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🌱FDA Guidance on Plant-Based Food Labeling and Compliance

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled "Labeling of Plant-Based Alternatives to Animal-Derived Foods." This draft guidance, when finalized, will provide our recommendations on best practices for naming and labeling of certain plant-based foods that are marketed and sold as alternatives for animal-derived foods (plant-based alternative foods), especially in the absence of a common or usual name for the product. This draft guidance does not address the naming and labeling of plant-based milk alternatives; FDA is providing recommendations regarding these products in a separate guidance document.

⚖️Compliance Requirements for Off-the-Record Communications Notice

📦USPS Notice on Priority Mail Express and Ground Advantage Changes

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

🐾FDA's Guidance on Animal Food Ingredient Consultation Released

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #294 entitled "Animal Food Ingredient Consultation (AFIC)." This guidance describes FDA's interim AFIC process and explains one way FDA will work with firms that are developing animal food ingredients now that the Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expired on October 1, 2024, and while FDA evaluates the animal Food Additive Petition and Generally Recognized as Safe (GRAS) Notification programs. The AFIC process provides an additional way for engagement with FDA regarding ingredients for which firms may otherwise have used the AAFCO ingredient definition process. AFIC will help FDA identify any potential safety concerns associated with such ingredients. The AFIC process also allows for public awareness of and input on such ingredients. In addition, this guidance describes FDA's enforcement policy for certain ingredients assessed using the AFIC process.

📦USPS Notice of Product Change for Priority Mail and Ground Advantage

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

📦Notice of Postal Service Product Change for Business Shipping Options

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

⚓Temporary Safety Zone Established for Cypress Passage Powerline Demolition

The Coast Guard is establishing a temporary safety zone for navigable waters within a 500-yard radius of 29[deg]47'38.18" N, 91[deg]21'50.52" W, approximately MM 105.5, on the Atchafalaya River, locally known as Cypress Passage, during an overhead electrical powerline structure demolition operation on Thursday, January 9, 2025. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the demolition of the powerline structures resulting in electrical powerlines on the navigational water's surface. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Marine Safety Unit Houma.

🌍EPA Final Rule on Source Reclassification

The Environmental Protection Agency (EPA) is making corrections to the Review of Final Rule Reclassification of Major Sources as Area Sources Under Section 112 of the Clean Air Act (CAA) final rule that appeared in the Federal Register on September 10, 2024. Following publication of this final rule, the EPA discovered an inadvertent typographical error in the regulatory text and is correcting the error in this action.

📋FDA Guidance on Accelerated Drug Approval and Confirmatory Trials

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." For drugs granted accelerated approval, sponsors conduct confirmatory studies that must be completed postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. This draft guidance describes FDA's interpretation of the term "underway" and discusses policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to accelerated approval.

📦Postal Service Notice on New Shipping Agreement Impacting Businesses

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.