On April 29, the Federal Trade Commission received a petition for rulemaking from lifestyle entrepreneurs Durk Pearson and Sandy Shaw, as well as the trade organization Alliance for Natural Health USA. Pearson and Shaw, former technical and science advisors for Hollywood filmmakers, are best known in industry for their Life Extension brand of supplements and a series of books on health and longevity.
The petition, drafted by Washington DC-based law firm Emord & Associates, concerns the marketing of health claims, and speaks to the many recent consent orders FTC has reached with companies like Nestle, Iovate and Dannon, and FTC’s current litigation against POM Wonderful. The petition bemoans FTC’s requirement of said companies to provide two clinical human trials on finished products and seek FDA pre-approval if they continue marketing their health claims.
This raft of consent orders has had a chilling effect on many companies’ marketing language, an issue the petition seeks to remedy. The two clinical trial requirement violates a First Amendment standard set in the previous case of Pearson v. Shalala, the petition argues, and FTC oversteps its Constitutional authority with the impositions created in its consent orders.
Furthermore, Pearson and Shaw seek to market a prune juice product they call FLUSH, and in their marketing intend to include language like “FLUSH prune juice helps relieve chronic constipation.” They lack either FDA approval or two clinical trials to bolster the claim. The petition essentially asks FTC to approve or disapprove of the claim, and assuming disapproval, Pearson and Shaw are apt to sue FTC for some infraction of the precedent set in Pearson v. Shalala.
According to attorney Jonathan Emord, principal author of the petition and founder of Emord & Associates, one issue at stake is the “overbearing” collusion of FTC and FDA in the recent consent orders. “The FDA is circumventing the requirements set in Pearson v. Shalala by having FTC do its duty,” Emord told Nutrition Business Journal. He calls the strategy a “sophomoric approach.”
The petition is an interesting complement to the current FTC case against POM Wonderful. Where POM continues to argue (so far to little avail) that its existing scientific evidence adequately supports its product claims, Pearson and Shaw admit up front that they lack credible evidence. But through a series of legal moves, Emord may be able to build them a free speech case.
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Emord certainly carries the clout and the legal track record to build a case and garner some industry publicity. He’s argued and won numerous cases against FDA, including the landmark Pearson v. Shalala decision in 1999. And the petition helps to foster continuous discourse around certain terms like the two clinical trial requirement.
But a petition to FTC is a strange approach, especially considering that the prune juice and its marketing materials don’t yet exist. According to attorney Ivan Wasserman, of Washington DC-based Manatt, Phelps & Phillips, he’s “not aware of FTC ever having permitted or denied a citizen’s petition for a health claim in the abstract.”
The prune juice seems a bit like a straw man, set up in front of FTC to be knocked down, thus forcing litigation. From there, Emord could continue to build precedents and gradually drive a wedge between FDA and FTC. But, since the agency likely gives low priority to prosecuting non-existent claims, it could take a long time for FTC never to respond to Pearson and Shaw’s appeal.