1 Analyses of this federal-register by attorneys

  1. Wrap-Up of Federal and State Chemical Regulatory Developments, June 2024

    Bergeson & Campbell, P.C.June 20, 2024

    ation that tara flour does not meet the Generally Recognized as Safe (GRAS) standard and considers it an unapproved food additive. FDA notes that this evaluation “is part of our approach to enhance food chemical safety.” Tara flour was linked to roughly 400 adverse events, including 133 hospitalizations. FDA notes, in its memorandum, that “[o]verall, at this time, the available data are insufficient to support the safety of tara flour for use as a food ingredient that will be consumed by the general public” and that a lack of sufficient data exist to support its classification as GRAS. FDA states that “[m]anufacturers who are considering using tara flour as an ingredient in food are responsible for ensuring that its use is safe and lawful and are encouraged to consult with the FDA.”FDA Extends Comment Period For Proposed Fee Increase: On May 28, 2024, FDA extended the comment period for a proposed rule titled “Color Additive Certification; Increase in Fees for Certification Services.” 89 Fed. Reg. 46042. The proposed rule, originally published on November 2, 2022, would increase fees to recover FDA’s costs to administer the color certification program. Electronic or written comments must be submitted by June 27, 2024.FDA Extends Comment Period For Draft Guidance: On May 31, 2024, FDA extended the comment period for revisions to specific sections of its draft guidance entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food.” 89 Fed. Reg. 47108. The changes address comments from the drafts made available in 2016. FDA originally announced the availability of the revised elements of this draft guidance on February 2, 2024. FDA notes that it received a request to extend the comment period to allow stakeholders more time to “fully evaluate and develop meaningful comments.” Comments are due by August 2, 2024.FDA Announces Re-Organization And New Structure: On June 3, 2024, FDA announced the approval of its reorganization that, among other changes, establishes the Human F