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    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—6th Cir.: Regional chambers of commerce lack standing to challenge Medicare Drug Negotiation Program
    • ADMINISTRATION OF FDC ACT—PROPOSED RULES: Food standards of identity modernization proposed for pasteurized orange juice
    • ADMINISTRATION OF MEDICARE/MEDICAID PROGRAMS—PRRB DECISIONS: Provider’s appeal remanded for MAC to correctly calculate VDA
    • DIETARY SUPPLEMENTS—N.D. Cal.: No evidence dietary supplement packaging misled consumers
    • EXPERT INSIGHTS—FDA Announces Availability Of ICH Draft Guidance On Inclusion Of Pregnant And Breastfeeding Women In Clinical Trials
    • FOOD—PROPOSED RULES: Requirements for additional traceability records for certain foods, compliance date extension
    • GENERAL HEALTH CARE NEWS—N.D. Cal.: Claims of misrepresented genetic testing needed to satisfy Rule 9(b) fraud pleading standard
    • LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—2d Cir.: Second Circuit affirms dismissal of Tylenol 'Rapid Release' suit on preemption grounds
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    Health Law Daily Wrap Up, FOOD—PROPOSED RULES: Requirements for additional traceability records for certain foods, compliance date extension, (Aug 8, 2025)

    By WK Editorial Staff

    The requirements are intended to reduce the harm to public health caused by foodborne illness outbreaks and limit adverse impacts on industry sectors affected.

    The FDA is proposing to extend the compliance date for the final rule, “Requirements ...

    By WK Editorial Staff

    The requirements are intended to reduce the harm to public health caused by foodborne illness outbreaks and limit adverse impacts on industry sectors affected.

    The FDA is proposing to extend the compliance date for the final rule, “Requirements for Additional Traceability Records for Certain Foods,” due to concerns about the amount of time affected entities will need to implement the requirements of the rule. If finalized, the rule would extend the compliance date by 30 months from January 20, 2026, to July 20, 2028. The final rule establishes additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL) based on risk. The final rule requires these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods (FTL foods), such as initial packing, shipping, receiving, and transforming these foods (Proposed Rule, 90 Fed. Reg. 38084 (Aug. 7, 2025)).

    Dates. Either electronic or written comments on the proposed rule must be submitted by September 8, 2025.

    FederalRegisterIssuances: ProposedRules FDCActNews FoodNews FoodSafetyNews

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