Regulation of herbal remedies in Europe

Submitted by Aspergillus Administrator on 3 November 2010

April 1st 2011 marks the day when all products sold as herbal remedies or food supplements (including fungi) over the counter in the European Union will have to conform to new regulations. Specifically they will have to have:

1. Proved to the satisfaction of the regulatory authority that the drug has a beneficial effect
2. Be provided with full instructions on what specific use the medication is intended for and how to use it
3. Be proven to have no harmful effects

In other words, herbal remedies will have to pass some of the regulatory checks that ‘conventional’ drugs have to pass prior to going to market.

There is some opposition to the new regulations as there are large numbers of herbal medications that will have to comply and relatively little time to do so (though the industry has known that this regulation was coming into force since 2004).
Sceptics may say that the herbal industry will not be happy because many of their current medications have no scientific evidence to support their use and little hope of obtaining any proof  because they are either ineffective or testing would cost too much money. They may also argue that many herbs have been in use for thousands of years and thus must work and must be safe otherwise they would no longer be used.

Hard headed scientists would no doubt contend that if a substance cannot be proven to be effective or safe then it has no business being sold by multibillion dollar industries as remedies for a multitude of ills, regardless of their quaint antiquity.

There does still seem to be a way to access otherwise illegal herbalist remedies after April 1st and again this looks like an effort to bring them into line with ‘conventional’ drugs – these remedies will still be available via qualified herbalist practitioners after consultation with the patient.

From a neutral viewpoint it is difficult to criticise the new regulations. If the remedy has never been tested and proved to be safe & effective then its sale is at best a gamble for the patient. At worst a patient may feel embarrassed about telling their doctor about this untested remedy or feel that because it is marketed as a ‘natural’ product it must be harmless. They may then experience harmful effects caused by taking it alongside a conventional drug ordered by their doctor.

Once the regulations are in place people will be able  take a herbal remedy with more confidence that it has a proven value and that it is safe on its own and alongside other medications – the remedies move out of the ‘housewives cure’ category and into the realm of a properly verified treatment.