U.S. and European Leaders Agree on
Principles to Harmonize Dietary Supplement Regulations

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WASHINGTON, DC, November 20, 2000—The dietary supplements sector-working group of the TransAtlantic Business Dialogue (TABD) agreed on several key elements to harmonize the regulatory framework for vitamin and mineral food supplements on both sides of the Atlantic. These major breakthroughs were forged at the Sixth TABD CEO Conference in Cincinnati, Ohio, from November 16-18.

The working group approved the principles and components on definition, safety, and GMPs. The working group also agreed to continue its dialogue and that its next steps would be to:

1. Define types of claims and appropriate labeling for food supplements and develop criteria for transatlantic acceptance of credible scientific evidence to substantiate these claims; evaluate mechanisms for authorizing/approving claims; and assess conditions for exclusivity to encourage research and development.
2. Encourage the scientific bodies responsible for the evaluation of the safety of total intakes of vitamins and minerals (EU Scientific Committee on Food and US Food and Nutrition Board) to cooperate closely to harmonize setting upper safe levels for vitamins and minerals.
3. Define and recommend methodologies for setting maximum levels for vitamin and/or mineral food supplements on the basis of upper safe levels of total intake for these nutrients and intakes from other sources. The responsible regulatory bodies are encouraged to cooperate and establish one set of figures for maximum levels for vitamins and minerals in food supplements on both sides of the Atlantic.
4. Seek urgently, in light of the imminent proposed US rule on GMPs, transatlantic harmony for implementing common GMPs and quality standards. The working group also agreed to develop practical procedures to support GMP details; and seek acceptance, implementation, and appropriate enforcement.

Progress toward transatlantic harmonization of dietary supplements was led by a team of supplement CEO’s that included: Gale Bensussen, Leiner Health Products Inc.; William Van Dyke, B&D Nutritional Ingredients, Inc.; Johannes Burges, Hermes Arzneimittel; and Sonnich Fryland, Ferrosan. They were among the more than 120 industry leaders from the U.S. and the European Union who called on their governments to adopt a list of progressive trade liberalization measures at this TABD CEO Conference.

The CEO’s, meeting with senior officials form the U.S. Administration, the European Commission, the U.S. Congress, and the European Parliament, made recommendations on how best to boost transatlantic and global trade and investment. They focused on specific mechanisms for resolving trade disputes and expanding the U.S.-EU commercial marketplace, which at $1 billion per day in two-way trade, is the world’s largest trading relationship.

"The recommendations we have developed at this meeting will, if adopted by the governments, expand trade and investment opportunities for large, medium, and small companies by removing obstacles and inefficiencies in the U.S. and European regulatory regimes," said George David, chairman and CEO of United Technologies Corporation and US TABD chair for 2000. "Adoption of these recommendations will create jobs, raise living standards, lower costs and improve access to goods–that is, provide concrete benefits for business, for labor, and for consumers."

The TABD is a results-oriented forum that seeks to increase transatlantic trade and investment opportunities through the removal of costly inefficiencies from excessive regulation, duplication and differences in the EU and U.S. regulatory systems and procedures in a manner consistent with sustainable development.