FTC Settles “Deceptive” life’sDHA Memory-Health Claims-but Is the Substantiation Bar Too High?

June 9, 2014

One Commissioner calls FTC’s requirements “unduly high."

As the FTC moves forward to settle its deceptive-advertising case over memory-health claims made for a dietary supplement containing omega-3 ingredient life’sDHA, one FTC Commissioner has dissented against the agency’s vote, claiming that the FTC’s consent order “imposes an unduly high standard of substantiation on a safe product.”

According to BrainStrong Adult’s advertising and labeling claims, the supplement is “clinically shown to improve memory,” “boost short-term memory, naturally,” and “helps protect against normal cognitive decline as we age.” BrainStrong Adult’s manufacturer is i-Health Inc., a subsidiary of Parsippany, NJ–based ingredients firm DSM Nutritional Products. It features algal DHA omega-3 ingredient life’sDHA, manufactured by Martek Biosciences Corp. DSM acquired Martek Biosciences in 2011.

To support its claims, BrainStrong’s marketing cites the Martek Biosciences–funded Memory Improvement with Docosahexaenoic Acid Study (MIDAS), a six-month randomized, double-blind, placebo-controlled multicenter trial published in The Alzheimer’s Association journal Alzheimer’s & Dementia in 2010. The study examined the effects of 900 mg/day of life’sDHA on 485 healthy patients aged 55 and older with mild memory complaints and considered to have age-related cognitive decline. Evaluation was done via the CANTAB Paired Associates Learning (PAL) test, which is designed to assess episodic memory and learning in those “with questionable dementia, mild cognitive impairment, Alzheimer's disease, and age-related memory loss.” According to the MIDAS researchers, life’sDHA subjects displayed improved episodic memory performance. They had significantly fewer PAL test errors and exhibited improved immediate and delayed Verbal Recognition Memory scores. (The study also included one working-memory test, which did not result in significant improvements.)

In the FTC's complaint, the argues argues that the MIDAS study does not support BrainStrong’s general claim of improving memory; moreover, the agency questions the appropriateness of an even narrower cognitive claim for episodic memory specifically, stating that the study’s evidence for episodic memory is not consistently strong.

The agency argued against a broad cognitive claim because it says MIDAS only tested two types of memory-episodic memory (remembering past events “linked to a time and place”) and working memory (the ability to remember “transitory” information that a person uses later); it did not address other types of memory, including sensory memory (remembering visual stimuli or sounds), semantic memory (“general knowledge about the world,” including facts, concepts, and vocabulary), and procedural memory (needed to learn new skills).

In his written statement, FTC Commissioner Joshua D. Wrightacknowledged that the MIDAS study “was a well-designed attempt to evaluate the improvement in episodic memory.” However, he wrote, “The shortcoming of the MIDAS study as it relates to substantiation is not study design or methodology but rather that, put simply, its results were inconsistent and insufficiently robust to support claims about noticeable improvements in everyday memory...”

FTC further stated that the MIDAS results were not strong enough to support an episodic memory claim. Commissioners Edith Ramirez and Julie Brill, who also assented with the FTC’s verdict, wrote that MIDAS “reports only a very small improvement from BrainStrong in relation to episodic memory-the positive result was essentially limited to performance on a single test of one of three types of episodic memory that were measured” (namely, the visuospatial test). (The MIDAS test employed three episodic-memory tests: visuospatial memory, visual pattern recognition memory, and visual-verbal memory.)

Not all of the FTC Commissioners disagree with BrainStrong’s claims. While Commissioners Ramirez, Brill, and Wright assented, Commissioner Maureen K. Ohlhausen dissented, stating that the FTC’s complaint against BrainStrong “imposes an unduly high standard of substantiation on a safe product.” In Ohlhausen’s opinion, the conclusions from the MIDAS study align with the product’s claims-namely, to “improve memory.”

“An improvement in episodic memory is indeed an improvement in memory, and the claim accurately conveys the study’s findings in consumer vernacular,” Ohlhausen wrote. She further stated, “The fact that some experts may disagree with the conclusions of a well-conducted study does not render that study unreliable or incompetent, nor make claims based on the study unsubstantiated.”

It’s also important to consider the larger body of research on an ingredient. DHA has shown positive results in a number of cognitive studies, Ohlhausen points out. She specifically referenced the larger body of research in her statement on MIDAS and BrainStrong: “Thus, I believe this study, in the context of other supporting studies involving DHA and memory, provides a reasonable basis for the ‘improves memory’ claims.”

Nevertheless, the FTC will move forward in its settlement against BrainStrong and is seeking public comment on the consent agreement, now published in the Federal Register.

If the MIDAS results are limited to episodic memory, it may be a good idea for BrainStrong to specify that the benefits are geared to just one aspect of memory at this time, until more research supports a broader claim. Companies must be sure not to overpromise the effect of their products and must be sure that claims accurately reflect study findings.

While the FTC should enforce against unsubstantiated claims, in the case of BrainStrong, the study in question is relatively robust-485 patients, as opposed to the small-subject studies more common in the dietary supplements industry. Simply put, the companies did invest in what even the FTC describes as a well-designed study.

Superficially, the BrainStrong case may be a case of responsible versus deceptive-advertising claims, but beyond the issue of claims, does it merit a broader conversation? One wonders how high the bar is set when it comes to supplement studies and whether a decision like the FTC’s case against BrainStrong will be a disincentive to other companies to invest in larger studies. As Commissioner Ohlhausen wrote:

This unduly high standard not only risks denying consumers useful information in the present but may also, in the long term, diminish incentives to conduct research on the health effects of foods and supplements and reduce the incentives of manufacturers to introduce such products. The majority’s approach may ultimately undermine an efficient and reliable competitive market process and make consumers worse off.

In a public position statement, DSM says, "i-Health believes that MIDAS provided statistically significant results demonstrating the benefits of DHA in maintaining and improving brain health in older adults and was not deceptive in its advertising of the BrainStrong Adult product." Still, the company says that "in lieu of litigating this disagreement in a formal proceeding, and without admitting any wrongdoing," it will enter into consent agreement with the FTC.

Wes Parris, president and CEO of i-Health, stated that, "Due to the FTC Consent Agreement not imposing any monetary penalties, nor requiring i-Health to significantly modify their recordkeeping and preservation requirements, as well as requiring a substantiation threshold that i-Health is comfortable with, we saw no need to further pursue this matter and are pleased that the Consent Agreement resolves the FTC's investigation. We commend the FTC for their diligence throughout this matter and thank them for their cooperation in facilitating our response to the investigation in a professional and practical manner."

* Updated 6/11/14 5:15 PM PST

 

Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine jennifer.grebow@ubm.com