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The TNHA confirmed yesterday that the Milk Thistle herb (Silybum marianum) and its main active constituent ‘silymarin’ have been rescheduled from Schedule 3 to Schedule 0, after months of appeals to the Scheduling Committee of the Medicines Control Council (MCC). This herb has been proclaimed safe by many drug regulators around the world, and has an unblemished safety record when used responsibly.

Last year this herb and / or silymarin was unilaterally recalled from all health stores and front-shop pharmacy shelves, forcing tens of thousands users to obtain these products with a doctors prescription.  It appears that no risk/benefit studies were undertaken by the Scheduling Committee before the decision was made to withhold this substance from the public, and making it a practitioner prescribed only substance.

After intense and sustained pressure to rescind the Schedule 3 status (by prescription only), using good law and good science, the MCC have backed down and made these substances freely available to the public once again. The only condition attached to its new Over-The-Counter (OTC) status, is that the recommended daily dosage on product labels should not have a silymarin content exceed 600 mg. The fresh herb, Milk Thistle yields between 4-6% silymarin by weight.  This technically means that up to 12g of herb should contain less than the 600mg of silymarin.  This small victory demonstrates that the MCC are not beyond reproach, and that the natural health sector and consumers can claim their rights to natural health products and reverse bureaucratic restriction when they are demonstrably safe.  Suppliers we contacted today were elated with this good news, and will begin stocking health stores and pharmacies with their Milk Thistle containing products within days.  According to the MCC, a formal rescheduling notice will be published in the government gazette soon.

WHAT IS MILK THISTLE & WHY WAS IT RESTRICTED IN THE FIRST PLACE?  Milk Thistle is a remarkable herb, the benefits of which have been experienced by hundreds of thousands of South Africans and, without doubt, many millions worldwide.  Like broccoli, the humble cabbage and other members of the Brassica family, Milk Thistle originates from the Mediterranean. Its use as a liver tonic has been known and documented for hundreds of years.  Its unique mode of action makes it work, among other things, as a selective antioxidant in liver cells, conferring protection from the damaging effects of free radicals.  UK-based magazine The Ecologist states that, “Milk Thistle is another weed that can prove a tasty addition to your supper…raw shoots can…be eaten as crudités”.  Elsewhere, the National Toxicology Program of the Department of Health and Human Services in the USA, citing an article by Awang published in a 1993 edition of the Canadian Pharmacists Journal, declares that, “Milk Thistle has a long history of European cultivation for food”.

Despite Milk Thistle’s remarkable safety record and proven benefits, many EU Member States begun to wipe it off the shelves of health food stores, and made it available by prescription only at the same time our Medicines Control Council arbitrarily scheduled it last year.  It appears whenever the FDA or EU Commission sneeze, our MCC copy and paste their directives and advisory notices without applying their own mind, or scientific interrogation of the facts.

Milk Thistle’s two main crimes, it seems, were its effectiveness and the competition that food supplement products containing Milk Thistle represent to drug versions of Milk Thistle.  Ladies and gentlemen, welcome to the world of EU / Big Pharma protectionism, dressed up as consumer protectionism!  Milk Thistle works more like a food than a typical drug.  It has more or less no safety issues, other than very occasional allergy (among those allergic to the ragweed family), something that can apply equally to any food.  Accept that Milk Thistle is pharmaceutical drug and it’s as good as saying all herbs should be reclassified as pharmaceutical drugs.

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