THMPD registration may be unnecessary

Companies offering herbal products in Europe have been told they can bypass the potentially labourious and expensive Traditional Herbal Medicinal Products Directive (THMPD) if products do not seek to make pharmaceutical-grade claims.

Patrick Coppens, executive director of the Brussels-based European Responsible Nutrition Alliance (ERNA), said unless companies wanted to employ medicine-style claims the THMPD was, in part, established to permit, there may be no need to register products through the directive. These pharmaceutical-style registrations have each been estimated to cost upwards of $150,000 and have led many to accuse the directive of discriminating against smaller companies who are less likely to be able to afford such costs.

Coppens told Functional Foods & Nutraceuticals: "The costs vary between member states but they are high, and the thing companies need to keep in mind is: do I need these registrations? Many products could continue life as food supplements under the Food Supplements Directive and not really be affected by the THMPD if no medicinal claims are sought."

He said companies should think carefully before committing to a THMPD claim because the evidence level is high, and many herbal products may not meet the criteria, nor would the claims necessarily assist the product's marketing. He did say, however, that in some cases claims were important to convey a product's intended usage. The THMPD was concerned only with claims registration and not product registration, he noted. "Even within the THMPD there is scope for streamlined registration where efficacy proof is not required," he said. "This should assist smaller companies if they do seek registration. But there is still the pharmaceutical-style plant inspections that will occur and these may be beyond many smaller companies." The THMPD has a built-in transition period for products currently on the market that have until 2011 to comply.

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