In the Matter of i-Health, Inc. and Martek Biosciences Corporation #00003

Submission Number:
Caleb Laieski
Initiative Name:
In the Matter of i-Health, Inc. and Martek Biosciences Corporation
Matter Number:

122 3067

Chairman Leibowitz, Your agency has charged a supplement company with false advertising for their Omega-3 product BrainStrong Adult, even though they had a double-blind random-controlled trial to substantiate their statements. According to your consent decree, the single RCT was insufficient and now a second RCT is required.

The double RCT standard is used under the Food Drug and Cosmetic Act (FD&C) to establish disease claims for drugs. This process is overseen not by the FTC, but by the FDA. And, importantly, there is no such requirement for health claims for supplements. For the FTC to insist that RCTs are now the standard for health claims, by law your agency would at the very least have to undergo a formal, rulemaking procedure.

Your consent decree, if accepted, broadens the scope of when RCTs are required. This will deter other supplement companies from investing in RCTs, which will limit the number and kind of claims that supplement companies will be able to safely make.

It is also worth noting that your commissioners were not unanimous in their ruling. FTC Commissioner Maureen Olhaussen found that the FTC's evidentiary bar is being set "unduly high on a safe product" which "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 found that the study's conclusions matched up well with the "improves memory" efficacy claim and so should have been allowed.

Please revise your proposed consent decree or withdraw it altogether until such time that your agency takes this new RCT standard through the formal rulemaking process, as required by law.