Medicines agency intervention on regulation for botanical supplements
The French food supplement association, SYNADIET, has received a letter from its Food Agency (DGCCRF) which has confirmed fears about possible conflict between regulation in France for botanical food supplements and herbal medicines.
DGCCRF advises that the French Medicines Agency (AFSSAPS) is considering the possible reclassification of products containing botanical ingredients previously authorized by DGCCRF as appropriate for use in food supplements because they consider the ingredients to be 'medicinal by function.'
The botanical ingredients particularly singled out by AFSSAPS are:
- Artichoke leaves, because of their purgative effect
- Horsechestnut, because of the aesculin content and the anti-oedematous, anti-inflammatory effect
- Lesser Holly root, because of its saponin content and its effect on the vascular on circulatory system.
Confirming that in cases of doubt, medicines legislation takes priority over food legislation at national or European Community level, DGCCRF refer to a statement in their public health code, based on Art. 2 of European Directive 2004/27, amending Directive 2001/83 on medicinal products: 'In cases of doubt, where, taking into account all of its characteristics, a product may fall within the definition of a "medicinal product" and within the definition of a product covered by other Community legislation, the provisions of this Directive shall apply.'
Synadiet is now taking legal advice on possibilities for future action to safeguard botanical food supplements.
Vitamin D supplements recommended for infants
Following the identification by its Scientific Committee of the re-emergence of rickets, previously thought to have been eradicated, the Food Safety Authority of Ireland (FSAI) has issued a report, Recommendations for a National Policy of Vitamin D Supplementation for Infants in Ireland,in which it advocates vitamin D supplementation for all babies under 12 months, and particularly for those with dark skins.
While most of the cases of rickets have been in children of African-born parents, the FSAI is also concerned that much of the indigenous Irish population may also be deficient in vitamin D as a result of Ireland's northerly latitude and consequently restricted sunlight during the winter months.
In advocating supplementation, the FSAI report makes the point that dietary sources of vitamin D — including fortified foods — do not adequately raise the level of vitamin D in the Irish population.
FSA advice on folic acid
Following a positive recommendation from its Scientific Advisory Committee on Nutrition and a subsequent public consultation, the Board of the Food Standards Agency (FSA) is to recommend to UK health ministers the mandatory fortification of either bread or flour with folic acid.
The Board also agreed that Health Departments should be encouraged to educate the public, and particularly at-risk groups, on the issue of folic acid and neural tube-defects. Their recommendations will also include controls on the voluntary fortification of foods with folic acid, and clearer advice consumers on taking supplements, so as to avoid over-consumption.
The decision on whether folic acid should be added to bread or flour is expected shortly, along with consideration of labelling.
Goji berries and Novel Food status
In response to a request from the FSA for evidence of the Novel Food status of Goji berries (Lycium barbarum), the Health Food Manufacturers Association (HFMA) has compiled a dossier of evidence demonstrating that Goji berries have a 'significant' record of consumption in the European Union prior to 1997.
The FSA's response is now awaited.
Draft opinion on refined echium oil and baobab
The expert advisers on novel foods and processes of the FSA have formed an initial opinion to approve two applications to market novel food ingredients.
The Advisory Committee on Novel Foods and Processes (ACNFP) is calling for comments on its two draft opinions on refined echium oil and baobab dried fruit pulp.
Echium oil is a vegetable oil rich in omega-6 and omega-3 polyunsaturated fatty acids obtained by super refining oil extracted from the seeds of Echium plantagineum. The applicant wants to use its refined echium oil as a novel food ingredient in a range of food products and in food supplements.
Baobab dried fruit pulp is derived from the fruits of the baobab tree, also known as the 'upside down tree'. In this case the applicant proposes to market a baobab dried fruit pulp as a novel food ingredient for use in range of food products.
The ACNFP is a non-statutory, independent body of scientific experts that advises the FSA on any matters relating to novel foods (including genetically modified foods) and novel processes (including food irradiation).
Any comments on the ACNFP's draft opinion should be sent to the ACNFP Secretariat by 20 June.
For further information, go to http://www.food.gov.uk/news/newsarchive/2007/jun/baoech