As you know, the emergence of our increasingly health conscious public is driving the growth of the nutraceutical industry.

It is one of the fastest-growing industries worldwide (Forbes, 2013) and is already highly profitable.

In 2012, Forbes reported that nutrient supplements brought in revenue of $32 billion and that more than $60 billion is expected by 2021.

Alongside this expansion, regulation has tightened, and research into nutraceuticals has grown.

Regulatory squeeze

In December 2006, the European Commission adopted European Health Claims regulation (EC/1924/2006) that limits the statements industry can make about food, nutritional and nutraceutical products to protect consumers From heightened or distorted claims (EC, 2014a).

Food claims should now be substantiated by scientific evidence and worded so that they are reliably understood by consumers. Claims can be substantiated in one of two ways:

• selecting or combining ‘generic claims’ authorised for vitamins, minerals and a limited number of other substances (Article 13.1); the EC published a registry of over 2000 ‘generic claims’ that can be used where appropriate without further supporting research (EC, 2014b)
• testing the product by clinical trial and filing an application for a proprietary health claim

The EC also published a registry of the more than 2000 nutrition claims that are permitted without extra supporting research, and ‘health claims’ that are permitted, rejected or pending.

Nutraceutical gamble: to settle or spend?

In this recent environment, nutraceutical companies have the option of settling for the limited, but cost-saving, option of the ‘generic’ claims allowed by the directive (Nutraceuticals World, 2014a) or applying for individual health claims. Individual claims are submitted to the European Food Safety Authority (EFSA) with one or more clinical trials for assessment of the product’s health claim. If the EFSA gives a favourable opinion, the product is then put forward to the European Commission for an authorization decision (Nutraceuticals World, 2014b).

The overwhelming majority of health claim applications have been rejected by the EFSA (BBC, 2010), but nutraceutical companies are still motivated to strengthen their research portfolios.

Motivation to grow

The attitude of nutraceutical companies towards research is clearly evolving. In the past, the cost–benefit balance of research limited scientific substantiation of claims. Now, the nutraceutical industry is increasingly recognising the power that clinical trials offer to further their business case.

Robert Pattison, Vice President of Business Development, Clinical Research, SPRIM America, San Francisco, California, told Nutraceuticals World: “Companies many times see clinical research as a necessary evil or a huge cost and don’t see the marketing and regulatory power to performing such.”

Now, he says, they see that clinical research “protects the company from unnecessary liability and provides marketing fire power to aggressively penetrate the market, increase sales and provide key insights to the product to fuel new intelligent innovation.”

He added: “There is a direct relationship between the level of research performed and a company’s success on many levels.”

Expert support

In development efforts, nutraceutical companies have turned to clinical research organisations (CROs) to benefit from their trial experience. As stated by Nutraceuticals World, CROs can help navigate rough regulatory terrain.

Clinical research organisations may have connections at trial sites that offer the type of patients sought in large numbers and are located in workable geographic areas. Sites are wanted in places that work to the same regulatory requirements, for example. It’s also good for them to be local to one another to enable effective investigator communication.

Pharma insight

Comparatively young nutraceutical companies also benefit from learning the approaches taken by pharmaceutical companies.

Pharmaceutical companies have significant experience of selecting the right clinical outcomes to pursue when designing expensive clinical trials. They also have experience of designing and running preclinical trials to explore the potential of a substrate to produce desired effects before committing to spending millions of dollars, pounds or euros on a clinical trial.

References

Forbes 2013. Nutritional supplements flexing muscles as growth industry: http://www.forbes.com/sites/davidlariviere/2013/04/18/nutritional-supplements-flexing-their-muscles-as-growth-industry/

Nutraceuticals World 2014a. Devising innovative products without health claims: http://www.nutraceuticalsworld.com/issues/2013-06/view_columns/devising-innovative-products-without-health-claims/

Nutraceuticals World 2014b. Contract Research Organisations: Partners in Science: http://www.nutraceuticalsworld.com/issues/2013-06/view_features/contract-research-organizations-partners-in-science/

European Commission 2014a. Health and consumers: food. http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm

European Commission 2014b. EU Register of nutrition and health claims made on foods: http://ec.europa.eu/nuhclaims/

BBC 2010. EU health foods claims begin to bite: http://www.bbc.co.uk/news/10240263