EU health-claims environment remains uncertain
EUROPE The European Union regulation on health and nutrition claims has become law after a protracted and much-amended legal passage, but like much European food law, much remains to be resolved. The final set of health and nutrition claims is not due to be published until January 2010.

Despite the fact that submissions must be lodged by companies or trade associations by January 2008, the assessment body, the European Food Safety Authority (EFSA), only issued guidance in July as to what scientific data are required in health-claim dossiers. And that was interim guidance with amendments expected.

Miguel da Silva, food law and nutrition advisor at Belgium-based consultancy EAS, said EFSA's "scientific data requests were too strict" and "biased against small- to medium-sized companies. There remains much to be resolved," he said.

In the meantime, member-state government bodies such as the UK Food Standards Agency — which submits claims to the EFSA on behalf of UK companies — have set a deadline of September 19 to receive dossiers, giving them time to scrutinise them before passing them onto the EFSA. Some expect the EFSA to be inundated with thousands of dossiers by January 2008.

The EFSA's workload is being further increased by the development of a major annex in the area of polyunsaturated fatty acids, mainly in response to the rise in popularity of omega-3s, da Silva said.

US re-opens qualified health-claim debate
UNITED STATES The Food and Drug Administration has issued draft guidance on qualified health claims and called for public comment, despite its earlier "final guidance" in May 2006, when it justified the existence of qualified health claims by stating: "…past court decisions have clarified the need to provide for health claims based on less science evidence rather than just on the standard of significant scientific agreement (SSA), as long as the claims do not mislead the consumers."

Its latest communication indicates it may be about to do a U-turn and up the ante on required scientific evidence in the defense of qualified health claims with SSA principles again in the ascendancy. "Health claims represent a continuum of scientific evidence that extends from very limited or inconclusive evidence to consensus, with evidence supporting SSA claims lying closer to consensus. The FDA's determination of SSA represents the agency's best judgment as to whether qualified experts would likely agree that the scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim."

The FDA issued a recent guidance on complementary and alternative medicines (CAMs), which was widely stated as being confusing. It will be hoping its latest effort will be received more warmly.

Find the ruling: www.cfsan.fda.gov/~dms/hclmgui5.html