The Federal Trade
Commission has charged a supplement company with false advertising
because they have been saying their Omega-3 product BrainStrong Adult was
“clinically shown to improve memory [and] help protect against normal cognitive
decline as we age.” They had a double-blind random-controlled trial (RCT) to
substantiate their statements. The FTC said the single RCT was insufficient and
now a second RCT would be 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 the
agency would at the very least have to undergo a formal, rulemaking procedure.
The 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.
On July 9, JUST ONE DAY FROM NOW, the FTC must consider
comments and decide whether to sign or withdraw the consent decree. Please contact
the agency TODAY and demand that they revise the proposed consent decree!
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Proposed Consent Orders: i-Health, Inc. and Martek Biosciences Corporation
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