Maile Gradison

Jan 13, 2025 | jdsupra.com | Anneke Baran Altieri |Maile Gradison

On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event.1 Although this document is not part of the multi-chapter Preventive Controls for Human Food (PCHF) rule (21 CFR Part 117) guidance series, it is must-read material for manufacturers of low-moisture ready-to-eat (LMRTE) human foods that are covered...

Nov 22, 2024 | jdsupra.com | Maile Gradison

VQIP BackgroundVQIP is a voluntary import approval and preclearance program that expedites the import review and entry process for human and animal foods from participating importers.

Nov 6, 2024 | jdsupra.com | Maile Gradison

[co-author: Chigozie Akah]The Food and Drug Administration’s (FDA’s) newly-reorganized Human Foods Program (HFP) recently released a document explaining its Fiscal Year (FY) 2025 Priority Deliverables. The Priority Deliverables reflect what FDA plans to accomplish in FY 2025. FDA plans to provide updates on the FY 2025 Priority Deliverables as it makes progress throughout the year. The agency also is in the process of developing a multi-year strategic plan to advance the HFP’s vision and mission.

Jan 29, 2024 | hoganlovells.com | Martin Hahn |Brian Eyink |Elizabeth Fawell |Maile Gradison

2024 is poised to be a big year for food regulation, particularly as federal agencies work to implement their regulatory agendas in preparation for a possible change in administration after the 2024 election. Here are the key issues the Hogan Lovells food and beverage team is keeping our eye on for the food industry this year.

Jul 24, 2023 | jdsupra.com | Maile Gradison |Mary A. Lancaster

The U.S. Food and Drug Administration (FDA) recently announced the results of its pilot program evaluating whether several third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls for Human Food (PCHF) and Produce Safety regulations. FDA concluded that three third-party audit standards are in alignment with the relevant PCHF regulations and one audit standard is in alignment with select portions of the Produce Safety regulations.