FDA

FDA Compliance Mistakes top Avoid

FDA Compliance Mistakes: Common Errors That Trigger Warning Letters and Enforcement Actions

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

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FDA vs USDA Jurisdiction

FDA vs USDA Jurisdiction: Who Regulates What

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

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USDA Labeling Laws for Meat, Poultry and Egg Guide

Meat, Poultry & Egg Labeling Laws: USDA Labeling Requirements

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

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Analyzing the 2025–2030 Dietary Guidelines and MAHA Policy Impacts

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

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FDA Food Labeling Laws Guide

Food Labeling Laws: FDA vs USDA Requirements and Enforcement Risks

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

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Examining FDA’s New Alternative Tools for Drug Pre-Approval and Pre-License Inspections

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

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FDA compliance

What is FDA Compliance? Complete Guide for Food Companies

Your food company operates with the highest quality standards and proven manufacturing processes. Yet one FDA compliance gap can trigger warning letters, product seizures, and import alerts that devastate your business operations overnight. I know this because FDA compliance failures cost food companies millions annually – not just in direct penalties, but in lost market

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DOJ RFI Seeks Input on State Laws Affecting the National Economy; Opportunity to Address State Patchwork Impacting the Food Industry

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

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Changes To Food And Color Additive Regulations Leave Stakeholders Grappling with Uncertainty

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

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FDA Recent Announcements: Proposed Front-of-Package Nutrition Labeling & Revoking Red Dye No. 3

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

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Food, Ag, & Trade Outlook in the Incoming Trump Administration

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

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Priority Deliverables For 2025 Under the New Unified Human Foods Program

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

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Loper Bright + Corner Post = Supreme Court Opinions and Their Impact on FDA- and USDA-Regulated Industries 

The U.S. Supreme Court recently issued two important opinions for any entity regulated by a federal agency, such as FDA and USDA.  1. Loper Bright Enterprises v. Raimondo, slip op. 22-451, (June 28, 2024) (Loper Bright): For 40 years, Chevron USA, Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984) required courts to defer

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