The Natural Products Association (NPA) hailed U.S. District Judge Jose Linares’ decision to not hold Bayer AG in contempt for claims made by the supplement manufacturer regarding a drug it marketed to promote digestion. NPA filed two Amicus briefs in support of Bayer during the case.

“We are happy with the decision of the court and it appears our Amici were considered heavily in the decision as only NPA’s comments were repeated verbatim in the opinion” said Dan Fabricant PhD, CEO and Executive Director of the Natural Products Association. “Still, this case is evidence that the FTC is willing to try and expand their authority through enforcement decisions, even with a bad case which they had from the start, and this remains one of the biggest, if not the biggest concern for the industry. As we said throughout the court proceedings, NPA felt the FTC would have set a dangerous precedent had the overbearing standards it was seeking become affirmed.”

NPA filed an Amicus brief to the court in October of 2014 arguing that the actions by the FTC conflicted with the Dietary Supplement Health and Education Act (DSHEA); were contrary to the Administrative Procedure Act (APA); and posed significant threat to the industry and consumers.

In a second Amicus brief filed in February of 2015 NPA established the Phillips’ Colon Health product under scrutiny makes the claim to defend against occasional constipation, diarrhea, and gas and bloating; these types of claims are sufficiently qualified and limited in scope to declaim any implied disease origins as structure/function claims permitted under the Jan. 6, 2000 Structure Function Final Rule.

Key arguments presented by NPA include:

•    Dietary supplements that are not marketed with drug claims were not intended to be subject to the same standards as drugs, which do require substantiation by full clinical trial research. Case law does not require drug-level/gold standard RCTs for all human dietary supplement claims.

•    The FTC’s position is contrary to DSHEA. The legislative history of DSHEA never discussed drug-level RCTs to substantiate the labeling of dietary supplement products, but rather created a unique category of food that was recognized as safe already in the marketplace and the regulatory framework around it.

•    FDA/FTC guidance documents for the dietary supplement industry do not equate the substantiation standard with drug-level RCTs.

•    Other expert scientists with experience developing research protocols to substantiate structure/function claims disagreed with Dr. Laine’s opinion.

•    The FTC is using consent orders and contempt proceedings to force the dietary supplement industry to substantiate with RCTs alone, rather than through public rulemaking as outlined in the APA.

The POM Wonderful decision requiring two RCTs for disease claims was contrary to the First Amendment. The FTC’s position here on Bayer similarly conflicts with the First Amendment.