The sale of popular herbal remedies could
be banned because of an "unworkable and impractical"
European law, health campaigners said yesterday.
The European Union directive, which came into force
yesterday, was introduced to ensure that natural products
sold over the counter were safe and of a high standard.
Previously, most herbal remedies were available in Britain
under Section 12 of the 1968 Medicines Act as "medicines
exempt from licensing".
Under the new directive, manufacturers will have to
provide evidence that their products are safe before they
are given a licence. Only products which have been on sale
in the EU for 30 years will be automatically approved.
Campaigners, including the actress Jenny Seagrove,
attacked the directive as "ludicrous" and warned that
companies could be forced out of business because of the
high cost of conducting safety tests. She said: "The
herbal remedy market should be regulated to ensure
consumer safety, but this directive is far too
heavy-handed."
Sue Croft, of Consumers for Health Choice, a European
lobby group, said the directive would deprive consumers of
some of the most effective herbal remedies.
"The directive lays down unduly onerous burdens on
industry, for smaller businesses in particular, and
jeopardises the future of many safe, popular and effective
herbal remedies," she said.
"It insists that manufacturers prove the 'stability' of
its products, meaning they must show that all the active
ingredients work. That's easy when you are dealing with a
pharmaceutical drug. . . but hugely difficult when you are
dealing with a combination of plants, which can be made up
of up to 100 components. That's just impossible,
unworkable and impractical."
She also attacked the directive for excluding herbalists,
which means that while "standards are to be imposed on the
manufacturers and health food shops, herbalists can carry
on making up bespoke remedies in their kitchen".
About five million people are thought to be treated by
complementary practitioners a year.
Campaigners said that "single" remedies such as echinacea,
which helps to fight off colds, will survive the
directive. Not so fortunate will be "combination"
products, such as bilberry extract with ginkgo biloba.
The law comes into force only two months after the
introduction of another EU directive, which banned the
sale of more than 300 vitamins and minerals.
Designed to harmonise the sale of vitamin and mineral
supplements across the EU, it contains a list of approved
nutrients that can be sold in Europe. The law also follows
a study, commissioned by the Prince of Wales, recommending
that complementary therapies should be more widely
available on the NHS.
Some manufacturers will have until 2011 to comply with the
law, which was enforced by the Medicines and Healthcare
Products Regulatory Agency, part of the Department of
Health. Roy Alder, its director of executive support,
said: "This legislation. . . will allow for more informed
choices as registered products will be accompanied by
reliable information about the product and how to use it."
forwarded by
Zeus Information Service
Alternative Views on Health
www.zeusinfoservice.com