The UK medicines agency has reclassified the ‘wellbeing’ botanical Bach flower as a food stuff, making it subject to EU health claim laws.
The change followed a 2011 consultation where the Medicines and Healthcare Products Regulatory Agency (MHRA) recommended ending the medicinal status of Bach flower and other ‘flower remedies’.
“MHRA intends to take the position, against the criteria set down in European legislation, that such products should normally no longer be regulated as medicines,” the agency wrote at the time.
“Indeed there are many Bach flower remedies on the UK market, (and we understand on the markets of other EU Member States) that are legally supplied under other regulatory categories, such as food supplements. This change would represent a useful simplification and create a more level playing field for suppliers of this kind of product.”
Bach flower remedies consist of 38 versions that were developed by Dr Edward Bach in the 1930s. Bach Natural Flower Remedies are owned by natural products specialist, Nelsons Natural World in the UK.
In the UK, the Nightingale Collaboration, a group that, “challenges misleading healthcare claims” welcomed the move from the MHRA, about which it made a freedom of information request about last year.
That enquiry led to the MHRA acknowledging that had in the middle of last year advised Nelsons, “that all Product Licenses of Right for Bach flower remedies would be cancelled and that products quoting Product License of Right reference numbers and that include homeopathic/medicinal references on their packaging must be cleared from warehouses within 6 months and must not be put on the market after 28 January 2014.”
Products already on-shelf could be sold through, MHRA noted.
Nelsons said it was ensuring, "all packaging has a seamless transition and that the change is made with no disruption to our customers or consumers."