Gras

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Inconsistencies between NDI, GRAS raised in letter to FDA

By Hank Schultz

A letter from a member of Congress to FDA calls into question the inconsistencies between the NDI process and how GRAS submissions are evaluated and the lack of communication between the staffs working on these issues.

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Kaneka gets GRAS status on baby probiotic

By Hank Schultz

Kaneka has announced self affirmed GRAS status on its Baby Colic probiotic dietary supplement meant to ease babies through gut discomfort episodes.

© iStock / Olgaorly

Self-affirmed GRAS omitted from new NDI draft guidance

By Stephen Daniells

The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as an ‘alternative’ to an NDI notification.

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