The second brief, filed in the US District Court of New Jersey, takes into account new information not available when the association filed its first brief, said NPA executive director and CEO Dr Daniel Fabricant. The crux of this new information is testimony from a deposition of the expert witness that FTC used in the case, a gastroenterologist named Dr Loren Laine. Laine’s opinion of what constitutes good scientific research in the field of nutrition formed the basis of FTC’s thinking in the case. Laine testified that he believes that at least one randomized, controlled trial (RCT) is needed to underpin any and all claims on dietary supplements, including structure/function-type claims that NPA and others have contended are specifically authorized by law.
“The testimony is very suppositional,” Fabricant told NutraIngredients-USA. “It is not a good way to make policy. The whole notion that there is some magic number of studies that makes this valid and that not valid—that is a huge fallacy.”
Concerns over Laine’s testimony
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 sole opinion of 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 said it 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 Laine, the government’s expert.
“What concerns NPA and its members is the opinion expressed by Laine that such RCTs would be required to substantiate structure/function claims of all human dietary supplements. The Government has not rejected that opinion; to the contrary, it is attempting to force that standard on the industry by picking off one company at a time through litigation and administrative proceedings,” NPA wrote it its brief.
NPA wrote that in his deposition testimony, Laine conceded that he was not an expert in dietary supplements or claims substantiation and that he has never conducted research on the effects of supplements and admitted that he was ignorant of how dietary supplements are regulated and even went so far as to say that the regulatory structure was irrelevant.
“The Government has not disavowed Laine’s over broad opinion in this case. While the Government's brief purports to limit Laine's opinion to the probiotic- supplement claims at issue, Laine himself disagrees. He unambiguously testified that, as a matter of science, his high-quality RCT study design would apply to probiotics and all other dietary supplements, as well as ‘foods’ and all ‘other interventions,’” NPA wrote.
Among key elements of NPA’s argument in the brief are:
• 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 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.
• 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.
“We are talking about legitimate structure/function claims here. 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,” Fabricant said.
To read the full text of NPA’s brief, click here.