June 4, 2015

Iovate Muscles Through Challenge to Dietary Supplement Health Claims

Seller Beware: Consumer Protection Insights for Industry

Dietary supplement makers are often faced with the question of whether studies conducted on ingredients in their products are sufficient to support efficacy claims about the products themselves. Product formulations change regularly in response to consumer demands, but product studies take time and money to complete, making it important to be able to rely on ingredient studies for a range of finished products. In a recent decision, the National Advertising Division (NAD) laid out a roadmap for such reliance.

The NAD determined that Iovate Health Sciences International had sufficiently supported health claims for its "Six Star Whey Protein Plus" dietary supplement with an ingredient study. The Council for Responsible Nutrition (CRN) —which for almost a decade has run an industry self-regulatory program in conjunction with the NAD—had challenged Iovate's claims, including that the supplement is "enhanced with core ingredients clinically shown to build more muscle and strength than whey protein alone" and "scientifically shown to build 70% more muscle," because of alleged differences in formulation and dosage between the supplement and the ingredient study.

Iovate supported its muscle mass and strength claims with a randomized, double-blind, placebo-controlled study that found that weight-trainers who consumed whey and creatine, two of the ingredients in Iovate's supplement, gained over 70% more lean muscle mass than those who consumed whey alone, and also showed a greater increase in the average weight they could bench press.

The NAD concluded that Iovate had a reasonable basis for these claims. Iovate's study met the "gold standard" for study design, the NAD found, and its results were statistically significant to the 95% confidence level. The NAD also observed that dosage data and unrefuted expert reports submitted by Iovate provided a reasonable basis for concluding that supplement users would receive at least the same dosage of whey and creatine as the study participants and that additional ingredients in the study formulation were not present in sufficient amounts and had biochemical process by which to affect the study's results.

The NAD next determined that Iovate "narrowly tailored" the claims on its website and product label to reflect accurately the study. Iovate did this by prominently disclosing that the study was based on ingredients and not the supplement itself, and further disclosing: (1) the amounts of muscle mass and strength gained by the study participants; (2) the comparative product (whey or placebo); and (3) the type of exercise affected by the supplement's ingredients, since the study found no significant strength improvement for exercises other than the bench press. The NAD recommended that Iovate include similar qualifying language "clearly, conspicuously and in close proximity" to its print advertising claims.

The NAD's decision shows that supplement makers should be able to rely on ingredient studies versus product studies if they have competent and reliable scientific evidence (like a "gold standard" human clinical trial), the supplement has a similar amount, formulation and route of administration as the ingredient in the study, and the advertising claims are carefully qualified to match the evidence. The Federal Trade Commission's dietary supplements advertising guide has additional guidance in this area.

© Arnold & Porter Kaye Scholer LLP 2015 All Rights Reserved. This blog post is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

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