False and misleading educational products incur FTC wrath, particularly when it comes to claims about training pr protecting or improving the brain, treating ADD and ADHD, and marketing to children.
Although both FDA and FTC require that efficacy claims for a healthcare product be substantiated (or proven), FTC is typically the heavy when it comes to substantiation violations. (See our post, Dietary Supplements, Cosmetics, Medical Devices–Why Substantiating Claims Matters).
Penalties can be in the millions of dollars, as shown by some of the FTC enforcement actions below.
Misrepresenting the benefits of educational goods or services–children’s learning performance
FTC focused its attention on misrepresenting the benefits of educational goods or services in its charges against WordSmart Corporation.
The FTC complaint alleged that the company targeted parents who wanted to improve their children’s performance in school or help them prepare for standardized tests, such as the SAT or ACT. The main claim was that by using the company’s product a designated period of time, students would improve letter grades by at least one GPA point, various standardized test scores by certain amounts, and IQ scores.
There were other alleged violations, but this is the gist of deceptive claims allegation: that the company misrepresented the “benefits, performance, or efficacy of their educational goods or services,” including that the products would help students:
- learn faster,
- improve reading speed, or
- increase grades, IQ scores, or test scores.
The order imposed a $18.7 million judgment, to be be suspended when the company paid $147,400.
–“baseless ‘brain training’ claims
FTC charged Jungle Rangers with “making unsubstantiated claims that their computer game, Jungle Rangers, permanently improves children’s focus, memory, attention, behavior, and school performance, including for children with attention deficit hyperactivity disorder (ADHD).”
This enforcement showcases FTC’s targeting of “cognitive products.”
The company’s ads claimed that the product had “scientifically proven memory and attention brain training exercises, designed to improve focus, concentration and memory.”
Beware of that claim, “scientifically proven.” It’s easy to say, tough to prove. As FTC reiterated, the claims must be “non-misleading” and supported by “competent, reliable evidence.”
FTC defines competent and reliable scientific evidence as ““human clinical testing of such 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.” And, the evidence bar is set high:
Such testing shall be (1) randomized, double-blind, and adequately controlled; and (2) conducted by researchers qualified by training and experience to conduct such testing.”
Again, the claims here involved:
- focus
- memory
- attention
- behavior
- school performance
It didn’t help that ADHD was also mentioned in the company’s promotional materials.
More recently, FTC slammed brain training app Luminosity for:
- claiming that its games were designed by neuroscientists to prevent Alzheimer’s and improve cognitive performance
- claiming improvement in academic or athletic performance
- claiming prevention of dementia
- claiming treatment of ADHD or PTSD
absent competent and reliable scientific evidence. The fine was $50 million (with $48 million suspended due to the company’s financial condition).
According to FTC:
“Lumosity preyed on consumers’ fears about age-related cognitive decline, suggesting their games could stave off memory loss, dementia, and even Alzheimer’s disease,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “But Lumosity simply did not have the science to back up its ads.” …
The FTC alleges that the defendants claimed training with Lumosity would 1) improve performance on everyday tasks, in school, at work, and in athletics; 2) delay age-related cognitive decline and protect against mild cognitive impairment, dementia, and Alzheimer’s disease; and 3) reduce cognitive impairment associated with health conditions, including stroke, traumatic brain injury, PTSD, ADHD, the side effects of chemotherapy, and Turner syndrome, and that scientific studies proved these benefits.
–claims about reducing risk of concussions
FTC went after Brain-Pad, Inc. for unsupported claims that its mouth guards reduce the risk of concussions.
The ads appeared:
- on product packaging
- on the Internet in online marketing
- in print advertisements
One of the ads said: “creates new brain safety space!” Sounds innocuous enough to the marketer, except that FTC cited it as unproven.
–claims about improving adult memory
FTC brought charges against i-Health,Inc. and Martek Biosciences around advertiising for their BrainStrong Adult dietary supplement.
These claims involved:
- improving memory
- preventing cognitive decline
–claims about promoting healthy brain and eye development in children
In its press release entitled, Even Heroes Need Substantiation, FTC announced a $2.1 million settlement with major dietary supplement manufacturers for “allegedly deceptive claims that their products promote healthy brain and eye development in children.”
The supplements were in a line of Disney- and Marvel Heroes- licensed children’s multivitamins and gummies in the form of superheroes.
FTC also informed consumers that if they purchased vitamins featuring Disney Princesses, Winnie the Pooh, Finding Nemo, and Spider-Man, they might be due a refund.
–more claims about preventing cognitive decline and improving memory
FTC, in its press release, creatively entitled, Where did I Put Those Keys, slamed Brain Strong Adult for false promises about:
- improving memory
- preventing cognitive decline
for its DHA dietary supplement.
FTC took occasion to critique the company’s take on a scientific study of DHA.
According to FDA, “the claim that a clinical study proved the memory benefit” was “false–and here’s why:”
- For starters, there is no single type of memory.
- The study “touted in marketing materials tested only two types of memory – episodic and working – and reported no effect of BrainStrong on working memory.”
- The study “didn’t show a pattern of statistically and clinically significant improvement on the various episodic memory tests when the group that used the product was compared to the placebo group”.
- The study “also didn’t show that taking the product would improve episodic memory outside the lab, like when trying to remember where you put your keys or sunglasses.”
- The study’s focus on episodic memory in the lab “doesn’t capture the overall state of the person’s cognitive function.”
- 24 weeks is too short a period to test the impact of DHA on cognitive decline.
Once again, FTC required “double-blind, placebo-controlled human clinical testing conducted by qualified researchers.” And no creative interpretation of the data.
–claims that a product would restore 10-15 years of memory loss
Marketers of a dietary supplement called Procera AVH were required to give up $1.4 million in settlements with FTC involving claims that a supplement was “clinically proven” to improve memory, mood, and other cognitive functions.
Marketing methods included:
- infommercials
- direct mail flyers
- newspapers
- online
FTC cited the marketers’ description of their product as a “memory pill.”
–claims against marketer of “Learning Machine”
This is an oldie but goodie, since it involves an early product that sounds something like virtual reality:
“This is a case where nationally circulated newspapers and magazines ran ads claiming that consumers could learn foreign languages, quadruple their reading speed, or quit smoking just by putting on a headset with flashing lights,” said Jodie Bernstein, Director of the FTC’s Bureau of Consumer Protection.
Claims involved such things as:
- accelerating learning
- enabling users to lose weight
- enabling quitting smoking
- increasing IQ
- allowing users to learn foreign languages overnight
- improving cognitive and other mental functions
This serves as a warning to manufacturers of virtual reality headsets to have claims for their product reviewed by legal counsel for FTC enforcement triggers.
The Bottom Line: FTC heavily enforces truth in advertising and marketing of health claims
False and misleading educational products incur FTC wrath.
FTC says it has filed over 120 cases challenging health claims for dietary supplements, and others against device manufacturers or other consumer products.
FTC concludes: ‘All too often, the health claims made for these products are false or unproven.”
Whenever you market a health and wellness product, be sure to have all you claims reviewed by legal counsel against the risk of false and deceptive advertising charges. Whether these claims are made online, in product labels and packaging, in print advertisements, radio, television, or elsewhere, they make you vulnerable to FTC enforcement. Million-dollar penalties are not to be disregarded.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
