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If it hasn’t happened yet, it’s only a matter of time.  You walk into a room – say, to get your sunglasses – and then can’t remember why you’re there.  So it’s no wonder that claims for BrainStrong Adult, a dietary supplement advertised on TV, online, and through an active social media presence, caught consumers’ eye.  Ads said that Brain Strong Adult “helps protect against normal cognitive decline as we age” and is “clinically shown to improve memory.”  But according to the FTC, the marketers didn’t have adequate science to support their claims. 

The main ingredient in BrainStrong is docosahexaenoic acid – DHA – an omega-3 fatty acid found in certain fish, organ meats, and oil derived from sea algae.  Consumers could buy a one-month supply for about $30 at national drugstore chains.

BrainStrong’s marketing campaign went out of its way to emphasize that the claims were backed by a clinical study:

Losing your memory as you age may be natural.  But improving your memory can also be natural.  New BrainStrong™ with �����ڱ�’s�ٱᴡ™, is safe, natural and clinically shown to help protect against normal, cognitive decline as we age.†

THE STUDY THAT PROVED IT.

Adults 55+:  The Memory Improvement with Docosahexaenoic Acid (DHA) Study, or MIDAS, was the first large, randomized and placebo-controlled study demonstrating the benefits of DHA in maintaining and improving brain health in older adults.  The study indicated that the use of DHA improves learning and memory recall in healthy aging adults with mild memory complaints.

IN OTHER WORDS:

MIDAS found that healthy people with memory complaints who took 900 mg/day algal DHA capsules for six months had almost double the reduction in errors on a test that measures learning and memory performance versus those who took a placebo, a benefit roughly equivalent to having the learning and memory skills of someone three years younger.

According to the complaint, the company’s promises about improving memory and preventing cognitive decline were unsubstantiated, and 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 word “memory” might mean your recollection of personal events from your life, like your wedding or the birth of a child.  This is episodic memory.  Memory also might refer to your ability to recall the meaning of words or facts about the world, like place names, historical figures or events. That’s called semantic memory.  Or it could mean your ability to follow a story or a discussion, so-called working memory.  Beyond that, there are sensory memories of sights and sounds and procedural memories of how to do things, like ride a bike. 

For BrainStrong’s memory improvement claim, the complaint alleges that the MIDAS study touted in marketing materials tested only two types of memory – episodic and working – and reported no effect of BrainStrong on working memory.  In addition, 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.

What about the promise that BrainStrong would prevent cognitive decline?  According to the complaint, a subject’s performance on lab tasks that measure only one kind of memory – for example, episodic memory – doesn’t capture the overall state of the person’s cognitive function.  For example, in the MIDAS study, people who took DHA for 24 weeks actually performed worse than the placebo group on one important cognitive task.  Furthermore, the FTC says 24 weeks just isn’t long enough to test the impact DHA might have on cognitive decline.  The MIDAS study itself says that it wasn’t designed with that purpose mind.

The proposed order against the marketers of BrainStrong – i-Health, Inc. and Martek Biosciences Corporation – bans claims that any covered product improves memory or prevents cognitive decline in adults unless the advertisers have randomized, double-blind, placebo-controlled human clinical testing conducted by qualified researchers.  For other health claims, the companies will need competent and reliable scientific evidence.  Also banned:  misrepresentations about the level of scientific proof the companies have to support what they say.

by July 9, 2014.  Looking for more about substantiating product representations?  Bookmark the Business Center’s Health Claims page.