Seanna Tully, the WholeHealth Chicago Apothecary manager and Herbal Specialist, was interviewed again in this week’s Northwestern’s MedIll Report.
Traditional herbal medicines face deadline for EU regulations
by Alexandra Arkin
Feb 03, 2011
Herbal remedies are about to face tougher scrutiny in the European Union.
As of May 1, a new EU registration requirement for herbal treatments takes effect, addressing potential side effects of many alternative medicines.
The EU defines “herbal medicinal products” as products made from plant substances which may be used to treat illnesses. These cover traditional herbal medicinal products – herbs that have been used for at least 30 years anywhere, including at least 15 years in the EU – that are intended for use without a medical practitioner’s supervision.
The medicines may not be administered by injection. Examples of traditional herbal products are Echinacea and calendula.
All medicinal products – and herbs are treated as medicinal – need authorization to be placed on the market in the EU. However, because of traditional herbal medicines’ long tradition of use, the EU introduced the new but simpler registration procedure in March 2004 with the Traditional Herbal Medicinal Products Directive.
Member countries of the EU have had seven years to register traditional herbal medicines. Traditional herbal product manufacturers must provide documentation showing the product is safe in specified conditions of use and that its effectiveness is plausible based on long-standing medicinal use (30 years worldwide, including at least 15 in the EU).
If the makers can prove this, the product does not have to undergo the rigorous safety tests and clinical trials necessary to register other mainstream and non-traditional herbal medicinal products.
Traditional herbal medicinal products not registered by the April 30 deadline may not be sold in the EU. New herbal products will require the same safety tests and clinical trials that are required of mainstream and non-traditional herbal products. The directive does not apply to holistic alternative therapies such as acupuncture or reiki.
The United States hasn’t made a similar move to tighten use of herbal remedies and largely regulates them more as foods or supplements.
But Seanna Tully, clinical services manager of the Apothecary at Whole Health Chicago, said she worries the Food and Drug Administration will follow suit in the U.S. because the FDA usually follows Europe’s lead.
keep reading: http://news.medill.northwestern.edu/chicago/news.aspx?id=177732
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