In its ongoing review of food product health claims, the European Food Safety Authority (EFSA) has adopted 75 new opinions addressing 808 claims. EFSA’s independent scientists opined that claimed functional-food effects, such as improves the “immune system” or “immune function,” “supports immune defences,” “reduces inflammation,” or “decreases potentially pathogenic gastro-intestinal microorganisms,” were either insufficiently defined or unsupported by scientific data. The authority also turned aside claims that the probiotic bacteria in a specific brand of yogurt maintain immune defenses against the common cold.

According to a news source, the scientific studies that yogurt-maker Yakult submitted to justify such claims were inadequate. Some suggest that this week’s rulings by EFSA have seriously compromised industry efforts to promote functional foods, in which companies have made significant investment. Industry is reportedly challenging the determinations, complaining that the authority is applying excessively rigorous standards, and has asked for meetings to discuss the criteria used.

According to EFSA, “many” general function claims in this series were subject to unfavorable opinions “due to the poor quality of the information provided to EFSA.” Information gaps the authority identified include (i) “inability to identify the specific substance on which the claim is based (e.g. claims on ‘dietary fibre’ without specifying the particular fibre)”; (ii) “lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of body functions (e.g. claims on renal ‘water elimination’)”; (iii) “lack of precision regarding the health claim being made (e.g. claims referring to terms such as ‘energy’ and ‘vitality’)”; (iv) “or lack of human studies with reliable measures of the claimed health benefit.”

Overall, the opinions were favorable only where sufficient scientific evidence
supported the claims and generally “related mainly to vitamins and minerals
but also included claims on specific dietary fibres related to blood glucose
control, bowel function or weight management; fatty acid claims related to
brain function, vision or heart health; or claims related to live yoghurt cultures
and lactose digestion.”

The opinions have been forwarded to the European Commission (EC) and EU
member states which are responsible for authorizing product claims. EFSA
plans to finalize all “general function” health claims, other than for botanicals,
by the end of June 2011. This is EFSA’s third series of opinions; to date, the
authority has assessed 1,745 claims from a list of more than 4,500 submitted
by the EC and member states. See The Guardian, October 19, 2010.

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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