Drugstore giant CVS is being sued for marketing and advertising its algae-based Algal-900 DHA supplements as proven memory enhancers, when the science used to prop up that claim is allegedly bogus.

Dietary supplements, which generally require no FDA approval, can make all sorts of dubious claims if they are worded a certain way. They can’t claim to “treat a bladder infection” or “improve vision” without supporting scientific evidence, but they can “support urinary tract health” or “promote healthy eyes.”

On the packaging for CVS store-brand Algal-900 DHA [Docosahexaenoic acid, an omega-3 fatty acid], it repeatedly states that the product has been “clinically shown to improve memory,” in addition to the more generic claims of supporting eye and heart health.

 

On the back, CVS provides more in-depth information about the research backing these claims. It reads:
“In a clinical study of healthy subjects 55 years and older, after 6 months of rail supplementation with 900mg of algal DHA in an episodic memory test:
• Errors were reduced 50% more in the algal DHA group than in the placebo group.
• When contrasted against expected performance levels, the algal DHA group’s memory improved like it was 7 years younger versus the placebo group which improved by 3.6 years.”

But the Center for Science in the Public Interest, which sued CVS in federal court today [PDF], says that the one study used to anchor the above claims has already been shown to not support the product’s purported benefits.

Back in 2010, a study published in the journal Alzheimer’s & Dementia touted a link between DHA supplements and memory improvement. But not only was the author of the study an employee of a company making these supplements, the Federal Trade Commission also concluded [PDF] that the study’s conclusions did not match the data.

According to a statement from FTC Chair Edith Ramirez, the research “did not show a pattern of statistically and clinically significant improvements on the episodic memory tasks among subjects who took [the supplements], relative to the placebo group. Specifically, it failed to show meaningful, statistically significant improvements on two of the three episodic memory tasks measured. Further, it failed to 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 makers of the supplement tested in that study were subsequently barred from making memory-improvement claims unless they could provide “competent and reliable scientific evidence.” They were also enjoined from using terms like “clinically proven.”

And yet, notes the CSPI lawsuit, CVS is using this same questionable study to bolster their own product. CSPI also points out that subsequent studies have shown no apparent correlation between omega-3 fatty acids and memory improvement.

“CVS cites no scientific evidence that supports the outlandish memory claims used to market Algal-900 DHA supplements,” says CSPI litigation director Maia Kats in a statement. “CVS is relying on a discredited study, and one that the FTC has specifically prohibited from being used by another company in this context. And CVS is ignoring a large body of clinical testing and research on omega-3s, DHA and memory that indicates no benefit whatsoever in adults.”

You might have noticed all the little asterisks at the end of the “clinically proven” statements made on the Algal-900 packaging. Those lead to microprint on the back that clarifies that none of these statements have been evaluated by the FDA and that, “This product is not intended to diagnose, treat, cure, or prevent any disease.”

This is standard, required wording for dietary supplements. However, CSPI notes that federal law requires that this disclaimer “shall appear on each panel or page where there such is a statement.” Since the Algal-900 makes statements on both the front and the back of the packaging, the lawsuit contends that the disclaimer belongs on both front and back.

The potential class action seeks to represent anyone who purchased Algal-900 DHA at some point after Feb. 1, 2012.

UPDATE: CVS has provided the following statement to Consumerist regarding today’s lawsuit —
“Our store brands are designed to maximize quality and assure the products we offer are safe, work as intended, comply with regulations and satisfy customers. We have not been served so are unable to comment specifically on the allegations within the complaint.”

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