DuPont Obtains FDA GRAS Status

MADISON, Wis.DuPont Nutrition & Health has obtained official confirmation from the U.S. Food and Drug Administration (FDA) that the probiotic strains in its Bifidobacterium lactis range are generally recognized as safe (GRAS)and suitable for use in all food products and dietary supplements.

FDA had previously granted the Bifidobacterium lactic strains full GRAS status for use in dairy applications. With this notification, FDA extends the status to food categories including juice, dry beverages, confectionery and bakery products and the dietary supplement market, where probiotics are widely used.

DuPont previously had self-affirmed GRAS status for the use of its Bifidobacterium lactis strains in this range of additional applications.

 Along with proving the health benefits of the strains in our Bifidobacterium lactis range, we are committed to safety," said Scott Bush, vice president of marketing, DuPont Nutrition & Health. GRAS affirmation by FDA confirms that the science behind these strains is sufficient to guarantee their safety in foods and supplements. This greatly expands the application options available to our customers."

Strains in the B. lactis range include Bifidobacterium lactis HN019, marketed as HOWARU® Bifido. These strains are effective, stable and one of the most clinically studied probiotic strains available today.

Bifidobacterium lactis Bi-07 and Bifidobacterium lactis Bl-04 are part of the FloraFIT® custom probiotics range, which offers manufacturers a wide selection of strains for the formulation of dietary supplements and nutritionals.

Bush said DuPont invests significant resources in scientific research to investigate the potential of probiotics to benefit health.

The results of our human clinical trials document the immune and digestive health benefits of probiotics in infants, children and healthy adults. Weve just had a study published in Clinical Nutrition, and many more are in the pipeline," Bush said.

These findings are backed by numerous external studies. Among the most recent is the Human Microbiome Project, initiated by the U.S. National Institutes of Health. This confirms that the strains in HOWARU® and FloraFit® probiotics are natural, beneficial components of the gastrointestinal tract.