The Law, Science & Art of Health claims
In most of the industry articles I have written since 2000 they have focused on the technical aspects of food law, product marketing, or food science and technology. However, as the managing director of a food law consultancy, I though it of interest to consider such issues in a pragmatic and client centric approach. It’s been over 10 years since the Nutrition and Health Claims Regulation (EC No 1924/2006) (HCR) came into force and its continues to frustrate legitimate communications to consumers about product benefits. Navigating the implementation of health claims in “the real word” on-pack and marketing environment requires an understanding of legislation, science and the commercialisation of food products (the art). The following provides some context on how to address health claims from a food business or a food law consultancy perspective.
Navigating the HCR involves a detailed understanding of 37 recitals and 29 Articles as well as 11 new regulations and implementing decisions (excluding the 13(5) submissions). On top of that we have over 13 guidance documents from across the 28 Member States (including the European Commission) and 21 cases before the European courts over the interpretation of the HCR. Layer on top of this Member State individual approach to claim interpretation, enforcement, and related prosecutions means we cannot deny a deep legal understanding of the HCR is required.
However, at a practical level what we see is at minimum food business looking at the main regulation or making decisions based on a health claims register search. Is this enough? Will this allow free movement of claims across the Member States, Will this advise if all non-mandatory information can be viewed as a possible nutrition claim? How flexible can a health claim be? etc etc…
The approval of health claims are based on the decisions from the European Food Safety Authority (EFSA) and then implemented into European law by parliament. However, the evidence presented in EFSAs opinions are based on ‘science’ within a legal framework - but are de facto based on clinical research trials. As such interpretation of the final wording of health claims and etiologic interpretation of any individual health claim must be based on the underlying evidence as assessed by EFSA. For example we have the claim;
“Phosphorus contributes to normal energy-yielding metabolism.”
Yet in some states the assessment of this health claim can extend the claim wording to also mean;
“Phosphorus contributes to normal production, storage and transfer of energy.”
Or what about the same claim based on copper, can we say Copper contributes to the production of ATP? How would we validate such a claim? Is there a difference between Member States?
With many claims now on-hold (especially botanicals) a grasp of the science submitted to EFSA means a deep understanding nutrition science is even more important. With on-hold claims seeming to be under political review for at least the next 18-months businesses are looking for any legitimate opportunity to make claims that consumers understand and help communicate the beneficial properties their products can deliver on health - be it performance, weight management or cardio health. However, the lack of legal certainty has resulted in many businesses holding back on just the level or interpretation to adopt on a state by state basis. Furthermore, the complex requirements of understanding of the legal framework and related science inhibits a joined up approach within both the legal services and food industry.
Business want to communicate to consumers and one way they do this is by on-pack claims, social media and also face-to-face. We hear so many times that ‘cleaver’ marketing can overcome claims restrictions (use of imagery) and connect to consumers. However, over the phone or face-to-face engagement with consumers begs the question with that 'clever' approach what are staff going to do; hold up a picture to the consumer? Play a pre-recorded advert? How are SMEs going to reach out with such imagery when they cannot afford a big ad campaign including print media?
Consumer also want to engage with companies through forums and through social media where ‘words’ are as important as imagery and this means knowing what you need and can to ‘say’ to your consumers within the legal bounds of the HCR. The Art of the HCR requires that in advising clients an understanding of their specific market how customers find value in their ingredients, brand, product or total package. Additionally, thought has to be given to the client’s competitors and in this context exists the application of health claims.
One of the biggest concerns raised when beginning compliance work with clients is a fear of what I would call ‘health claims myopia’, in other words being so focused on the regulatory/legal side, consultants forget their clients are trying to sell a 'commercial' product. As such an inflexible approach to health claims work can damage product sales and dent client confidence. Guiding clients must take into consider both legal restrictions (risks) and commercial needs by giving weight to the legal and scientific underpinning of health claims. Managing and balancing the needs of the client with the legal constraints of the NHC is an art and key to effective food law interpretation.