Premium
FDA's Evaluations of GRAS Food Ingredients
Author(s) -
Dausch Judith
Publication year - 2015
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.29.1_supplement.741.1
Subject(s) - ingredient , food and drug administration , generally recognized as safe , food safety , business , food additive , novel food , microbiology and biotechnology , presentation (obstetrics) , food science , medicine , risk analysis (engineering) , chemistry , biology , radiology
Nutritional substances have been the subject of numerous Generally Recognized as Safe (GRAS) notices that have been voluntarily submitted to FDA via its GRAS Notification Program. FDA's evaluations of manufacturers' GRAS notices depends on the regulatory framework for food ingredients laid out under the Federal Food, Drug, and Cosmetic Act (the Act). Under the Act, there is a single standard for “safe” pertaining to food additive uses and GRAS ingredient uses. The regulatory framework for ingredients added to food, the safety standard, and the criteria that sets GRAS ingredient uses apart from food additive uses, namely, availability of appropriate safety data to qualified experts and consensus among those experts, will be the focus of this presentation. Case studies highlighting the types of data and information in GRAS notices for nutritional substances, such as fiber, and how FDA evaluated such notices will be used to reinforce key points.