The Damoclean Risk: Circumventing Consumer Confidence

The Sword of Damocles hangs over our industry's head, but unlike that age-old tale warning of the imminent threat hanging above us, we ourselves have hung the sword by a thread, and we ourselves are carelessly risking bringing it down upon ourselves.

We promise so much, perhaps bewitched by our own words: take these pills, apply this cream, drink this liquid, eat this cereal and rosy health shall be yours. But what if our trusting customers, one by one, dozens by dozens, learn that we are purveyors of an orchestrated mirage?

As members of the consumer health/self-help products community of industries, we aspire to offer and market ingredients and finished goods that improve, increase, decrease, augment and heighten various and sometimes specific biochemical processes. From promising to decrease markers of oxidative stress and waist sizes to elevating HDL cholesterol and mood, a promise of benefit is both implicit and explicit.

Perhaps the most odious way in which the promises of pulchritude and prevention are cast is in 'infomercials' and 'printfomercials.' Here a new breed of television and radio evangelists, and ad copywriters, pitch their cures. And, unfortunately, these nefarious sales pitches, like it or not, do represent our industry to the general public, and in omnipresent and powerful ways, particularly on television.

Many within the community say they have no part in this on-air/print onslaught on consumer confidence. We in North America are perhaps preoccupied with 'chemical quality,' assuring the presence of exact amounts of labeled ingredients. However, even though one company may be able to assert (with conviction) that its products do exactly provide the ingredients and the amounts claimed on the label, this may be tantamount to an archer who can hit the target but never the bullseye. Thus, how our industry defines 'quality' and 'functional' may be a gulf apart from what the consumer anticipates and expects.

How our industry defines 'quality' and 'functional' may be a gulf apart from what the consumer anticipates and expects
In the realm of 'heteromolecular' products, for example those with more than a single molecular active ingredient, or those that contain at least one plant or animal-derived ingredient, too much is unknown and only speculated. Does one company know from reliable scientific evidence that its unique ratios and sources of blood lipid-modifying mix of fibre and sterols are superior to another? Almost invariably the answer is no. I argue that a majority of consumers ultimately seek not chemical precision but biological accuracy (experience and evidence) coupled with precision (reproducibility)—biological accuracy being defined as meeting label and off-label benefit and 'efficacy' claims.

The most elaborate analytical laboratory can never determine, in the current stage of the biotechniques game, if a product is biologically functional in a human. In the land of functional foods and nutraceuticals, consumers want products that work, and that work reproducibly, and which have adequate evidence to support their safety. To their credit, Uncle Toby's in Australia (Reducol), Tropicana in North America (P&G's calcium citrate malate [CCM]), or Valio in Finland and ConAgra (anemically) in the US (Lactobacillus acidophilus 'Goldin and Gorbach') would never have embraced the 'active ingredients' in some of their products if the evidence package was empty. Valio and Tropicana have even gone on to validate the human efficacy of their actual finished products incorporating the star bioactives.

Virtually every company asserts that its ingredient or finished product is safe and effective (tacitly understood as in humans), or even superior to another company's, or to that of all companies. Ask for evidence and the file drawers open, brimming with testimonials, before-and-after pictures, or even some scientific research papers. Scrutinise these papers and they almost invariably pertain to in vitro or animal studies, or to a single constituent, yet the company markets a formulation consisting of multiple constituents. Unfortunately, all too often they relate to a different preparation of a specific heteromolecular ingredient (e.g., not EGb 761 Ginkgo biloba, Remifemin black cohosh extracts, or Procter & Gamble's CCM). Chemistry confers efficacy and safety. Thus, other forms of the innovator compositions may be viewed as ineffective or less safe—until proven otherwise.

For the consumer, a product that is tasted provides an almost instantaneous experience, a mini experiment of efficacy. It tastes good, bad or insipid. It has a pleasant, unpleasant or forgettable mouthfeel. This acute physiological experiment (taste is a magnificent chemo-neurophysiological sense) can be pleasurable and sufficient, since no other systemic, positive, functional expectation may exist, save that of providing calories and some non-specific form of nourishment.

For products that are intended to be 'functional' from a health, condition or disease perspective, the taste experiment often is absent/irrelevant (e.g., an encapsulated or tableted product), or even overlooked (e.g., most botanical liquid extracts). In this case, functionality is defined as a desired result from a series of complex and interrelated biochemical, molecular and perhaps microbiological events; that is, it has 'systems functionality.' A psyllium husk powder is deemed effective if laxation/bowel habits are altered. A weight-loss product is deemed effective if the user experiences an appreciably greater loss of weight or fat than what she had noted before ingesting the product. This is the essence of functional efficacy: the consumer experience aligns with the expectation.

Bait And Switch
If appropriate and adequate evidence does not exist to support the claim or assertion that is advertised, the organic cotton strand holding that sword we've hung over our heads may unravel to a dangerous degree. Of greater concern is the occasion when evidence to the contrary of the claim or assertion exists, especially if it comprises the majority of the evidence. Examples abound.

In Europe, one company aggressively promoted as fact that its 'proprietary' glucosamine sulfate plus other ingredients product was being studied at a prestigious academic institution (the company was also a partial sponsor of the study). When the results were published in a prominent rheumatology journal last year, no mention of the product failing was made by the company in the press or on its Web site (up to the time of this writing, February 2003). The study's authors concluded: "As a symptom modifier in osteoarthritis patients with a wide range of pain severities, [the product] was no more effective than placebo." Note: the glucosamine sulfate that has in fact been shown to have significant symptom- and disease-modifying effects (from Rotta Pharmaceuticals), is chemically different from all other glucosamine sulfate products offered for sale.

In Australia, one of the leading weight-loss products is comprised of a cocktail of various ingredients that have equivocal evidence of efficacy, if at all. Furthermore, in this product the ingredients are present in amounts far less than the limited data indicate to be efficacious. These claims are approved for advertising by a governmental advertising oversight council, despite no evidence base for the product.

In the US, one company has been claiming that its unique collagen extract is backed by clinical studies at a prestigious medical school and proven to improve certain rheumatic conditions. However, one finds that the product offered is chemically different from that promoted and enjoys no published clinical studies showing efficacy.

How long can we exploit consumer confidence? Is the thrust for new product development and new product launches simply a response to the paucity of 'old' products and ingredients that truly deliver effective functionality? Somewhere between the snake oil and the prescription drug rests the purgatorial place where we reside. Only through purging the sins and sinners, abandoning specious hyperbole, and pursuing specific evidence will we ever be worthy of a global mass of zealous believers and disciples. Unless we undertake this task, we will bring the sword down upon ourselves and suffer a fate that other industries have already experienced.

Disclosure: Anthony Almada/ IMAGINutrition Inc has been a recipient of a sponsored research grant from Biocell Laboratories, a US company marketing an avian collagen extract, and oversees the pre-clinical and clinical research programme for a marketer of a phytosterol glycoside product (Moducare.)

Anthony L. Almada, BSc, MSc, was co-founder of Experimental and Applied Sciences (EAS) and is the founder, president and chief scientific officer of IMAGINutrition Inc.

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