The current state of clinical substantiation in nutraceuticals

The trend of rising standards in the nutraceutical industry in terms of scientifically proven product quality has been present for some time now ... and awareness is spreading amongst businesses and consumers alike. But how far have we really come and how has the average on-shelf product actually changed?

True clinical substantiation is based on both performing best-standard clinical trials and marketing the message correctly.

Both steps are equally important and have room for improvement in nutraceutical ingredients and finished products alike. Historically, our industry was far less concerned with proving claimed effects than the pharmaceutical sector.

With no regulatory requirements motivating change, word of mouth testimonials and tradition of use sufficed for successful nutraceutical sales for a long time.

Consequently, a large portion of the nutraceutical market continues to comprise herbal extracts or other commodities that rely on bibliographical data for proof of efficacy. All too often, ingredients included in a product don’t have any connection to the cited scientific support apart from the name.

However, with the rise of the educated and proactive consumer, such substantiation is losing credibility. In areas such as deficiencies, prenatal nutrition or immunity, global consumers are recognising products with proven added value and are increasingly prepared to invest in it.

Such successes are pushing more and more companies in the nutraceutical industry to invest in clinical trials; yet, there is still a discrepancy between quantity and quality. Whereas randomised double-blind, placebo-controlled trials have now become the standard, there are still plenty of questionable behaviours that require reading beyond the abstract.

One of the more important aspects is the inclusion of a sufficient number of test subjects. Statistically relevant numbers can be difficult to achieve and inclusion criteria are often compromised.

Quality of data also rarely meets the standards of other industries. The importance of measuring relevant biological output markers and using validated questionnaires should be emphasised.

Similarly, the objective and statistically correct analysis of results is far from given and should always be questioned when putting one’s brand on the line. For this, co-operation with recognised CROs and independent research managers with a proven track record is a must. The circumstances of a trial’s execution should eliminate all possible external effects on the outcome.

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Unfortunately, trials tend to be performed in a single testing centre, sometimes of questionable credibility. Ideally, utilising several reputable testing centres would eliminate geographic variation, equipment bias or any other variables.

In specific health areas, such as immunity, testing during several seasons is also advisable to eliminate season-specific anomalies ... yet this is rarely the practice. Specifics of what are actually best-standard clinical trials are obviously plentiful and require substantial expertise to be able to guarantee value for the purchasing business or consumer.

We are aware of several ingredient manufacturers who understand the importance of proper clinical substantiation and are investing in the quality of their clinical trials. At the same time, they need to invest in educating the industry to be able to recognise best standards.

Recently, more educational B2B content is surfacing on many media platforms and events, which is a great leap forward. Finished product brands, by contrast, are lagging behind in the quantity and quality of their clinical trials.

If, previously, there was no pressure for such investments, today there is: consumer trends and the shift of pharmaceutical companies into nutraceuticals are providing ample reason. Clinical substantiation will gradually become a must for brands to avoid competing in the price-driven product range. Currently, however, performing clinical trials on finished products presents a clear differentiation opportunity.

Although communicating trial results to consumers with busy lives is challenging, new packaging technology and accessibility through so many channels provides unlimited ways to influence the all-important first purchase and secure brand loyalty. In our experience, the synchronised delivery of a concise and simplified message across many platforms has proven to be key for a successful product launch.

An important channel, especially for challengers of the industry, who choose to differentiate through quality and clinical proof, is medical detailing. Often neglected by leading brands, medical and pharmaceutical professionals still enjoy high consumer trust rates and present an opportunity for growth.

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