Guest guest Posted September 19, 2006 Report Share Posted September 19, 2006 Hi Stuart, Well, as you asked, here goes! Your comment: > As herbalists, we already know that tinctures and liquids are far more > unstable than solid extracts. Interestingly, and worryingly, tinctures > already subjected to testing do not appear to make the grade. This hasn't been our experience at all. First of all, this is a bit of a generalisation. If you take a very hydrophobic tincture, of let's say, Commiphora - myrrh in 90% alcohol, there is little reason to suspect any degradation in solubilised components over a time scale of thousands of years. On the other hand, some plant extracts, say lipids, degrade in a matter of minutes if purified, and so have to be bound into excipients in some standardised extracts. We have done a little stability testing, actually not of simple tinctures, but of proprietory mixtures made up of our fresh plant tinctures, specifcally bcause the MHRA told us that they had a real concern about the stability of mixtures. In two years, we have yet to detect any degradation in the marker compounds at all. (btw, the 'finerprints' of phytochemistry you referred are hardly ever the same as herbalists 'active components' ). I would be shocked if the markers remaining after stability trials were only 5 - 10%. I would say 75% was rather more reasonable. If tinctures don't 'make the grade' after stability testing, I doubt they did before hand. When you say 'do not appear to make the grade' what exactly do you mean? I am aware that we are constantly seeing exceptionally speculative sciencey stuff put out, in the name of marketing. This sort of thing is grossly unfair on the practitioner and public alike and is just the sort of 'claim' that MHRA need to regulate, so that we are not all duped. Microbiology and heavy metal testing doesn't cost thousands (although the capital cost of the equipment does). Such tests cost from a few pounds up to a hundred or so at most. So therefore, we don't agree at all with your conclusion: So what is > happening now is that companies are dropping liquid extracts in favour of > solids in tablets and capsules. This trend means that post 2011 companies > with registered/licensed products for OTC sale to the public will be > selling > tablets or capsules. Indeed we are putting lots of research effort into ensuring that traditional herbal tinctures, of the sort which herbalists have used in the UK for hundreds of years, will continue to be available, but with guarantees of quality which never before could be assured. All the best, Chenery www.rutlandbio.com Worrying prospect! >I have been examining the detail of the 'Traditional European Herbal > Directive' and how it affects production of tinctures, tablets, capsules > etc. > The biggest problem for suppliers of OTC tinctures etc is that all > products > have to be quality and stability tested. This means, in short, that all > herbal products have to justify the shelf-life applied to them by > manufacturers, suppliers etc. This means that 'fingerprints' of active > constituents have to remain within 5-10% of the starting point through the > life of the product (it also means microbiological and heavy metal type > testing etc...all costing thousands) . Most companies would be looking for > a > 2 year shelf-life. > As herbalists, we already know that tinctures and liquids are far more > unstable than solid extracts. Interestingly, and worryingly, tinctures > already subjected to testing do not appear to make the grade. So what is > happening now is that companies are dropping liquid extracts in favour of > solids in tablets and capsules. This trend means that post 2011 companies > with registered/licensed products for OTC sale to the public will be > selling > tablets or capsules. This will leave us with the interesting position of > companies using 'high quality, tested, legal, registered products', and > herbalists using unregistered, and as far as the 'authorities (MHRA)' are > concerned, poor quality and untested tinctures. We are then one step away > from the MHRA advising that the public not use unregistered, untested > products, which is only a short step away from a ban. Fuel (i.e. cash and > publicity) for such a ban could come from the MHRA's own publicity machine > and herbal companies post 2011 with vested interests in products that took > thousands of pounds to register. > Is anyone as scared as I am? What are all you tincture makers doing? Any > thoughts? > Stuart Fitz > > > > List Owner: Graham White, MNIMH > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2006 Report Share Posted September 19, 2006 The markers are decided by the manufacturer in their license application Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2006 Report Share Posted September 19, 2006 Hi Stuart/, Who decides on what the so called 'active constituents are? Surely if this is the MHRA, with no herbal knowledge, standardising to an arbitrary constituent does not measure quality? It measures the amount of 1 constituent which puts them on a par with pharmaceutical drugs and will not predict their medicinal qualitites. The basis of herbal medicine is the interaction of multiple constituents in a plant and this needs to be taken into account. Kate. Worrying prospect! >I have been examining the detail of the 'Traditional European Herbal > Directive' and how it affects production of tinctures, tablets, capsules > etc. > The biggest problem for suppliers of OTC tinctures etc is that all > products > have to be quality and stability tested. This means, in short, that all > herbal products have to justify the shelf-life applied to them by > manufacturers, suppliers etc. This means that 'fingerprints' of active > constituents have to remain within 5-10% of the starting point through the > life of the product (it also means microbiological and heavy metal type > testing etc...all costing thousands) . Most companies would be looking for > a > 2 year shelf-life. > As herbalists, we already know that tinctures and liquids are far more > unstable than solid extracts. Interestingly, and worryingly, tinctures > already subjected to testing do not appear to make the grade. So what is > happening now is that companies are dropping liquid extracts in favour of > solids in tablets and capsules. This trend means that post 2011 companies > with registered/licensed products for OTC sale to the public will be > selling > tablets or capsules. This will leave us with the interesting position of > companies using 'high quality, tested, legal, registered products', and > herbalists using unregistered, and as far as the 'authorities (MHRA)' are > concerned, poor quality and untested tinctures. We are then one step away > from the MHRA advising that the public not use unregistered, untested > products, which is only a short step away from a ban. Fuel (i.e. cash and > publicity) for such a ban could come from the MHRA's own publicity machine > and herbal companies post 2011 with vested interests in products that took > thousands of pounds to register. > Is anyone as scared as I am? What are all you tincture makers doing? Any > thoughts? > Stuart Fitz > > > > List Owner: Graham White, MNIMH > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 19, 2006 Report Share Posted September 19, 2006 Dear Kate, You are quite correct but the MHRA most certainly do not decide which is the active constituent. Indeed, they conceded years ago (despite constant rumour mongering) that the active components of herbs (which are not usually chemical compounds [despite what many were taught on our courses] but consist of what we might call complexations of what you called multiple constituents) are not something which can be regulated at all. They just require assay of agreed marker compounds, which only go some way to demonstrate that the plant you have extracted has some known relationship with the plant which was harvested for the purpose ! Chenery www.rutlandbio.com Worrying prospect! > > >I have been examining the detail of the 'Traditional European Herbal > > Directive' and how it affects production of tinctures, tablets, > capsules > > etc. > > The biggest problem for suppliers of OTC tinctures etc is that all > > products > > have to be quality and stability tested. This means, in short, that all > > herbal products have to justify the shelf-life applied to them by > > manufacturers, suppliers etc. This means that 'fingerprints' of active > > constituents have to remain within 5-10% of the starting point through > the > > life of the product (it also means microbiological and heavy metal type > > testing etc...all costing thousands) . Most companies would be looking > for > > a > > 2 year shelf-life. > > As herbalists, we already know that tinctures and liquids are far more > > unstable than solid extracts. Interestingly, and worryingly, tinctures > > already subjected to testing do not appear to make the grade. So what > is > > happening now is that companies are dropping liquid extracts in favour > of > > solids in tablets and capsules. This trend means that post 2011 > companies > > with registered/licensed products for OTC sale to the public will be > > selling > > tablets or capsules. This will leave us with the interesting position > of > > companies using 'high quality, tested, legal, registered products', and > > herbalists using unregistered, and as far as the 'authorities (MHRA)' > are > > concerned, poor quality and untested tinctures. We are then one step > away > > from the MHRA advising that the public not use unregistered, untested > > products, which is only a short step away from a ban. Fuel (i.e. cash > and > > publicity) for such a ban could come from the MHRA's own publicity > machine > > and herbal companies post 2011 with vested interests in products that > took > > thousands of pounds to register. > > Is anyone as scared as I am? What are all you tincture makers doing? > Any > > thoughts? > > Stuart Fitz > > > > > > > > List Owner: Graham White, MNIMH > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 25, 2006 Report Share Posted September 25, 2006 Stuart I am concerned at where you get the £20 k per herb. Normal charges for ICHC storage is £80 per month and tests should cost around £100 each month. This means that the cost is more in the region £1100 than £20,000. Regards Whitton Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 25, 2006 Report Share Posted September 25, 2006 Stuart Why pay them when the MHRA will provide most of the information for free. I have looked up the company you mentioned and am surprised they can offer this service as from what I know of the people involved they have no knowledge or qualifications and certainly no UKAS validation to offer these services. Regards Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 25, 2006 Report Share Posted September 25, 2006 Sorry, by 5-10% I meant that markers must not degrade more than this over the given trial period. Testing is expensive. If you approach a company to put your tinctures through testing for you it costs about 20K per herb (thanks to, as you say, having to get the cost of machinery back). I know though that the actual tests are not that expensive per se. The marker chemicals are based on the European Pharmacopoeia. If a herb is in there it must comply with that, if not you have to justify your 'profile'. So what herbs did you test, how did you test them, and what were the results? In other words, what are your guarantees of quality? Stuart Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 25, 2006 Report Share Posted September 25, 2006 Stuart The MHRA will agree what marker compounds need to be measured and they will help with the requirements for GMP. The format for the dossier is freely available on their website and the information required is also listed. As far as getting the stability testing done they will advise on methodology but cannot reccomend people who can perform it. If you are looking for people who can do this then a good place to look is the Royal Society of Chemistry website as they have lists of consultling chemists who specialise in this area who are fully accredited. If you need further help please contact me offline. I can help put dossiers together and provide contact details for companies who can help. I can provide the testing facilities for you if needed. Regards Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 25, 2006 Report Share Posted September 25, 2006 People like BPI Global Research. I know it does not cost much if you have access to the equipment, but I'm talking about companies bringing products to market and being able to fill out the dossiers for those products. Stuart Quote Link to comment Share on other sites More sharing options...
Guest guest Posted September 26, 2006 Report Share Posted September 26, 2006 What free information are you talking about ? Quote Link to comment Share on other sites More sharing options...
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