A knowledgeable FDA attorney is critical whether you are a medical device start-up or an established company. When navigating FDA requirements and regulations, setting up a new quality management system (QMS) or auditing an existing one, preparing for a new medical device launch, or responding to an enforcement matter or complaint by a competitor or
The Strategic Advantage of FDA Counsel for Medical Device Companies Read More »
Every facility that needs an FDA food facility registration has to renew it between October 1 and December 31, 2026. There is no fee, and the filing goes online through your FDA Industry Systems account unless FDA has granted a waiver. With nothing changed since the last filing, a shorter abbreviated renewal is enough. A
How to Renew Your FDA Food Facility Registration in 2026 Read More »
Your product is ready. The packaging looks good. The marketing copy is compelling. Then someone on your legal team circles a phrase in red – and the launch slows to a crawl while everyone debates what you can actually say on the label. I’ve seen this scenario repeat itself across food and beverage companies that
Food Label Claims 101: FDA, FTC, and USDA Rules Brand Marketers Can’t Ignore Read More »
For decades, cosmetics manufacturers operated in a regulatory environment where product recalls were almost entirely voluntary. While the U.S. Food and Drug Administration (FDA) could request a recall or seek a court-ordered seizure, the agency lacked the statutory power to compel a company to pull a cosmetic product off store shelves, even when it posed
FDA’s MoCRA Final Guidance on Mandatory Cosmetics Recalls – What You Need to Know 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 »
On October 28, 2026, HHS announced the availability of “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,” covering HHS’s enforcement policy regarding the use of certain peptide bulk drug substances in compounding pursuant to section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Usually, substances not yet on
A warning letter arrives and your first instinct is to fix everything before you write back. That instinct is expensive. I’ve worked FDA enforcement matters across inspections, recalls, and litigation, and the same pattern keeps showing up. The letter gets treated as a quality chore. Someone in operations drafts the reply, and the company hands
How to Respond to an FDA Warning Letter Read More »
On October 19, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of a guidance for industry entitled “New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry” (Guidance). This document finalizes portions of the 2016, “Dietary Supplements: New Dietary Ingredient Notifications and Related
The Food Safety Modernization Act moved through Congress after years of pressure from outbreaks, committee work, consumer groups, food companies, and trade associations. FDA did not write a new food safety statute on its own. Congress did, and the record that made FSMA passable was built long before President Obama signed it on January 4,
Food Safety Legislation and Government Advocacy: How Industry Shapes Federal Policy Read More »
OFW is pleased to announce that Rachael Vieder Linowes has joined the firm as a Principal in its Medical Products Practice. Rachael’s practice will leverage her experience at the Food and Drug Administration (FDA) to counsel clients on compliance, regulatory strategy, product development, enforcement actions, clinical trial oversight, and emerging regulatory policy. Rachael comes to
Rachael Vieder Linowes Joins OFW Law Read More »
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,
Mason Weeda Featured on FDA Watch Podcast: Food Safety in the Spotlight 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 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
Federal Court Upholds Oregon Packaging EPR Program Read More »
On July 6, 2026, the U.S. Department of Health and Human Services (HHS) and USDA released their 2026 Unified Agendas of Regulatory and Deregulatory Actions, which provides summaries of regulatory actions in various HHS and USDA agencies. The Unified Agendas are traditionally published twice a year, around the fall and spring, and contain the regulatory
July Food and Agriculture Regulatory Recap Read More »
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
June Food and Agriculture Regulatory Recap Read More »
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
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
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
May Food and Agriculture Regulatory Recap Read More »
The April 10, 2026, update announced that the U.S. Customs and Border Protection (CBP) had launched the first phase of the Consolidated Administration and Processing of Entries (CAPE), a new system being developed to manage the large volume of entry transactions and tariff refunds resulting from litigation over IEEPA‑based tariffs. CAPE is intended to centralize
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 the
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 »
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).
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 »
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
January Food and Agriculture Regulatory Recap Read More »
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
Analyzing the 2025–2030 Dietary Guidelines and MAHA Policy Impacts Read More »
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
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 »
The 43-day federal government shutdown ended on November 12, 2025. During the shutdown, FDA and USDA continued to provide mandatory food supply chain support. However, the shutdown did impact a myriad of USDA and FDA functions, such as expert consulting (i.e., many federal experts were furloughed). It also resulted in delays in the response to
November Food and Agriculture Regulatory Recap Read More »
FDA and USDA are in the early stages of considering a Federal definition of Ultra-Processed Foods (UPF). On October 23, 2025, the comment period closed for the USDA and FDA Request for Information (RFI) regarding UPFs. Additionally, on October 8, 2025, CA AB 1264, also known as the Real Food Healthy Kids Act, passed and establishes the
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 cut,
Examining FDA’s New Alternative Tools for Drug Pre-Approval and Pre-License Inspections Read More »
