Exclusivity Agreement: Exclude the Bad & Exalt the Good

As the dearth of blockbuster bioactives continues, the drive to inflate the small into the superior and the new into allowed proceeds unabated.

By Anthony Almada, B.Sc., M. Sc.

Energies continue to be focused upon the myopic milestones and defense, while a select few, cognizant of the imminence of tectonic plate shifts in the regulatory-political crust, aim for distance and distancing themselves from the mundane.

A year ago in this column an article entitled “Flags of Convenience” was published. It described the widespread practice of building message campaigns around select research studies. Notably, this was practiced at the exclusion of other research evidence on the same ingredient that revealed no benefit or, sometimes, a less than positive effect. Much to my chagrin, and to that of regulatory and political agents, the practice has only increased. One can convincingly assert that the augmentation of this practice is a function of human behavior, resultant to the very low enforcement to infraction ratio (EIR; largely a product of the paucity of FTC/FDA agents relative to nutraceutical marketers and claims). Many marketers appear to subscribe to a philosophy of “Whatever the competition is getting away with, we can do also, and better.” One may also assert that the practice has displayed incremental growth because the risk, or more specifically, the penalty, is perceived to be innocuous.

The emergence of ORAC as an index of “efficacy” is yielding to a morphing into a marketing monster. A very recent example centers upon açai (Euterpe oleraceae) fruit (pulp and skin), showing high in vitro antioxidant values (despite a low concentration of phenolics) (J Agric Food Chem, 2006). Despite this being the most detailed and advanced in vitro study to date on a specific brand of açai concentrate, there appear to be NO randomized controlled trials (in the public domain) that have evaluated the “effectiveness” or “efficacy” of any branded and marketed açai products or ingredients.

Independent of this fact, açai has been marketed for various benefits to consumers, including “energy” and “antioxidant” claims. The absence of a disclaimer or disclosure that the effects of açai as an ingested component in humans are unknown would align with the marketing philosophy cited above. However, highest (in vitro) ORAC scores bear NO relevance to the performance of a natural bioactive as an antioxidant in vivo.

The test tube tactic has given way to in vivo, but the benefit in question is an extrapolation to the bioactive or finished good. A recent illustration of this is embodied in bioactives that have demonstrated acute, single dose reductions in appetite or food intake. Several examples exist, with none showing the outcome or benefit that is implied, i.e. weight/fat loss. Similarly, with near pure EGCG bioactives, the animal evidence is compelling (thermogenesis, weight loss, fat loss) but the only existing (public domain) human evidence shows no greater benefit than placebo. Add in the numerous randomized controlled studies that have been conducted on various specific green tea extracts and yielding no greater weight or fat loss, or prevention of fat regain, than placebo, an outsider looking in can only scratch her head and wonder “How can these companies exalt these ingredients (or finished goods) when the (majority of the) data show no better than placebo?!”

The continued plummeting of the EIR has compelled some U.S.-based marketers to harness the powers of the government via a low cost and fast track tool offered by the National Advertising Division (NAD) of the Council of Better Business Bureaus. The use of NAD as a forum for relatively inexpensive and rapid resolution of disputed advertising claims is embraced by other consumer packaged goods industries, and is gaining acceptance in our industry. Cases enter NAD through (direct or stealth) submission by competitors, or by the NAD’s constant monitoring. A recent case affords insight into the assessment of proprietary compositions. A specific lipoic acid dietary supplement, which claimed to be patented and therefore able to produce superior results, was cited as lacking any evidence substantiating any of the anti-aging skin claims being made for the actual composition being advertised. The decision stated, “NAD recognizes that there may be instances when health performance claims can be substantiated without clinical studies of the specific product in question. In such cases however, an advertiser must demonstrate by reliable evidence that it is scientifically sound to extrapolate the conclusions drawn from other studies and data and apply them to the performance claimed for the product in question.” The direction of things (and legislation) to come??NW