Unfortunately, Chinese herbal medicine has enticed negative attention when an article revealed that a multidisciplinary approach to assess the molecular content of 26 patents described found that 92% of their samples have some form of contamination and/or substitution.
The research was funded through an Australian Research Council Future Fellowship awarded to Michael Bunce and a National Health and Medical Research Council grant.
Details about the products that were randomly purchased and tested have not been revealed but it was apparent that at least 50% of these purchased products were not listed on the ARTG (Australian Register Therapeutic Goods) and hence regulated by the TGA (Therapeutic Goods Administration).
What is sure is, that they were so called pre-packaged products (‘patents’). The composition of the products is derived from classical formulas, possibly modified with additional herbs and then sold as Hay fever tablets, Clear Cough, Menopause fix or something along those lines. These products are widely available through many channels, over the counter (OTC).
If these products are pre-packaged and sold over the counter, they have to be listed with the ARTG (the TGA register). If they don’t have an AUSTL or an AUSTR reference, they are sold illegally.
As registered Acupuncturists in Australia, the law permits us to recommend or sell those patent products. As registered Chinese herbalists, we also dispense customized herbal formulas to our patients. These formulas are made up from single herbs, such as raw herbs (unprepared, twigs, leaves, roots, flowers, barks, etc.) or from prepared single extracts such as granules or liquids. This means those products result from single raw herbs but have undergone testing with the relevant manufacturers before being extracted.
The tests in an accredited laboratory are:
- Botanical identification (the testing method most appropriate for the product is chosen, but often HPTLC = High performance thin layer chromatography)
- Pesticides: Total BHC’s, Total DDT’s, Quintozene (PCNB)
- Heavy metals: Lead, Arsenic, Mercury, Cadmium
- Microbiology: aerobic count, yeast and mold count E. coli, Salmonella, Bile-tolerant gram-negative, Staphylococcus Aureus
The contamination thresholds for herbs are much lower than the ones used in Food Standards. Safflower has always advocated that raw materials (Herbs, animal products and minerals) need to undergo testing to make the end product a safe and stable product for human consumption. This is the reason, why we dispense formulas (for patients of our clinic and for other practitioners) compounded from single substances that have been certified.
It is needless to say that customized herbal formulas cost more due to the fact that the raw materials have received much attention. Thankfully both of our manufacturer KPC and Conforma are serious about the production of their extracts and hence meet the pharmaceutical standard called GMP (Good Manufacturing Practice). Each single substances is received with a Certificate of Analysis (CoA) that outlines each test and that has been conducted and the results achieved, before the product is released for compounding and consumption by adults and children.
We also receive our paraffin-free cream base from a local GMP manufacturer.
It is unfortunate that the contaminated products were available in Australia and have left the Australian public in mistrust towards Chinese herbal medicine. Without a doubt, the article has sent a powerful message.
- At this stage, the branding of the products analyzed have been kept anonymous which means that the Australian public can’t be warned of the products in question.
- The results of the listed products have been forwarded to the TGA and will most likely be investigated, it could also mean that complementary medicine products won’t be able to list on the ARTG but could require analysis and extensive testing in the future.
- Each and every formula dispensed by Safflower contain single substances in liquid or granulated extracts that have undergone extensive testing and are received with a Certificate of Analysis which means that they are safe for consumption for both adults and children.
If you have any questions or queries, please do not hesitate to contact us via email or telephone 03 5956 7011.