The promise of improved cognitive capability or memory appeals to almost everyone. So it’s no surprise that the market for such enhancements is broad, ranging from “brain training” apps for your phone to dietary supplements promising memory boosts.
Manufacturers of these products should be aware, however, that “cognitive performance” claims of this sort have attracted the attention of the Federal Trade Commission (“FTC”) and various state Attorneys General in recent years. For example, in 2016, the FTC filed a complaint in the Northern District of California against Lumos Labs, makers of the popular personalized “brain-training-program” Luminosity – a series of games and puzzles played online or through a phone app. See FTC v. Lumos Labs, Inc., No. 16-cv-00001 (Dkt. 1) (N.D. Cal. Jan. 4, 2016). The FTC alleged that the company (and its co-founders) had violated the FTC Act by making unfounded claims that the program could help its users improve performance on everyday tasks; delay age-related mental decline; and reduce cognitive impairment associated with certain health conditions, such as stroke and PTSD.
The case settled quickly. The stipulated court order, inter alia, required the company to possess competent and reliable scientific evidence to substantiate its cognitive-related claims, consisting of “human clinical testing” of the product “that is sufficient in quality and quantity, based on standards generally accepted by experts in the relevant field, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true.” Order at 6. Under the settlement, Lumos Labs also had to pay $2 million in redress and notify certain subscribers of the action, providing them with a way to cancel their Luminosity subscriptions. Id. at 9-12.
On the supplements side, the FTC has sought relief against a number of companies making promises of increased cognitive capabilities by way of pills.[1] One case that reemerged recently: FTC v. Quincy Bioscience Holding Co., 272 F. Supp. 3d 547 (S.D.N.Y. 2017). Back in 2017, the FTC and the New York Attorney General sought relief against the developers of a dietary supplement known as Prevagen. The makers of Prevagen make advertising claims (1) that Prevagen improves memory and provides other cognitive benefits; (2) that the effects are clinically proven; and (3) that Prevagen’s active ingredient “supplements” brain proteins that are otherwise lost with age. Though the complaint was originally dismissed by the trial court, in a summary order, the Second Circuit Court of Appeals recently vacated that judgment and remanded the case to the district court. See FTC v. Quincy Bioscience Holding Co., 753 F. App’x 87, 87 (2d Cir. 2019). The Appeals Court found that the FTC plausibly claimed that defendants’ representations about Prevagen were contradicted by the results of its clinical trial and, moreover, that claims about Prevagen’s active ingredient (apoaequorin) “enter[ing] the human brain” to supplement proteins lost with age were false. Id. at 89-90. What will happen at the trial court level remains to be seen.[2]
A few lessons that manufacturers should themselves not forget about advertising the memory- and cognitive-benefits of products:
Reliable Scientific Evidence, On-Hand
Many of the FTC’s complaints center upon whether companies developing and advertising these products—phone apps, supplements, or otherwise—possess the clinical data to back up the cognitive claims they promote. This dovetails with an earlier post on the Misbranded blog, discussing the distinction between, on the one hand, regulators “who have the power to demand affirmative substantiation from advertisers when consistent with the public interest,” and, on the other, private parties who have to plead and prove the falsity of the defendant’s statements.
Given the FTC’s authority and recent interest in claims about memory aids, companies are wise to have clinical data in place, and readily accessible, to support all advertising claims that a given product “is proven” to result in certain outcomes. See FTC v. Global Comm. Innovations LLC, 19-cv-0078 (Dkt. 1) (N.D. Oh. April 10, 2019) (recent FTC Complaint: “[C]linical tests do not prove that the Geniux Products: increase concentration, including by 32% or 312%; boost brain power, including by up to 89.2%; or enhance memory recall.”).[3]
Ingredients Matter
In both the memory-based products world and beyond, courts have suggested that merely highlighting the presence of an ingredient—when such ingredients are “perceived” to have particular health benefits—can sometimes be seen as advertising those associated benefits. Setting aside the soundness of this legal theory, in addition to assuring the underlying data substantiates the proffered cognitive performance claims, companies should be mindful of/aware about the potential pitfalls of highlighting the presence of ingredients that they know to be associated in consumers’ minds with cognitive and health benefits.
[1] Dietary supplements are regulated by the FDA under a different set of regulations than those covering most food and drug products. See FDA, Dietary Supplements, https://www.fda.gov/food/dietary-supplements (last visited June 25, 2019).
[2] The appellate court noted that the defendant-appellees had “raised several grounds for affirmance that the district court did not consider,” with the appellate court expressing “no opinion on [those] arguments.” Id. at 89.
