By Robert Verkerk PhD

Executive and scientific director, ANH-Intl

How would you feel if your lifeline was taken from you?  Fortunately, if you were unlucky enough to find yourself in the intensive care unit of a hospital and were dependent for your recovery on a drip, we’ve seen no plans to forcibly remove drips without consent.  But, unfortunately, the same can’t be said for herbs that millions depend upon for their health. 

Milk thistle: the archetypal case in point?

Take milk thistle (Silybum marianum), for example.  It’s a remarkable herb, the benefits of which have been experienced by hundreds of thousands of Europeans 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 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”.

Milk thistle (Silybum marianum)

So let’s be clear: it’s been historically used in food, food supplements and as an herbal medicine.  Now, however, does the full implementation of the Traditional Herbal Medicinal Products Directive (THMPD) mean that we should not be allowed to use milk thistle as a food herb or as a food supplement?

Despite milk thistle’s remarkable safety record and proven benefits, many EU Member States are in the process of trying to wipe it off the shelves of health food stores, remove it from sale on the Internet and from prescription by practitioners.  Its two main crimes, it seems, are 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 protectionism, dressed up as consumer protectionism!

Swedish lament

I heard many practitioners and herbalists lamenting the demise of milk thistle as a food supplement at a practitioner conference in Sweden, from which I have just returned.  Most repeated what we’ve heard in Germany, Belgium, the UK and Ireland, sentiments commonly along the lines of: “We don’t want to use the products licensed as ‘drugs’ under the EU herbal directive, they don’t or they won’t work.  The formulations are inferior because they only contain isolated fractions of actives from the herb and they generally include nasties other than the herb itself.”  Others indicated the dose was too low or the price too high for an appropriate dose.

In the nearly 2 years since the THMPD became fully implemented, the difference between formulations found in many food supplements and their registered herbal medicine ‘equivalents’ has been very apparent.

Swedish clean-sweep? Not quite

Milk thistle has been forced off the market by the Swedish Food Agency (Livsmedelsverket); the Swedish Medical Products Agency (Läkemedelsverket) considers that any product containing the herbs milk thistle, hoodia, Ginkgo biloba or Echinacea, among others, is, “Normally deemed to be a medicinal product”.

A 2011 report by the Swedish Food Agency on food supplements sold via the Internet makes clear that food supplement products have been forced off the market owing to the inclusion of milk thistle.  What’s more, the Swedish trade association Svensk Egenvård seems to have accepted this; in a 2009 report it lists milk thistle as one of a slew of herbs the inclusion of which will likely lead to a medicinal classification.  It uses the Swedish list of plants considered inappropriate for use in food (växtdelar som är olämpliga i livsmedel or VOLM) as the justification.

One of my first tasks on Monday morning, following my return from Sweden the previous night, was to examine the latest copy of the VOLM list I could find.  In a quirk of typical regulatory contradiction, milk thistle (Silybum marianum) appears to be missing from the list.

Does this mean that food supplements containing milk thistle can be sold again?  Have the Swedish authorities responded to the European Food Safety Authority’s (EFSA's) advice to EU Member States, as given in its botanicals compendium, and listed it in Annex B?  For the uninitiated, Annex B is described as, “Botanicals appearing on a negative list or subject to restricted use in at least one European Member State but for which the Scientific Committee, through the analysis of the data found, could not identify substances of concern, or other data for the inclusion in the compendium”.

In layperson’s speak, this almost amounts to saying, “We’ve noted that these herbs are banned in one or more EU Member States.  Because we don’t see any safety concerns, we assume the bans are protectionist in nature and are intended to protect drugs which compete with these herbal food supplements.”

So, what now?  Will the Swedish authorities actually allow milk thistle to be sold in Sweden as a food supplement?  Is the trade association advice now out of date?  Is milk thistle’s omission from the Swedish VOLM list an error? Or is it just a case of inconsistency between the medicines and food authorities of an EU Member State; because EU medicines law has supremacy over food law, and because the Swedish Medical Products Agency (Läkemedelsverket) lists milk thistle in their "normally deemed a medicine" (negative) list, is it irrelevant that the Swedish Food Authority omits milk thistle from its own negative list for food supplements? While the latter probably applies, what’s for sure: doing nothing is not an option. And it's very worthwhile remembering that that the Swedish Medical Products Agency's negative list is not an absolute negative list, given that products are "normally", rather than always, considered medicines.

Lessons learned from non-herbals

And it’s not just herbs that are under the spotlight.  We’re still scratching our heads after reading the FAQ on the Swedish Medical Agency website.  It states that products containing, among other things, vitamins, minerals, fatty acids and, “Amino acids (with certain exceptions for tryptophan)" are normally considered foods.  It then lists problematic ingredients that would normally lead to a medicinal classification.  Included on the list is Europe’s favourite joint support supplement, glucosamine, already reserved in the ‘drug-only’ category in Sweden and Denmark.  But you’ll also find two amino acids.  The first is, no doubt, the tryptophan exception alluded to above: 5-HTP.  The other is N-acetyl-cysteine (NAC).  5-HTP is used to elevate serotonin and enhance mood, so competes directly against the considerably less safe SSRI drugs.

NAC, on the other hand, is an amino acid that has been used widely by natural health aficionados to support detoxification.  But it’s also used for detoxification in mainstream healthcare, for example after paracetamol (acetaminophen) overdose.

What makes the Swedish authorities single out 5-HTP and NAC from the other amino acids?  The most likely explanation is two-fold: firstly, they demonstrate clear health benefits, giving the regulators the opportunity to cite a ‘pharmacological, immunological or metabolic effect’, a characteristic that is reserved for medicines under EU law.  Secondly, these amino acids compete with existing drugs on the market: SSRIs in the case of 5-HTP, and for NAC, drug-licensed versions of NAC.  The first reason provides the mechanism for the ban, the second, the motive.  While drug versions of amino acids or herbs are not inaccessible to consumers, they are typically much harder to access (especially if you have no clinical signs of illness and simply want to stay healthy), they are considerably more expensive and they may have inferior formulations.

Few Swedes appear aware that one Swedish company specialising in products used by practitioners wasn’t willing to accept this fate for NAC.  The amino acid had been an indispensible tool, given the chemical burden experienced by so many in our toxic, contemporary world.  With our help, the company put forward arguments about the food/medicine borderline vis-a-vis EU and national laws.  The Swedish authorities eventually conceded and allowed NAC to remain on the market, albeit at a reduced dose.  There was no fanfare and most people, other than the company’s staff and those relying on its products, remained in the dark.

The fundamentally incorrect rationale used for NAC has been applied to milk thistle and other herbs that have now been licensed under the THMPD.  But there are two main differences:

  1. The position of the Swedish authorities on milk thistle is contradictory, and
  2. No one appears yet to have stood up to the Swedish authorities to challenge them over their decision to categorise milk thistle as a ‘medicinal herb’.

Is the UK any better?

The situation for the humble milk thistle plant and its use as a food supplement is not much less bleak in the UK.  Some companies have faced challenges by the UK drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), and had their milk thistle products declared as unlicensed drugs, forcing them off the market.

The MHRA's justification?  In the case of one such product, containing a rather paltry, sub-pharmacological dose (100 mg) of silymarin, on page 10 of the its 4th volume of final determinations (October 2010 – March 2013), was:

“The product fell within both limbs of the definition of a medicinal product.  The first limb was satisfied due to the familiarity of the averagely well informed consumer with the current day and long traditional uses of the herb Milk thistle in medicine, and the extensive published information on the herb’s uses.  Arguments for use of products containing this herb for another purpose would not be tenable.  The second limb was satisfied due to the well known and documented pharmacological properties of the herb which has been used to treat a variety of adverse medical conditions, in particular hepatic complaints.  Products containing this herb require authorisation before being placed on the UK market.

The MHRA takes the view that the erroneous labelling of a herbal medicinal product as a food or dietary supplement is unacceptable and may mislead consumers.  Such mislabelling does not alter the correct legal classification.”

Other than this justification being self-serving and an example of a national regulator using the loaded gun of EU medicinal law in its typically arbitrary manner, you could just as easily apply the same logic to carrot juice.

It’s the blatant protectionist agenda of these laws, coupled with the frustration that is experienced by manufacturers, suppliers, retailers and consumers who depend on such products, that leads more and more people to the view that the Courts should be asked for their view.  European case law from the European Court of Justice (ECJ) has, after all, found more than once in favour of lower-dose herbs functioning outside the pharmacological range.  Case law from the ECJ also does not allow across-the-board medicinal classification for herbs, as we’ve seen in the recent garlic and red yeast rice cases.  Case-by-case assessment must be undertaken, and that includes consideration of dosage.

Whichever way things go with milk thistle, it will be an important decider for the whole herbal sector.  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 a medicine and it’s as good as saying all herbs should be medicalised.

We will do whatever we can to resist the pressure to force ‘medicalisation’ of herbs simply because they work, or they compete with drugs.  If companies want to register these herbs as drugs, that’s fine with us.  But don’t stop us being able to access full-spectrum food supplement products that contain these same herbs.  And so lies our reasoning for campaigning so steadfastly for a dual regime for herbs, allowing both food supplement and herbal medicinal variants to give consumers the freedom of choice they have had since time immemorial.

Call to action

Consumers: Please notify us of any food supplement products, anywhere in the EU, which contain milk thistle or any other herbs and have been forced off the market, so that you can no longer source them.  We are building a picture of what national authorities are doing EU-wide, and your information could be very valuable in our overall campaign to protect access to a diverse range of herbs with long histories of safe food, and food supplement, use.

Suppliers, distributors and manufacturers: Don’t blindly accept decisions to classify as medicinal food supplement products that have a long history of safe use.  Stand up and challenge what you consider to be unwarranted medicinal classifications whenever the opportunity arises, using the best scientific and legal arguments possible.  This has been the history of herbal use for hundreds of years – others before you waged this battle – now it’s your turn!

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