The big news in the nutraceuticals sector over the past few weeks was a review that suggested that fish oil may not have the health benefits previously attributed to it. A comprehensive review of this well-known and well-studied nutraceutical concluded:
“Despite all this information*, we don’t see protective effects.”
* review of 112,000 people
Fish oils and Omega-3 fatty acids are the most widely taken dietary supplement in the UK, with a global market expected to reach $57 billion by 2025.
According to the European Food Safety Authority (EFSA), any source of the Omega-3 fatty acids Docosahexaenoic acid (DHA), Eicosapentaenoic acid (EPA) and Alpha-linolenic acid (ALA) are approved for a range of health claims, once they comply with specific criteria. This is still the case and UK government nutrition advisers maintain that there is ample evidence of Omega-3 fatty acids protecting against cardiovascular disease.
What are neutraceuticals?
‘Nutraceuticals’ is the broad term attributed to medicinally or nutritionally functional foods, sometimes produced at a pharmaceutical level. The phrase was originally used in 1989, defining nutraceuticals as: food, or parts of a food, that provide medical or health benefits, including the prevention and treatment of disease. A key function of nutraceuticals is to provide active elements of a food product in an easy format that it may not be possible to consume at the same levels through normal diet.
The global nutraceuticals market is projected to reach $578 billion by 2025 and covers a wide range of sources, applications, and claims. Health claims are a key selling point for nutraceuticals, however this is tightly regulated by the European Food Safety Authority (EFSA). Only claims that have been rigorously researched, proven through clinical trials and meet the EFSA’s approval are sanctioned for a health claim.
In 2008, recognising the range of unsubstantiated health claims being used across a range of sectors, the EFSA began a process of evaluating these claims. In 2011 the EFSA published its final evaluations of established health claims, and laid the groundwork for reviewing new health claims, with a view to tighter regulation of this sector.
Shannon ABC and neutraceutical research
Shannon Applied Biotechnology Centre was established in 2008 as a result of a merger between the Nutraceuticals Research Centre in Limerick Institute of Technology and the Natural Products Research Centre in Institute of Technology Tralee. Since then, Shannon ABC has built significant expertise in the area of bioresources (natural products) and their use in food and nutraceuticals (as well as (cosmetics, healthcare, biotechnology and so on).
For companies wishing to develop nutraceuticals, an essential part is scientific validation at each step of product development. Shannon ABC has extensive experience in the screening and testing of extracts for a range of applications. Ingredients can be screened prior to inclusion in a formulation, in addition to final product testing. The types of biological activities that can be screened for include:
- Anti-oxidant
- Anti-inflammatory
- Anti-microbial
- Prebiotic
- Bone regeneration
- Skin health
Over the past 10 years, Shannon ABC has worked with a range of companies and research organisations in the area of nutraceuticals, for both human and animal applications. This work has included:
- Development of a scalable extraction process for a seaweed carbohydrate
- Proof of efficacy of a yeast extract for mediation of traveller’s diarrhoea
- The prebiotic activity of a range of marine extracts
- Bioavailability of nutraceutical ingredients
- Mode of action and efficacy testing of a nutraceutical for hair growth
- An investigation into the impact on skin of a nutraceutical formulation
- The anti-inflammatory and antioxidant activity of a nutraceutical formulation (bio-specific)
- Sensory analysis and shelf life testing
Shannon ABC has built significant expertise in the area of nutraceuticals screening and testing over the past 10 years. We also partner with other research groups around Ireland for specific capabilities, such as those led by Dr Lisa Ryan in the MET Technology Gateway for human intervention trials or by Dr Ioannis Zabetakis in the University of Limerick for health claims related to cardiovascular disease.
Bringing neutraceutical products to market
Good marketing is absolutely required in the nutraceuticals sector, but that shouldn’t be interpreted as a lack of science. In order to have an EFSA health claim approved for a food product, significant research must be undertaken at high cost, with no guarantee of success, even if the data produced is positive. Companies thinking of developing a nutraceutical product should start by reviewing the EFSA health claims database; there are 261 health claims approved for a variety of foods and food components.
The biggest challenge within the nutraceuticals sector is the cost of carrying out clinical or human intervention trials, and the subsequent return on investment. While the cost of the final product justifies the cost of clinical trials in the pharmaceutical sector, the same cannot be said for the nutraceutical sector. For this reason, very effective nutraceutical compounds may not get the comprehensive scientific validation required to make a health claim as the return on investment is not there.
Nutraceuticals intrinsically make sense, if someone is deficient in a nutrient it can become evident in their health or their appearance. Conversely, if that person takes a nutraceutical with the compound that their body is deficient in, this should (more or less) remedy the situation. It becomes more complex to identify clear results where people follow a normal healthy diet – additive impacts from nutraceuticals are more difficult to interpret as the person already has a healthy diet.
This is undoubtedly a complex sector that requires significant scientific support in order for companies to be confident about their products and their impacts.
If you have any queries about testing your nutraceutical product, get in contact with Shannon ABC today.