The Natural Products Association (NPA) last week filed another “friend of the court” or amicus brief with the U.S. District Court of New Jersey that challenges legal action by the Federal Trade Commission (FTC) and Department of Justice (DOJ) against Bayer for its marketing of its Phillips’ Colon Health product.
In October, the court accepted an amicus brief from NPA in the FTC/DOJ case against Bayer. The association argued 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 its second amicus brief, NPA listed its new concerns regarding the government’s actions against Bayer. Those concerns pertain to the fact that the current 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.
The government is holding Bayer in contempt over the opinion of one doctor, Loren Laine, who suggests the only way for Bayer to substantiate the aforementioned structure/function claims is to conduct one or more drug-level randomized, placebo-controlled, double-blind clinical trial (RCT). NPA continues to summarily reject any broad requirement from the FTC that structure/function claims for human dietary supplements may only be substantiated using expensive and burdensome RCTs, as directed by the sole opinion of the government’s expert.
While the FTC’s expert admittedly did not consider a cost analysis for why Bayer and all dietary supplement firms should conduct RCTs for their structure/function claims, the FTC guidance has always suggested that evidence to support a supplement claim should include a cost/feasibility analysis of developing substantiation. It was not surprising that Dr. Laine was not familiar with DSHEA, relevant guidelines issued by the FDA and FTC for substantiating structure/function claims, or the structure/function final rule. The government’s witness believed that the delicate balance struck by Congress in enacting DSHEA was irrelevant, and should be ignored when developing such substantiation. His only solution to the industry regarding substantiation was conducting drug-level RCTs, using the specific formulation of the product being sold.
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.
“As we have said before, NPA feels the FTC would be setting a dangerous precedent if the overbearing standard of requiring two RCTs is upheld,” said Daniel Fabricant, Ph.D., NPA executive director and CEO. “NPA outlined our concerns in our initial amicus brief that was accepted in this case, and we are continuing to expand the dialogue on those concerns here. It is imperative that these points be made and addressed on behalf of the entire dietary supplement industry, before the FTC’s overreach snowballs into an even bigger issue deeply affecting industry innovation and consumer choice.”