UK group formed to defend ‘divine weed’ from THMPD

By Shane Starling

- Last updated on GMT

Related tags: Herbal products, European union

A group has been formed in the UK to pressure regulators into “lightening” the impact of the Traditional Herbal Medicinal Products Directive (THMPD) which requires all herbal medicines within the European Union to attain THMPD registrations before 2011.

The group, called Herba Sacra (Latin for ‘divine weed’), argues that while herbal products should be able to demonstrate their safety like any other product legally available for public purchase, the THMPD is “excessive and disproportionate”​ and should be amended.

Herba Sacra, which is backed by a number of supplements manufacturers including G&G Vitamins, Viridian Nutrition, Pukka Herbs, the UK lobby group, Consumers for Health Choice, as well as the UK National Association of Health Stores, is calling for an extension of the 2011 registration deadline.

It also seeks an easing of the pharmaceutical-style testing requirements it says are inappropriate for herbal products and financially prohibitive.

An average product registration costs about €60,000.

Appropriateness

Solgar UK technical director Paul Chamberlain told NutraIngredients.com the reforms Herba Sacra was lobbying for would simplify a registration process that was “completely inappropriate”​ to herbal products.

“The fact there has been something like 38 applications so far out of the 1000s of products on the UK market alone says a lot about this process,”​ he said. “If it was a fair and reasonable process there would be 100s of registrations by now.”

Chamberlain said large companies were just as likely to be adversely affected by the THMPD as smaller companies because they had more products to register.

If the legislation remains unchanged Solgar may have to register something like 100 products which would cost the company upwards of €5m.

Divine Weed demands

In briefing notes released this week, Herba Sacra called for:

• THMPD review. “The European Commission must conduct another review of the THMPD which fully reflects the impact of this over-burdensome regulation to the sector.”

• Lightening of the testing regime. “What is required is a balanced and proportionate testing regime that acknowledges the uniqueness of herbal remedies”;

• 30-year rule (that states products should be on-market for 15 years within the EU or 30 years outside the EU). “The overall period should be shortened and the requirement should take into consideration use anywhere in the world without geographic discrimination”;

• Extension of the 2011 deadline;

• Practical assistance to SMEs.

Herba Sacra said the THMPD would result in a reduction in market diversity and see small companies and independent health product retailers forced out of business.

In a such a scenario public safety would be jeopardised as consumers sourced products from the internet and other markets where quality and hygiene were less stringently controlled.

Registration process

The THMPD came into being in 2005, at which point companies were eligible to begin registering products. To date the UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), has approved 18 herbal products ranging from Echinacea to rhodiola to St John’s wort to valerian.

None have as yet been rejected.

The MHRA said the fact small companies were achieving registrations vindicated the system although it had opened a public consultation to consider the manner in which existing herbal marketing authorisations should be handled.

That consultation is available here​ and closes on November 7.

A small Kent based company Bio-Health had a valerian product registered in July and told NutraIngredients.com at the time: “We are a small company with limited resources and we have proven these registrations are economically viable as we have paid for it from our revenue streams and have two more on the starting blocks."

The Irish Association of Health Stores had conducted a survey of some of its members to determine THMPD-readiness, to which it had had little response, according to UK magazine, Natural Products News​.

In addition to the health claims potential of a product registration, the THMPD dictates that all herbal products not classified as food supplements (like many culinary herbs such as garlic and sage) or those considered medicines, must gain THMPD registration by April 2011 to legally remain on market.

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