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DuPont affirms GRAS status of its Bifidobacterium lactis range with FDA letter

By Stephen Daniells , 19-Nov-2013

DuPont affirms GRAS status of its Bifidobacterium lactis range with FDA letter

The US Food and Drug Administration has no questions for DuPont (Danisco) and the generally recognized as safe (GRAS) status of its Bifidobacterium animalis subsp. lactis strains HN019, Bi-07, B1-04, and B420 (B. animalis subsp. lactis strains).

The GRAS status covers use in all food products and dietary supplements, said the company, up to a maximum level of 2 x 1011 colony forming units (cfu) per serving.

“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.”

DuPont markets the Bifidobacterium lactis HN019 as HOWARU Bifido, while the Bifidobacterium lactis Bi-07 and Bifidobacterium lactis Bl-04 strains are part of the company’s FloraFIT custom probiotics range.

“The results of our human clinical trials document the immune and digestive health benefits of probiotics in infants, children and healthy adults. We’ve just had a study published in Clinical Nutrition , and many more are in the pipeline,” Bush stated.

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