FDA should regulate digital games, and potentially other apps, as medical devices.
Why, pray tell?
One doesn’t have to look very hard to find a growing belief (recognition?) that video games are addicting. CBS has been on the story since at least 2007. In 2014, “60 minutes” suggested that a violent video game could prompt murder. Well, they posed it as a question, but to raise it as they did sounds kind of like asking someone, “have you stopped beating your wife?” And this past April, they did a piece with a former Google employee who suggested that tech companies are designing games, if not apps in general, to draw people into compulsive use. They revisited the topic, with the same interviewee, in June, using the term “brain hacking.” Frontline on PBS did a series on the topic in 2010, looking at concerns about internet addiction as well as arguments that some games may hone desirable skills.
Concern about the effect our entertainment media have on us, especially on our kids, is certainly not new. Remember Tipper Gore, who, among other things, wrote a book about the subject 30 years ago?
The difference comes if our apps and games are not just addictive and self-reinforcing, but if their creators and marketers not only know it but make them that way on purpose.
According to the FDA, a medical device, subject to premarketing and postmarketing regulatory controls by the FDA, is defined in Section 201(h) of the Food, Drug, and Cosmetic Act as (emphasis mine in what follows):
- “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
That strikes me as a pretty broad remit.
So do video games or other apps affect the body of man, notably the brain? Apparently there is evidence for that.
So–FDA regulates cigarettes, couldn’t it regulate video games and other apps by similar reasoning?
Well, FDA has separate statutory authority for cigarette regulation. Arguably, a new law addressing video games would be required. And it’s probably a safe bet that people generally do not consider our games, apps, and smart phones to be quite the danger that cigarettes are.
Why shouldn’t our government agencies put up some barriers to these things? We may come to demand it in the realm of privacy, but would we also want to have our destructive tendencies inhibited? Or would we prefer more funding for treatment of the troubled? Perhaps the latter.
China is regulating at least one video game, and a Nature editorial last month said that the effects on young minds should be rigorously evaluated.
In the meantime, if you are concerned and want to help your family, by all means–seriously–check out Families Managing Media for terrific resources. I’d go so far as to say that no family should go without bookmarking the web site.
(HT to my business colleague Al Beardsley for suggesting this “modest proposal.”)