by Alexander G. Schauss, PhD, FACN

Summary: There is every indication that recent events unfolding in Europe by Member States of the European Union, relative to legislation affecting nutraceutical products, including herbal medicines, will have a long-term effect on countries world-wide that export products into Europe. The author reviews the recently passed Food Supplements Directive (FSD), recent amendments to the Pharmaceutical Directive, and the Traditional Herbal Medicinal Products Directive (THMPD), with comments on their impact, including proposed legal challenges to the FSD that may set the stage for similar challenges to the restrictions imposed by the THMPD.

There has been much activity—and much confusion—about recent regulatory developments in Western Europe that affect the manufacture and sale of herbs and herbal products. Manufacturers, suppliers, retailers, practitioners, and consumers in Europe have received a wide range of sometimes conflicting messages about the likely impact of the European Union (EU) legislation on the availability of dietary supplements to Europeans. EU legislation may have a profound impact on the availability of a wide range of dietary supplements in the future, particularly traditional botanical medicines found outside of Europe and not yet in the European marketplace. (See sidebar for summary of EU legislation.)

Many stakeholders with an interest in the dietary supplement marketplace in the United States (US) assume that events in Europe will have minimal or negligible impact on Americans or the US supplement industry. The following discussion will make it clear that this position is erroneous.

The Directives that have become law or are about to become law among EU Member States (soon to expand from 15 to 25 countries) are part of a comprehensive plan for the regulation of dietary supplements, including botanical medicines. If contemplated challenges to the first Directive are not successful, as will be discussed below, the chances of a successful challenge to a second or subsequent directive will inevitably be reduced. The second directive, which was formally adopted by the European Council of Ministers on March 11, 2004, involves the sale of traditional botanical medicines and is known by its acronyms, THMPD and DTHMP. To understand that directive it is essential to review the first directive that passed into law and will be enforced in EU Member States beginning August 1, 2005.

Legislation making its way through the EU law-making process covers the full spectrum of “nutraceutical” products, including herbal products, so-called “borderline products,” fortified foods, and sports nutrition products. [Editor’s note: Nutraceutical refers to substances found in food or food derivatives, other than nutrients with established needs in human nutrition, that have beneficial effects on the structure/function of the human body and are non-toxic when consumed in amounts needed to produce beneficial health effects. Nutraceuticals may be distinguished from pharmaceuticals in that pharmaceuticals generally have toxic side-effects at doses needed to deliver a desired pharmacologic effect.] New EU regulations on health claims have recently been enacted and for many observers here in the US, the effects of recently enacted EU Directives are of concern to the American marketplace and its consumers.

By July, 2004, two directives had passed into EU law, affecting all member countries: (1) the Food Supplements Directive (FSD) and (2) the Traditional Herbal Medicinal Products Directive (the acronyms THMPD and DTHMP are both used to refer to this directive).¹ Various European and international groups have been engaged in legal campaigns to amend and shape the FSD legislation.

To fully understand the European regulatory situation, it is important to start with the FSD to see how botanical products will be impacted through other related directives.

Of concern to critics of the FSD is how this legislation will restrict sales of some popular higher dose nutrients presently in the marketplace, such as vitamins C, B-6, and E, and certain essential minerals, including selenium and zinc. These critics contend that the FSD would limit consumers to purchasing low doses of these supplements, as higher doses would be considered “drugs,” thereby dramatically increasing the unit cost for those desiring to consume higher doses. A good illustration of this was observed by the author when Norway, the first country in Europe to effect such legislation on a national level, in the early 1990s restricted the allowable dose for most vitamins and minerals. Vitamin C, for example, which could be obtained at a cost of $9.80 (US) for sixty 250 mg tablets at any health food store, became a “prescription” drug at that same dose, and only obtainable at a pharmacy for a cost of $47.00 (US). One of the reasons the FSD managed to get through the European Parliament (EP) is that major international and European trade associations advised their member companies and supporters that the directive was going to be beneficial for the dietary supplement industry. However, there was no consensus supporting this position within the European natural products industry. For example, consumer, retailer, and practitioner groups—in the United Kingdom (UK), some Scandinavian countries, and Ireland—opposed restrictions that would be imposed on supplements by the FSD. These groups and their respective countries include the UK’s National Association of Health Stores (NAHS), the Health Food Manufacturers Association (HFMA), the Consumers for Health Choice (CHC), the Alliance for Natural Health (ANH), and the Institute for Optimum Nutrition (ION); Denmark’s MayDay; the Swedish Practitioner Association (Näringsmedicinska Terapeutförbundet); Norway’s Health Freedom Association (Fritt Helsevalg [FHV]); and Italy’s La Leva de Archimede. The above groups consistently claimed that the legislation would be “catastrophic” for sectors relying on dietary supplements for their patients or customers.

Since the FSD’s passage into EU law, many companies and associations with an interest in innovative product development within the European dietary supplement industry have come together. For example, Consumers for Health Choice (CHC) [www.healthchoice.org.uk] expanded from being a UK-based lobbying organization for consumers, to lobbying on their behalf in the UK’s Parliament in London and the EP in Brussels. Similarly, another UK-based organization, the Alliance for Natural Health (ANH) [www.alliance-natural-health.org], developed into a pan-European umbrella organization, coordinating concerns on behalf of a diverse group of consumer associations.

A detailed look at the FSD legislation suggests that the primary reason for discrepancies in viewpoints regarding the legislation’s impact is the difference in how the legislation will impact different sectors of the nutraceutical industry Innovative suppliers (engaged in the development of new dietary supplements not currently found in the EU market) and those who depend on existing products, many with doses higher than that permitted by FSD legislation, will inevitably be hardest hit. By contrast, companies manufacturing or selling relatively low-dose, synthetic vitamins and certain forms of minerals, will gain considerably from the legislation. They will benefit from the single market conditions throughout all EU member countries set by the directive, which is its primary intent. One of the primary advantages to these low-dose, synthetic vitamins is the quantity and quality of research to date that supports their safety and benefits.

Others, however, are concerned about the loss of many food-derived vitamins (e.g., mixed tocopherols, tocotrienols, natural carotenoids, and methylcobalamin) and a range of minerals (e.g., sulphur, boron, vanadium, silicon, and many chelated or plant-derived forms). Because the FSD is incremental in its effects, with any bans on nutrient forms not coming into full force until August 1, 2005, many detractors argue that future effects could cumulatively have a catastrophic impact on innovators, independent retailers, practitioners, and consumers. Some of the ingredients affected are so new that relatively little is known about their bioavailability or safety. Therefore, the concern is that excluding them may chill further interest in doing research on them.

Food Supplements Directive: Key Concerns

From the perspective of those involved in the innovation sector of the dietary supplement and botanical industries, there are four primary concerns about the Food Supplements Directive: (1) Limited range of nutrient forms allowed on the “positive list,” (2) Difficulties and costs in submission of dossiers, (3) Reductions in maximum permitted levels, and (4) Future restrictions on supplementsother than vitamins and minerals as of 2007.

1. Limited range of nutrient forms allowed on the “positive list” (Annex I & II of FSD). The UK Food Standard Agency has determined that there are at least 270 ingredients (nutrient forms) presently used in the UK that are not included on the positive list (e.g., such popular ingredients sold in the US as pro-vitamin A carotenoids, chromium picolinate, and selenium yeast). In contrast, the UK’s National Association of Health Stores (NAHS), an industry group representing independent and chain retail health food stores, has determined that this is an understatement and that the real figure exceeds 300 ingredients. These “missing” (i.e., unlisted) ingredients are included in some 5,000 commercial products currently sold in the UK market. The Irish Association of Health Stores (IAHS), for example, has determined that around 85% of vitamin/mineral products in Irish health food stores contain one or more of these missing nutrients or nutrient forms and would require reformulation to comply with the FSD. One of the greatest concerns of the Alliance for Natural Health (ANH) is that many missing ingredients are food-forms, which in many cases are believed to be more bio-available and generally safer. These food-forms lack the chemical residues found at almost undetectable levels in synthetic or inorganic forms that appear on the positive list. However, the science to support these concerns remains inadequate and controversial.

2. Difficulties and costs in submission of dossiers (Article 4.6 of the FSD). The process of permitting the use of unlisted nutrient forms is a highly contentious issue, based on the fact that most supplement companies are formulation companies that buy raw ingredients from a limited number of manufacturers or producers. If these manufacturers choose not to submit dossiers to get their ingredients on the positive list, then the formulation company would not be able to use them. However, if one manufacturer submits a particular dossier and has it approved, any formulator can use that ingredient (at least until December 31, 2009). Costs for dossiers vary greatly according to the amount and nature of existing data. Estimates vary from $25,000 (US) to more than $300,000 (US), depending on the ingredient and data needed for submission. In addition, because the deadline to submit dossiers is July 12, 2005, there may not be sufficient time to generate all of the required data for the vast majority of the 300-plus affected ingredients. As of July 2004, less than 20 dossiers have been filed, supporting critics’ concerns about the lack of motivation of raw ingredients suppliers to submit dossiers and the often-prohibitive additional costs needed to complete whatever studies are needed for submission.

3. Reductions in maximum permitted levels (Article 5 of the FSD²). Reductions in maximum permitted levels, via unnecessarily low “Upper Safe Levels” (USLs), are being developed without procedures that would allow for open consultation with outside scientists or industry experts. An Expert Committee formed by the ANH determined that much of the science justifying low maximum levels of nutrients in food supplements is flawed. Consequently, products containing higher levels will be regarded as drugs and can therefore only be prescribed by physicians, which is currently the protocol in many of the countries with less permissive legislation.

4. Future restrictions on supplementsother than vitamins and minerals as of 2007 (Recitals 6 & 8, Article 4.8). Examples include amino acids, fatty aids, phytonutrients, enzymes, fibers, probiotics, and peptides. These restrictions could be brought in via a positive list system as well, resulting in exclusion of ingredients currently in the marketplace, on top of exclusion of non-European traditional botanical medicines. It should be noted that there is no published or acknowledged EC schedule in place at this writing to implement the FSD for ingredients other than vitamins and minerals.

From reviewing the above four points, it seems evident to critics of the FSD Directive that the intended purpose of the FSD is to protect a limited number of low-dose food supplements, the type typically sold in European supermarkets and pharmacies. Supplements that would be excluded from the marketplace unless their dossiers are approved by August 2005, and those that do not appear on the positive list, could become history in Europe. (As of July 2004, it was not known what maximums would be set.)

It has also been the contention of critics that for many companies there is simply not enough time to conduct the necessary safety studies. This is based on the lack of incentives to invest in the high cost of research for many of the botanicals and other supplements that have a relatively long history of traditional use that are affected by the FSD. For others the task is simply too expensive. Take, for example, selenomethionine, the most common form of selenium found in foods and well known as an important antioxidant mineral by experts who have reviewed the data.³ This form of selenium was rejected in 1999 by a committee of the FSD because long-term safety studies had not been conducted. Ironically, the same committee agreed to permit use of two inorganic forms of selenium (sodium selenate and sodium selenite) that have a higher potential for toxicity and less effectiveness as an antioxidant. For consumers this is confusing. On the one hand, they are told by the FSD committee that they should increase their consumption of Brazil nuts (Bertholletia excelsa Humb. & Bonpl., Lecythidaceae), which contains high doses of selenomethionine (16 to 30 mcg/g).^4-6 But on the other hand, the EU Commission does not include selenomethionine on its positive list as a safe form of selenium simply because it claims the studies are not available. Are food manufacturers being asked to provide safety data on natural products that are used as conventional foods? Who, for example, has been required to prove via clinical trials that commonly consumed fruits and vegetables are safe?

Whether the critics are correct or not will be determined by which botanical products receive registration or not under the next directive to be discussed, the Traditional Herbal Medicinal Products Directive (THMPD).

Definitions of Acronyms

Legal challenge of the Food Supplements Directive

The ANH is working with its Expert Committee of scientists, legal advisers, and public affairs and media specialists to either annul or positively shape key EU legislation that is expected to severely impact the innovative supplement industry and its beneficiaries. Although there is plenty that can still be achieved through effective lobbying on amendments to the Pharmaceuticals Directive (PD) and the Traditional Herbal Medicinal Products Directive (THMPD), ANH believes there are few lobbying options for the FSD without a legal challenge.

There is still some possibility to influence the maximum permitted levels and positive lists for nutrient groups other than vitamins and minerals, but the FSD has already passed into European law. It was adopted by the EP and Council on June 10, 2002, became effective on July 12, 2002, and implemented by the Member States by July 31, 2003. Food supplements containing vitamins and minerals that do not appear in Annex I, or are taken from a source other than those listed in Annex II, may not be entered into commerce or manufactured in the EU after August 1, 2005. During a transitional period, Member States may allow the use of vitamins and minerals in their respective territories if the ingredient has been marketed in the EU before July, 2002. This temporary availability will be allowed only on the following conditions: (1) if a dossier supporting an ingredient’s use is submitted by July 12, 2005; (2) if the ingredient has not been the subject of an unfavorable opinion by the European Food Safety Authority (EFSA); and (3) the ingredient must not be on Annex I’s and Annex II’s “positive list.” This exception is valid only until December 31, 2009.

In some ways challenging the FSD in particular would make no sense unless there were reasonable grounds and probabilities of success. The ANH has retained the only legal team to have ever had an EU directive overturned by the courts. After ANH’s law firm completed an extensive examination of the FSD, ANH made the decision to proceed against the EU by filing a suit on August 8, 2003. The case is being built on a number of grounds, but of particular importance are EU constitutional grounds that suggest there is a reasonable chance to annul the directive.⁷

In addition, it appears that the effects of the FSD directive can be challenged on grounds of proportionality, based on the fact that that it will disproportionately impact certain sectors of the industry, notably those associated with innovative products.

ANH’s legal challenge resulted in a British High Court ruling in February 2004 that gave opponents of the FSD permission to argue their case before the European Court of Justice. Interestingly, if the FSD directive is annulled, all national laws that rely on the directive are likely to be invalidated. Should the Judicial Review result in the suit proceeding, this could have a significant impact on the THMPD, should aggrieved parties wish to pursue similar action based on the same issues.

In an e-mail to the author on August 15, 2003, Robert Verkerk, Ph.D., Executive Director of the ANH, said that “The case will allow the real science of nutrients to be showcased to the Commission, to the EP and to the public generally. People will understand that supplementation of a good diet with high quality nutrients is a valid and effective way towards optimum health. There is no scientific rationale for only accepting synthetic vitamins and a limited range of inorganic mineral forms while rejecting the plethora of naturally occurring vitamins and minerals. Winning the case will pave the way to a very bright future for the industry. We are not suggesting that there should be no directive at all, but the existing directive needs to be replaced with a re-worked version that allows for high quality, effective supplements across the whole of Europe. It’s about harmonizing to good standards, not bad ones.”

The Traditional Herbal Medicinal Products Directive

The key EU directive that will regulate basic supplements will be the FSD. For botanicals, however, the amended Pharmaceutical Directive (PD) (Directive 2001/83/EC),⁸ of which the THMPD is a part, will be critical.⁹ Essentially, if a product is not able to be controlled under the FSD, it will default to the PD. If it falls under the PD, it will either require a full drug license (with very substantial data requirements and costs required for drug approvals) or, if appropriate, botanically-based products can be classified as “medicinal herbs” and benefit from a “fast-track” licensing process. This “fast-track” THMPD procedure initially requires that the applicant demonstrate many years of safe use or traditional use in lieu of providing formal safety data (the major component of data required for market authorization as a drug).

The THMPD was debated during a Plenary Session of the EP on December 16, 2003, and became law on March 11, 2004. One particularly contentious issue has been the requirement in the EU Commission’s proposed legislation that calls for 30 years of safe use and that 15 of those years occur within the EU. CHC has tabled this amendment and campaigned to allow 30 years use to demonstrate safe use anywhere it has occurred in the world. CHC argued that limiting non-EU use will prevent interesting and beneficial herbs found outside Europe with very strong herbal cultures (e.g., China, India, South East Asia, South Africa, South America) from being brought into Europe, and therefore strongly impacting future innovation and availability to Europeans. The legislation would essentially have the effect of freeze-framing the industry’s products to what was available in the early 1990s. As reasonable as this may sound, the reality is that once the law was passed on March 11, 2004, the provision requiring a minimum 15 years safe use in the EU out of the 30 years of traditional use will become the critical criterion for acceptance in commerce.

However, this may not “freeze frame” the herbal market as far as non-EU herbals are concerned for all, because UK herbal practitioners, for example, are not bound by the THMPD (i.e., if herbal products are custom-made as individual medicines for their patients). Such products are not industrially produced and, therefore, not subject to the Directive (2001/83/EC). Thus, the UK herbal practitioners’ use of herbs not previously used in Europe for 15 years may subsequently be used as evidence of the 15-year requirement within the EU. Hence, this may be the route by which many botanical products will eventually qualify for commercial manufacturing and subsequent marketing. This refinement to the THMPD, which would allow for entry of botanical medicines that have no history of use in Europe, was championed by CHC and ANH along with their supporters, following considerable lobbying efforts in the EP in Brussels and the UK Parliament in London.

It should also be emphasized that the THMPD gives a legal basis for over-the-counter (OTC) herbal medicines in the EU for the first time. The EU Medicines Directive (2003/83/EC) requires that any product that has a medicinal use or action and is industrially produced must have a “market authorization,” also known as a medicines license. Until the advent of the THMPD, this meant that if EU law were applied throughout the EU, nearly all herbal products would disappear, as none could afford the huge cost of licensing, including the proof of efficacy that was required. The THMPD has substituted traditional use for this proof of efficacy and, hopefully, a much less expensive licensing procedure. It also allows for the first time limited claims to be made for the product, which until now has been forbidden, while also requiring good manufacturing practices to be applied to all products. Additionally, the THMPD will allow for the first time a limited range of vitamins and minerals to be included in formulations with an herbal ingredient. Previously, and continuing to this day, a number of Member States prohibited combination products containing botanicals and conventional nutrients.

In addition to the FSD and THMPD, other directives/regulations being prepared by the EU Commission are the Sports Nutrition and Fortified Foods Directive and a draft of Health Claims Regulations for conventional foods and dietary supplements. Both are tabled in Brussels as of July 2004.

Conclusion

The US dietary supplement industry has flourished in the face of what must be regarded by many around the world as relatively liberal laws since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). A significant contingent of House and Senate members in the US Congress, and others, are taking steps to alter the existing regulatory environment, but so far it seems that the industry (together with its extensive consumer support base) has defended itself against what it deems to be unnecessarily restrictive legislation.

The current US industry campaign against the Dietary Supplement Safety Act of 2003 (S.722) sponsored by Sen. Richard Durbin (D-IL) is a good example of how a diverse range of interested parties can work together.

However, recent significant media coverage over the FDA’s banning of ephedra (Ephedra sinica Stapf., Ephedraceae) as a dietary supplement ingredient, plus alleged concerns over the safety of kava kava (Piper methysticum Forst., Piperaceae), St. John’s wort (Hypericum perforatum L., Clusiaceae), and other botanicals, have given those in Congress with a desire to amend DSHEA considerable substance for their efforts. It is important to realize that it is now 2004, not 1992 when initial efforts to pass DSHEA began. Basically, the regulatory landscape, both in the US and particularly in Europe, has changed and will continue to change as events such as the problems associated with ephedra unfold.

DSHEA was important and essential to the US natural products industry when it passed in 1994. New supplement legislation for the US is possible. In fact, it may become inevitable in the face of consumer demand for quality assurance and substantiation of safety. Hence, whatever happens in Europe, especially related to the lawsuit against the EU’s FSD, may or may not prove to be the bellwether for what happens in the US in the future. Should the EU impose its various supplement-related directives on its over two dozen member countries, there is every reason to believe that there is enough critical mass in the US Congress for similar legislation to be passed to ensure that supplements are more stringently regulated, especially related to safety. The impact this would have on the US dietary supplement marketplace would be nothing short of significant, impacting every stake-holder in the nutraceutical industry, especially those in the botanical medicines industry, which has been a particular target of the media in recent years. To disregard what the ANH, CHC, and others have tried to do to bring attention to their plight in the EU with the FSD and THMPD is equivalent to putting one’s head in the sand. In this author’s opinion, what happens in Europe in the next several years will impact the future of the US dietary supplement marketplace in profound ways.

The US industry is, without question, the nutraceutical world leader. Its growth comes at a time when there is mounting evidence that many nutrients and botanical compounds found in dietary supplements may be useful in the prevention, mitigation, and treatment of a wide range of conditions and diseases, as well as their possibly more obvious beneficial effects on the structure and function of the human body.

Owing to trends towards global harmonization, and in particular increased pressure towards trans-Atlantic harmonization, the EU directives will in time have a direct influence on the shape of future US laws. In addition to this, many US companies have substantial and growing markets in Europe, which has a consumer population of over 500 million people, nearly double that of the US.

In July 2004, the joint international committee of the National Nutritional Foods Association (NNFA) and American Herbal Products Association (APHA) unanimously supported the ANH’s legal action against the EU’s FSD. Hence, some US trade associations are beginning to give Europe’s challenges the political attention they deserve. However, there has been little financial support of this effort, which has been a frustration to organizations such as CHC and ANH that have had to rely on funding support from primarily European sources.

Time is of the essence. Every company or individual with interests in the future of the dietary supplement industry in Europe should study the regulations within the FSD and THMPD and consider how these regulations will affect their product’s marketability in future years in Europe. They may want to accept the FSD and DTHMP, or they may want to be part of the potentially ground-breaking challenges that would pave the way to a more open future market within the EU supplement industry marketplace.

As a final note, there is a real difference between the FSD and the THMPD, which is worth considering. The latter Directive may be viewed by many as draconian and arbitrary; however, it may have allowed botanicals to take their place among the panoply of medicines readily available to health care consumers. Care should be taken to differentiate the two Directives, rather than lump them together, which may be a mistake, considering the new protections given botanicals under the THMPD.

Alexander G. Schauss, Ph.D., FACN, is President and CEO of AIBMR Life Sciences, Inc., in Puyallup, WA (www.aibmr.com), a nutraceutical consulting and R & D company. AIBMR Life Sciences has worked on regulatory requirements for dietary supplement products in 42 countries and has coordinated pharmacokinetic, toxicological, and clinical trials to assess the safety and efficacy of these products. Dr. Schauss is also Adjunct Research Professor of Botanical Medicine at the National College of Naturopathic Medicine in Portland, Oregon, and he has held appointments at the Southwest College of Naturopathic Medicine and Health Sciences in Scottsdale, Arizona; Bastyr University in Seattle, Washington; and City University, in Bellevue, Washington. He is the author of over 125 scientific papers on a wide range of subjects related to dietary supplements and nutraceuticals.

Acknowledgements: For their assistance in providing information and viewpoints for this article, the author would like to thank Christopher J. Whitehouse, Managing Director, The Whitehouse Consultancy Ltd.; Ralph Pike, Director, National Association of Health Stores; Robert Verkerk, MSc, Ph.D., Executive Director, Alliance for Natural Health; and Ingrid Franzon, MN, with the Swedish Practitioner Association (Näringsmedicinska Terapeutförbundet).

References:

1. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002, on the approximation of the laws of the Member States relating to food supplements. Official Journal of the European Communities. July 12, 2002, pp. L183/51–L183/57.

2. Alliance for Natural Health Legal Challenge of EU Food Supplements Directive. David Hinde, LLb, Solicitor, Legal Director, Mount Manor House, 16 The Mount, Guildford, Surrey GU2 4HS, United Kingdom. Available at: www.alliance-natural-health.org.

3.Combs GF. Impact of selenium and cancer-prevention findings on the nutrition-health paradigm. Nutrition and Cancer 2001; 40(1): 6-11.

4.Thorn J, et al. Trace nutrients. Selenium in British food. British Journal of Nutrition, 1978;39:391-396.

5. Ampe C, Van Damme J, de Castro LA, Sampaio MJ, Van Montagu M, Vandekerckhove J. The amino-acid sequence of the 2S sulphur-rich proteins from seeds of Brazil nut (Bertholletia excelsa H.B.K.). European Journal of Biochemistry. 1986;159(3):597-604.

6. Ip C, Lisk DJ. Bioactivity of selenium from Brazil nut for cancer prevention and selenoenzyme maintenance. Nutrition and Cancer 1994; 21(3): 203-212.

7.Anderson D, Stratford J. Alliance for Health. Re: Challenge to Supplements Directive. Joint Opinion. July 18, 2003. Available at: www.brickcourt.co.uk.

8. Pharmaceutical Directive (PD) (Directive 2001/83/EC), by letter of January 17, 2002, the Commission submitted to EU Parliament, pursuant to Article 251(2) and Article 95 of the EC Treaty, the proposal for a directive of the European Parliament and of the Council amending the Directive 2001/83/EC as regards traditional herbal medicinal products [COM(2002) 1 - 2002/0008(COD)].

9. Final Report on the Proposal for a Directive of the European Parliament and of the Council Amending the Directive 2001/83/EC as Regards Traditional Herbal Medicinal Products. Committee on the Environment, Public Health and Consumer Policy, European Parliament [COM(2002) 1-C5-0026/2002 – 2002/0008 (COD)], November 5, 2002, AS-0365/2002.

10. Draft Recommendation for Second Reading on the Council common position adopting a Directive of the European Parliament and of the Council amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Committee on the Environment, Public Health and Consumer Policy. Provisional, 2002/0008 (COD), November 7, 2003.

Summary of Key European Union Directives on Food Supplements and Herbs

There are three European Union directives of concern to the nutraceutical industry and its consumers: (1) amendments to the Pharmaceuticals Directive, (2) the recently passed Food Supplements Directive, and (3) the Traditional Herbal Medicinal Products Directive.

Amendments to the Pharmaceuticals Directive

This amends the existing Pharmaceuticals Directive (which governs the supply of drugs in the EU) by expanding the definition of a drug in a way that will enable reclassification of any supplement as a drug if it “restores, corrects, or modifies physiological functions” in the body. The proposed wider definition would cover practically all natural health products and put them at grave risk of being reclassified as drugs.

It also extends jurisdiction of the Pharmaceuticals Directive so that it takes precedence over any product defined as a drug under the wide definition, even if that product was already regulated and permitted under other EU legislation (e.g., Food Supplements Directive, Traditional Herbal Medicinal Products Directive, and Cosmetics Directive).

The Food Supplements Directive

The FSD, passed into law by EU Member States on July 21, 2003, creates a “safe harbor” for “food supplements,” so that they are not classified as drugs, but it limits the spectrum of nutrients, initially only vitamins and minerals. In the near future, however, FSD could substantially limit the potency of nutrients in such products by reducing maximum permitted levels. It provides a severe restriction on freedom of speech by preventing publicity over inadequacies of a normal diet. By 2007 it may be applied to other nutrient groups such as fatty acids, amino acids, fiber, and plant extracts. Because this directive has already passed into EU law and is now being transposed into the law of Member States, it will become fully implemented on August 1, 2005.

Traditional Herbal Medicinal Products Directive

This directive, currently working its way through the EU legislature, creates a new class of “traditional herbal medicinal products” by providing for a “simplified pharmaceutical registration” (e.g., avoiding provision of safety and efficacy data) for specific “traditionallyused >herbal medicinal products.” However, this directive covers only those products (including the same combination of herbal ingredients) that comply with a range of conditions, including having been in safe use for 30 years, 15 of which must be in the EU. This will mean that herbs with a history of traditional use outside the EU would not be eligible and could only be used following compliance with the full drugs regime required under the EU’s Pharmaceuticals Directive.

A particularly sensitive topic of the THMPD has been acceptance of non-European tradition when deciding on the status of traditional herbal medicinal products. The EP advocated that a minimum term of use was needed within the European Community at least 30 years preceding the date of application. Following concerns expressed by critics, the Committee on the Environment, Public Health and Consumer Policy of the European Commission agreed to open up an additional route for products with less than 15 years of use in the European Community. After an application for a traditional use registration was submitted, Member States could refer such an application to the Committee for Herbal Medicinal Products. The Committee would consider the relevant documentation and decide on the establishment of a community herbal monograph, which would allow for the acceptance in national markets within the EC. This was considered by the Committee to be an acceptable compromise in an effort to ensure “an open attitude towards tradition from outside the European Union while applying the general quality, safety and efficacy standards as established for this kind of medicine in the European Union.”¹⁰

While the original approach of the European Commission in relation to traditional herbal medicines was based primarily on the acceptance of each botanical in each national market of EC Member States, the EP insisted on the possibility of mutual recognition by other Member States. That is, the acceptance of a particular botanical in one Member State would require acceptance in another where the botanical has not been heretofore accepted. Both the European Commission and the Council claimed they took this request of the EP into account, which resulted in a common position that foresees mutual recognition for all products that are covered by a community monograph listing herbal substances.

On November 7, 2003, it was agreed and reported out of committee for consideration by the EP, that the THMPD would require a statement on labeling and advertising of all traditional herbal medicines in which the product is used for a specified indication that is based solely on its long-standing use. This is contrary to the original proposal which advocated a quite negative disclaimer. In recommending this approach, the Committee stated that it represented an “appropriate reflection of the reality and allows the patient and consumer to have the necessary background information on the product concerned. Such a message does not frighten the individual unnecessarily…”¹⁰

Of considerable interest is the proposed establishment of an independent Committee for Herbal Medicinal Products within the European Medicines Evaluation Agency. This committee’s scope of tasks includes final judgment in any arbitration process in cases where a mutual agreement among EU Member States could not be consummated. What this committee’s responsibilities and authority will be, if any, cannot be determined until the EP passes the THMPD into law.