1 Analyses of this federal-register by attorneys

  1. Wrap-Up of Federal and State Chemical Regulatory Developments, November 2023

    Bergeson & Campbell, P.C.November 20, 2023

    on of the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures (discussed immediately above).Color Additive Petition Approved For Jagua (Genipin-Glycine) Blue: On November 3, 2023, FDA amended the color additive regulations to include the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice (GMP). 88 Fed. Reg. 75490. This action is being taken in response to a color additive petition (CAP) submitted by Exponent, Inc. on behalf of Ecoflora SAS. The color additive regulations at 21 C.F.R. Part 73 will be amended to include this color additive effective on December 4, 2023.FDA Proposes To Revoke Authorization For Brominated Vegetable Oil: On November 3, 2023, FDA proposed to revoke the authorization for the use of brominated vegetable oil (BVO) in food, giving the reason that “[…] there is no longer a reasonable certainty of no harm from the continued use of BVO in food.” 88 Fed. Reg. 75523. If made final, the action would remove the approval in 21 C.F.R. Section 180.30 that currently permits use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. FDA cites a 2022 study that indicates BVO “is toxic to the thyroid and results in bioaccumulation of lipid-bound bromine in the body at doses relevant to human exposure.” Electronic or written comments on the proposed rule must be submitted by January 17, 2024.FDA Updates CFSAN Online Submission Module: On November 6, 2023, FDA announced an update to its CFSAN Online Submission Module (COSM), through which users are able to submit notifications, including Food Additive Petitions (FAP) and Food Contact Notifications (FCN), to FDA’s Office of Food Additive Safety (OFAS). The update introduces three new features:Users may now submit documents directly to OFAS via COSM;COSM now allows for secure communication between FDA and users for submissions and amendments to submissions created in COS