The Traditional Herbal Medicinal Products Directive, now law across the European Union, will make life difficult for smaller herb manufacturers and restrict consumer choice, according to a leading industry group.
Ric Hobby, chairman of the UK's Council for Responsible Nutrition (CRN), said the costs of registering herbal medicines, establishing Good Manufacturing Processes and tracing herbs back to the farm will compel some traders to pull products from the market, others to increase prices and others to go out of business completely.
"It is going to make it very tough on small companies, especially those that want to bring new products to market," Hobby told FF&N."If they haven't got a long history of safe use, it is a time-consuming process that could cost companies more than $150,000 per product."
Even the UK's Medicines and Healthcare products Regulatory Agency (MHRA), a strong advocate of the directive, estimates the average cost of a single-herb product registration at about $70,000.
It is expected some products will become exclusively available from licensed herbalists whom it appears the legislation allows to use unregistered herbs. Some see this as a loophole that may allow some herbs to gain free-market status under the directive's history-of-safe-use criteria (because if they are being dispensed by herbalists, it can be argued this is creating a history of safe use).
Others fear the directive's licensing requirements will mean fewer herbs available to practitioners as well.
Some support CRN, along with others such as the Herbal Forum, which represents herbal practitioner associations across Europe, that continue to lobby for some herbal products to be regulated under food and food supplements law.
Others are more optimistic, such as Rachel Dale, sales and marketing manager at UK-based Herbal Concepts. "There is a lot of confusion about the issue and many consumers are unaware that many herbal products on the market are not currently tested or regulated," she said."The EU Directive will help manufacturers and retailers communicate to consumers."
June Crisp, sales and marketing director at UK manufacturer Bio-Health, expressed commitment to the directive. "We have always been aware of the frailty of the herbal medicines industry because until now, consumers could not be sure of the quality of the products they were buying," she said."The directive will help raise herbal medicine to a new platform that will allow the use of herbal medicines for the treatment of an array of health conditions to be taken seriously by health professionals."
Organisations such as the European Herbal Practitioners Association and the British Herbal Medicine Association support the directive on similar grounds.
Robin Ward, commercial manager at Swiss-based botanicals supplier Linnea, said his company supported the directive, but held reservations about the difficulty in gaining health claims for herbs that do not meet the history-of-safe-use criteria.
EXPECT HIGH COSTS
The directive applies pharmaceutical-style checks to herbal products that cannot demonstrate a 30-year history of safe use within the EU, or 15 years within the EU and 15 years' use elsewhere. While not as exacting as pharmaceutical registration procedures, meeting these standards will be costly.
For products that combine herbs with other nutrients, fresh registrations will often be required because such offerings have no history of safe use as combinations.
"If a company changes the formulation of a product, they will have to apply afresh," Hobby at CRN noted. "Very few products in the combination area will qualify under this directive. We would like to see an extension of the Food Supplements Directive to cover the majority of these kinds of products."
Similarly, new herbal products that arrive in Europe in the form of Indian or Chinese medicines, or from the relatively liberal US market, will have to go through the registration process, even if they have decades of safe use in their own jurisdictions.
While this aspect of the directive is potentially exclusionary, in European markets that previously prohibited the mixing of herbs with other nutrients, the directive will have a liberalising effect.
The MHRA said the directive sought to ensure quality and boost consumer confidence in herbal products."Until now, unlicensed herbal remedies in the UK have not had to meet set standards for safety, quality and consumer information," it said in a statement. "Responsible companies following high standards have been at a commercial disadvantage."
An adjustment period is built into the directive that permits products legally on the market on April 30, 2004, to retain their status until 2011, at which point registration will be required.