HerbalEgram

FWD 2 HerbalEgram

HerbalEGram: Volume 6, Number 4, April 2009

Prince of Wales’ UK Company Launches Herbal Line

Prince Charles' Duchy Originals, a company that produces organic food products, has created a line of herbal remedies.¹ The company was founded by Prince Charles in 1990 and is owned by the Prince’s Charities Foundation, to which all profits from Duchy are donated.

That the Prince of Wales is involved with a company getting herbal products registered* as medicines stands out in the United Kingdom, where schools like the University of Salford and the University of Central Lancashire have either dropped their homeopathy and complementary medicine degrees or stopped recruiting new students for the degree programs.² So far the Duchy Herbals line, introduced in January, includes an Echinacea-relief tincture (containing the root of Echinacea purpurea), a Hyperi-lift tincture (containing St. John’s wort, Hypericum perforatum), and a Detox tincture containing artichoke (Cynara scolymus) leaf and dandelion (Taraxacum officinale) root.

Involved in the development of Duchy’s traditional herbal medicines is Michael McIntyre, a practicing herbalist in Oxfordshire and consultant for Asanté Academy of Chinese Medicine. McIntyre is the former president of the National Institute of Medical Herbalists and founded and served as the first editor of European Journal of Herbal Medicine. According to McIntyre, his role so far has involved supplying expert advice; writing the data sheets for the line on traditional use, safety, and relevant pharmacology; and discussing which products they should attempt to register under the European Union’s Traditional Herbal Products Directive (THMPD) (e-mail, March 3, 2009). However, McIntyre was involved only in helping get the registration for the 2 THMPD products. He was not involved in the development of the Duchy detox tincture which has received some media attention lately in the UK³ and on ABCNews.com in the United States (where ABC’s Founder and Executive Director Mark Blumenthal was quoted about issues related to detoxification, see article here⁴).

The Echinacea-relief and hyperi-lift tinctures are the first herbal tinctures produced in the United Kingdom to be registered under the THMPD.¹ According to McIntyre, the EU passed the Directive in 2004 and each Member State has to fully implement it by passing national laws by April 2011. The THMPD allows herbal products to be registered under medicines law. To earn a registration a company must submit a complete file to the Medicines and Healthcare Regulatory Authority (MHRA) containing extensive evidence of a product’s traditional use, safety, and quality. According to one source, cost estimates for putting together the required scientific dossier and other related costs to meet these standards are as high as €100,000 and up (about US$140,000).⁵

Though McIntyre could not discuss the cost of this specific venture, he did add, “Perhaps as the process gets bedded in, the costs of licensing* may come down. We certainly hope so!”

However, the benefit of registration may outweigh the cost. If a registration is extended, a product can have more information available on its label, including medicinal claims about traditional uses. However, these claims are limited to mild or moderate self-limiting conditions and cannot address more serious conditions that require a physician’s care, such as cancer. The first 2 above-mentioned tinctures have been registered with the MHRA, but the detox tincture requires no such registration as it is classified as a food supplement. By 2011, every herbal product that is judged as medicinal by the MHRA will require a registration. (The criteria used to determine whether a product is a medicine or not are set out in the main EU medicines Directive 2001/83/EC). A product may be deemed medicinal by function or by presentation. Thus an herbal product can be deemed a medicine by the claims it makes or the way it is marketed, i.e., it’s intended use.)

“The herbal medicines in the Duchy range are manufactured to exact standards and to provide popular herbal remedies over the counter that the public can be certain are quality assured with all necessary safety information,” said McIntyre. “The launch of Duchy Originals herbal tinctures reflects the Prince’s passion for adopting an integrated approach to health.”

In the wake of some controversy over claims related to the promotion of the 2 herbal tinctures on the Duchy Web site, Duchy Herbals has changed the wording of its advertising and removed all previous claims of efficacy of those 2 products.⁶ More information about Duchy Herbals is available at www.duchyoriginals.com.

*This article refers to registration of THMPs. According to McIntyre, the MHRA uses the term traditional herbal registration for THMPs to avoid confusion with other more rigorous forms of approval known as licensing. A license requires proof of safety, quality, and efficacy, whereas a traditional use registration requires evidence of safety, quality, and tradition of use. More information about this can be accessed at the MHRA web site: http://www.mhra.gov.uk/index.htm.

—Kelly Saxton Lindner

References

1. Duchy Originals encourages consumers to adopt an integrated approach to healthcare with launch of duchy herbals [press release]. East Twickenham, London, England: Duchy Originals. January 22, 2009.

2. Frean A. Universities drop degree courses in alternative medicines. Times Online. January 30, 2009. Available at http://www.timesonline.co.uk/tol/life_and_style/education/article5614896.ece. Accessed January 30, 2009.

3. BBC News. Prince Charles detox ‘quackery.’ BBC News. March 10, 2009. Available at http://news.bbc.co.uk/1/hi/health/7934568.stm. Accessed March 11, 2009.

4. Childs D. Prince Charles’ herbal products stir controversy. ABCNews.com. March 13, 2009. Available at http://abcnews.go.com/Health/WellnessNews/story?id=7071267&page=1. Accessed March 16, 2009.

5. Starling S. Can the EU traditional herbal medicines directive be amended? NutraIngredients.com Europe. November 20, 2008. Available at http://www.nutraingredients.com/Regulation/Can-the-EU-traditional-herbal-medicines-directive-be-amended. Accessed February 9, 2009.

6. Jones A. Prince's firm told to amend ads. The Guardian. March 21, 2009. Available at http://www.guardian.co.uk/uk/2009/mar/21/prince-charles-duchy-originals. Accessed March 21, 2009.