Licensing and Regulation of Herbal Remedies

Hundreds of traditional and imported remedies that line the shelves of health food and herbal medicine stores are set to be banned under new sales licensing rules.

The EU Directive aims to protect users from harmful side effects that can result from taking medicines inappropriately.

Only high-quality, time-tested, and scientifically safe herbal medicines are sold in stores.

Some traders selling goods imported from outside the EU say their businesses will be hit.

Herbal remedies with names like cascara bark and horny goat weed are gaining popularity.

But following concerns that some products may cause harm, an EU directive will come into force from May 1st making all such products mandatory to be authorised.

Manufacturers and independent health food store owners say the directive, passed in 2004, is draconian and favours Europe’s biggest manufacturers.

Selwyn Soh, who runs The Herbal Factory, a contract manufacturer of herbal medicines in Croydon, south London, believes smaller businesses like his will be shut out completely.

“Unfortunately, it looks like we’re going to have to close down because of this law,” he said.

“The problem for us is that we have to pay thousands of pounds for a licence to continue making each product, but unlike pharmaceutical companies we don’t have an exclusive licence to make the product. It’s just not worth the money.”

Maple Leaf Pharmacy in Twickenham, west London specialises in alternative and holistic medicines as well as traditional pharmacy services.

Store owner Garen Rosenberg estimates that about 20% of the health foods sold at his pharmacy will disappear from the shelves, and some health food stores will see a much larger percentage of their existing products banned.

Rosenberg said he welcomed the improved labeling of side effects, but the rest of the directive goes too far.

“For example, there are products we recommend for menopausal hot flashes – they are incredibly effective – but from April you will not be able to order these products because the manufacturers are too small to afford the hundreds of thousands of pounds of investment required by the new regulations,” he said.

“The new rules heavily favour big companies. My concern is that freedom of choice will be taken away. We will also see significant price increases because of the costs of compliance.”

But the authorities who regulate all these pills and drugs say their aim is to protect consumers, not crack down on small suppliers.

Richard Woodfield, from the Medicines and Healthcare products Regulatory Agency, also rejected claims the laws were too draconian.

“The purpose of regulation is to ensure products meet guaranteed standards. Standards are hard but achievable and manageable,” he said.

“There are already 24 companies regulated under this system, but not all of them are large companies.”

But one leading pharmaceutical expert said he fears consumers will not be much wiser come May.

David Colquhoun, professor of pharmacology at University College London, said the changes were of limited value because the rules don’t require manufacturers to provide evidence that newly approved products are effective.

There are fears that people who are determined to continue taking their favourite herbs will choose to buy them online from sellers who don’t care about quality or efficacy.

The EU insists that from now on only high-quality, time-tested and scientifically safe herbal medicines can be sold over the counter – but labels cannot tell customers whether their medicinal properties are proven or not.