EU Health Products Directives To Have 'Serious International Impact'

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Legislation

The contentious issue of European health legislation has not been properly considered by the EU Commission before acting to support a series of directives - which will be applicable law in all member states - on preventive and curative foods and supplements as well as pharmaceutical medicines.

During a conference at the international exhibition SANA in Bologna, Italy, Dr. Robert Verkerk of the Alliance for Natural Health told a select gathering of Italian industry experts and consumer representatives on Saturday 11 September, that his group is proceeding with a legal challenge against the EU Food Supplement directive's prohibition of a large number of leading edge nutritional supplements.

The directive, he said, was whipped through the EU legislative process without proper consultation of affected health sectors, such as leading edge manufacturers, health stores, nutritional practitioners and consumers of the products. The hurried passing of the laws without due consultation resulted in the Alliance's legal case now pending before the European Court of Justice. Verkerk invited Italian industry representatives to unite with opposition from other EU countries in support of the legal action, to prevent widespread prohibition of natural health products, which according to Alexander G. Schauss, PhD, could have a serious impact on natural health options internationally.

According to Schauss, the new EU legislation already passed for food supplements and herbal products could affect availability of these products not only in Europe but internationally, especially in view of ongoing work by Codex Alimentarius, where European member countries are heavily lobbying for an extension of the new EU rules to the world wide regulations being developed by Codex....

Article first published in Herbalgram

A Review of the European Food Supplements and Traditional Herbal Medicines Directives

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.

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 (recently expanded 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 are soon to be 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.anhcampaign.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