Consumer protection is a priority for the EU. Directive 2005/29/EC defines and condemns unfair commercial practices of all kinds, misleading advertising and aggressive sales methods. Health is also a priority, which led to the creation of the Directorate General for Health and Consumers that was tasked “to help make Europe's citizens healthier, safer and more confident, to make laws on the safety of food and other products, and to check that the rules are properly applied by the member states”.
The EU directive is unambiguous. Any claim about treating or curing a disease or malformation is considered as unfair or misleading[i] unless the product is registered as medication and sufficient proof for its efficacy and related claims have been presented to and accepted by the EU or national pharmaceutical authorities.
Producers of food and food supplements are allowed to make claims about promoting health or diminishing the risks of disease, but only after the phrasing has been substantiated as well as presented to and approved by the European Food Safety Agency (EFSA). Hundreds of such claims have already been rejected as unfounded or misleading[ii]. By 2011 all false claims should have disappeared.
Medication has been regulated since much longer. The first strict EU ruling was established in 1965 (EU Directives 65/65/EEC, 75/319/EEC and 89/341/EEC). A medication can be registered at a national or EU level by the European Medicines Agency (EMEA). All member states have to accept medical products recognized by other states. Since 1965, any claim on curing or relieving symptoms or disease has to be solidly substantiated, with the consequence that thousands of “traditional” products have disappeared from European pharmacies for lack of efficacy or safety. This system functioned fairly well for many years, though there is still room for improvement.
However, in 1992 the EU parliament voted for a very strange exception to the protection against false claims. In the EU Directive 92/73/EEC, the requirement for proven efficacy was dropped for a special group of products: homeopathic and antroposophic medicinal products.
Art.7 §4. The criteria and rules of procedure provided for in Articles 5 to 12 of Directive 65/65/EEC shall apply by analogy to the special, simplified registration procedure for HMP (homeopathic medicinal products), with the exception of the proof of therapeutic efficacy.
One of the motivations was: “... the very low level of active principles they contain and the difficulty of applying to them the conventional statistical methods[iii] relating to clinical trials, ...”. Another argument was “that homeopathic treatment is so highly individualised that it is not possible to associate one product with one disease”[iv].
The consequences of the above directive are that HMP (Homeopathic medical products) must be registered by the states as medication even if they contain nothing but sugar or water. They are even exempted from the obligation to mention their contents in weight or volume. Indicating the name of the first drop of the initial substance and the number of shakes, knocks and dilutions suffice.
Since such HMP are regulated by medication laws, they escape the rules for food or food supplements, perhaps they even escape the laws on unfair commerce.
The original text of the 1992 Directive imposed some strict limitations on such HMP: It was not permitted mention of any disease and use brand names. It was required to have a very highly diluted content and a warning on the label with the text “product without scientifically proven indication”. These limitations were swiftly circumvented by the homeopathic industry. They were allowed to put “complex” products on the market, meaning a mixture of several HMP, with disease-suggestive brand names. Flyers with medical indications may be distributed. None of this requires any proof whatsoever for efficacy.
The argument that homeopathy requires a highly individualised choice of medication that got them the exception in the first place was totally forgotten, but it had served its purpose of getting an exception.
Other additions to the directive opened more back doors: special registration procedures taking in consideration “national traditions”, the creation of a “special category homeopathy with indications” that still did not need any proof of efficacy. This law was passed in The Netherlands “in the interest of the Homeopathic export industry”. Concentrated tinctures are labelled and sold as “homeopathic medication”, of which some are dangerous.
In 2004, all this and more consumer fraud was legalized by Directive 2004/27/EC. The vendors of HMP may now mention diseases or symptoms if there is some past record of “traditional homeopathic” use. “Adequate bibliography” is sufficient as proof, without any elaboration of what that means. Since 2004, all member states had been obliged to install special pharmaceutical committees to register such HMP with indications. Genuine pharmacologists have to sit in committees with homeopaths and are obliged to register “medication” that contains nothing but water, alcohol or sugar pellets, and they have to register the “traditional use” as a medical indication. Several scientific organisations and national Academies of Science or Medicine have officially protested against such absurdities, but authorities refer to the law as their guiding principle, even if pseudoscience and potential harm, possibly serious, to patients is being legalized. The emperor’s new clothes are now defined by law against science.
The homeopaths openly admit that most of their products are diluted beyond Avogadro’s number, with not a single atom or molecule of the original product remaining. The Directive further mandates that the EU Pharmacopeia must have a separate chapter on homeopathy. There we read that the difference between solvent and HMP cannot be made by allopathic analytic methods. (sic!)
They omit to mention that this difference cannot be made by anyone, neither by homeopaths, nor by clairvoyants, nor by any other method[v]. The claim by proponents of homeopathy that water, alcohol, or sugar has a memory is still lacking any scientific proof. The Belgian skeptics’ organisation offers a prize of 10.000 Euro for a proof that water has a memory, and a 1,000,000 US$ challenge by the US James Randi Educational Foundation is also available for a similar feat. A few years ago, a campaign by the homeopaths included the claim that they could differentiate HMP and solvent. The claim was put to the test by the BBC program Horizon. If they would have succeeded, they would have won the 1,000,000 US$ prize. They failed.
It is not our intention to deprive those who believe in magic water their cherished nostrum. However, we do ask our European Members of Parliament to consider whether it is ethically acceptable to sell and advertise products as medication that cannot by any means or by anybody be differentiated from plain solvent, whether it is water or alcohol, or from sugar.
Considering that no one is able to distinguish two homeopathic products[vi], we ask all concerned to consider whether it is acceptable to sell and advertise such products under different names and with different indications.
We call on our European Members of Parliament to stand up to their responsibility to protect citizens and to close this unacceptable gap in consumer protection laws that allow products without content to escape rules against consumer fraud, for food and supplements, and for medicinal products. We need uniform and non-discriminatory laws that protect citizens and patients, not promote selected industries against all good sense and fairness.
Whether as food or as medication, all ingredients must be mentioned on the label with their internationally accepted chemical or biological names, expressed in verifiable weight or volume units. The homeopathic name of the starting product, the number of times it was diluted, shaken and knocked may also be mentioned provided it does not serve to mislead the consumer.
Citing that a product was once used by somebody for a specific indication certainly cannot be tolerated as proof of efficacy. This could be used as a precedent by other ancient or folk-remedies, opening a Pandora’s Box for other desires.
[i] ANNEX I of the Directive contains a LIST of commercial practices which are IN ALL CIRCUMSTANCES CONSIDERED UNFAIR: Nr 17: Falsely claiming that a product is able to cure illnesses, dysfunction or malformations.
lists of rejected claims can be consulted at: http://ec.europa.eu/food/food/labellingnutrition/claims/community_register/rejected_health_claims_en.htm, also claims for herbal products must be substantiated,
[iii] The expression that “conventional statistics” are not applicable to homeopathy seems absurd. What prevents them from counting how many persons got better (or not) after a homeopathic treatment, and compare it with the number of persons who got better (or not) in a control group? The same nonsensical phrase can be found in several EU documents concerning homeopathy, also in the EU Pharmacopeia. Note: The quote is condensed.
[iv] Note: the quote is condensed.
[v] if the dilutions are higher than DH24 (24 decimal) or CH12 (12 centesimal), many popular products are infinitely more diluted
[vi] if they are prepared with the same solvent or granulae.