The European Food Safety Authority’s (EFSA) recent backing of folate’s (vitamin B9) ability to reduce the risk of spinal birth defects is a good thing for infant health and the vitamin industry – but is it actually a prohibited disease claim in disguise? asks author and consultant, Bert Schwitters.
Manufacturers of products offering folate rejoiced when, on July 11 2013, EFSA published a positive, article 14 opinion , suggesting that the claim, "Supplemental folate intake increases maternal folate status. Increasing maternal folate status contributes to the reduction of the risk of NTD", may be accepted by the European Commission as a disease-risk-reduction claim. NTD is the abbreviation of ‘neural tube defects’.
While this is good news for pregnant women and their babies, the reasoning applied by EFSA's Panel on Dietetic Products, Nutrition and Allergies (NDA) to reach a positive conclusion is of particular interest for the food business industry. In its opinion, the NDA Panel has opened the door for claiming a direct causal relationship between a deficiency in a food or one of its components and a disease, and an equally direct causal relationship between taking care of the deficiency by supplementing the daily diet and the prevention of the occurrence of that disease.
In its folate opinion, EFSA consistently uses the term "supplemental folate." The term implies that we should make up for a deficiency, presumably in the form of a food supplement or through the addition of folate to certain foods intended for use by women of child-bearing age. Other than the folate deficiency that supplemental folate takes care of, no risk factor is mentioned in the opinion. The folate deficiency is the risk factor and so, in all its simplicity, supplementing the diet with folate significantly reduces this risk factor.
When folate deficiency is the risk factor, a direct relationship between folate status and NTD is established. In other words, supplemental folate does not reduce a risk factor in the development of NTD other than the deficiency itself. Likewise, supplemental vitamin C does not reduce a risk factor in the development of scorbut, other than the vitamin C deficiency itself.
In article 14 of the nutrition and health claims regulation (NHCR), the EU legislature used the word ‘risk factor’ to create a minute but legally justifiable difference between disease-risk-reduction and disease prevention.
In the prevention of diseases, there is a direct and causal relationship between the preventive measure and the occurrence of the disease. Preventive medicine or preventive care consists of measures taken to prevent diseases. Prevention targets the disease. This places prevention in the legal context of medicinal products law.
Disease-risk-reduction is not prevention, because there is only an indirect, non-causal relationship between the risk-reductive measure and the disease. Risk reduction targets the risk factor, not the disease. Cholesterol being a risk factor for heart disaease is an example. This makes disease-risk-reduction claims possible under EuropeanFood Law, under article 14.
Risk reduction, disease prevention
The fine difference between risk reduction and prevention was erased in EFSA's folate opinion as the claim is medicinal in nature. After all, when low folate status is the risk, supplemental adequate folate causes the benefit of preventing NTD.
However the risk that the folate opinion could be interpreted as endorsing a medicinal claim, is significantly reduced by the systematic insertion of the word 'risk', which masks the direct relationship between supplemental folate and the prevention of NTD.
In the ‘Scientific substantiation of the claimed effect’ section of the opinion, the NDA refers to work by researchers and health authorities that refers to such direct relationships between folate status and prevention of the NTD disease.
Risking 'risk of'
Although the word ‘risk’ frequently and inappropriately pops up in the context of prevention, this should not mislead us to think that by intentionally or unintentionally spraying texts with the word ‘risk’ we're no longer in the field of prevention. EFSA's folate opinion clearly concerns the prevention of NTD by supplementing the daily diet with supplemental folate.
Does that turn a food supplement containing 400 μg of folate into a medicine? Of course not. Does that turn the folate disease-risk-reduction claim into a medicinal claim? Of course not.
In this respect EFSA is to be commended for taking the step to place prevention in the context of disease-risk-reduction under article 14 of the NHCR. It opens the door to numerous disease-risk-reduction claims concerning the use of ‘supplemental’ food constituents in the prevention of the occurence of a disease.
Just make sure that in your application for authorisation you insert the words ‘risk of’ before the name of the disease.
Further explanation of the difference between disease-risk-reduction and disease prevention can be found in Schwitters’ NHCR critique, Health Claims Censored.