EFSA Publishes Negative Opinion on Beta-Glucans; Science Was "Inappropriate"

September 17, 2010

The European Food Safety Authority (EFSA; Parma, Italy) published its negative opinion on a health-claims application for beta-glucans on May 26. But the details of Leiber GmbH...s (Bramsche, Germany) Article 13.5 application may be of greater concern.

The European Food Safety Authority (EFSA; Parma, Italy) published its negative opinion on a health-claims application for beta-glucans on May 26. But the details of Leiber GmbH...s (Bramsche, Germany) Article 13.5 application may be of greater concern.

Leiber GmbH submitted an application for its Yestimun brand beta-D-glucans from brewer...s yeast. The claimed effect was that the ingredient can reduce the risk of common cold infections 'by strengthening the body...s natural defenses and improving the body...s immune defense against common cold viral infections"'

Leiber GmbH provided EFSA...s Panel on Dietetic Products, Nutrition, and Allergies (NDA) with 17 studies: 10 human studies, five animal studies, and two in vitro studies. But the NDA panel concluded that many of these could not be considered 'pertinent,' including four human studies involving beta-glucan administration through intravenous injection (a method deemed 'inappropriate' for the claimed effect).

In fact, this administration method was further deemed inappropriate because the beta-glucan injected, in at least one of those studies, was a pharmaceutical drug candidate.

The beta-glucan in question is Imprime PGG, a pharmaceutical-grade beta-glucan from Biothera (Eagan, MN). According to Biothera...s website, Imprime PGG is a Phase II cancer drug candidate that triggers immune cells to kill cancer cells in the body.

'Leiber borrowed and inappropriately used research that was conducted with our products,' said Biothera vice president of communications David Walsh in an interview with Nutritional Outlook.

Walsh notes that in addition to using Imprime PGG, the applicant borrowed a study conducted for Biothera on Wellmune WGP, a food-grade beta-glucan that was misidentified in the application as being derived from brewer...s yeast. (Wellmune WGP is a proprietary strain of baker...s yeast.)

'Many don...t realize that even among yeast beta-glucans, subtle differences in molecular characteristics can have an impact on bioactivity," said Walsh. 'What this illustrates is that you need to have your own research, and if you...re borrowing research or using it inappropriately, that...s a reflection on the safety, efficacy, and claims possibilities for the entire class of ingredient.'

Biothera...s Wellmune WGP, a baker...s yeast beta-glucan, has applied for Novel Food status in the European Union and is allowed to use an immune health claim on packaging in Canada.