Friday 20 March 2009

Duchy Originals: Told off by MHRA

Just a quick update to my post earlier today. The MHRA have had a go at Duchy Originals for misleading advertising of their tinctures.

Here's what they had to say:

A member of the public complained to the MHRA about the advertising of Duchy Herbals Echina-Relief Tincture and Duchy Herbals Hyperi-Lift Tincture which appeared on the Duchy Originals website from 24 January 2009. The complainant alleged that the advertising suggested that the products had been assessed for efficacy and was therefore misleading.

The MHRA upheld the complaint. Nelsons, the registration holder, on behalf of Duchy Originals agreed that they would amend their advertising and remove claims of efficacy from their website and all future advertising. Following delays in implementing the changes, Nelsons provided additional training to Duchy Originals staff on the legislative requirements.

MHRA advice
These two products have been registered under the Traditional Herbal Medicines Registration Scheme as required by Directive 2004/24/EC on Traditional Herbal Medicinal Products. The MHRA, as UK regulator, is required to assess applications for traditional herbal medicinal products for safety, quality and evidence of traditional use. Efficacy of the product based on scientific data is not assessed, although the MHRA is required to refuse registration if efficacy on the basis of long established traditional use is not plausible.


Date case raised: 26 January 2009
Date action agreed: 30 January 2009
Date of publication: 20 March 2009



Hats off to the complainant!

Duchy Originals Tinctures: Never described as a cure, treatment or remedy. Oh really?

Back in January I posted about Duchy Original’s new range of herbal tinctures and the claims they were making for them.

The story was picked up in the mainstream press when Prof. Edzard Ernst, the UK’s first Professor of Complementary Medicine, accused Prince Charles and his advisors of deliberately ignoring science and promoting quackery, claiming they “financially exploits a gullible public in a time of financial hardship."

The main criticism, not only from me but also from other bloggers (such as Rob Hinkley at semiskimmed.net) was that Duchy Originals were claiming that the tinctures had been tested for efficacy, and were basing this claim on MHRA approval of the product. The MHRA specifically state that they do not test medicines for efficacy and that they are only tested for safety and quality.

Since then, Duchy Originals have changed their product descriptions of their site to reflect that. For example, their Hyperi-Lift Tincture is now described as:

A traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety, based on traditional use only. “
(my emphasis)

This is to be welcomed. What is less welcome is the fact that Duchy are still trying to claim they never did anything wrong. In a recent article in the Daily Telegraph , a Duchy Originals spokesman made the following statement about their Detox Tincture:

It is not – and has never been described as – a medicine, remedy or cure for any disease.”


It’s interesting that he chose to talk about their Detox Tincture, since they had made medical claims about other tinctures. Indeed, they had even stated:

Each of our tinctures provides an alternative and natural way of treating common ailments such as colds and flu.”


The Detox tincture is the only one that didn’t’ need MHRA approval as it’s being sold as a food supplement.

It’s somewhat disingenuous of them to imply that they hadn’t therefore made claims about their products efficacy.

Duchy Originals have also felt the need, given the bad publicity this has caused, to put the following statement up on their blog:

Following recent press articles regarding our Duchy Herbals range, we are aware that some of our customers may be seeking reassurance about the range. Our CEO, Andrew Baker, says: 'Together with our partners, Nelsons - leaders in the field of natural medicine, we spent many years researching and developing our first range of herbal tinctures. It is a range that we are truly proud of. Our Duchy Herbals Echina-Relief Tincture and Duchy Herbals Hyperi-lift Tincture have both been approved and licensed as traditional herbal medicines by the UK regulatory authorities, the Medicines and Healthcare Products Regulatory Agency (MHRA). Our Duchy Herbals Detox Tincture, which is traded as a food supplement, has been produced to the highest quality standards and within the regulatory framework of both UK and European food law. I do hope, therefore, that you are able to share our confidence in the compliance of the Duchy Herbals range to the very highest regulatory standards.' We'd love to hear what you think, click on comments below and send us your thoughts.


As you can see, they’d “love to hear what you think”, so why don’t you tell them?

Lots of people have been telling them, but for some reason their posts are still “awaiting moderation”, mine included. I wonder if they’ll ever get published?

Here’s a selection of comments that a range of people across teh interwebz have left, which are still awaiting moderation, starting with my own. It could be a long wait:

What you fail to mention, again, is that MHRA approval does not give any indications as to effectiveness. The MHRA never make any claims as to a products efficacy, just that it is safe to use and has been well manufactured. This is not in doubt.

What is in doubt is whether or not these tinctures have any effect. Nothing you have said removes any of that doubt.

Where is your evidence that these tinctures work
?



“Beermonkey” from the Badscience.net forums left the following:

While I don't doubt that the tinctures are produced to a high standard, is there any actual evidence that they work? As far as I'm aware, that isn't covered by the 'regulatory framework' you mention; you simply have to demonstrate that they've been taken for a long time, which isn't the same thing at all.

If you're going to sell a mixture claiming to alter your digestion, your immune response or especially your brain chemistry, it seems reasonable to ask you to back up your sales patter with some real evidence. If these tinctures work, they could have some major effects that need investigating; if not, selling them is a waste of everyone's time, however traditional they may be
.


“Alan H” over at Thinkhumanism.com:

Yes, yes. You've provided evidence that your 'tinctures' are safe and of a certain quality, but they still don't work. And that's what's different between your products and proper medicines: they have to provide proper evidence that they work. Dodgy Originals don't have to bother with such minor details!

Yet, you make claims that will fool customers into thinking they need it and that your product actually has some effect. You sell it like a medicine, with careful use of language. You take great pride that your products are 'regulated', just like proper medicines, but you don't fool everyone.



“Stvb2170”, again from Badscience.net wrote:

Customers seeking reassurance are probably not concerned whether the products are of high quality (I'm not entirely sure what that means) or that they are produced within legal regulatory frameworks (the minimum you would expect). What customers would probably like reassurance on is that these products are of any benefit as this is the reason that they have been fairly criticised in the media.

Is there any evidence that each of these products is beneficial and hence worthy of the price tag
?



I’m sure there are many more out there also awaiting moderation. If you posted something that hasn’t shown up yet, why don’t you post it below for the record?

I will be pleasantly surprised if Duchy Originals do finally allow these messages on their site!

Thanks to Dr*T over at Thinking is Dangerous, who has also written about this