Are Guns Medical Devices?


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).