Will we let FTC bureaucrats decide what “science” is, and how it can be interpreted? Action Alert!
The legal claims that supplements can make are repeatedly attacked and restricted by federal regulators. This is a great situation if you’re a drug company selling expensive, dangerous drugs, but if you’re an individual trying to manage your health with cheap, safe, and effective natural medicines, you are being denied truthful information about the products you buy. This time, the FTC is banning truthful information about a supplement that can help with memory—even though the company, Quincy Bioscience, had a randomized controlled trial (RCT) to back up their claim.
The product in question is Prevagen, a supplement that is marketed for its ability to prevent memory problems associated with aging. The FTC and the New York Attorney General’s (NYAG) office alleged that Quincy, in making a structure/function claim related to Prevagen’s ability to help with memory problems, violated state and federal deceptive advertising laws. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans; they are not pre-approved by the FDA, but must be backed up by “competent and reliable scientific evidence.”
Notably, the FTC was claiming not that the RCT was inadequate to substantiate marketing claims, but rather the company’s analysis of the study’s findings was at fault. The RCT did not find benefits for the population as a whole, but did find statistically significant benefits for certain subgroups. The FTC claimed that such an analysis introduced an unacceptable risk of error, arguing that the subgroups might have experienced benefits by pure chance. A US District judge rejected this argument and dismissed the FTC’s case. The case is now being appealed by the FTC and the NYAG to the Second Circuit.
Note that requiring RCTs for structure/function claims is itself an overreach by the FTC, as we’ve argued before. By the FTC’s own admission, “there is no fixed formula for the number or type of studies required or for more specific parameters like sample size and study duration”—yet for supplement claims, the agency wants RCTs, and even then, the agency may find issue with the conclusions drawn from an RCT. Put simply, the FTC is trying to define what “science” is and how it should be interpreted. As we’ve noted before, we suspect the FTC is doing the FDA’s dirty work here, since food and supplement claims are under the authority of the FDA, and the FDA knows it couldn’t get away with requiring RCTs—a drug standard—for food and supplements.
This case sends a message to supplement companies: even if they do invest in expensive RCTs to validate claims relating to supplements, it still may not be enough to meet the FTC’s ridiculous standard. What company would spend millions on an RCT to make a claim, with the knowledge that if the FTC doesn’t like the conclusions of the study, the agency will still reject the claim?
Of course, this all takes place in the context of an unleveled playing field for dietary supplements. Only FDA-approved drugs can claim to treat or prevent disease. Supplements cannot afford to go through the FDA approval process, which costs billions of dollars, since they are not patentable—no one would pay to take vitamin D through the FDA approval process, because they couldn’t patent it and recoup those costs the way they could with a man-made synthetic drug.
ANH-USA submitted an amicus curiae (friend of the court) brief in support of the lower court decision that threw out the FTC’s case. Concerned consumers should also contact the agency, and tell them to stop gagging free speech about supplements and denying consumers important health information.