The FTC Has Kidney-Punched Lumosity. Could Brain Stimulation Tech Be Next?
2016 got off to a bleak start for Lumos Labs, the brain-training software company whose advertisements you have almost certainly heard if you listen to NPR. On January 5th, the Federal Trade Commission announced that it had reached a settlement in a deceptive advertising case brought against Lumos over its Lumosity program, which purported to enhance cognitive performance and stave off age-related decline. The FTC alleged that “Lumosity simply did not have the science to back up its ads,” and rather than litigate the issue any further, the company folded its cards and agreed to comply with a list of demands from the agency.
Although Lumos Labs takes a $2 million hit and henceforth will have to scale back its claims, it’d be an overstatement to call this settlement all stick and no carrot. The attractive part of the deal is that the makers of Lumosity don’t have to admit to any of the FTC’s pointed allegations about overblown or unsubstantiated marketing claims. Maybe they were not confident that the scientific grounding for their program would hold up in court; maybe they believed it would, but simply weren’t spoiling for a big legal battle. Winnable cases still get settled when the game’s not worth the candle.
While the no-fault-admitted provision is good news for Lumos Labs, it’s too bad for those of us who would have liked to see the agency and the company slug it out in open court. Just how much data, and of what overall quality, does a purportedly brain-boosting product’s maker need to pony up in order to survive having their bluff called by the FTC? Even if you’re convinced of a given method’s efficacy while wearing your scientist hat, the legal question is interesting and not self-evidently identical to the scientific one. The proceedings would have been … illuminating.
Along with a few other scholars who monitor this space, I had heretofore been in the habit of envisioning the Federal Trade Commission as something of a slumbering giant in the brain-enhancement regulatory framework. Ordinarily the agency we think of throwing its weight around is the Food and Drug Administration. The FTC’s action, then, shakes up the usual way of thinking about these things and may turn out to be a game-changer, in two ways.
First, this might end up being a “blood in the water” moment for other consumer protection bodies, such as state agencies or local attorneys general. (As someone who has worked with a local government body wielding the absolutely fearsome power of California Business & Professions Code §17500 et seq., I know that I’d be licking my chops right about now if I had enforcement authority.) That’s not to predict a pile-on against Lumosity specifically; but now that this has happened once in the brain fitness software world, the wheels are greased for it to happen again with a fresh cast of characters.
Second, there’s no particular reason why this development has to remain confined to brain fitness software. In particular, it seems to me a short leap from here to technologies like transcranial direct current stimulators and cranial electrotherapy stimulators marketed for cognitive enhancement. The burgeoning prominence of devices from companies like Fisher-Wallace, Foc.us, and Thync has prompted interesting discussions about who else besides the FDA might step into the regulatory breach. If I were the general counsel for such an outfit, I would be worrying — not panicking yet, but certainly feeling a tinge uneasy.
This is not at all to assert that the aforementioned companies lack scientific ammunition for the claims they make in selling their products. No one disputes that tDCS, CES, etc. have some data on their side (though we are far from consensus). But the question that players in the brain stimulation space ought to be asking themselves is rather: “do we have stronger science for our product than Lumos Labs had for theirs?” Or, at a minimum — “do the claims that we’re making to the public correspond better to our science than Lumos’ claims did to their science?”
The fact that the case against Lumosity settled means that any serious attempt to answer that question will involve some guesswork; we just don’t know how much of the outcome was driven by the scientific merits. But it’s an attempt worth making. From where I sit, it’s hard to see much reason for the FTC or another consumer protection watchdog not to continue poking and prodding at brain enhancement claims now that the inaugural exercise in doing so has yielded a respectable payoff.
Gary
I always cringed when I heard Lumosity’s ads. But the implication in the tone of this article is that tDCS companies can be unfairly lumped together in making unsubstantiated claims.
[No one disputes that tDCS, CES, etc. have some data on their side (though we are far from consensus). But the question that players in the brain stimulation space ought to be asking themselves is rather: “do we have stronger science for our product than Lumos Labs had for theirs?” ]
There IS scientific consensus of tDCS benefits in certain areas (eg. depression treatment) with more than just “some” data, while the jury is still out on others. Some tDCS companies are conservative in their statements; others make bolder and shakier claims on, as yet, inconclusive research. The following quote from the article is accurate only as it applies INDIVIDUALLY to each tDCS company’s specific marketing, not collectively:
[Or, at a minimum — “do the claims that we’re making to the public correspond better to our science than Lumos’ claims did to their science?”]
tDCS companies’ misleading or false claims should be addressed by the FTC, and all consumer protection laws should all apply, as is clearly appropriate. But the greater question of my concern is whether, additionally, FDA involvement would be overkill for a product that has shown low public risks great potential benefit. FDA regulation would force prices up, startups out, foster a higher risk underground DIY market, slow acceptance, and withhold the benefits from those who need it.
Roland Nadler
Hi Gary — I think you’re quite correct that individually, there’s pretty significant variation in the quality of evidence behind commercially available neurostimulation devices, and that there is a scientific consensus as to the real benefits and low risks of certain applications. I suppose the point I want to make is that, in the wake of this FTC-Lumos news, it’s time for each company to ask itself how it might fend off a similar challenge. I’m actually not *sure* that any of the companies I’m thinking of here (Fisher-Wallace, Thync, Foc.us, &c.) would wither under regulatory pressure to substantiate their claims; part of the problem is we just don’t know how high the bar is set. Maybe it’s really easy to satisfy the FTC … but if I were one of these companies I’d sure like to have more concrete assurances of victory!
To your point about the costs of FDA regulation, it’d be silly for anyone to ignore the significant downsides of forcing neurostimulation technologies through the full premarket approval process. On other occasions I’ve maintained that I would love to see federal agencies learn to regulate these technologies with a light yet precise hand. Perhaps one question is — if the goal is to avoid unduly burdensome regulatory regimes while still ensuring robust consumer protection, might it be good news if the FDA steps back a bit at the same time as the FTC steps up? I don’t have an answer (since we don’t know how stringent the FTC’s test is) but “yes” seems quite possible to me.
Gary
Roland, thank you for your well reasoned response. I would just like to add some important points for your readers. My concerns are specific to tDCS as a (potential) small startup device provider.
There is a distinction between tDCS and CES (and the companies named). Those non-tDCS technologies are varied and mostly proprietary, and while they may each be supported by some research and companies with deep pockets, they have nowhere near the level of published research and scientific acceptance that some aspects of tDCS receive.
While there is still an enormous amount to be learned about tDCS (as much is unknown about the brain and all neurostimulation technologies, and may take decades for clarity), a tDCS device is pretty simply defined. It either safely delivers up to 2mA DC of current and performs to its published specs, including whatever bells and whistles, or it does not.
All well behaved tDCS devices should be able to point to the same publicly available body of research for efficacy and application protocols. Companies’ marketing claims that are unsupported by research that are unscrupulous, misleading, deceptive, fraudulent, or just plain wrong should be little different from other consumer devices regulated by the FTC or CPSC. Additionally, we live in an Internet age where bad news travels fast, and the public will quickly vet out bad actors – unlike ever before.
Consumers should be allowed to benefit from tDCS sooner, not later, with economical choices. The restrictions of access, restrictions of choice, time delays, and increased costs that come with over-regulation are unnecessary and not in the public’s interest.
Gary
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