Medicines regulator cancels product licences for non-medicines — now covered by food regulations
They look like medicines: they have a licence number after all and come in a little glass bottle with a dropper and lots of detailed instructions, precautions, restrictions and warnings and even Boots, that trusted pharmacist on the high street, is in no doubt what they are:
There are a very precise 38 'remedies' in the set of original Bach Flower Remedies, all made from different flowers, invented in the 1930s by Dr Edward Bach (pronounced 'Batch'), a medical doctor who studied at University College Hospital, London. However, it wasn't his medical training that led him to come up with these flower remedies. He was also a homeopath, working for some time at the then Royal London Homeopathic Hospital, and apparently believed that:
…early morning sunlight passing through dew-drops on flower petals transferred the healing power of the flower onto the water.
Exactly what healing power of the flower he was referring to is not clear but the remedies were:
…intuitively derived and based on his perceived psychic connections to the plants
He gave them all their own little description, like this one for Pine:
You feel guilty or blame yourself.
“For those who blame themselves. Even when successful they think they could have done better, and are never satisfied with the decisions they make. Would this remedy help me to stop blaming myself for everything?”
These have been used as indications of what 'problem' each product is supposed to address.
Bach Flower Remedies are made by soaking flowers in water and exposing them to full sunlight for three hours or by boiling them in water (and left to cool, outdoors of course). They are then diluted in "40% proof" [sic] brandy, diluted further with grape alcohol and then bottled. The final product typically contains 27% by volume of alcohol.
The most well known one is, of course, Rescue Remedy® (a combination of five different flower remedies), used by many to calm their nerves in times of stress, or as the manufacturer, Nelsons, puts it:
…provide comfort and reassurance for daily stressful situations.
There are now over 50 producers of flower remedies in the UK, but Nelsons is probably the most well-known one, selling products under the Bach Original Flower Remedies brand name with their trade marked®logo.
The 'remedies' are divided into seven categories and have been given new names in recent years:
Old name → New name
Fear → Face your fears
Uncertainty → Know your own mind
Insufficient Interest in Present Circumstances → Live the day
Loneliness → Reach out to others
Oversensitivity to influences and ideas → Stand your ground
Despondency and Despair → Find joy and hope
The newer ones are even woollier than the old ones, but maybe the shift was to move them away from sounding too 'therapeutic'?
Bach finalised his set of 38 remedies in 1935. He died in 1936.
Do they work?
There is little doubt that someone who takes Flower Remedies may well believe they have an effect, but maybe there are placebo effects at play. What does the scientific evidence say?
There have been a few studies done:
We conclude that Bach-flower remedies are an effective placebo for test anxiety and do not have a specific effect.
The results suggest that BFE Rescue Remedy may be effective in reducing high levels of situational anxiety.
This last conclusion might come as a surprise, particularly since the trial was double-blinded, randomised and controlled. However, Prof Ernst has roundly criticised this trial as 'data dredging', saying that the positive result is "clearly based on a post hoc analysis".
It is clear there is no good reason to think Flower Remedies have any specific effects and therefore should not be considered medicines.
This therapy is described as a “therapeutic system that uses specially prepared plant infusions to balance physical and emotional disturbance”. Normally, flower ‘remedies’ are ingested to provide ‘energy’ to overcome negative thoughts. CAP is unaware of a relevant trade body or regulatory organisation. The method seems to lack scientific rigour and is supported mainly by anecdotal reports. In the absence of more compelling evidence, marketers are advised not to make claims for the efficacy of this treatment (Rule 12.1).
We've mentioned Product Licences of Right (PLR) before in relation to homeopathic 'medicines', but the same applies to Bach Flower Remedies: they were given a free pass over 40 years ago and allocated a PLR licence number. Like homeopathy, the manufacturers have not had to provide any evidence whatsoever for claims made for these products. It is an anachronism that can only mislead the public.
The MHRA launched an informal consultation in January 2011 to look at some of these issues, hoping to use the upcoming review of the Medicines regulations to scrap the PLR scheme for all products:
The MHRA considers that it would be undesirable to use the current review of the Medicines Act and associated legislation to further perpetuate the existence of PLRs. This kind of licence, by its nature is envisaged as a pragmatic, temporary arrangement until products are reviewed and, where appropriate, moved to an ongoing regulatory scheme where they meet the relevant standards. It is highly desirable that product licensing schemes should reflect current regulatory standards and not represent a hangover provision from a number of decades ago. The review of the Medicines Act provides a suitable opportunity to bring the PLR arrangement to a close. This would also have the benefit for homeopathic products of achieving improved consistency of regulatory provision for labelling and advertising. This will better enable MHRA to regulate the market for these products. Improved patient information will benefit the consumer and facilitate informed choice.
In considering Flower Remedies specifically, they said:
A number of PLRs are for Bach 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. 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.
This didn't happen: there was no mention of this in the consolidated medicines regulations.
However, the MHRA have not been idle. There may well have been lobbying from Flower Remedy manufacturers — we suspect there was, but we don't yet know. But as a result of an FOIA request we submitted a few months ago, we now know that Bach Flower Remedies are no longer classed as medicines and have been relegated to being just food.
We asked the MHRA:
Question 4: Can you confirm that you still agree with your proposal of January 2011 that Bach flower remedies no longer be regulated as medicinal products? If so, what are the timescales for this?
Response 4: The MHRA contacted Nelsons on 29 July 2013 to advise them 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. However, such products already on the market may be sold through and will not need to be recalled.
So, as of today, Bach Flower Remedies are not allowed to be placed on the market with a PLR licence number and they must have no medicinal or homeopathic references. That includes therapeutic indications, but exactly what that means isn't too clear.
We should now (or at least after products have cleared the supply chain) no longer see Bach Flower products with misleading licence numbers and they should no longer have homeopathic/medicinal references in their packaging or their advertising.
Since they are no longer medicines, they are just foods now and health and nutrition claims fall within the remit of EU Directive 1924/2006, as enforced by European Food Standards Agency (EFSA). In the UK, advertising claims under EFSA regulations are regulated by the Advertising Standards Authority.
So, if advertisers of Bach Flower Remedies use the same claims as they have in the past, are they likely to be EFSA-compliant?
Given the lack of evidence, it would seem unlikely: but it's very easy to check the EFSA Register on nutrition and health claims. The Bach Flower products are, of course, mostly alcohol, but even if the decoctions of the various flowers are in sufficient quantities to be considered ingredients, it would be easy to check the EFSA register for all 38.
But there is no need.
Foodstuffs that contain more than 1.2% by volume of alcohol are singled out specifically in the EFSA rules:
Beverages containing more than 1,2 % by volume of alcohol shall not bear:
(a) health claims;
(b) nutrition claims, other than those which refer to a reduction in the alcohol or energy content.
So, because Flower Remedies contain little more than alcohol, they are not allowed any health claims whatsoever. Whether the flower ingredients themselves warranted any authorised health claims is entirely moot.
But are the words in the category names implied health claims? Is the woolly description for each product a health claim? Can they still be called 'remedies'? What about 'Rescue Remedy'?
A German court gives us the answer.
In Germany, there is no equivalent PLR scheme and in August 2013, a regional court in Bielefeld, Germany confirmed that Bach Flower products are indeed covered by the EFSA regulations (HCVO in German) and confirmed that medicinal claims were not allowed.
This was a case brought by a trade association against a pharmacist who was selling Bach Flower products online. The association claimed unfair competitor behaviour from the pharmacist by falsely advertising both "RESCUE® - The original Bach® Flower mix" and "original Bach Flower essences" in general with health claims. Note the slightly different product names used in Germany — they don't include the word 'remedy', although this is sometimes seen on Bach products in Germany directly imported from abroad.
The defending pharmacist was supported in their case by their supplier for these products, that in the court's judgement was referred to as "the German subsidiary of B. & Co. Ltd. from England", as "sister company of B. Ltd. - the producer of the original Bach Flower products", and as "the German sales branch for all their respective products". We believe this means that they were supported by Nelson GmbH in Hamburg, the German distribution subsidiary of A Nelson & Co Limited, the multi-million pound UK company that produces Nelsons homeopathic products.
The accused argued that they didn't make any actual health claims but only referred to "potential improvements in general well-being". The court wouldn't have any of this, as they said the advertisement clearly refers to specific circumstances of life where the Flower products "could be" helpful, and the HCVO regulation asks for a broad interpretation of "health claims" to make sure consumers are protected: "even unspecific indications with reference to health are to be considered health-related indications under the HCVO".
When the supplier argued to support the accused, they suggested their ordinary customer would not consider their claims as health-specific (which would require scientific evidence), but only expect that "those products were designed for and would have some impact on specific everyday emotional states". "These expectations are fulfilled by the Bach Flower products", they continued, "be it because of their energetic properties as ascribed to them by Edward Bach, or because of the reminder or suggestive function that accompanies their consumption." They would appear to be simply saying the products provide placebo effects and no more!
But the court ruled these were claims towards psychological support and hence qualified as health claims no matter how unspecific the manufacturer thinks the claims were.
So it does appear that even the woolly claims are not allowed, and the pharmacist was told to stop making them. If the pharmacist continues to make the stated claims, they can fine him up to €250,000 cash or send him to jail for up to two years if he doesn't pay the fine. That's worth repeating: up to €250,000 in fines or up to two years in jail.
The pharmacist has to pay for the trial costs, and the Bach Flower company, who supported him in his defence, has to cover their own costs.
How much this has cost the pharmacist and the German and UK Bach Flower companies we cannot know. Because of the importance of the case, we suspect it was fought hard. What we can do is look at the finances of the UK company:
Data from Company Check
It's good to see the MHRA finally catch up and cancel the PLRs for these non-medicines — even if it has taken 40 years — and we urge them to do the same for homeopathy PLR products so that the public are not misled into thinking they are medicines.
However, now Bach Flower products are just foods, we look forward to manufacturers and all others who supply and advertise these products to fully comply with the EFSA regulations, enabling the public to make fully informed choices.
We believe the German ruling sets a precedent that is binding in the UK, but if we have to test the various claims for Bach Flower Remedies with a complaint to the ASA, we will.
29 January 2014
02 February 2014
The Advertising Standards Authority has now updated its guidance on Therapies: Bach and other flower remedies:
This section should be read in conjunction with the entry on ‘Therapies: General’.
Bach flower remedies are described as “a system of 38 Flower Remedies to help mankind achieve joy and happiness”. CAP understands that at the time the Medicines Act (1971) was implemented, Product Licences of Right (PLRs) were issued to all medicines, including homeopathic remedies, and that a number of PLRs were granted for Bach flower remedies.
In January 2014 the MHRA took the decision that Bach flower remedies would no longer be regulated as medicines but instead be classified as foods. Any health or nutrition claims made for foods must be made in accordance with those claims permitted on the EU Register and Annex. CAP understands that some Bach flower remedies contain levels of alcohol which would preclude them from bearing health claims altogether (Rule 18.17). While it may be possible for a flower remedy to carry a nutrition claim, the nutrition claims permitted for products containing alcohol are limited.
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