by Mark Hostetler
since Adam and Eve first consulted their lawyer about claims for “the better
for you” apple, marketers, R&D groups and lawyers have grappled with issues
of claims substantiation. Marketers may desire broad product claims based upon
the media reports of one study; corporate R&D may be looking for that
perfect study which establishes the claim beyond any question. However, there
is regulatory guidance available to help answer the question of how much and
what kind of claims support is required.
FDA’s Center for Drug Evaluation and Research has recently stepped into the fray, having issued draft guidance for “Developing Products for Weight Management.” (72 Federal Register 7441—February 15, 2007.) While the guidance targets drug products, its discussion of the elements of “a well-conducted clinical trial” reaffirms basic principles of claims substantiation that are applicable to foods and dietary supplements.
I. The Draft Guidance for Weight Management (the guidance). The guidance includes basic recognized study parameters and rigorous drug research protocols, both adult and pediatric. A study to assess weight-control efficacy should be random, double-blinded and well-controlled, including a placebo; the sample size should be large enough to include sufficient sub-group populations by sex, weight (BMI), ethnicity and any other relevant determiners.
Efficacy should be measured at two endpoints: mean—“the difference in mean percent loss of baseline body weight in the active-product versus placebo-treated group” and categorical—“the proportion of subjects who lose at least 5% of baseline body weight in the active-product versus placebo-treated group.”
Secondary endpoint measures would include blood pressure, pulse and changes in body measurements. The guidance includes specific measurements of statistical significance for the product to be considered “effective for weight management” for one year.
II. Draft Guidance for Structure/Function Claims. The Dietary Supplement Health and Education Act of 1994 (DSHEA) permits companies to make structure/function claims without agency pre-approval. This FDA (11/04) draft guidance proposes a “competent and reliable scientific evidence” standard. Without defining that standard, it suggests that in applying the standard, companies should consider the meaning of the claim; the relevance of the evidence to the claim; the quality of the evidence; and the totality of the evidence. FDA’s structure/function guidance gives the following example:
“The labeling of a dietary supplement includes the statement ‘promotes weight loss.’ The dietary supplement contains various vitamins and minerals and a botanical extract. The manufacturer relies on a randomized, controlled, double-blind clinical study showing that subjects who took the botanical extract had a small but significant increase in metabolism over subjects taking a placebo over a 24-hour period. The study did not examine the effect of the extract on subjects' weight, and there is no research showing that a short-term increase in metabolism will translate into any measurable weight loss. The weight loss claim would likely not be adequately substantiated.”
III. The Federal Trade Commission (FTC) standard generally (and for dietary supplements). The FTC shares claims oversight with the FDA and is most active in claims interpretation. To determine the “reasonable basis” required to support a particular claim, the FTC posits that the standard is the amount of evidence that experts in the field would find to be adequate. In the health claims arena, an advertiser is expected to possess “competent and reliable scientific” evidence defined as “tests, analyses, research, studies or other evidence based upon the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
Conclusion. Companies looking to make weight management or other claims—whether for a drug, a dietary supplement or a conventional food—should carefully plan their claims support and design any required studies or clinical research to meet the relevant regulatory standards for their anticipated claims.