We have blogged quite a bit about efforts by one or both of the Federal Trade Commission’s (FTC or Commission) Democratic commissioners to push the Commission into a more enforcement-minded posture and to think creatively and expansively about the enforcement tools the Commission has at its disposal. Thus it seems appropriate to give equal time to an attempt by one of the Republican commissioners to push the Commission to narrow rather than broaden its focus.
In a recent partial concurrence and partial dissent, Commissioner Wilson laid out her views on when it is appropriate for the Commission to utilize its enforcement authority. The case involved a TENS device – a device that electrically stimulates the nerves and provides relief from pain. While the device had received Food and Drug Administration (FDA) clearance for some pain relief claims, the FTC alleged that the company’s claims deceptively exceeded the scope of its FDA clearance by, among other things, claiming that the device provided pain relief far away from the point at which the device was applied. Commissioner Wilson agreed that the company had failed to substantiate that its device could provide pain relief in all areas distant from the application site. However, she argued that the manufacturer had substantiated a claim that its device could provide some more limited, nonlocalized pain relief.
The commissioner argued that her fellow commissioners had undertaken too harsh an application of the Pfizer factors in looking at the substantiation proffered by the company, and in doing so, had, in the words of former Chairman Pitofsky, sought to achieve truth at the expense of determining whether the advertiser had supplied a reasonable basis for its claims. Citing the Commission’s decision in 1984 to permit Kellogg’s to make now well-documented claims that diets high in fiber may help prevent certain types of cancer, Commissioner Wilson argued that imposing too high a bar to substantiate claims for products that are known to be safe can deny consumers useful information, diminish incentives to conduct research and chill incentives to bring new products to market. In doing so, she echoed arguments long made by one of the most recent former Republican FTC chairmen, Tim Muris.
Finally, Commissioner Wilson noted that it was undisputed that the challenged product did provide pain relief, and the advertiser had commissioned several randomly controlled clinical trials. She argued that the Commission should focus its resources on cases where there were serious health or disease claims “with little or no scientific support,” and that the Commission should carefully consider all relevant data including emerging science and real-world consumer data. Finally, she urged the Commission to balance the potential consequences of chilling research and innovation and the dissemination of useful information against the benefits of any proposed enforcement.
Does Commissioner Wilson’s “lone voice” presage a broader turn by the FTC toward a less aggressive posture? Only time will tell.
