What factors overcome innovation inertia, compelling a nutrition business entity to develop products that promise and deliver consumer-relevant benefits? In the absence of innovation, and amidst the stream of “invention”, can an enduring bioactive ingredient or finished good be created that enjoys an extended life cycle? When such innovations are achieved what recourse does the innovator have to exclude ostensible duplicates and protect their investment? Within a global climate of regulatory under-enforcement and ubiquitous messaging of unsubstantiated claims can a viral spread of science-driven enterprise manifest and infect even 25% of the industry? Will consumer-centric legal actions eclipse the might of governmental agencies and inject a decisive, otherwise lacking swiftness? Will a brand emerge that enjoys an inspiring evidence base on EACH bioactive or finished good? Where does the ripe, high-hanging fruit rest for the pioneering innovator brand and company willing to climb where others avoid?

Keywords

Nutraceutical; functional food; functional beverage; class action lawsuit; clinical trial; innovation; bioactive; gluten; glycemic index; patent; freedom to operate

1.1 Myths devolve into faith and dogma

The consumer promise of an NFx holds the allure of improved or preserved physiologic or metabolic function. The spectrum of consumer expectation ranges from disease/condition prophylaxis to disease/condition treatment, to even cure. The quest for “natural,” the drive to engage in “self-care,” and the almost free and boundless access to the virtual, omniscient libraries called the Internet and social media messaging are forging a new breed of companies and consumers. Armed and dangerous, with a modicum of evidence or simply a sugar-coated science tale, bioactives are birthed, brands are born, products are launched, and tribes are formed.

In the world of NFx, from a seedling of science often emerges a fad or a trend. In 1981 a Canadian research team developed the glycemic index (GI), a tool conceived to provide a physiological metric related to a carbohydrate-containing food, supplement, or beverage and its influence on blood glucose dynamics [1]. An NFx exhibiting a “high” GI value is widely believed to deliver its glucose to the circulation at a “faster” rate, while an NFx displaying a “low” GI value is believed to deliver its glucose at a slower rate. However, the GI does not reflect the rate of digestion and absorption of glucose entering the blood [2–5]. Rather, it is simply the net result of how much glucose entered the blood (from the gut; hepatic gluconeogenesis) less how much exited the blood (primarily disposal into tissues, especially skeletal muscle and liver) over a certain time or time interval. Despite this, numerous influencers and marketers of NFx state that GI is correlated to the rate of entry of glucose into the blood or that a low GI NFx is equivalent to a “slow burning” carbohydrate [6–8], despite zero or contravening, direct evidence in place [2–5].

A more recent entrant into the faith-fueled NFx category is the gluten-free moniker. Despite the identifier, a gluten-free NFx is not free or devoid of gluten but exhibits ≤20 parts per million of gluten in the final consumable form. In the United States, from 2012 forward the Food and Drug Administration issued 17 product withdrawals due to undeclared wheat allergen in foods [9]. Over the same interval Health Canada issued 13 undeclared gluten recalls [10]. This, coupled with the observation that most “gluten-free” certifications do not typically require quantitative, post-manufacturing testing for gluten on each batch of any certified product, imparts a questionable degree of confidence to the gluten-sensitive or celiac individual (who typically pays a premium for “gluten-free”). What if a manufacturing or labeling error or omission was committed, or an intentional act of domestic bioterrorism was perpetrated, within a manufacturing facility, rendering an NFx labeled as gluten-free to be effectively gluten-rich?

In the previous edition of this book I wrote:

From this author’s perspective the NFx products that enjoy (or have enjoyed) robust, sustainable revenues are those defined by one of two phenomena: 1) consumer experience, and 2) high circulation, incremental media editorial messaging.

Reflecting upon this passage I see the lack of emphasis upon the operative phrase “one of two” and word “sustainable” as problematic. Numerous NFx action words/phrases (low glycemic; gluten-free; açai; probiotic, antioxidant; super fruit; anti-inflammatory; coconut water; omega-3) enjoy moderate to broad consumer awareness, linked to salutary or desirable effects. However, few enjoy robust and sustainable (or incremental) revenues, with less being buttressed by an even semi-compelling evidence base.

1.2 Value addition or illusion?

Our own market and scientific research still indicates that less than one out of a thousand finished NFx products—not individual bioactive ingredients but the final form purchased and ingested by a consumer—enjoys at least a single randomized controlled trial (RCT) performed against a placebo or a positive control (e.g., an appropriate drug), and demonstrating a statistically significant outcome superior to that of the placebo, or equivalent or even superior to a positive drug comparator. Add in the additional criterion of such an RCT published in a reviewed journal and the percentage of qualifying NFx falls precipitously. What is more unsettling is our finding that of the ~250–300 RCTs conducted on NFx products in North America annually only a fraction are made public (via presentation or publication). This underscores the prevalence of publication bias and reveals the far more haunting truth that data suppression is not uncommon. Sadly, the “gagging” of investigators related to dissemination of clinical trial data on NFx products reaches into the ranks of publicly traded and multinational NFx marketing entities. The “burial” of this data is achieved by increasing numbers of studies performed with contract research and clinical service organizations, where data ownership (and intellectual property rights) is exclusive to the study sponsor.

The emergence and adoption of clinical trials registries (http://clinicaltrials.gov/; http://www.controlled-trials.com) has augmented the integrity of reporting while reducing publication bias, albeit in biomedical journals that require timely clinical trial registration (before enrolling the first participant within a 60 day grace period). A large proportion of the journals that entertain a large number of NFx publications do not require registration of a clinical trial as an inclusion criterion for publication (and editors of the “elite” journals may assert that the rigor and sample size of many NFx manuscripts do not warrant inclusion in their journals…). Given that a notable number of registered clinical trials on NFx do not publish their results after completion suggests that clinical trial registration alone is insufficient to convey transparency of research outcomes. Nevertheless, the adoption of clinical trial registration requirements [11] by the editors of journals that de facto cater to NFx manuscripts would raise the bar.

The importance and utility of NFx is defined not by revenues, share price, the annualized number of product introductions, nor calculated annual growth rate of the sector. NFx should serve the consumer by making a favorable, measurable impact upon her/his biology, congruent with the claimed benefit of the product and perhaps beyond. A probiotic beverage or solid dose that improved laxation and reduced LDL cholesterol could become a product that enjoys legions of brand zealots. The provision of NFx products, in its purest form, can be viewed as a public health initiative, centered upon offering consumer goods that meet four criteria: (1) excellent tolerability and...