I was sure it was true. My over-40 forgetfulness could be helped by the over the counter supplement Prevagen. Of course, the first time I went to purchase Prevagen proved unsuccessful – I could not remember the name.
With an active ingredient derived from jellyfish! It sounded so hopeful. And then there were the clear and unqualified advertising claims “clinically proven to improve memory.” I am an advertising lawyer and know an “establishment” claim when I hear one. This means that the advertisers were required to have competent and reliable scientific evidence “in hand” that provided a reasonable basis for its claims.
Alas, it appears that the science was bad – or that is what the Federal Trade Commission thinks as evidenced by its lawsuit filed on January 9 against the company (that has enjoyed revenues from the product of more than $160 million).
In its legal action, the FTC claims that the study the supplement company relied upon, which scored those who took Prevagen against those taking a placebo across nine distinct memory tasks, did not yield statistically significant results. In short, the investigation target “sliced and diced” the data in such a way, including by sorting subjects into various subgroups, that the results of improved performance were not sufficiently reliable to support the claims.
The FTC requires “competent and reliable scientific evidence,” to support health and safety claims. This means “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” Other types of advertising claim require only a “reasonable basis,” although the level of substantiation is driven by what a reasonable consumer would expect.
There is no fixed formula for exactly the number or method of studies required or even minimums for sample size or study duration. The claims must match what the study shows and the study must be designed and conducted in a scientifically accepted manner. I guess jellyfish everywhere are safe.