FDA

Mason Weeda Featured on FDA Watch Podcast: Food Safety in the Spotlight

OFW Law is pleased to announce that Mason Weeda, Chair of the firm’s FDA Food Practice, was recently featured on the FDA Watch podcast in an episode focused on the evolving landscape of food safety. In the episode, Mason discusses key issues shaping food safety regulation and enforcement, including thoughts on FDA’s GRAS proposed rule,

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Federal Court Upholds Oregon Packaging EPR Program

On August 27, 2026, the U.S. District Court for the District of Oregon upheld Oregon’s Plastic Pollution and Recycling Modernization Act (RMA), rejecting constitutional challenges brought by the National Association of Wholesaler-Distributors (NAW). The ruling is one of the first federal court decisions addressing constitutional challenges to a state packaging extended producer responsibility (EPR) program

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June Food and Agriculture Regulatory Recap

On June 26, 2026, USDA-FSIS shared that it is inviting poultry establishments to participate in, “Pilot Projects: Salmonella Control Strategies,” to test new or improved strategies for controlling Salmonella contamination in poultry. This program is part of the broader USDA effort, launched in October 2021, to reduce Salmonella illnesses, including evaluating new or existing pathogen

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The 2026 Landscape of State Baby Food & Infant Formula Legislation – What Is Here, What Is Coming, And How to Prepare?

Mandatory testing for toxic heavy metals (arsenic, cadmium, lead, mercury) Public disclosure of results, typically via manufacturer websites Labeling requirements, often including QR codes linking to transparency data Approved Laws and Pending Legislation Following 2021 Congressional recommendations and FDA’s response regarding manufacturers and testing baby and toddler foods for heavy metals and publicly disclosing the

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FDA’s Next Steps on Traceability: Challenges and Solutions in Lot-Level Food Traceability

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

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May Food and Agriculture Regulatory Recap

On May 21, 2026, USDS-FSIS published in the Federal Register its Final Rule, “Visual Post-Mortem Inspection in Swine Slaughter Establishments.” In this Final Rule, FSIS is amending its regulations to end mandatory mandibular lymph nodes incision and viscera palpation of swine carcasses. This applies to ALL swine slaughter establishments—including establishments operating under traditional slaughter inspection

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FDA and USDA rulemaking

How to Prepare for FDA and USDA Rulemaking and Public Comment

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

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Government compliance in food and agriculture

Government Compliance and Risk Management in Food & Agriculture

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

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FDA Considers the Definition of “Dietary Substance” as New Technologies Transform Supplement Ingredients

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 the

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February Food and Agriculture Regulatory Recap

On February 25, 2026, USDA’s Secretary of Agriculture Brook Rollins, Deputy Secretary Stephen Vaden, Senator Joni Ernst (R-Iowa), and General Services Administration (GSA) Administrator Edward Forst announced forthcoming steps towards USDA’s reorganization efforts: (1) the disposal of the USDA South Building in Washington, D.C. and the local relocation of USDA’s Food and Nutrition Service (FNS).

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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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January Food and Agriculture Regulatory Recap

On January 14, 2026, USDA’s Food Safety and Inspection Service (“FSIS” or the “agency”) hosted a public meeting on “Exploring Practical Strategies to Reduce Salmonella in Poultry Products”  (both remote and in-person) (“Public Meeting”). The Public Meeting initiated a new discussion around practical strategies to reduce Salmonella illnesses linked to poultry products, including the use

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Analyzing the 2025–2030 Dietary Guidelines and MAHA Policy Impacts

School Lunches and Additional Nutrition Assistance Programs Food Additives and Generally Recognized as Safe (GRAS) Substances Although not noted in the DGA recommendations, Appendix 1 includes a list of food and food packaging chemicals where researchers call for more research due to potential safety concerns. Nutrition Labeling (Nutrition Facts Panel, Front-of-Package labeling), and Nutrient Content

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December Food and Agriculture Regulatory Recap

Recently announced, the Department of Justice’s (DOJ’s) new Health and Safety Unit (HSU) in the Criminal Division will investigate and prosecute federal crimes involving threats to public health and consumer safety, with a particular focus on the integrity of the food, drug, and product supply chain. In relevant part, HSU has been charged with criminal enforcement of

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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 cut,

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FDA compliance

What Is FDA Compliance? A Practical Guide for Regulated Businesses

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.

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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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April Food and Agriculture Regulatory Recap

On April 29, 2025, USDA’s Agricultural Marketing Service (AMS) announced via a notice the 2025/2026 rates (regular, overtime, holiday, and laboratory services) it will charge for voluntary grading, inspection, certification, auditing, and laboratory services for a variety of agricultural commodities including meat, poultry, fruits, vegetables, eggs, dairy products, rice, and cotton and tobacco. The 2025/2026

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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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