Opportunities For High-Dosage Products In Europe

Examining the challenges and possibilities of brining a high-dosage supplement/food to
market in Europe.

By Joerg Gruenwald & Cordula Mueller

In the past, U.S. companies had great difficulties bringing their creative supplements to Europe because of the diverse and strict regulations in the European countries. Only the U.K. and the Netherlands were accessible and the main markets such as Germany and France, were almost impossible for bringing high-dosage supplements to market. This situation is starting to change and we are working with our partners to find the best possible market entry strategies.

The creation of a single European market for nutritional products is still a long way off but progress to­wards this goal is finally underway. As a first stage, the European Union (EU) Food Supplement Directive, published July 12 , 2002, laid down specific rules for food supplements, regarding only vitamins and minerals. The directive contains a “positive list” of vitamins and minerals, to­gether with a list of the permitted chemical forms and sets out labeling requirements. As maximum limits have not yet been set, national limits must be applied. Other vitamin and mineral preparations, as well as other nutrients, e.g. amino acids, essential fatty acids, or various herbal extracts, may be included at a later stage if adequate and appropriate scientific data becomes available. The regulations on vitamins and minerals must be included in the laws of the member states by July 31, 2003, and become effective August 2005. Until these rules are adopted, national rules are effective. Member states have the opportunity to allow the continued sale of products containing vitamin and mineral substances not yet on the permitted list for up to seven years until December 2009.

In Germany, currently no specific law on food supplements exists. In practice, supplements are classified as foods, drugs or in certain cases, as dietetic foods depending on their purpose of use, ingredients and dosage. Although there are no official maximum limits for vitamins and minerals sold in food supplements, the German Federal Institute for Risk Assessment (BfR) published guidelines on nutritional supplements stating that:

• Vitamin levels may generally not exceed 3 x RDA
• Mineral levels may generally not exceed 1 x RDA

Certain nutrients such as vitamins A and D and supplements containing slightly higher nutrient levels than 1-3 x RDA, are only permitted to be sold following the issue of an authorization for exemptions (Ausnahmegenehmigung). Also, the use of amino acids is only permitted either following an authorization request for exemptions or in dietetic foods. An Allgemeinverfügung (general court order) can be requested for food supplements imported from another EU country. This is based on the principles of free movement of goods in the EU and is not valid for German manufacturers. An Allgemeinverfügung is related to a specific product category, such as dietetic food, and is not only effective for the applicant but also for other third country EU-based companies producing a similar dietetic product. Producers from non-EU countries (for example the U.S.) have two possibilities for importing nutritional products containing substances that have not yet been licensed. They may request an Ausnahmegenehmigung or the product must first be marketed in a European country before it can be imported via Allgemeinverfügung. Note that these exemption regulations will definitely change when the EU Food Supplement Directive comes into force in August 2005.

There is unrestricted sale of food supplements and traditional herbal products, however, there are pharmacy re­strictions on most other herbal medicines, for example mistletoe, that have primarily pharmacological properties and are classified as medicines. Medicines must not be mixed with foods. There are exceptions for some herbals, such as ginseng and St. John’s Wort, when they are added in concentrations of less than 10% of the pharmacological effective dosage. Vitamin and mineral products can be sold freely if they contain only 2-3 x the RDA.

In summary, this means that there are currently marketing possibilities for high-dosage food supplements above the 1-3 x RDA with the request of an Allgemeinverfügung or Ausnahmegenehmigung. However, in order to reduce the numerous authorization requests for imported food supplements, German authorities have said they do not intend to provide the seven-year exemption for non-listed vitamins and minerals and that companies should follow a strict application of the positive list until August 2005.

Taking the Dietary Foods Route

At first glance the marketing of high-dosages supplements appears to be quite restricted. However, there is a promising alternative by selling high-dosage supplements as dietary foods, especially as nutritionally incomplete foods for special medical purposes (IMFs). Dietary foods are regulated by the EU PARNUTS (foods for particular nutritional uses) Directive, which has been mandatory since November 2001 for all member states.

Dietary foods for special medical purposes are categorized as nutritionally complete (suitable as a sole source of nourishment) or incomplete (not suitable as a sole source of nourishment) foods with a standard or nutrient-adapted formulation.

When marketing these types of products general labeling provisions must be taken into consideration. In principle, the labeling, presentation and advertising of medical foods may not refer to the prevention, treatment or cure of a disease. The term “dietetic” or “dietary” may be mentioned and the purpose for the use of the product must be given. Marketing guidelines for medical/dietary foods are listed in Table 1.

Notification Procedure

This procedure only requires manufacturers/importers to notify the member state where the product is first placed on the market by forwarding an example of the product label. In Germany, additional scientific data is required, proving the particular nutritional use, as well as compositional details of the product. Producers of compositions not completely complying may request an Allgemeinverfügung or Ausnahmegenehmigung as described previously. As opposed to food supplements, these exemptions will not expire. The official decision will be given within 90 days.

Currently there are numerous IMFs on the German market for special nutritional needs in the following indication areas:

• coronary heart disease
• impaired immune defenses
• rheumatoid diseases
• age-related eye diseases (e.g. macular degeneration)
• menopausal disorders
• prostate and breast cancer
• expenditure of intense muscular effort
• osteoporosis
• men/women with extreme performance/occupational stress
(an example of a high-dosage supplement for the immune system is provided in Table 2.)

Summary

In the past we have found creative ways to best enter the European supplement market but these new options give greater chances for medium-sized companies to come to Europe with innovative supplements.NW