FDA Forms Office of Food Additive Safety

FDA Forms Office of Food Additive Safety

WASHINGTON--In a move to streamline the Office of Premarket Approval at theFood and Drug Administration (FDA) (www.fda.gov),the Office of Food Additive Safety (OFAS) (www.cfsan.fda.gov)will replace it. Scheduled to be operational by June 18, this office willprimarily oversee the food industry, although FDAs Office of NutritionalProducts, Labeling and Dietary Supplements will still handle the field ofdietary supplements.

OFAS director, Alan Rulis, Ph.D., stated in a June 5 letter that two majorchanges have accounted for this change in safety review activities. First,programs for premarket notification, GRAS (generally recognized as safe)notification and biotechnology have created a mishmash of paths that ended up atFDA to be reviewed for safety as food additives and ingredients. Secondly, twolarge fiscal year 2000 appropriations were given to FDA for streamliningprograms such as the additive petition review process.

OFAS will be broken down into four units: Food Contact Substance NotificationReview; Petition Review; Biotechnology and GRAS Notice Review; and ChemistryResearch and Environmental Review.

[W]e now have the [resources] for creating a much more responsivepremarket function for food ingredient safety review, Rulis wrote. I seethe potential for greatly increased responsiveness to pending applications,greater potential for conducting meaningful prefiling consultations withprospective applicants [and] greater accessibility of our scientific reviewersto petitioners for the purpose of issue clarification and scientific dialogue.