By Mike Mozart [CC BY 2.0] via flickr
By Mike Mozart [CC BY 2.0] via flickr
The FTC suffered a resounding defeat late last month in the U.S. District Court in New Jersey in its effort to hold Bayer Corporation in contempt of a 2007 court order.  The 2007 order resulted from allegations that Bayer made unsubstantiated representations for its One-A-Day WeightSmart product in violation of a 1991 order.  The current litigation was based on the FTC’s allegation that Bayer made unsubstantiated representations for its Phillips’ Colon Health (“PCH”) probiotic.  Both the 1991 and 2007 orders required competent and reliable scientific evidence for any dietary supplement claims in the future.  The orders used the FTC’s standard definition of competent and reliable scientific evidence:  “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.”

Bayer made the following express claims for PCH:  “To promote Overall Digestive Health” and “Helps Defend against Occasional Constipation, Diarrhea, Gas and Bloating.”  The FTC argued that these express claims also implied a claim that PCH can help prevent, treat or cure, constipation, diarrhea, gas, and bloating. 

The court rejected the FTC’s effort to imply this claim on multiple grounds.  First, the claims made by Bayer had been categorized by the FDA as appropriate structure function claims under DSHEA.  Second, the court credited Bayer’s disclaimer that the product was not intended to diagnose, treat, cure or prevent any disease.  Third, the FTC had offered no copy tests or survey evidence to support its interpretation.  Fourth, the claims made by Bayer were ubiquitous in the industry for similar products.  Fifth, the court held that it did not need to defer to FTC counsel’s arguments that the claim should be inferred because the FTC had not made a formal adjudicative finding regarding what claims were made, as was the case in the D.C. Circuit’s ruling in POM, where the court deferred to the FTC’s ad interpretation.  Thus, absent survey evidence or a formal FTC administrative adjudication the court found it was not bound by or required to defer to the FTC’s ad interpretation.  This was especially so, the court noted in a contempt proceeding, where the FTC had to prove an order violation by clear and convincing evidence.  Whether other courts, in a non-contempt setting, limit POM’s holding that courts should defer to the FTC’s ad interpretation to situations where the FTC has made an adjudicative ruling will have to be seen.

The court also rejected the argument of the FTC and the opinion of its expert that the claims made required Random Clinical Trials of the precise blend of probiotics in PCH to be properly substantiated.  The court agreed with Bayer’s experts that the standard in the field for assessing the efficacy of probiotics was not RCTs, and that Bayer could rely on: public domain studies for each of the three ingredients; online literature even if Bayer only kept the reference and not an actual copy of the literature, and RCTs on the individual strains found in PCH.  The court also found that an RCT on PCH that resulted in neutral findings that only “trended positive” did not undercut Bayer’s substantiation because many successful products including FDA approved drugs have neutral studies.

Many of the arguments adopted by the court in Bayer are routinely dismissed by FTC staff in the course of investigations involving dietary supplements.  One can hope this opinion gives staff pause in their position that staff’s views regarding science and ad interpretation are the only permissible views.  Absent that, one has to hope a few more judges view the world in the more balanced manner that the court did in this case.