Tell the FTC to Revise Its Consent Decree for an Omega-3 Memory Supplement!

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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Dear [Decision Maker],

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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.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]

Protecting Natural Health