Regulators are increasingly scrutinizing product claims in the booming brain-health market.
Been forgetting things lately? Maybe your keys? Your sunglasses? Where you parked at the supermarket? Never fear. Brain-health and cognitive-function products have flooded the market in recent years. These products come in all forms, from beverages and dietary supplements to app-based games, and often promote claims of better brain development, function, and even disease protection and recovery. And while many of the products are directed toward the aging baby boomer set, there are products out there for all age groups. As consumer interest in brain-health products grows, regulators are taking a closer look at the products and the claims manufacturers make about them.
Beverages and dietary supplements making brain-health claims fall within the joint jurisdictions of the FDA and the FTC. Games and learning programs that feature similar claims typically would be solely within the FTC’s jurisdiction, unless their claims would cause them to be considered FDA-regulated medical devices. Ahead, we look at examples of how regulators scrutinize these products.
Case Study: How FDA Analyzes Brain-Health Beverages
The March 2015 warning letter FDA sent to the Bebida Beverage Company regarding its product Koma Unwind Liquid Relaxation is a good example outlining FDA’s concerns over brain-health products, particularly those sold as beverages.1
In the warning letter, FDA discussed Koma’s labeling and ingredients. FDA pointed out that the product’s website used language consistent with food products by referencing the terms relaxation drink and lightly carbonated beverage. The product also had a Nutrition Facts panel and was created from ingredients commonly found in soft drinks.
One ingredient in particular, melatonin, was particularly concerning to the agency. FDA pointed out that, as a food product, Koma Unwind Liquid Relaxation was subject to FDA’s food additive regulations. But melatonin, while commonly used in pill-form dietary supplements, is not an authorized food additive and is not considered generally recognized as safe (GRAS) for food use. Thus, when included in a beverage sold as a conventional food, the melatonin, FDA said, rendered the product both misbranded and adulterated.
Companies marketing food or dietary supplement products making brain-health claims can use the Bebida Beverage Company warning letter as a helpful guide. Identifying any ingredient-specific limitations that could impact a product’s classification-e.g., whether it is a food additive or whether it would actually be considered a new dietary ingredient-is key. In addition, ensuring that claims on websites are consistent with how the product is labeled can help avoid unwanted agency attention. Companies should also refer to FDA’s guidance for distinguishing liquid dietary supplements from beverages, including labeling and verbiage considerations.2
FTC Focuses on Substantiation: Looking for Gaps between Evidence and Advertising Claims
FTC’s analysis of brain-health claims focuses solely on product claims, without regard to product classification. The FTC looks at both express claims (the claims a company makes) and implied claims (what a consumer may infer about a product from a claim, even if not expressly stated), and determines whether those claims are supported by “competent and reliable scientific evidence.”
“Competent and reliable scientific evidence” is a flexible standard, but those who have paid attention to FTC’s enforcement actions in recent years know that the agency’s expectations for substantiation are high. In 2014, for instance, the agency found that claims that i-Health’s Brainstrong supplement was “clinically shown to give your memory a boost” were not substantiated3-even though the product was supported by a 485-person finished-product clinical study showing certain types of memory improvement. The agency said its concern was that the study did not show improvement in all types of memory and, thus, could not substantiate a broad, “clinically shown to give your memory a boost” claim.
More recently, the FTC has taken enforcement action against makers of certain “brain building” programs, such as Learning Rx.4 According to the FTC’s complaint to LearningRx Franchise Corp. and its CEO, Dr. Ken Gibson, the company’s claims were deceptive. The claims stated that the brain-training programs were clinically proven to permanently improve serious health conditions like ADHD, autism, dementia, Alzheimer’s disease, stroke, and concussions, and, additionally, that the training substantially improved school grades and college admission test scores, career earnings, and job and athletic performance.
Learning Rx defended its product claims, posting a detailed statement about the FTC settlement and the company’s claims substantiation and explaining that the firm’s ultimate decision to settle was pragmatic.5 The company discussed how it had “completed randomized, controlled trials on cognitive skills and IQ as well as several quasi-experimental controlled studies and numerous observational studies using pre- and post-standardized assessments from thousands of clients.”
“This large body of clinical data demonstrates that LearningRx brain-training programs increase cognitive skills (including clients with diagnoses), IQ scores, reading skills, and standardized reading and math test scores for their clients regardless of previous diagnosis,” the company said.
In addition, Learning Rx’s expert, Dr. Howard Wainer, examined the firm’s research and data. According to the company, Wainer concluded that LearningRx had competent and scientifically reliable evidence to back claims made for cognitive skills, IQ, reading, and training in different populations, including seniors and people with autism, ADHD, traumatic brain injury, and dyslexia.
Although the FTC’s most recent brain-health enforcement has involved non-nutritional products, the lessons from these cases still apply to foods and dietary supplements. Specifically, they signal that brain-health claims remain an enforcement priority for the FTC. In addition, they demonstrate how carefully the FTC is examining the evidence put before them and how closely it matches advertising claims.
Practical Tips to Help Avoid Agency Enforcement
Here are a few takeaways to help firms operate within the heavily scrutinized brain-health market.
First, a company should make sure that it does its research well before a product launches, not at the end of production. This includes ingredients, label considerations, and advertising claims.
In addition, companies should evaluate all of the relevant research related to a topic, not just the studies that support its claims, and consider whether the study subjects and doses used are consistent with their specific product and any directions for use. This means also keeping up to date on research related to claims after a product has launched.
Third, and perhaps most importantly, companies should always be on the lookout for any gaps between the science supporting their claims and the claims they make. Keep these goals in mind, and smart companies can help keep regulatory heat off of their products.
Kristi Wolff is a partner in the Advertising and Food and Drug Law practice of Kelley Drye & Warren LLP.