Traditional medicinal plants: dietary supplements and/or medicines
p. 219-222
Résumé
Abstract
The market for dietary supplements is expanding rapidly. Nevertheless, some national regulations differ widely, or even do not exist. Therefore, namely in France, coherent data must be proposed to set up an appropriate legislation comprising positive and negative lists of plants as well as precise specifications that could be used as a guideline for the manufacturer and protect the consumer by providing him with as many information as possible.
Texte intégral
Bench marks
The expanding market for "dietary complements"
1The mass-media refer routinely to "being in good form", good health, "health food", supplements to "have greater comfort, enhanced well-being"...? Consumers are supposed to be more proactive as they are willing to have better control on their health. Marketing officers are aware of this trend and capitalise on it in their advertising campaigns. But at no time are they supposed to mention any therapeutic properties, which would be a fortiori deceptive. Moreover, the authorities (in France the Direction Générale du Consommation, de la Concurrence et de la Répression des Fraudes, a department of Ministère de l'Economie et des Finances) work as a watchdog for the safety of consumers, making sure that accurate information is provided, with a clear distinction between such ffod supplements and drugs.
2However, there is deliberate vagueness concerning the sale of several hundreds of plants put on the market being labelled as "pseudo-food" and often linked to the consumption of vitamins and minerals, trace elements, fibres, essential polyunsaturated fatty acids... The "Mediterranean" diet - in particular that of Crete - has become a fashion or even a fad.
3An increasing number of molecules present in our daily diet do have valuable biological properties that can be beneficial to the maintenance of good health balance. This applies, for instance to the large class of polyphenols: we have now collected valuable information about their numerous pharmacological properties (inhibiting the oxidation of low-density lipoproteins (LDL), increasing high-density lipoproteins (HDL), inhibiting platelet aggregation, reducing antioxydant activity and trapping of free radicals...). Other therapeutic activities exist in parallel, such as having a spasmolytic, anti-inflammatory, antibacterial, diuretic effet, reducing capillary permeability, operating preventive inhibition of the experimental lympho-edema, even reducing hypercholesterolemy...
4This can also apply to an improvement of specific physiological conditions, in particular at the time of inceptive menopause - a situation that some 10 million women have to face in France, with increased risks related to a oestrogen and progesterone deficiency, as a consequence of the reduction in ovarian production and its incidence on osteoporosis - or an increase of cardiovascular risks. The industrialists in the agro-food branch have invested heavily in this commercial niche, claiming that the isoflavones contained in soya have a beneficial effect on hormonal and lipidic metabolism, with daily doses of 70 mg.
Legal provisions for the marketing of plant-based drugs
5The provisions contained in the French Law, if examined in detail, are actually quite clear (Les Cahiers de l'Agence 1998). They refer primarily to a list of atoxic plants, whose use is a priori safe A list of specifications including therapeutic indications has been set up; it also provides for a list of constraints to guarantee flawless pharmaceutical quality.
Evaluating the harmlessness of plants sold out of pharmacies
6This issue should be examined by a taskforce set up by the French Direction Générale de la Santé, upon request from DGCCRF (French Direction Générale de la Consommation, de la Concurrence et de la Répression des Fraudes) in cooperation with the French Agence Française de Sécurité Sanitaire des Aliments. We have been appointed to "pilot" a taskforce whose primary goal was to submit a list of atoxic plants safe for human consumption, with the relevant conditions of use (part to be used, form, amount, informative labelling etc).
Data of the issue
7Here are the data available for an evaluation of the problem. A basic distinction should be made between:
Plants involved in drugs and registered in the pharmacopoeia
8These plants are submitted to the pharmaceutical monopoly when they are not used for other purposes.
Plants known as "released" plants
934 such plants have been "released" and can be sold out of pharmacies (French Decree 79-480 passed 15.06.79). These plants can be used for the manufacturing of drugs, but also of food products; they can also be listed in the pharmacopoeia.
Some basic definitions
10According to the draft decree, "food supplements are products meant to be ingested by man as a supplement to daily dietary amounts to remedy a shortage - real or regarded as such - in the daily dietary amounts (excluding specific food products and drugs)".
11This definition obviously applies to plants containing vitamins. But can it really apply to plants sought after out of the pharmaceutical circuit, such as e.g. hawthorn or valerian? To some extent, it might be more reasonable to regard these raw materials as "dietary supplements", rather than as complements;
12Aromatics are odorous food substances being used as condiments and produced by various parts of a plant (leaf, flower, seed, root, stem, bulb, fruit...);
13Spices are food substances produced by various parts of exotic plants having organoleptic properties - predominantly gustatory;
Recommendations published by the Council of Europe
14The recommendations refer in particular to "aromatizing substances and natural sources of aromatizing matter" (3rd edition). They have the form of lists of plants and aromatic substances whose ingestion is not dangerous a priori or can be done under certain conditions. The parameters selected have been elicited, taking into account the information on toxicity, their concentration in food products, their frequency of use, a possible analogy between the chemical structure and other known compounds, and a possible accumulation potential.
15This document presents a classification of plants, distributing them under the following headings:
- N1: plants without any restriction on their use;
- N2: aromatic plants admissible when added in small quantity
- N3: plants acceptable temporarily, but state-of-the-art documentation is considered insufficient
- N4: plants for which information is obviously insufficient
16These data make it possible to set reference marks, and also set thresholds for drinks; for instance
- for ß-asarone: 0.1 mg/kg
- for safrole: 1 mg/kg
- for α- et ß- thuyones: 0.5 mg/kg
- etc.
17Of course, no associated allegation is possible. However, a re-evaluation of this publication is underway.
Setting up national lists
18Such national lists are being set up in various countries, including Italy, Germany, Spain, France.
19As far as Belgium is concerned, a Royal Decree has been passed on 29.08.1997 relating to the manufacturing and trading of food products or preparations containing plants, with positive and negative lists; numerous plants mentioned there are regarded in France as purely pharmaceutical. Moreover, free movement of goods and food products is authorized in Europe only if the harmlessness of the product has been clearly established (which is not the case with drugs). Consequently, for instance, capsules containing ginkgo can be manufactured in Belgium and be pout on the French market without referring to any specific allegation.
New food products and new ingredients
20A document published by the European Commission lays down legal provisions concerning new food products and new ingredients (Regulation 258/97/CE). This text concerns specifically GMOs, with a paragraph relating in particular to medicinal plants. As a matter of fact, marketing a new food product entails that a well-documented file is available with evidence of its harmlessness and refers to all similar or analogous products for which there are no records testifying of any former consumption in Europe.
A reflective approach
21A taskforce made up of experts, representatives of the French industrial world and administration (Agence Française de Sécurité Sanitaire des Aliments, Agence Française de Sécurité Sanitaire des Produits de Santé, Direction Générale de la Santé, Direction Générale de la Consommation, de la Concurrence et de la Répression des Fraudes, French Ministry of Agriculture) has initiated a classification of plants into several categories, including:
221. Plants with a nutritional value including among others:
- common edible plants
- new food products, based mainly on exotic plants
- dietary complements aiming at "compensating for a deficit".
23In this context, we could possibly take up:
- fibrous plants acting on the gastro-intestinal transit
- plants containing polyphenols and contributing to the maintenance of vascular integrity.
242. Plants without special nutritional value which would be amenable to the concept of food supplement: they are atoxic, and consuming them is common in Europe, but they are often just at the frontier with medicinal plants in the strict sense of the term.3. Pharmaceutical plants in the proper sense
25These plants are used for specific therapeutic indications such as cough, pain, etc.
264. Finally, problems with various denominations, cropping up on a daily basis, calling for a solution: how should we maintain a clear difference between the various terms used, e. g. en English "functional food", "health food", "nutraceuticals", in French "alicaments" etc.? Which term should be retained at the end of the day?
27More specifically, positive lists of atoxic plants can be set up according to following classification and belong to:
- common diet and/or in the form of a beverage, without any restriction on consumption: garlic - bilberry - winter-cherry...
- common diet and/or in the form of a beverage, but with restrictions on consumption: bitter almonds - angelica - borage...
- aromatizing raw materials, without restriction on use dill - green anise - citron tree...
- aromatizing raw materials, with some restriction on consumption milfoil or yarrow - wormwood - root of calamus...
- plants "released" for marketing: common mullein - cherry - couch grass...
- plants whose use must be justified beach wormwood - aloe (mucilage) - pineapple...
- pharmaceutical plants in the strict sense of the term agripaume - anemone - hawthorn - boldo - alder buckthron - large camomile - Saint-Mary's thistle - chelidonium... ginkgo, ruscus, Florida palm tree, Marie thistle
- plants posing interface problems; for example, plants containing caffeine and guarana-based derivatives, for which concentration limits are imposed because of the well-known - and important - pharmacological side-effects of caffeine, i.e. in particular:
- psychostimulation and an antiasthenic effect (keeping awake)
- cardiotonicity (cardiac erethism)
- breathing stimulation (bulbar center)
28We still have to deal with the problem of some plants which are currently an object of envy; they are not listed in Cahiers de l'Agence yet, such as purple cone flower, St-John's wort....
29In the same way, a negative list is being set up, listing plants which might have noxious effects when used.
305. It is necessary to establish a list of specifications to meet the conditions imposed to file a demande d'autorisation d'emploi (application to obtain permission to use the product). The finished product must indeed comply with the quality standards and conditions to guarantee safety of use.. The application file should provide detailed information about the manufacturing process, the controls and validated dosages of the raw material and the finished product, referring, if need be, to the requirements of the European Pharmacopoeia and including a study on the stability of the finished product.
316. Galenic forms
32The agri-food industrialists would like to use numerous galenic items with a view to having commercial originality. The businesspeople still have to refer to traditional forms which can then provide invaluable guidance so that risks are minimized when using the product.
33Plants are usually (in most cases) presented in the following form:
- fresh, dried, freeze-dried, fragmented or mixed, frozen or in the form of juice;
- herb teas, exclusively in the case of plants that have been released (at least in theory!).
34Of course, there are other galenic forms, such as powders, plant juices...
35The question of administered doses will have to be solved to avoid any over-consumption; a permissible daily amount should even set, together with admissible plant associations, just as we have for drugs.
36Some limits will also have to be determined concerning certain components which could turn to be more or less toxic. Conversely, a preparation of wormwood containing no thuyone as having been extracted by means of e.g. supercritical CO2 should be authorized. The end product should be absorbed exclusively per os and consumers should have comprehensive and transparent, with accurate labelling mentioning the maximum daily amount recommended and the use-by and best-before dates.
377. The problem of allegations
38The allegation issue is currently regulated by the French DGCCRF Office, or sometimes by a PP visa.
39An allegation is defined as a message, a mention or a representation implying or suggesting that a food product has specific features, characteristics, properties or effects according to its nature, its composition, its food value, its mode of production or transformation. Some of them may be functional allegations, health allegations, related to a specific condition; however therapeutic indications are not permitted. For instance, we will find such statements as calcium "contributes to the good condition of bones, improves bone density, prevents osteoporosis" rather than calcium "is used in cases of decalcification".
40In some years' time, certain allegations might become acceptable and thus be added - at least partially - to those established for plants belonging to the MA (marketing authorization) list with special conditions.
41This could apply, hypothetically, to the following cases:
- "lack of appetite": gentian, ményanthe, centaury, wormwood, sour orange tree...
- whatever is related to "digestion": mint, lemon balm, verbena, fennel, star anise, green anise, tarragon, cumin, caraway, coriander, yarrow, angelica, sweet woodruff, goose-grass, liquorice, unsavoury chamomile, Roman camomile...
- the condition of "liver and gall insufficiency": artichoke, lime tree sapwood, curcuma, dandelion, horseradish...
- increasing "kidney excretion": plants containing flavonoids, terpenoids...
- beneficial action on "blood circulation": plants containing flavonoids, anthocyans, cumarins, tanins, saponosides (bilberry, sweet clover, ruscus...)
- having a "tonic" kind of effect: cinnamon, wild rose, éleuthérocoque, ginseng, cola tree, Paraguay tea, paullinia, tea... and also to cases relating to
- the "gastro-intestinal transit": plants with mucilage, fibre and gum...
- "disorders linked to menopause": soya...
42The European authorities are currently examining the question. For instance, the Council of Europe has created a Nutrition Expert Committee in charge of evaluating food safety and the impact on consumers' health, and drafting a handbook entitled Guideline on Health Claims for Functional Foods.
43An expert committee in Brussels is currently investigating nutrition issues but has been content so far with just mentioning the problems related to dietary complements meant for human consumption and containing vitamins and trace elements. A draft decree deals in particular with substances with a nutritional purpose to be added to foodstuffs for specific dietary purposes.
Conclusion
44A great number of plants used traditionally can be regarded as food complements and/or supplements, but also as drugs. Nature offers indeed a wide - possibly infinite - range of original molecules. However, we ought to establish with great accuracy functional allegations and health allegations that are "reasonable" for all.
45The point concerning consumers' safety should be given special attention and provisions should strictly enforced.
46We should also keep in mind that exoticism and innovation are fashionable; actually, we should be fearful of them and make sure that the risks are properly assessed: it is essential that a well-documented dossier be prepared for each "new food item".
47Finally, we should find ways to harmonize national legal provisions as a step towards short term harmonization within Europe and the whole world.
Bibliographie
Références
WICFITL M., ANTON R. (1999) Plantes Thérapeutiques. Tradition, pratique officinale, science et thérapeutique, Paris - Cachan, Editions Tec & Doc - Editions médicales internationales, 636 p.
(1998) Médicaments à base de plantes, Paris, Agence Française du Médicament. (Les Cahiers de l'Agence, 3)
(2000) Natural Sources of Flavouring, Editions du Conseil de l'Europe.
(1998) Nettox list of food plants, Danish Veterinary and Food Administration, Soborg, Denmark.
Auteur
-
Robert Anton
Université de Strasbourg - Faculté de Pharmacie, 74 route du Rhin, B.P. 24, 67401 lllkirch Cedex (France)
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