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Frequently Asked Questions on
Herbal Legislation

I heard there was a herbal ban - why are some of my favourite herbal remedies under threat?

After 30th April 2011, herbal products that are considered to be medicinal will have to be registered with the MHRA (Medicines and Healthcare products Regulatory Agency—a government body) before being supplied to the public. At time of writing, it is clear that only a small number of products currently available will be registered and this may mean that the herbal product you are using will not be available to you in the future.

How will I know if the herbal remedy I use has been authorised?

Products that have already been authorised will have the letters PL, PLR or THR followed by a number printed on the product label and packaging. These products will also have a Patient Information Leaflet inside the box, giving relevant information and instructions on how to use the product.

Will all licensed herbal products then be 'the same'?

No, products will still have their individual characteristics such as how they are grown (organic or non-organic), what herbal material is used (fresh or dried) and how they are processed and manufactured. In addition, dosages of each licensed herbal product will also vary.

I have heard that some herbal products will continue to be sold as foods.

Yes, this is correct. Some products contain herbal ingredients that have a clear history of food use. Examples include culinary herbs and spices such as coriander, turmeric, thyme and sage. Although not guaranteed, it is unlikely that the MHRA will see these products as medicinal and they will therefore not require a licence.

What about my Echinacea face cream and my peppermint tea?

Cosmetic products containing herbs will not come under the new EU legislation and will continue to be sold as usual. It is anticipated that most herbal teas will not be affected by the legislation.
Will I still be able to grow herbs in my garden?

I heard that even books on herbs would be banned.

There is no truth in any of this. People are free to grow herbs in the same way as ever. Herbal publications are not affected at all.

Why is the law changing?

In the past, different laws covering herbal remedies existed in EU countries. In the UK, herbal products have been marketed under a UK specific law known as Section 12(2) of the Medicines Act. This diversity is seen to be unacceptable to the EU and has lead to the new legislation across the EU. However, implementation of the law across the EU has come at different speeds —the UK is one of the first to fully implement the new legislation.

Are there any advantages to me, the consumer?

With registered herbal products, the consumer will have the assurance that the product used has been produced to specific quality standards. With unregistered or unlicensed products, these standards are voluntary—some responsible manufacturers use them, others do not.

In addition, registered herbal products will carry more information on packaging and in the in-pack leaflet. This information will guide the consumer on how to use the product safely and for the correct condition.

What negatives are there with this new herbal legislation?

To obtain a registration, a herbal product or its equivalent will have to have been in use for at least 30 years, 15 of which has to be within Europe. This means that some products such as Ayurvedic or Chinese herbal remedies will be difficult to register. In addition, some manufacturers will find the cost of obtaining registrations too high for the sales generated.

So will it just be big pharmaceutical companies that end up owning all the herbal products as they can afford to register them?

No. Many small herbal manufacturers have already obtained registrations with many more in the pipeline.

If a product is not registered by 30th April 2011, should I assume that it's gone forever?

No, there is no cut-off point in the licensing process. A product that hasn't yet been registered by the end of April could still be registered later.

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