DECEMBER 8, 2010 ADDENDUM IMPORTANT

HerbalEGram: Volume 7, Number 12, December 2010
Editorial Perspective: Campaigns Against EU Herbal
Regulations are Misguided

By Thomas Brendler, PlantaPhile Ltd.

In less than 5 months, the notorious EU Traditional Herbal Medicinal Products Directive (THMPD) will take full effect. With this final deadline, all herbal products classified as medicines must have traditional-use registration, or well-established-use or full marketing authorization; if a product does not have the appropriate license, it will either have to be taken off the market or marketed as a food or food supplement without a health claim, when appropriate. (For a detailed article on the THMPD and varying opinions surrounding its implications, please see HerbalGram 86:58-60.)

As was the case from the moment the THMPD was introduced, numerous groups are voicing their disapproval of the regulations and are calling for action to prevent it from becoming fully implemented. Recently, petitions to the European Union and to the German government were launched, condemning THMPD as an “an egregious abridgement of the rights of individuals to obtain and use the health treatments they choose,” and also claiming that all EU member states will ban medicinal plants and herbs from sale without license. Meanwhile, the Alliance for Natural Health International and the European Benefyt Foundation is lobbying to prevent interruption of the availability of herbal products already in the market. In a position paper the organizations state that “full implementation of the Traditional Herbal Medicinal Products Directive (THMPD) (EC Directive 2004/24/EC) as of 1st May 2011 is likely to force from the European market thousands of products associated with traditional systems of medicine that have up until now been sold mainly as food supplements.”

For the most part, however, this movement is based on false labeling. It mixes up restrictions and legal foundations of 2 entirely different classifications, resulting in what might be seen as fear-mongering and confusion.

On the one hand, there is Directive 2002/46/EC on food supplements and Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. The latter involves the European Food Safety Authority (EFSA) assessing and approving health claims associated with food and food supplements, including herbal products that are not otherwise registered as medicines. As of April of 2011, food products with health claims require EFSA approval.

On the other hand, there is Directive 2001/83/EC, as amended by Directive 2004/24/EC, stating that no medicinal product may be placed on the market of a EU member state unless a marketing authorization has been issued by the competent authorities. This directive provides for a simplified registration procedure introduced to facilitate the placing on the market of traditional herbal medicinal products (THMPs) without adequate clinical proof of efficacy. THMPs have to be registered with competent national authorities by April of 2011. After that date unregistered products can no longer be associated with medicinal claims, unless these are approved under Regulation (EC) No 1924/2006, discussed in the previous paragraph. While this is an EU guideline, it has not yet been transferred into national law by all EU member states and it remains unclear how member states will enforce it after the end of the transitional period in April of 2011.

The purpose of both guidelines is to create consumer safety and assurance and to weed out products of questionable quality and/or with unreasonable health claims. This is of particular importance in view of an increasing number of products being marketed and traded via the Internet and the repeated discovery of fraudulent and adulterated products. It is thus not an initiative or result of “Big Pharma” lobbying, as it simply asks everybody to follow the same rules applied to all EU pharmaceutical manufacturers, regardless of size and market “influence.” As a matter of fact, manufacturers of products with a high quality and safety profile will benefit from a simplified and harmonized regulatory environment. Attacking these regulations with factually questionable allegations could raise suspicion over the campaigners’ underlying motive.

Any assumption that herbal, ayurvedic, or other natural medicines will no longer be allowed to be marketed as of April of next year is therefore incorrect. The market remains open, except for products with unapproved claims. Every manufacturer can carry on selling their herbal tea, Traditional Chinese Medicine (TCM), or ayurvedic product without THMP registration or EFSA approval, as long as these products are recognized foods and do no make health claims. This seems logical, as it would otherwise amount to marketing an unapproved drug, which is and always has been not just outright dangerous but illegal.

The following is taken from an answer given on behalf of the European Commission by Commissioner John Dalli in response to several questions raised by Members of the European Parliament in relation to the THMPD and its implementation/end of the transitional arrangements:

The simplified procedure does not reduce access to Chinese or Indian ayurveda medicinal products or of products of companies with reduced financial capacity; the adoption of the simplified procedure facilitates the possibility to place specific traditional medicinal products on the European market and does not introduce new requirements more burdensome than the ones following from the marketing authorization procedures. On the contrary, the aim of these rules is to safeguard public health and at the same time facilitate the free circulation of traditional herbal medicinal products within the European market… On the other hand, herbal products may be classified and placed on the market as foods provided that they do not fulfill the definition of medicinal products; and that they comply with EU food law. In particular, herbal products marketed in the form of food supplements should comply with Directive 2002/46/EC on food supplements and Regulation (EC) No 1924/2006 on nutrition and health claims made on foods.

The THMPD, introduced in 2004, has given manufacturers 6 years to develop the required documentation and submit applications. While requiring investment, the procedure’s feasibility—even for smaller manufacturers without substantial resources—is shown in the increasing number of successful THMP registrations. For instance, in the United Kingdom, 78 traditional herbal registration applications have been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as of October 2010 (out of the 166 applications received by the agency). Indeed, this procedure may not be possible for hundreds of products from one portfolio, and will cause a market adjustment that may very well have been intended by the lawmakers. Further, as a result of increasing complexity and volume of applications, EFSA has postponed ongoing assessment of health claims for herbal products and raw materials classified as foods. In practice, this means that in absence of a negative EFSA assessment, legislators will tolerate for the time being manufacturers’ continuing to market food supplements with respective claims.

To summarize, quality herbal products, no matter which regulatory paradigm they fall into, are not under threat. They will continue to be available to the general public—as herbal drugs, traditional herbal medicines, foods, and food supplements, with and without health claims. A harmonized regulatory environment will create a marketplace in which assurance of the consumer and product quality, efficacy, and safety are the primary concerns.


thomas Brendler is a natural product consultant and founder of PlantaPhile Ltd. He co-authored A Practical Guide to Licensing Herbal Medicinal Products (Pharmaceutical Press, 2009), a book offering detailed information on the THMPD and instructions on how herbal medicine manufacturers can achieve THMP registrations for their products. The views expressed herein do not necessarily reflect those of HerbalEGram or the staff and Board of Trustees of the American Botanical Council.