Science and Law
29th September 2013

Who Decides Competent and Reliable Evidence in Dietary Supplement Litigation?

Your client’s dietary supplement is under fire.  The manufacturer has been hit with a class action lawsuit alleging its marketing claims are false and misleading. The issue has attracted attention from the Federal Trade Commission. Subject matter experts are lining up to present their unfavorable research results.

Who Decides Competent and Reliable Evidence in Dietary Supplement Litigation?

This blog post was co-authored by David H. Schwartz and Steven M. Weisman of Innovative Science Solutions, LLC

Your client’s dietary supplement is under fire.  The manufacturer has been hit with a class action lawsuit alleging its marketing claims are false and misleading. The issue has attracted attention from the Federal Trade Commission. Subject matter experts are lining up to present their unfavorable research results. The media has already latched onto the story. The pressure is building, and your client is facing a tough decision: retract the marketing claims or mount a strong defense.

While your client may view the situation as bleak, you know that a rigorous analysis of the available scientific evidence is the solution. Dietary supplement manufacturers or their attorneys typically call on our experts to substantiate their marketing claims based on the available science. Innovative Science Solutions has worked on product categories ranging from blood pressure lowering agents to weight loss products to joint health supplements.

 

We often find that the product was developed based on sound scientific principles, and rigorous scientific studies supporting the manufacturer’s marketing claims already exist. In the best cases, the manufacturer has performed randomized controlled studies on the product as formulated, and the studies support the advertised product benefits. More commonly, the product has been formulated based on the recognized benefits of the product’s individual ingredients. In these cases, published scientific literature will substantiate the advertised benefits of the product, although issues may arise, such as varying exposures and routes of administration.

To illustrate how an expert analysis of the available science can support a product’s marketing claims, we’ll look at one of our recent cases. In this example, the FTC challenged marketing claims made by Garden of Life (GOL), a large, nationally recognized manufacturer of dietary supplements. GOL had retained ISS to substantiate the proposed marketing claims for two Omega-3 products before they hit the market: Oceans Kids and Grow Bone System (also containing the algae-based calcium ingredient AlgeaCal). When the FTC later asserted  that GOL’s marketing claims were not adequately supported, in violation of their consent decree, GOL asked us to produce a report substantiating the claims.

The FTC based its assertion about Oceans Kids on an expert report in which Dr. David C. Bellinger concluded that GOL’s claims were not substantiated by competent and reliable scientific evidence. In ISS’s expert report, we provided an analysis that refuted Dr. Bellinger’s conclusions. In his precedent-setting opinion, U.S. District Court Judge Donald Middlebrooks agreed with ISS’s position, stating “To find that GOL violated the terms of the Order solely because another well-respected expert defines ‘brain development’ differently or disagrees with certain aspects of a study’s ‘trial design’ would require this Court to read additional requirements into the Consent Decree.” Judge Middlebrooks essentially ruled that ISS’s expert report presented competent and reliable evidence supporting the marketing claims.

Judge Middlebrooks’ ruling on Grow Bone System also supported ISS’s analysis: “Essentially, on its own initiative, GOL obtained competent and reliable evidence supporting its representations concerning the results and validity of the AlgeaCal clinical studies.”

Judge Middlebrooks found for our client, largely based on the evidence summarized in ISS’s report, and his decision was upheld in an appeal opinion written by the 11th Circuit.

In ISS’s report, we reviewed ingredient-specific studies that supported GOL’s marketing claims about the products. Due to years of experience substantiating supplement claims, we were able to integrate the study findings.

The GOL case demonstrates that legal and regulatory challenges to a dietary supplement manufacturer’s marketing claims can be deflected by an expert analysis of the available science. Ideally, the manufacturer should commission an expert analysis to substantiate the marketing claims before the product’s release, as in GOL’s case. A great deal of literature is available on supplement ingredients, but it takes an experienced expert to perform the type of rigorous, systematic analysis required to counter legal and regulatory challenges.

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