The U.S. Food and Drug Administration (FDA) regulatory authority over devices that “affect the structure or function of the body” can be used to limit the manufacture of firearms, according to a forthcoming paper in the Connecticut Law Review.
Lars Noah, a law professor at the University of Florida, argues that the FDA’s oversight power over devices that can also inflict “accidental harms” offers an unconventional approach to the epidemic of gun violence in the U.S.
While the device regulation authority is primarily used for instruments like hypodermic needles, syringes and automated external defibrillators (AEDs), it provides a precedent for regulating potentially harmful products.
Gun manufacturers currently operate with “far too little oversight at present,” the paper maintained.
Noah suggested its worth bringing up the idea since gun violence is already considered a public health challenge by many scholars and researchers.
Defining FDA “Devices”
Presently, the FDA defines “devices as an instrument, apparatus, or a component intended to either diagnose, cure and treat — or “affect the structure or any function of the body of man or other animal.”
Using this definition, firearms and ammunition clearly are devices and accessories that can affect the structure or function of a body because of its ability to cause deliberate or accidental harm, Noah wrote.
If regulated as a “device” through the FDA, this would mean that they’d have the ability to impose a national minimum age for purchasing, demand clearer storage instructions, and introduce performance safety standards.
Noah noted that while some might consider it a stretch to include firearms in this definition, the FDA is used to regular indoor tanning equipment and sunlamps.
These skin-darkening devices clearly serve primarily a cosmetic purpose, but fall under the FDA’s “device” authority because it has the ability to affect the structure or function of the body while also being an instrument.
“Guns and ammunition literally fit within FDA jurisdiction over ‘devices’ because these products unmistakably intend to affect the structure or function of the body,” Noah concluded.
For other skeptics who Noah said may argue that Congress should handle this issue and not the FDA, Noah responds by saying that Congress had their chance — and they “responded in a chaotic fashion” with disjointed state regulation and differing purchase rules.
Roadblocks and Opportunities
This would not be the first time that the FDA’s regulatory power has been invoked in the gun control debate.
While testifying at a Senate subcommittee hearing focused on regulating the chemical, mace, the Commissioner and Chief Counsel of the FDA in 1969 said the agency would not look to regulate mace — or firearms for that matter — as it would be a “slippery slope” in “rulemaking.”
Because of the FDA’s past stance on this, Noah concedes that pushing for “device” regulation is a long shot and an unconventional idea in the fight against guns. However, he said it’s worth pushing the envelope to get people discussing other possibilities for tackling gun violence as a public health threat, in the same way discussions about curbing tobacco use began.
“I do not imagine for a moment that this will ever happen,” Noah wrote. “Then again, crazier ideas have gotten traction, and the FDA’s experience with tobacco products amply demonstrates that something previously unthinkable and ultimately unsuccessful can still bear fruit.”
Lars Noah is a Chesterfield Smith Eminent Scholar and Professor of Law at the University of Florida Levin College of Law where he teaches courses in Administrative Law, Medical Technology, Public Health Law, and Torts, among other subjects.
The full forthcoming paper can be accessed here.
Andrea Cipriano is a TCR staff writer.