While member states like Germany and France say most products are in compliance with the regulation, the UK market is very different with most products not registered – a situation local trade groups, retailers and manufacturers are understandably concerned about.
Massive product recalls, restricted consumer choice, multi-herb blend bias and retailer closures have been predicted by various parties, perhaps none more vehemently than the Alliance for Natural Health Europe (ANH-EU), which has raised more than €100,000 for a legal challenge against the Directive.
“We have been working hard with stakeholders across Europe to bring this challenge and we are nearly ready to file,” said the group’s executive and scientific director, Robert Verkerk, PhD.
“But the complexity of the case has meant that we are taking a little longer than planned, given we'd hoped to file our case by the end of April.”
The regulation is being felt differently in different countries, depending on existing policies and procedures toward traditional medicines of botanical origin.
“In some EU countries, such as the Netherlands and the Czech Republic, that have liberal regimes, we will expect to see no change for the time being as these countries seem content to regard Traditional Chinese Medicines (TCMs) and Ayurvedic products as food supplements. Others, such as the UK and Germany, the two countries that have registered the most products under the THMPD, have a different view,” Verkerk said.
While the UK and German medicine agencies take the same position that all non-prescription botanical supplements must be registered, all but a few hundred of the estimated 2500 products on the German market have had previous national registrations accepted under the THMPD.
The opposite is true in the UK, and the UK Medicine and Healthcare products Regulatory Agency (MHRA) has issued only 105 THMPD registrations, out of 211 applications. Dossiers backing individual products can cost more than €50,000 to prepare and process. The registration focuses on safety and tradition of use and demonstration of efficacy is not required.
To date there have been no rejections.
Food v medicine
Leading up to the deadline, the UK Health Food Manufacturers’ Association (HFMA) warned of ongoing ambiguity about the way certain herbs are to be treated, such as peppermint.
“There are many herbal ‘lists’ currently circulating within the industry, none of which are consistent or in any way definitive,” its executive director, Graham Keen stated.
“The reason for this is that simply stating that a particular herb is ‘medicinal’ or ‘food’ from the end of April is not the answer. This is because the great majority of herbs can be marketed as foods and as medicines.
“So, no question, there are challenging times ahead for botanical products as some companies try to maintain the unlicensed ‘food’ status of their products, whilst others seek to protect the traditional herbal registrations they have invested so heavily in."
Under the Directive, products already on shelves before April 30, are allowed to sell-through.