Drug War

Are Guns Medical Devices?

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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).

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  1. Jesus Christ man. Don’t give them any ideas.

  2. The FDA is working against public health with their stance on e-cigarettes. I have been using mine for over 6 months and smoke 90% less tobacco cigarettes. I feel and smell much better.

    I keep up on the FDA vs Njoy case at http://www.e-cig.org/2009/05/0…..cigarette/ if anyone else wants to get updates.

  3. How many people here know that the FDA already considers iPod earbuds as falling under its purview? Or that an iPod can be considered as a medical device if, for example, you download a biofeedback app? The last I heard, when I was working in medical informatics: you can bring ANY product under the FDA’s control if you find and promote a medical/therapeutic use for it. That is to say, SOMEONE ELSE can turn your product into a medical “device,” at which point you also must satisfy FDA requirements, or at least fend off FDA claims that they can do so.

    The FDA is out of control. I am so sorry Congress put them in charge of tobacco — and I’m not a smoker.

    1. xxx “fend off FDA claims that they can do so” should be “fend off FDA claims of regulatory authority over your operation.”

  4. I’m confused. NJOY is arguing that the FDA has authority over e-cigarettes under the 2009 Family Smoking Prevention and Tobacco Control Act, and that the FDA has no authority over e-cigarettes because they are not a medical device?

    1. The FDA wants to regulate e-cigs as a drug delivery device, which means that they would have to be pulled off the market until (if) they get FDA approval. This can take many years and cost millions of dollars. This would effectively ban the e-cig. If they ever did receive approval, it would only be as a smoke cessation product, not a smoking alternative.

      NJOY says they are not a drug delivery device, they are a tobacco product. If this is decided to be the case, the FDA would have as much control over them as traditional cigarettes and other tobacco products. E-cigs would still be available for sale while further safety testing was done.

    2. Thank you, Solstice. I see now that Jacob made a somewhat more elliptical observation at the end of his post.

  5. My God, don’t give the government any ideas! What are you doing?!

  6. I think a gun can be considered a medical device if Mayor Daley sticks it up a reporter’s rear end.

  7. There is nothing better than a high velocity lead injector for curing terminal phycosis.

    1. Nice handle.

      1. But I don’t actually remember him saying that.

  8. Look at what the FCC is doing. This is not too far fetched.

  9. I had my subordinates apply a variety of guns as medical devices during my administration.

  10. Thanks for the heads up!

  11. My favorite part of the NJOY appeal brief was the scathing analysis of the FDA’s toxicology test on 18 cartridges. The points raised in the brief make it obvious that the FDA’s July 2009 press conference was an artful spin job, calculated to convince smokers to continue lighting up the real thing. http://digg.com/health/FDA_Mis….._Backfires

  12. My smoker friend tried and liked the e-cigs, but found the batteries unreliable for heavy use. Expect them to catch on as the technology improves.

    1. Batteries are getting better. There’s still a definite flake rate. But some of the boutique batteries, and the larger 510 models will run all day pretty reliably. Equally important is finding good, clear, US / UK made fluids, which don’t gum up the works like the cheap Chinese competition.

  13. Cholesterol-lowering “statin” drugs often come with side effects. The most frequently reported consequence is fatigue, and about 9 percent of patients report statin-related pain http://bit.ly/d454ZR

  14. What have other state to this subject?

  15. While researching for medical supplies and dental supplies, I found New Line Medical. They have no user reviews section for their products, so I’m unsure how to rate their products. Can anyone help?

  16. Thanks to electronic cigarette store
    I was able to quit smoking for good. Don’t get me wrong it still took a lot of will power but the
    electronic cigarette store really helped with the

    cravings.

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