US and Europe Diverge On Health Claims Policy


They have the same goal in mind—increasing the good health and consumer power of their citizens—but the US and Europe are moving in opposite directions on health claims reform.

Spurred by the alarming and growing obesity rate in America, the US Food and Drug Administration (FDA) is liberalising the health claims process by allowing more 'qualified' health claims on a greater variety of foods.

"The FDA review process for making qualified claims will reward companies that make healthier products," said FDA Commissioner Mark McClellan, MD, PhD.

Starting this month, companies can submit proposals for health claims to the FDA based on a wide range of scientific evidence using an A-to-D ranking system. Prior to this announcement, health claims were granted based only on 'significant scientific agreement'—now designated an 'A' grade.

A 'B' grade is assigned to those petitions for which there is 'good scientific evidence but not entirely conclusive'. The FDA has already granted such a claim for walnuts and heart health.

Claims with 'limited and inconclusive' evidence are given a 'C' grade, which the FDA has allowed for most other nuts and heart health.

Those claims with 'little scientific evidence' to support them are graded 'D'.

Each submission will trigger a 30-day public comment period and an assessment of the supporting science. The FDA has not decided whether the grading system will appear on labels but the qualifying language will.

"This approach should clearly favour an industry like ours that is dedicated to products promoting good nutrition and educating consumers about them," said David Seckman, executive director and CEO of the National Nutritional Foods Association.

The European Union, meanwhile, is tightening up its health claims regime and has made it clear it will veto 'vague and meaningless' health claims. Not only is it legislating against spurious health claims about foods with high fat, salt or sugar contents, it may ban any nutritional fortification for such foods.

Claims the EU plans to abolish include general wellbeing ("helps your body resist stress") or claims making reference to cognitive and behavioural functions ("reduces stress and adds optimism"). Claims such as "fat free", "no added sugar" and "high fibre" will be permitted only on products that meet strict content criteria. Slimming claims and claims aimed principally at children will also be prohibited.

"Food producers will be able to use serious and scientifically substantiated claims as a marketing tool without being drowned out by the many unsubstantiated and inaccurate claims that currently exist on the market," EU Health and Consumer Affairs Commissioner David Byrne said. "The creation of a regulation at EU-level will enable operators to compete on a fair and equal basis in all EU Member States."

Critics say the proposal would restrict the amount of information consumers require to make informed choices.

—Shane Starling & Todd Runestad

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