Feb 1, 2010 12:00 PM

Severe new rules make it that much more difficult for firms to sell in Europe and may shape future U.S. policy

Marketing functional foods and drinks in Europe will never be the same again. A tough new law — the Nutrition & Health Claims Regulation — means companies wishing to sell food and beverage products or dietary supplements with a health claim in the European Union must now prove beyond doubt that the claim is true. The rule sounds straightforward on paper, but the regulation has evolved into perhaps the most severe piece of food legislation ever to be implemented anywhere in the world. For the many U.S. companies that sell their products globally, the new law has made it harder to market a nutrition product with a health claim in the EU than in any other region of the world.

Over the last 18 months, the European Food Safety Authority (EFSA) — the independent scientific body whose job it is to assess claims applications under the regulation — has adopted such an unyielding approach to the task that it will only be swayed by the kind of “gold-standard” clinical trials that are usually associated with pharmaceuticals. Further, EFSA has also demanded that these trials be conducted in healthy, rather than diseased, populations, which is making compliance that much more onerous and expensive for nutrition companies.

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