THMPD: Status questionis

Depending on member state legislation, interpretation, and the existence of negative/positive lists a traditional herb can either be considered a medicine or a food supplement, but everywhere there is a vast grey zone. There is not one single herb to be found that would fit 100 % in one category. Given the large number of herbs carried it is inevitable that any traditional formulation will have characteristics of both a traditional medicine and a food supplement. This grey zone is further blurred by companies who carry only a limited number of OTC products drawn from traditional sources. Especially pharmaceutical companies who present a Traditional Medicine as a Food Supplement, but also food industry companies who present their Food supplement as a Traditional Medicine.

Although every bona fide company in our sector has been looking forward to a regulation under an official status, we regret to find the present model of regulation merely a prolongation of the legal vacuum we are living in. The lack of a fair and suitable status, together with the possible enforcement of an inappropriate status (Novel Food and partly THMPD) has brought about a  climate of legal insecurity.

The consequences are obvious: very conservative investment policy, loss of earnings and profit, unfair competition and, in many member states a proliferation of cowboy-companies taking quick advantage of the regulatory confusion. The present situation already shows  that distribution immediately shifts to other channels (e-commerce, direct marketing, dispatching from US, Switzerland, Andorra, Hong Kong and even from member states where control is inexistent).

It is obvious to any expert in the field that only a one by one evaluation on identity, quality and safety could clear this issue. This would result in a list of substances that could  be considered food supplements only (ca 65%), a list of substances that could be considered traditional medicine only (ca 10%), and a list of ambivalent substances figuring in both lists, based on well defined criteria (30 %). This is the approach adopted by  the Belgian Plant Commission.

The THMP directive was essentially created to address these issues. To shed some  discriminating light in the grey zone and to provide a legal framework  for traditional medicinal herbs, which are present on the EEC market anyway. However, the present configuration of the THMPD fails to accommodate traditional systems on every level.

THMPD: remarks and conclusions

At present, the number of ingredients in a composition is limited to four ingredients. A limit of six seems to be under consideration. Even the latter option would leave only 20 % of classical formulas  possible. The combination with mineral and animal ingredients is not possible at this point.
Since, apparently, the combined end- product is subject to registration, there is no solution for tailored prescriptions. Personalized modifications and adaptations are common practice in our disciplines.
Even in the alternative approach of registering single ingredients, the total of registration   fees is financially completely prohibitive. Moreover, the fees seem to differ substantially in the various member states.

This means that companies carrying a large assortment, combining food ingredients and restricted herbs in large(r) formulas, mostly on customized prescription, have no future at all. Those companies are the same who have , by huge investments in R & D and quality/safety control,  achieved the cleanup of the market in the past 20 years.
 
Referring to the European directives on Food Supplements, the evidence of consumption history as Food and the safety data, our sector  claims  that the vast majority of used substances are to be categorized as Food Supplements. Nonetheless our sector initially welcomed the prospect of THMPD since the traditional catalogue also includes a  significant minority of  substances without food history. Those are the herbs that require not only a thorough and batch-specific quality and safety testing, but also need to be appropriately prescribed following the traditional evaluation, which has its own, evidence based safety rules. However,  these herbs are very unlikely ever to be registered as a traditional medicine since it would be inconceivable and even irresponsible that such substances would be available over the counter. This, as well by western scientific standards as by traditional safety standards!  This truly incredible clause in THMPD regulation means we lose  the only added value that THMPD could bring to our sector.
Generally applicable OTC products are systematically denied a Food Supplement status, while specific and justifiably restricted products would be available over the counter.

A majority of safe, well  tried and tested herbals, will be subjected to unnecessary quality-safety-control in order to obtain Traditional Medicine status.  An important minority for which this thorough control is imperative will probably never attain Traditional Medicine status.
Experts in traditional disciplines fail to understand why the Herbal Working Party at EMEA, who displays painstaking scrutiny in safety matters, would allow the more delicate herbs as OTC, when those are, even within their tradition, subject to differential diagnosis and supervision of a qualified therapist, both for safety and efficacy reasons.

Another area in which principles seem to overrule facts is the introduction of traditional plant monographs into the E.P.  In every member state the regulatory refers to those monographs to draw the conclusion that every traditionally used herb is to be considered a “medicine by function”. Apart from the fact that this mentality often leads to unworldly and even derisory conclusions, it systematically denies the existence of Food Supplements and their EU- legislation.
 
Similar to the THMPD regulation, the monographs fail to do justice to FS and TM alike. What we have seen thus far are mere compilations lacking consistency on every level. Vital data about dosages, preparations and synergy are partial or absent, and, as such, not allowing any serious assessments about safety, quality nor efficacy. Accessment criteria for processed materials are totally absent and the methods to achieve this (e.g. systembiology) are not valued. The parameters for identity, quality and safety tend to be exclusively associated with the quantitative determination of biomarkers and not with the full spectrum of the plant totum.
 
Meanwhile, invariably  referring to the definition of medicine,  local authorities leave no stone unturned to style any substance as a medicine by function. Whenever a herb is scheduled for a monograph in the EP, or when a combination is advised in a medical or paramedical practice, or when there is a registration as a medicine anywhere else in the world. All arguments are welcome except the item-by-item, thorough scientific and epidemiological assessment.

The few  registrations under THMPD thus far, confirm these anomalies. The registered products are food supplements!  (number and type of ingrediënts, OTC, weak claim)  As herbal medicinal solutions they have little or no value.
 
As such, THMPD regulation is an inconsistent catchall, unsuitable for traditional medicinals and denying the existence of food supplements.

Considering the actual and expected differences in approach within member states (fees, forbidden and restricted items, control capacity, prevailing national legislation) one may further ask whether it makes sense to outline a unifying regulation which will be selectively implemented in the different member states. And how all this concords with some general principles of justice in  EU (free movement of goods, fair competition, public nature and transparancy of government,  the right for legal certainty, adequate motivation on necessity and appropriateness , a.o.)

Conclusion

While THMPD was specifically created for the traditional systems it is financially prohibitive for  the very companies active in this specific sector.

THMPD does not provide any consistent methodological and scientific framework to accommodate complex formulas.

Implementation of THMPD in present form will increase the safety risks and multiply inadequate and inappropriate use of traditional plants:

G.R.A.S. Food Supplements are getting restricted or forbidden because of (weak) medicinal claims. Traditional medicinal herbs with plausible/proven efficacy but subject to differential diagnosis would be available through the FS distribution channel.

Consequence: Substances, rightfully forbidden as Food Supplements, will remain restricted as Traditional Medicine as well. There is no added value in the status of TM !

The legal and practical execution of the directive is generally experienced by its target sector as an attempt to keep traditional plants out of the FS status, rather than to create a workable framework for traditional medicine.  It will prove to be a pathetic failure on both, as long as the common sense middle way of one-by-one assessment isn’t walked.

Without significant amendments on every level all companies carrying a  full catalog of a traditional system will be out of business by 2011.