By Kristi Wolff, Partner, Advertising and Food and Drug Law, Kelley Drye & Warren
The approach of yet another fall brings alive the hopes of high school, college, and professional football players everywhere — to say nothing of all the parents and loyal fans for whom sport becomes lifestyle for several months each year. Recent media reports and litigation have brought focus to the risk of concussion and related head injury associated with contact sports. Concurrently, the Federal Trade Commission (FTC) has made brain health and cognitive function products an enforcement priority. For companies marketing products with brain health or cognition benefits, here is what you need to know about the FTC’s enforcement in this area and the strength of evidence required to support product claims.
The FTC’s Mission and Advertising Standards
The FTC is broadly charged with preventing unfair (harmful) and deceptive (misleading) practices. In regulating advertising claims, the FTC examines both express and implied claims, regardless of whether those claims were intended. The primary inquiry typically is whether the claims are properly substantiated by “competent and reliable scientific evidence.” “Competent and reliable scientific evidence” is generally defined as tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area that has been conducted and evaluated in an objective manner, by persons qualified to do so, using procedures generally accepted in the field to yield reliable and accurate results.”
Generally speaking, the gold standard for claim substantiation is the randomized, double-blinded, controlled trial. This standard can present particular challenges when testing sports equipment, e.g., the difficulty in sufficiently blinding sports equipment. However, when recently presented with those concerns, the agency stated that companies should try to follow those standards to the greatest extent possible.[1] Peer-review, a step previously thought by many to ensure that a study would be considered competent and reliable, is also not a guarantor of quality according to the FTC.[2] As of mid-2014, a data retention requirement for clinical study evidence has become standard language in consent orders, which serves as a mechanism to both require a company to obtain and preserve the data in certain instances and to allow the FTC to review it in the event of an enforcement investigation. In short, whether evidence is “competent and reliable” will vary depending on the claim at issue but, particularly in recent years, the bar is set particularly high.
FTC Scrutiny of Brain Injury Prevention Products and Claims
The FTC has taken action against a number of athletic product manufacturers for claims made about concussion risk reduction. In 2012, the Commission settled an enforcement action against mouthguard manufacturer, Brain-Pad, relating to claims that Brain-Pad’s products reduced the risk of concussions from lower-jaw impacts, reduced the risk of concussions generally, and were clinically proven to work. On packaging for the Brain-Pad Pro-Plus Junior mouthguard, the defendants claimed the device “creates new brain safety space!” and “Reduces Risk of Concussions! From Lower Jaw Impacts.” Similarly, packaging for the adult-size Brain-Pad Double Mouth Guard proclaims that the device, “Reduces risk of CONCUSSIONS! Protects Upper AND Lower Teeth!” However, the FTC said there was not sufficient evidence to substantiate these claims.
In 2013, the FTC conducted investigations into three companies that manufacture and sell football helmets: Riddell Sports Group, Inc., Schutt Sports Inc., and Xenith, LLC. The FTC staff closed the investigations without taking formal action. However, all three companies discontinued or modified potentially deceptive advertising claims. In addition to these enforcement actions, the FTC has issued numerous warning letters to manufacturers and retailers of concussion risk reduction products relative to performance claims and substantiation.
FTC’s Brain Health Enforcement More Recently Focuses on “Brain Building” Products
The FTC has demonstrated that its interest in brain health products extends beyond athletic equipment. The FTC has also taken actions against software companies whose products have been purported to help users build brain strength by playing games. Lumosity, for example, claimed that its online game would help to improve school performance, delay memory issues associated with aging, and even reduce the cognitive side effects of chemotherapy.[3] Although Lumosity could cite to studies showing improvement in game performance over time, those improvements were not directly tied to the real-world benefits Lumosity marketed. Additionally, FTC stated that there were competing studies that indicated that such games were not effective for real-world tasks.
In May 2016, the FTC announced a settlement with Learning Rx and its CEO relative to claims that its brain training exercises could help treat ADHD, improve academic skills, and increase IQ by an average of 15 points or more. The company argued that it relied on randomized controlled trials, quasi-experimental controlled studies, and an expert report from statistician, Howard Wainer to support its claims.[4] Still, the FTC alleged that the evidence was insufficient to support the claims and, while the company disputed this allegation, it opted to settle the case as a matter of practicality.
Practical Guidance for Manufacturers and Marketers
For companies seeking to determine what claims they can make in this regulatory environment, here are a few practical tips:
Start early. Evaluate the evidence intended to be used as claims support well before launch so that new evidence can be developed or claims can be modified as needed prior to a product entering the market.
Think broadly. Look not just at the evidence that supports your company’s product, but at all relevant evidence, including unfavorable results. The FTC recognizes that there is rarely complete scientific agreement but tends to frown upon reliance on outlier studies when used as claim substantiation. In addition, it is important to ensure that the claim ultimately bears a close nexus with the supporting evidence.
Consider the data. Given the data retention requirements in recent consent orders, consider whether your company would be able to obtain the data supporting a particular study if needed.
As is the case on the playing field, diligent preparation relative to advertising substantiation can reduce the risk of the FTC crying foul once your company’s product hits the market.
[1] See e.g., In the Matter of Carrot Neurotechnology, Inc. FTC Case No. C-4567 (Feb. 23, 2016).
[2] See id.
[3] See FTC v. Lumos Labs, Inc., et al., 3:16-cv-00001 (Jan. 5, 2016).
[4] See FTC v. Learning Rx Franchise Corp., et al., 1:16-cv-01159-RM (May 24, 2016).
