PAGB response to SACN Draft – update on folic acid

Published on: 1 March 2017


Proprietary Association of Great Britain (PAGB) is the UK trade association for over the counter medicines, medical devices and food supplements. We represent the major manufacturers of these products in the UK, many of whom are multinationals with experience of regulatory structures worldwide. PAGB member companies currently account for 50% of the branded UK market in food supplements.

We note SACN acknowledges that where evidence exists in relation to folate intakes impacting on vitamin B12 deficiency, such evidence indicates that this relates to interventions in excess of 1mg/d. Evidence from the UK Nutrition and Diet Survey (NDNS) years 5 and 61 indicates that even at the 95th percentile intakes fall far below that. It is unlikely that contributions from fortification will lead to intakes exceeding 1mg/day of folic acid.

The evidence evaluated by SACN on the impact of folate on all forms of cancer found that whilst there is some evidence of increased risk, this is genotype specific. Conversely, there is consistent evidence to show a protective effect of an intake of 400µg/d folic acid against the development of neural tube defects (NTDs) across the entire population (other than those individuals who have a genetic predisposition and require higher intakes).

A problem with the assay of unmetabolised folic acid (UMFA) was identified by the NDNS contractor and the final figures have not been published. However early indications are that serum free folic acid concentrations in the UK populations are low which in turn implies that UMFA is unlikely to present any significant risk in the UK.

Whilst it is not within SACN’s remit to consider the economic and social implications of health policy, these should, at the least, be acknowledged. A systematic review of the economic burden of NTDs from 20112 found average costs (in Euros) for a patient with spina bifida (aged 1 year) to be €34,007 as opposed to a cost for a patient of the same age but with no NTDs of €5,582. In addition, all studies suggested that the use of folic acid in preventing NTDs was, overall, cost effective.

A study published in 20173 found that if the UK had implemented folic acid fortification in 1998, approximately 2014 fewer pregnancies would have been impacted by NTDs. Average termination rate for pregnancies impacted by NTDs is 81% and it is worth noting that as NTDs are not generally diagnosed until the 20 week scan these terminations are all regarded as “late stage” which takes a significant emotional toll of parents and healthcare professionals alike.

PAGB welcomes this review of new evidence, however despite several decades of recommendations for supplementation the prevalence of NTDs has not decreased4. There is recognition that any approach in resolving the occurrence of NTDs should be holistic and multifactorial and unless action is taken to implement policy on this issue, the current incidence of avoidable NTDs within the UK will continue.