The FTC has been promising for awhile to tighten the definition of its "competent and reliable scientific evidence" standard. Last week, the agency made good on that promise in consent orders reached with a Nestle subsidiary and Iovate Health Sciences.
The orders provide that for certain claims "competent and reliable scientific evidence" is defined as
"at least two adequate and well-controlled human clinical studies of the product, or of an essentially equivalent product, conducted by different researchers, independently of each other, that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that the representation is true."
"Essentially equivalent" is in turn defined as
"a product that contains the identical ingredients, except for inactive ingredients, (e.g., binders, colors, fillers, excipients), in the same form and dosage, and with the same route of administration (e.g., orally, sub lingually), as the covered product; provided that the Covered Product may contain additional ingredients if reliable scientific evidence generally accepted by experts in the field demonstrates that the amount and combination of additional ingredients is unlikely to impede or inhibit the effectiveness of the ingredients in the Essentially Equivalent Product."
(There are other new provisions not discussed here, including a requirement that certain claims require FDA approval.)
These new definitions apply in the case of Nestle's Health Care Nutrition division to claims that any drink containing probiotics or any nutritionally complete drink, with certain exceptions, reduce the duration of diarrhea in children under the age of thirteen or reduce absences from daycare or school due to illness. In the case of Iovate, the new definitions apply more broadly to claims that any dietary supplement, food or drug causes weight loss, including rapid weight loss.
We think the key points from these new definitions is that the FTC has now predetermined that certain claims must be substantiated by:
- two human clinical studies;
- that should be evaluated in light of the entire body of scientific evidence; and
- are conducted on a product with identical active ingredients to the advertised product and in the same form, dosage and route of administration, unless there is sufficient reason to believe that the differences are unlikely to affect the efficacy of the advertised product.
Of course, the FTC has in the past required two clinical trials to substantiate certain claims so the requirement itself is not new. What is new is determining that up front in a consent order. Essentially, the FTC has taken the guesswork out of its definition of "clear and competent scientific evidence" and presumably minimized the risk of embarrassing court losses like Lane Labs.
However, for advertisers, the FTC's new definition has potentially significant ramifications. Several questions, though, remain unanswered. First, how broadly does the FTC intend to apply its new 2 clinical trial requirement? Our guess is that the Commission may try to insert the language (or the FDA approval requirement if the claim is a disease claim) in many orders covering health related claims. Second,the requirement that any supporting tests be conducted on an essentially equivalent product could have a significant impact on advertisers, depending upon how broadly or narrowly the FTC interprets the exception for differences that are unlikely to make a difference. Advertisers that comes out with a low fat version of a product or makes some other relatively minor product change may now struggle with whether the relevant health claims for the modified product have to be resubstantiated. Other companies that found it prohibitively expensive to conduct their own research for their product, but instead relied upon clinical studies of the principal ingredient may similarly face some difficult decisions.
Our two cents worth is that determining in advance the necessary quantity and quality of substantiation for claims ahead of time is an exercise in trying to balance risk: setting too strict a standard that discourages innovation and consumer communications versus allowing advertisements prone to misleading claims because the substantiation bar is set too low (or that courts will interpret general substantiation requirements in a way to harm consumers). Perhaps the benefits outweigh the harm when the product and claims at issue are ones that are unlikely to be truthful in any circumstance (e.g. "lose weight while you watch TV"). In that situation, there is little risk of inadvertently suppressing innovation or consumer communication and significant risk that misleading claims might otherwise be made. However, when the product and claims are ones that could in some circumstances be substantiated the risk/benefit analysis seems reversed. In this scenario, product innovation and communication of truthful information to consumers might be overly discouraged while the heightened standard does little to further prevent the communication of misleading information. In either event, if you know anyone pondering a career path, going into clinical research might not be such a bad idea.
- Randy Shaheen and Diem-Mi Lu