New herbal remedies registration rules come into force

1^st May 2011 -- People have been taking herbal remedies for centuries, but now companies making them need to get their products registered.

The Medicines and Healthcare products Regulatory Agency (MHRA) has received 211 applications for registration and so far granted 105 registrations for a variety of herbal products containing 36 different herbs including St John’s wort, echinacea and black cohosh.

Products containing only vitamins and minerals, and products like fish oils, are not included in the scheme.

So, why is the scheme in place and what does it mean for people who use traditional herbal remedies?

We spoke to the person in charge of the scheme at the MHRA - Richard Woodfield - group manager, herbals medicines policy.

Why has the scheme been set up?

"Historically, we had a situation with very patchy standards with unlicensed herbal remedies. They ranged from the downright dangerous, for example products that were adulterated or that had the wrong herb, to many more products that were not inherently dangerous but had weak information about safe usage, for example a lack of information about side effects and  contra-indications.

"Under the old system, you could have two unlicensed products side by side. One would have warning information: for example, about whether it was safe to use in pregnancy. The other would have no information whatsoever. There’s every chance that the consumer would think that the product with no warnings was actually safer.

"We wanted to have a system that enabled the public to make an informed choice from products made to assured standards.  We want to put the consumer in charge of making an informed choice."

How do you assess an application?

"These applications are dealt with in our licensing division along much the same lines as any other product that comes forward for a licence.

"The key things that are assessed are safety, quality, patient information and - in place of the efficacy requirement - there’s a requirement for evidence of traditional use."

So it doesn’t mean the product has to work, just that it has been in use for years?

"That’s broadly right. One feature of the scheme is that we should refuse a registration if the efficacy is not plausible.

"It’s widely known with herbals that many have some efficacy to some degree.  It’s all about the specifics - the particular formulations and precise extracts.  Requiring products to go through the expensive process of clinical trials for what are in effect minor indications would deny consumer access to some very widely used herbal medicines, so instead there is a pragmatic reliance on traditional use, combined with an assessment of safety."