The call has raised “major concern” for the Health Food Manufacturers’ Association (HFMA), which believed such recommendations would lead to confusion and undermine safe and widely-used ‘unlicensed’ vitamin D products.
Internis Pharmaceuticals, a manufacturer of vitamin D, said that food supplement products were not licensed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and were not therefore subject to its strict control.
The UK’s National Institute for Health and Care Excellence (NICE) has published draft guidance to help improve the implementation of existing recommendations on vitamin D to prevent deficiency.
The guidance focused on advice for at-risk groups to take vitamin D supplements. It also recommended that the Department of Health (DoH) work with manufacturers to ensure wider availability of vitamin D supplements supplying the recommended nutrient intake.
However, three vitamin D specialists - Dr Brian Curwain, Dr Sally Hope and Dr Michael Stone - and firm Internis Pharmaceuticals, said they feared that “unless the guideline makes clear that only licensed vitamin D products should be recommended, prescribed and dispensed”, at-risk groups, such as pregnant women and young children, could receive either a sub-therapeutic or an excessive dose.
Varying composition?
One of the experts, Dr Brian Curwain, an independent pharmaceutical consultant, said: “Food supplements are variable in their composition, both in terms of the active ingredient and potentially allergenic excipients, colours, etc that they contain.
“It is important that NICE acknowledges that there are greater risks to health professionals in terms of their legal responsibility in supplying food supplements than in licensed vitamin D medicines.”
Internis highlighted research that found products without an MHRA licence have a larger variation in the percentage label claim of vitamin D content, compared to licenced products.
HFMA response
Graham Keen, HFMA executive director, told NutraIngredients it and other industry organisations have been working with the DoH regarding messaging on vitamin D products targeting at-risk groups.
He added: “As such, we are very wary of unnecessary pharma-backed pressures for future guidelines to only recommend licensed vitamin D products, and of course we wholeheartedly disagree.
“This is a major concern as it has the potential to cause confusion over what is an extremely important public health issue, as well as ruin the great existing work to help increase essential supplementation consumption.
“There are a wide range of vitamin D products, including food supplements, that have an exceptional record of safety and efficacy, and which play a big role in helping prevent deficiencies here in the UK and should continue to do so in the future.”
Public consultation on the draft guidance closes on 24 June and final guidance is expected in November.