CRN objects to 2 clinical trials standard in comments on FTC consent decree
The consent decree is between FTC and a company called GeneLink, Inc. and foruTM International Corporation. Rend Al-Mondhiry, CRN’s counsel and the author of the group’s comments, said CRN is not disputing the facts of whether the company made non-compliant claims in its advertising. In her comments, she said, “CRN supports FTC’s ongoing enforcement efforts against dietary supplement marketers that engage in false and deceptive advertising practices.”
Making policy via consent decrees
She said what CRN does take issue with, however, is FTC’s developing policy of calling for the two RCT standard in every recent consent decree. It countermands previous FTC guidance on dietary supplement advertising claims and seems to constitute a program of making new policy via a series of consecutive consent decrees.
“We are concerned about this trend of requiring two RCTs in these consent decrees,” Al-Mondhiry told NutraIngredients-USA. “It started with FTC vs Iovate a few years back. We’re concerned that this could be the de facto new standard for dietary supplements.”
The Iovate Health Sciences consent decree, in June 2010, was followed in short order with decrees with Nestle Clinical Nutrition and Dannon. These decrees formed the basis of the new de facto policy requiring two RCTs for weight loss and certain other health claims.
Besides being inflexible, this newer approach sets RCTs up on a gold-standard pedestal they should not necessarily occupy when it comes to nutrition science, Al-Mondhiry said. In the group’s comments, Al-Mondhiry cited a number of scientific papers that point out the limitations of RCTs when it comes to the complex, multifactoral world of nutrition.
“We thought it was important to highlight the peer-reviewed scientific literature out there so that FTC was aware that there are limitations with RCTs in evidence based nutrition,” she said.
For example, in her comments Al-Mondhiry wrote, “For example, researchers may be unable to contrast a nutrient intervention group with a placebo group when studying the effect of a given nutrient in the human body, because achieving a 'zero exposure' (i.e., placebo) group is extremely difficult if not [im]possible, and in many cases unethical. Further, drugs generally have a single targeted effect and work within a shorter period of time, making it easier to contrast with a true placebo group. Unlike pharmaceutical ingredients, nutrients work together in complex ways, and their effects on health develop over a longer period of time.”
Apply Pfizer rules
As an alternative, CRN recommends that FTC return to its earlier, more flexible approach laid out first in a consent decree with Pfizer corporation in 1972. This case by case basis used a variety of factors to determine of the health claims are adequately supported including the type of product, the type of claim, the benefits if the claim is true and the consequences if its not and a level of substation that is based on “competent and reliable scientific evidence.” FTC defines that as “tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
Al-Mondhiry noted that RCTs are necessary for drugs as these products pose significantly greater dangers in terms of side effects and potential toxicity. For dietary supplement products with a history of safe use they are inappropriate. In fact two commissioners, Maureen Ohlhausen and Joshua Wright, voiced these concerns with FTC’s decree, Ohlhausen via a formal dissent.
“We therefore suggest that FTC carefully consider the methodology that is “generally accepted” by experts in the field, and also the inherent limits of RCT-based evidence, when evaluating the substantiation requirements for dietary supplements and other food products,” Al-Mondhiry wrote.
