On June 15, 2026, the U.S. Food and Drug Administration (FDA) hosted a 3-hour public meeting entitled “Challenges and Solutions in Lot-Level Food Traceability.” The Public Meeting provided the public with an opportunity to share information regarding the implementation of the Food Traceability Rule (Food Safety Modernization Act (FSMA) § 204) and provide feedback on […]
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from May. If you have any questions or would like more information, please do not hesitate to
May Food and Agriculture Regulatory Recap Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from April. If you have any questions or would like more information, please do not hesitate to
April Food and Agriculture Regulatory Recap Read More »
Your legal team sends an urgent alert – FDA just published a proposed rule that could fundamentally change your labeling requirements, compliance costs, or market access. The comment period closes in 60 days. You know you need to respond, but where do you start? What makes a comment actually influential rather than just another submission
How to Prepare for FDA and USDA Rulemaking and Public Comment Read More »
Your FSIS inspector flags a sanitation issue during routine review. FDA issues a warning letter citing preventive controls violations. USDA questions your animal-raising label claims. Any of these compliance failures can trigger enforcement escalation – from warning letters to civil penalties, suspension of operations, or mandatory recalls. The regulatory framework governing food and agriculture operations
Government Compliance and Risk Management in Food & Agriculture Read More »
The U.S. Food and Drug Administration (FDA) held a public meeting on March 27, 2026, to discuss “the evolving landscape of dietary supplement ingredients and how recent scientific and technological advances are shaping the industry.” At the center of the discussion was one part of the definition of “dietary supplement” in § 201(ff) of
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from March. If you have any questions or would like more information, please do not hesitate to
March Food and Agriculture Regulatory Recap Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from February. If you have any questions or would like more information, please do not hesitate to
February Food and Agriculture Regulatory Recap Read More »
Your production schedule just got derailed by an FDA inspection observation. Your quality team is scrambling to understand why procedures you’ve followed for years suddenly don’t meet current Good Manufacturing Practice requirements. And now you’re facing questions from executives about potential warning letters and what they mean for your business. I’ve seen this pattern repeatedly
Food manufacturers launching products with meat, poultry, or egg ingredients face a critical regulatory question – does FDA or USDA have jurisdiction over your product? Getting this determination wrong costs companies months of production delays, facility redesigns, and sometimes forces complete product reformulation. I know this because understanding FDA vs USDA jurisdiction requires analyzing ingredient
FDA vs USDA Jurisdiction: Who Regulates What Read More »
Meat and poultry processors face labeling rejections from FSIS that delay product launches and waste printing costs. Label approval specialists cite obscure policy memos and technical violations that weren’t apparent from reading the core regulations. I know this because USDA labeling laws and requirements represent one of the most detailed regulatory frameworks in food production
Meat, Poultry & Egg Labeling Laws: USDA Labeling Requirements Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from January. If you have any questions or would like more information, please do not hesitate to
January Food and Agriculture Regulatory Recap Read More »
On January 7, 2026, the Dietary Guidelines for Americans 2025-2030 (DGA) were released by the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA). The DGAs provide advice on nutrient needs, promote health, and help prevent chronic disease, which will influence current and forthcoming HHS and USDA food and
Analyzing the 2025–2030 Dietary Guidelines and MAHA Policy Impacts Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few significant developments from December. If you have any questions or would like more information, please do not hesitate to reach out
December Food and Agriculture Regulatory Recap Read More »
Your product launches are delayed. Your labeling team just received contradictory guidance from two different federal agencies. And now you’re facing questions from your legal department about which food labeling laws actually apply to your products. I’ve guided food manufacturers through this exact compliance maze for years – and the confusion isn’t your fault. FDA
Food Labeling Laws: FDA vs USDA Requirements and Enforcement Risks Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from November. If you have any questions or would like more information, please do not hesitate to
November Food and Agriculture Regulatory Recap Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from October. If you have any questions or would like more information, please do not hesitate to
October Food and Agriculture Regulatory Recap Read More »
In late March 2025, The U.S. Department of Health and Human Services (“HHS”) announced that it would cut 3,500 full-time Food and Drug Administration (“FDA”) positions. HHS claimed that those cuts would be focused on “streamlining operations and centralizing administrative functions” and “not affect drug… reviewers, nor… impact inspectors.” The positions that FDA
Examining FDA’s New Alternative Tools for Drug Pre-Approval and Pre-License Inspections Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from September. If you have any questions or would like more information, please do not hesitate to
September Food and Agriculture Regulatory Recap Read More »
Most companies meet the phrase “FDA compliance” on a bad day. An investigator leaves a Form 483 on the table after a plant walkthrough, or a buyer’s diligence checklist asks for records nobody kept, and the abstract idea suddenly has teeth. So here is the working definition, and then the part that actually decides outcomes.
What Is FDA Compliance? A Practical Guide for Regulated Businesses Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from August. If you have any questions or would like more information, please do not hesitate to
August Food and Agriculture Regulatory Recap Read More »
On August 15, 2025, the U.S. Department of Justice (DOJ), a Request for Information on State Laws Having Significant Adverse Effects on the National Economy or Significant Adverse Effects on Interstate Commerce (RFI). The RFI requests public input on state laws, regulations, and practices that significantly and negatively affect the national economy or interstate commerce. The feedback
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from June. If you have any questions or would like more information, please do not hesitate to
June Food and Agriculture Regulatory Recap Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from May. If you have any questions or would like more information, please do not hesitate to
May Food and Agriculture Regulatory Recap Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from April. If you have any questions or would like more information, please do not hesitate to
April Food and Agriculture Regulatory Recap Read More »
The robust science-based framework established by Congress for regulating food and color additives is encountering significant challenges. Concerns about these additives, first raised by advocacy groups, have been picked up by state legislatures. These concerns have been further amplified by the Make America Healthy Again (MAHA) movement and U.S. Health and Human Services (HHS) Secretary
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from March. If you have any questions or would like more information, please do not hesitate to
March Food and Agriculture Regulatory Recap Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from February. If you have any questions or would like more information, please do not hesitate to
February Food and Agriculture Regulatory Recap Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from January. If you have any questions or would like more information, please do not hesitate to
January Food and Agriculture Regulatory Recap Read More »
Last week, the U.S. Food and Drug Administration (FDA) made two major announcements pertinent to industry and consumers. First, on January 14, 2025, FDA issued a pre-published notice of proposed rulemaking to require front-of-package nutrition labels (FOP) on most foods that bear a Nutrition Facts label. If finalized as proposed, the rule would require a
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from December that should be highlighted. If you have any questions or would like more information, please do
December Food and Agriculture Regulatory Recap Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the significant developments from November. If you have any questions or would like more information, please do not hesitate to
November Food and Agriculture Regulatory Recap Read More »
The food, agriculture, and trade sectors are aware the Trump Administration could bring myriad policy changes that could have a significant impact on business. OFW Law provides an initial outlook at the new administration’s approach to food, agriculture, and trade, which will be influenced by individual cabinet and other executive branch appointments who will
Food, Ag, & Trade Outlook in the Incoming Trump Administration Read More »
On October 30, 2024, the U.S. Food and Drug Administration’s (FDA or Agency) Unified Human Foods Program (HFP or Program) released its Fiscal Year (FY) 2025 Priority Deliverables (the Deliverables). The Deliverables are areas, and subareas, that the HFP plans to prioritize in FY 2025: • Microbiological Safety: Preventing and addressing foodborne illness• Food Chemical
Priority Deliverables For 2025 Under the New Unified Human Foods Program Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients appraised of regulatory developments that may impact their business. Here are a few of the significant developments from October. If you have any questions or would like more information, please do not hesitate to
October Food and Agriculture Regulatory Recap Read More »
