CRN petition to FTC: RCTs aren’t required to substantiate ‘health-benefit’ claims

The Council for Responsible Nutrition on Thursday filed a petition with the Federal Trade Commission (FTC), requesting the agency clarify certain aspects of a guidance regarding advertising claims of health products, including dietary supplements.

In a 17-page petition, CRN expressed concerns that FTC’s Health Products Compliance Guidance is attempting to remove the flexibility in the types of evidence needed to substantiate various health claims, including those related to general well-being and an ingredient’s role in affecting the structure or function of the human body.

CRN requested FTC clarify:

FTC does not comment on petitions received from outside the agency, according to an FTC spokesman.

FTC in December published the Health Products Compliance Guidance, which supplanted an advertising dietary supplement guidance issued in 1998.

RCTs

Among the concerns expressed in the petition, CRN argued a requirement for randomized, controlled clinical studies—before making so-called “health benefit” claims—has no basis in the law and “conflicts with the existing intricate statutory framework Congress has created for dietary supplements and food, versus drug products.”

“Any such bright-line clinical trial requirement, in fact, would even exceed the current standard for drug approval, which while purposefully more rigid than the substantiation standard Congress created for dietary supplement and food claims, still allows for flexibility,” the petition asserted.

CRN pointed to other forms of evidence to substantiate claims that establish a connection between a nutrient and healthy function of the body, including uncontrolled clinical studies, laboratory analysis, animal testing and epidemiological evidence.

As a general matter, FTC requires “competent and reliable scientific evidence” to substantiate claims about the health benefits or safety of foods, dietary supplements, drugs and other health-related products. FTC’s guidance, however, concluded, “As a general matter, substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing to meet the competent and reliable scientific standard.”

While the guidance cites several court cases to support its position, CRN said “those cases simply show the CARSE [competent and reliable scientific evidence] factual analysis at work.”

For instance, the petition noted half of the eight cases involved claims to treat such diseases as cancer and erectile dysfunction, and one involved extreme weight loss claims. Following review of the claims, the courts considered expert testimony concerning the evidence required to support the claims and concluded the claims lacked sufficient support.

CRN suggested the “competent and reliable scientific evidence” analysis by the courts “does not support the position that RCTs [randomized controlled trials] are always required.”

“It demonstrates the opposite—that the type of claim being made dictates the level of support,” the petition added.

Testing of product vs. ingredients

CRN expressed further concerns over language in the guidance (citing two federal court decisions) that could be interpreted as suggesting testing of an entire product might be required to substantiate a health claim.

“What these case citations fail to acknowledge clearly is that the findings as to product testing were, in no uncertain terms, because the claims at issue were disease claims in the first case cited, and in the second case, because there was simply no other expert to counter the FTC’s,” the petition declared.

CRN distinguished those two cases from others in which “federal courts have repeatedly approved substantiation based on testing of individual product ingredients.”

CRN’s petition was signed by J. Kathleen (Katie) Bond, an expert on FTC requirements and partner in Washington, D.C., with the law firm Keller & Heckman LLP. Megan Olsen, SVP and general counsel of CRN, and her colleague, Andrea Wong, SVP of scientific and regulatory affairs, also signed the petition.

The document is the second petition filed in recent days with FTC by dietary supplement groups. On Sept. 15, a citizen petition filed by six industry trade groups led by the Consumer Healthcare Products Association (CHPA) urged FTC to withdraw substantiation-related “notice of penalty offenses” that it disseminated to nearly 700 marketers of dietary supplements and other products.

CHPA and the co-petitioners argued the notice attempts to require a substantiation standard that the law prohibits and that is inconsistent with long-standing regulatory guidance, as well as the Dietary Supplement Health and Education Act of 1994 (DSHEA).

“Both DSHEA and long-standing FDA guidance make clear that claims for non-drugs do not require drug-level RCTs,” the citizen petition proclaimed.