to ban e-cigarettes as unapproved "drug delivery devices," the brief notes, "any product that affects the structure or function of the body is a drug, device or drug/device combination under the Food Drug and Cosmetic Act," regardless of whether it is intended for medical purposes. NJOY says this broad reading of the statute, which has been repeatedly rejected by the courts and the FDA itself, would lead to "absurd results":
If applied as FDA now insists, without therapeutic intent as a limiting principle, the FDCA's structure/function definitions would transform into drugs, devices or combination products articles like guns, bullets, mace, seat belts, air bags, and street drugs—articles that FDA never has regulated under the FDCA and that are instead regulated by other federal agencies or under different statutes that were passed long after the FDCA was enacted. More broadly, it would bring within FDA's drug/device jurisdiction a limitless scope of articles—including barbells, jump ropes, running shoes, long johns, winter coats, Jacuzzis, foam mattresses, diving equipment, and cleats, which likewise have physiological effects when used—that Congress has never sought to regulate as a drug or device....
FDA's usual approach to this issue is exemplified by its treatment of exercise equipment and razors. The intended use of exercise equipment such as treadmills and rowing machines is unquestionably to affect the structure or function of the human body. Yet FDA has explicitly "regulate[d] exercise equipment only if the equipment is intended to be used for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. FDA does not regulate exercise equipment intended only for general physical conditioning and/or for the development of athletic abilities in individuals who lack physical impairment."...Likewise, although hair is a structure of the body, FDA has explained that "[r]azor blades and manicuring instruments as ordinarily represented are not devices within the meaning of the Act."
This is not the first time the FDA has tried to make an exception to its usual definition of drugs and devices. Back in 1996, reversing a position it had maintained for half a century, the agency tried to regulate conventional cigarettes as drug delivery devices—a gambit that was shot down by the Supreme Court. It was not until Congress approved the Family Smoking Prevention and Tobacco Control Act last year that the FDA acquired the authority to regulate cigarettes, along with "any product made or derived from tobacco that is intended for human consumption." NJOY argues that the 2009 law also covers e-cigarettes, since the nicotine in them is derived from tobacco. The crucial difference is that e-cigarettes, which offer a much safer alternative to conventional cigarettes, could remain on the market as tobacco products, while the FDA's requirements for approving them as pharmaceutical products would be prohibitive.
Here is NJOY's brief (PDF).
Well, they are sort of like a bionic fist, capable of reaching out over long distances to deliver a real wallop.
My finger is a medical device if I pick my nose.
Why do we need the FDA, again?
It's the only way to stop the insanity of the beltway zealots. It's an open-ended grant of power they have proven they can't be trusted with.
Bend Over, Here It Comes Again
But a gun CAN be a surgical tool. It can be employed to rid society of malignant growths.
1) Obama pushes on enough buttons, civil unrest ensues, martial law is declared, a communist dictatorship is openly declared, and the ungovernable members of the population are liquidated. Darkness falls. A good outcome for Obama's backrs. But very unlikely
2) Similar beginning, but it all falls apart. It's brother against brother, millions of casualties, physical and governmental infrastructures fall apart, and America truly becomes a third world country, broken into chaotic pieces. A good outcome for Obama's backers. And quite likely too.
3) Obama pushes, civil unrest erupts, Patriots rise up and do some housecleaning, and the country returns to its Constitutional roots.The only bad outcome for Obama's backers. It's what we're hoping for -- but how likely is it?
E-Cigarettes still allow the user to inhale nicotine into the lungs and nicotine is a drug. Nicotine causes vascular constriction and insulin suppression and a significant impact on dopamine levels in the brain.
well... guns do cause Lead Poisoning.
:-)
Maybe they should regulate electronic cigarettes but not with that language. Are these the "brightest" lawyers we keep hearing about? Lord save us from the brightest. I guess that's why Pol Pot ended up trotting all the academics out into the rice fields.
The Palm Pistol from Constitution Arms almost got FDA approval.
So do tobacco pipes. Should the FDA be allowed to ban tobacco pipes if one day an FDA bureaucrat decides they want to?
E-Cigarettes still allow the user to inhale nicotine into the lungs and nicotine is a drug. Nicotine causes vascular constriction and insulin suppression and a significant impact on dopamine levels in the brain.
I have one relative that smoked so much you couldn’t stand to even be in the same room with him due to the smell (same with his house). It was as though he was saturated with cigarette smoke. He started using the e-cigs, and it has really made a difference in his life. He has NOT cut down on the amount he smokes, but he no longer stinks to high heaven.
Yea, he is getting the nicotine, but he isn’t getting all the other gunk that also comes along with a regular cigarette (tar, smoke damaged lungs, etc...) Is it a perfect solution? No, but it is a heck of an improvement over where he was.
As conservatives, we need to start recognizing there is a difference between “businesses” and “corporations”. The reason big corporations (including Wall Street) have donated more to Democrats than the GOP is they like the idea of an activist government, because they can influence that activist government to protect their corporation/industry.
Tbe Wall Street bankers and big auto companies (corporations) got bailed out by the government. Regional/indepndent banks and local auto dealers (businesses) didn’t.
As an e-smoker I have quit smoking since the first of the year and am watching as the Obama administration is figuring out how to stop me. It is all about control with these folks. There are tons of small businesses that will go under if Obama’s control agenda continues. I get my supplies from a family in GA and there are tons of small businesses that will be shutdown and many folks back to smoking should Obama succeed. Yes it is safer than regular cigarettes.
1) Obama pushes on enough buttons, civil unrest ensues, martial law is declared, a communist dictatorship is openly declared, and the ungovernable members of the population are liquidated. Darkness falls. A good outcome for Obama's backrs. But very unlikely
2) Similar beginning, but it all falls apart. It's brother against brother, millions of casualties, physical and governmental infrastructures fall apart, and America truly becomes a third world country, broken into chaotic pieces. A good outcome for Obama's backers. And quite likely too.
3) Obama pushes, civil unrest erupts, Patriots rise up and do some housecleaning, and the country returns to its Constitutional roots.The only bad outcome for Obama's backers. It's what we're hoping for -- but how likely is it?
In any of these scenarios, the first and most important objective of any "civilian movement" must be to gain control of the airports, then the roads. And then communications. In that order.
Why?
So the scoundrels don't get away!
CA....
“My finger is a medical device if I pick my nose.”
FDA will toss you in the slammer if you dare pick it again without first receiving their approval.
A gun is an inanimate object, a tool, that can be used or misused like any other. I could drive nails with a hammer or use it to kill someone. I could drive my car to work or plow it into a crowd, killing more people than most guns are capable of. Shall we outlaw hammers or cars?
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