FTC seeking to extend 2 RCT standard to structure/function claims, CRN asserts in brief

By Hank Schultz

- Last updated on GMT

FTC seeking to extend 2 RCT standard to structure/function claims, CRN asserts in brief

Related tags Crn Dietary supplement

The Federal Trade Commission’s position on the requirement for 2 RCTs in its contempt case against Bayer's Philips Colon Health brand steps far beyond what Congress intended when it passed DSHEA and even contravenes earlier long standing FTC and FDA policy. That’s the position that the Council for Responsible Nutrition in the second amicus brief it has filed in the case.

“We are concerned that on the one hand that FTC is trying to depict this as a very narrow contempt action against one company operating under a consent order.  But the evidence indicates this is where they want to go with health claims generally,”​  Steve Mister, president and CEO of CRN told NutraIngredients-USA.

Applying 2-RCT standard to all claims

In CRN’s view, FTC has argued in the case that all health claims, not just those that pertain more obviously to disease states, should be supported by as least two randomized, controlled trials (RCTs).  CRN strongly objects to FTC’s proffered standard. In the brief CRN says that it contravenes Congress’s intention when the dietary supplement category was set up via DSHEA. CRN said it also flies in the face of the consensus in the sphere of nutrition research, where numerous experts have said that RCTs are not the best way to the discover the effects that nutrients have and certainly should not be the only approach taken.

The evidence of FTC’s intent Mister speaks of came to light since the first amicus brief CRN flied in the case which is being heard in the US District Court of New Jersey.  FTC engaged an expert witness in the case, Dr Loren Laine, a gastroenterologist. In testimony taken during a deposition that was filed after CRN submitted its first amicus brief, Laine articulated FTC’s philosophy on how health claims should be supported, calling for a blanket two RCT standard for any health claim.  Laine didn’t confine himself to referring to the Philips product alone.  According to CRN, Laine “testified that his evidentiary standard would apply equally to dietary supplements and drugs, as well as to physical therapy, dietary modifications, or anything else that may be the subject of clinical research.”


“I think this may be an example of overreach by the agency,” ​Mister said. “If you start down this road pretty soon a lot of structure/function claims are going to be held to a two RCT standard.”

Mister said adhering to this standard would be inordinately expensive for dietary supplement products.  It would have the effect of denying consumers access to health information, which raises a First Amendment issue, he said.  In addition, it could be viewed as a step down the road of rewriting the fundamental regulatory structure of the dietary supplements business.

“Such a drug-like evidentiary standard would wholly undermine the regulatory scheme established by Congress through the enactment of DSHEA, which created a new regime for the regulation of dietary supplements that is distinct from the regulation of drug products,” C​RN wrote.

Contradiction with earlier policy

The brief also lays out how this growing tide of requiring two RCTs to support health claims contradicts longstanding FDA and FTC policy on evidentiary standards.

The government’s rigid substantiation standard asserted in this case is novel and a grave departure from the longstanding ‘competent and reliable scientific evidence’ standard upon which the dietary supplement industry has relied for decades. As discussed in detail in CRN’s October Amicus brief, both the FTC and FDA have long insisted that the ‘competent and reliable scientific evidence’ standard is flexible and that there is no fixed formula as to the number or type of studies needed to support health benefit claims (unless the claim states that it is supported by a specific amount or type of evidence). Yet here, the government would insist on a highly-specific, multi-part test for substantiation that would apply equally to all dietary supplements, drugs, and other interventions that are the subject of clinical research,”​ CRN wrote.

Keep the fence short

Mister said this case differs for the FTC v. POM case, in which a district court was recently rendered.  That case hinges on what the court judged in its recent ruling were outright disease claims.  And it did not involve a contempt action;  POM was not operating under a consent decree with FTC.  Still, even though FTC appears to have gotten most of what it wanted in the recent ruling (which could still be appealed), the court did rein in FTC on its call for two RCTs, saying one ought to be enough to substantiate disease claims of the sort that POM was making on its pomegranate juice and supplement products. The Philips Colon Health case, on the other hand, is a contempt action, and revolves around claims of general digestive health and the relief of occasional diarrhea, gas and bloating.

In it’s summation, CRN asks the court to reject what it calls a novel standard that would require two RCTs for any health claim. Instead, the court should used “the longstanding, flexible substantiation standard upon which the entire dietary supplement industry relies.” ​But if the court decides to side with FTC, CRN asks the ruling be worded in such a way that it restricts the application of this standard to what FTC claims it is looking for, that is a fencing in position on one company.

“The FTC is saying that this is very narrow because we are just trying to fence this one in.  We ask that the court be very clear and specific about what it is going to allow the FTC to do or not to do.  Otherwise the FTC might see this as a clear light to apply this in other cases,”​ Mister said.

How hopeful is CRN that what it considers to be the voice of reason will be heard in this case?

“I think it’s dangerous to try to read the tea leaves this early in the process, but I was encouraged that the court allowed us to file these briefs. I think the court is very aware that this decision could have wider implications,” ​Mister said.

Related topics Research Regulation Product claims

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