January 13, 2011

Regulatory issues that impact the probiotic and prebiotic fields seem to be an overriding concern of late. In Europe, EFSA’s NDA panel continues to reject all probiotic/prebiotic health claims, including claims submitted by Danone that Actimel can help with antibiotic-associated diarrhea and Yakult that its product can help defend against pathogens of the upper respiratory tract. Evidence provided by Danone included a human trial published in the British Medical Journal. Evidence provided by Yakult included a recent human study being submitted for publication conducted at Loughborough University, UK (NUTRA ingredients-usa.com report). European prebiotic and probiotic researchers expressed disagreement with the EU health claim approval process, registering their dissatisfaction on a website http://www.gut-health.eu/ designed to tally likeminded scientists on this issue (NUTRA ingredients-usa.com report). In the USA, the FTC settled with Dannon over what claims it considers substantiated. Dannon agreed to some wording changes and qualifications on servings needed for gut regularity claim, but the settlement leaves Dannon able to continue making claims on immune support for DanActive and on digestive comfort and regularity for its Activia product (NUTRA ingredients-usa.com report). The FDA Centers for Biologic Evaluation and Research and Drug Evaluation and Research (CBER and CDER, respectively) published a draft guidance document on when researchers must file an Investigational New Drug application when doing human research. In ISAPP’s opinion, this guidance did not adequately address the lawful conduct of human research on foods in the US without the need for an IND. ISAPP filed comments January 11 outlining its concerns with the draft guidance as written.