CVS Pharmacy Inc. has agreed to pay refunds to consumers who purchased a supplement promoted to improve memory, resolving a 2016 class action lawsuit in New York that alleged the national retailer lacked the scientific evidence to support its marketing claims.
Although Algal-900 DHA was promoted as “clinically shown to improve memory,” the nonprofit Center for Science in the Public Interest (CSPI) asserted clinical studies demonstrated DHA (docosahexaenoic acid)—an omega-3 fatty acid—is no more effective than a placebo at improving cognitive function.
Last week, a federal magistrate judge approved terms of the settlement, which covers consumers in the U.S. who purchased the products between Nov. 15, 2008 and Sept. 30, 2016. The settlement bars CVS from making claims for two years that Algal-900 is “clinically shown to improve memory” or the supplement provides “clinically proven memory improvement,” according to CSPI.
“This is a great result for purchasers of CVS’s Algal-900 DHA supplement, many of whom can get all their money back,” CSPI associate litigation director Matthew Simon, who worked on the lawsuit, said in a press release announcing the settlement. “And we hope the resolution of this litigation sends a clear signal to the rest of the supplement industry, where too many companies are making promises they can’t deliver.”
Michael DeAngelis, a CVS spokesman, said the company is “pleased to resolve this matter.”
“Our store brands are designed to maximize quality and ensure they are safe, work as intended, comply with regulations and satisfy customers,” he said in an email. “In 2015, we updated the label on this product from stating ‘shown to improve memory’ to “pure DHA for memory support.’”
Asked in a phone interview to comment on the case’s significance for the supplement industry, Simon said marketers likely assume—based on “a lax legal structure and lack of enforcement—that they’re not susceptible to significant liability and can make promises that they can’t deliver on.”
“And what we hope to prove in this case and similar cases that we might pursue in the future is that there is a consumer harm here, and there are avenues for holding these manufacturers accountable,” the lawyer added. “And they need to take a serious look at the science behind their claims before making them.”
Citing “weak regulations and under-enforcement of the existing regulations,” Simon described the supplement market as “awash in false and misleading dietary supplement advertising.”
“Manufacturers are preying on vulnerable individuals who are really in no position to assess these advertising claims,” he said.
The 2016 class action lawsuit, filed against CVS in the U.S. District Court for the Eastern District of New York, alleged the retailer’s statements about the benefits of Algal-900 DHA were false and misleading.
The complaint cited a meta-analysis of 34 randomized, controlled trials of omega-3 fatty acids involving about 13,000 subjects. Researchers, the lawsuit said, concluded omega-3 fatty acids “do not improve cognitive performance in children, adults or the elderly.” The suit also cited a five-year National Institutes of Health (NIH) study that reached a similar conclusion as the meta-analysis concerning the effect of omega-3 fatty acid supplements on older adults.
“Comprehensive, high-quality clinical studies have shown that omega-3 fatty acids, including DHA, work no better than a placebo in tests of adults’ cognitive performance,” the lawsuit asserted.
The Global Organization for EPA and DHA Omega-3s (GOED), which represents members around the world in segments of the omega-3 supply chain, had no comment in response to an inquiry for this article about the settlement of the lawsuit.
CVS relied on a clinical study that purported to show DHA supplements improve learning and memory function in people with age-related cognitive decline, the suit said. But the plaintiffs noted the Federal Trade Commission previously concluded the “MIDAS study” failed to “reveal any improvement in working memory” and “clinical proof claims [based on the study] are false and misleading.”
The principal investigator and study author was an employee of Martek Biosciences Corp., which funded the study to promote its DHA product, "BrainStrong Adult,” the suit noted. Jennifer Himmelhoch, a marketing communications manager for DSM Nutritional Products, which owns Martek Biosciences, did not immediately respond to an emailed request for comment for this article.
Martek Biosciences and i-Health Inc. reached an agreement in 2014 with the FTC to settle charges of deceptive adverting for claiming their supplement would improve memory in adults and prevent cognitive decline.
In a joint statement at the time, two FTC commissioners said the MIDAS study only showed “a very small improvement” related to “episodic memory” and failed “to reveal any improvement in working memory.”
“In light of the narrow scope of the study and its limited results, we have reason to believe that i-Health’s marketing claims that BrainStrong improves ‘memory’ broadly speaking would likely mislead consumers, as there is no basis to conclude that it has any impact whatsoever on other important facets of memory, such as the ability to remember the meaning of words (semantic memory) or to follow an exchange of dialogue (working memory),” said then-FTC chairwoman Edith Ramirez and commissioner Julie Brill. Both women are no longer with the agency.
The study also “failed to show meaningful, statistically significant improvements on two of the three episodic memory tasks measured,” and it did not “demonstrate that the very small, statistically significant improvement on one of those tasks that it did report correlates with improvements in memory tasks outside of the laboratory,” the commissioners added.
Another commissioner at the time, Maureen Ohlhausen, partially dissented from FTC’s action, concluding “it imposes an unduly high standard of substantiation on a safe product.”
“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 dietary supplements and reduce the incentives of manufacturers to introduce such products,” she said in a statement.
About two years after FTC officials announced the settlement, CVS was hit with the lawsuit. Simon noted a copycat suit was filed in another federal district in Illinois where it was later transferred to the Eastern District of New York.
In that class action, the named plaintiff reached an agreement with CVS to settle the complaint. But the lawsuit was ultimately dismissed after a federal magistrate judge objected in 2018 to the settlement, recommending denial of the plaintiff’s motion for its preliminary approval.
In the most recent settlement approved, class members who provide full proof of purchase will receive a full refund, while others will get a credit on their loyalty card if they used one to buy the product, Simon said. Class members without proof of purchase can receive a voucher if they submit a claim and there is a record of an online purchase, while certain relief also is available for claimants without any documentation, according to the settlement agreement.
“It’s really quite robust relief for many of the consumers who purchased this product, and we’re really happy with the result,” Simon concluded.