The use of health and nutrition claims for food supplements has received a great deal of attention as more and more companies look to enter the ever-expanding nutraceutical market in Europe – valued at USD $41.95 Billion in 2019. With progressively more products entering the market to meet consumer demand, investment in your clinical strategy may in fact give you a competitive advantage in the long run.
Historically speaking, health claims were originally subject to general rules preventing false or misleading labelling information. This changed in 2007, in which European Regulation (EC) 1924/2006 on nutrition and health claims was adopted as a measure to protect consumers from spurious claims. As a result, all claims are now subject to a stringent review by EFSA before being approved or rejected.
The process sounds pretty straight forward, and yet countless claims submitted to EFSA have been rejected – in fact, more than 90% between 2008 and mid 2015 according to Dutch study. Although EFSA has set up rigid guidelines to navigate the approval process, many manufacturers continue to fail in achieving an approved claim for their products. Whilst on-hold claims pending for EFSA decision can still be used and poses a viable option, a general awareness of the importance of clinical evidence for new products is essential. This is in part due to rising consumer demand and preference for high quality food supplements, where there are enormous benefits for companies that invest into their clinical strategy during the development phase.
New product development can go down 2 pathways – new entry into the market, or to replace an older product. A key focus for new product development is the concept of ‘added value’ which is now more attractive to consumers. Product novelty allows manufacturers to gain greater profit margins than from a ‘commodity’ product which while necessary, can be described as familiar, widely available and sold at a predictable price throughout Europe.
Nevertheless, real potential and opportunities exist if companies develop products together with supporting clinical research for which a health claim can be made. This strategy requires greater investment and carries a higher risk; however, huge rewards if a claim is authorised, particularly under Article 13.5.
Considerations during product development for health claims
By including decisions about health claims at the product development stage, manufacturers can assess the feasibility and risks at minimal costs (i.e. before buying ingredients, running production trials or undertaking human trials). Here are a few questions to ponder during the development phase:
- What type of claim are you making?
- Could already approved claims be applied to your product?
- Would reformulation of an existing product result in the product meeting the conditions for an approved claim?
- Has any previous work been carried out, which can support your claim (e.g. in vitro)?
- What is your target market (e.g. age group, healthy or unwell)?
For manufacturers of any food which influences health, it is essential to demonstrate that the effect is real through human studies. RNI conducted a brief analysis of approved or rejected EFSA health claims and common trends among unsuccessful applicants were:
- Failure to use/test the food that was the subject of the claim
- Failure to supply robust evidence of beneficial physiological effects
- Insufficient characterisation of food/constituents
- Cause-and-effect could not be established
On the contrary, successful applicants had designed properly powered studies with complementary literature reviews, used the test food/compound in relevant target population groups with acceptable end points and biomarkers, clear primary and secondary objectives, and the product designed to have a health impact on the general population.
While there has been some criticism of EFSA’s strict approach to the assessment of health claims, there is now greater understanding of their expectations for the level and type of evidence required in a submission. The importance of having a clinical strategy in place in the product development stage will save you in the long run giving you a competitive edge in the everchanging market.
For over 15 years, RNI CONSULTING has been providing regulatory, scientific and clinical solutions and expertise to clients for the development of nutritional and health products. Our vast expertise covers formulation development, communication assessment, marketing authorisation and claim substantiation. RNI CONSULTING’s work method is based on solid regulatory and scientific competencies together with strong relationships with European and International authorities.
We welcome any questions or points for discussion. Please do not hesitate to contact us at email@example.com