Article: Regulations: Claiming Guidance -- June 2009
Marketing may desire and will certainly expect to rely on their R&D groups for evidence to support marketing’s demands for foods to meet certain claims expectations. Researchers charged with designing foods and vouching for the support of marketing claims made for those products must be cognizant not only of their own professional standards, but of the legal standards which will be used to examine the assumptions, protocols and results of the R&D professionals’ product development and claims support work. R&D personnel efforts in claims development and support can spell the difference between a claim being found to be substantiated and one which can be successfully challenged, resulting in loss of the claim(s), removal of the product from the market and potential legal liability.
* The basic rule of all advertising is that advertisers must have a reasonable basis for making objective claims (claims that are not “puffery”) prior to dissemination of the claims.
* Advertisers must have in their possession at least the level of substantiation expressly or impliedly claimed--including those reasonably inferred--in the advertisement. For example, if the claim is for a particular use or application, there must be evidence of testing of the product for the indicated use or application in support of the claim.
* If there is no specific level of support implied or expressed by the claim (for example, “three out of four doctors” or “clinically shown”), a case-by-case analysis is applied, including type of product and type of claim; benefit of claims, if true, or harm, if false; difficulty in obtaining substantiation; and level of support experts in the field would agree is reasonable.
* For health and safety claims, including claims of dietary guidance and structure/function, a higher level of support is required: “competent and reliable scientific evidence,” often defined as “tests...or other evidence based upon the expertise of professionals...that has been conducted and evaluated...by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” It stands to reason that a claim of “better for you” ought to be held to a higher level of support than “tastes better than...”
In its recent proceeding, now in the form of a Consent Order for public comment, the FTC argued that a claim that a breakfast food was “clinically proven” to improve children’s “attentiveness” by “nearly 20%” was not supported by clinical research which showed that about half of children eating the food demonstrated any improvement (after three hours) vs. the baseline; that one in seven improved their attentiveness by 18% or more; and only one in seven appeared to improve attentiveness by 20% or more.
As to claims made for meal-eaters vs. meal-skippers, the FTC challenged a claim that attentiveness was improved by 20%. The FTC argued that in the clinical study used to support the claim, eaters had an average of 10.6% better attentiveness (three hours later) than skippers, while “relatively few” experienced better than a 20% improvement.
The FTC’s position was that, taken together, the evidence offered in support of the claims did not rise to the level of “competent and reliable scientific evidence that substantiates the representation.”
While functional foods and dietary guidance advertising are and will continue to be areas of interest for producers and consumers, the support for the claims that R&D professionals will be asked to provide will continue to be scrutinized against a high standard of evidentiary and scientific support. pf