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FDA

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

FDA /

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 »

FDA compliance

What is FDA Compliance? Complete Guide for Food Companies

FDA /

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

FDA, USDA /

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

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

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

FDA, Food Manufacturing, Processing, and Marketing /

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

FDA /

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

FDA, Agriculture & Agribusiness, Customs and Trade, Food Distribution & International Trade, For Export, Government Relations, Health Care, Healthcare, USDA, USTR /

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

FDA /

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 

FDA, USDA /

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

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

The Emerging Legal Impacts of Generative AI on Patents and Trademarks: A Symposium with the USPTO and U.S. Copyright Office

FDA, Food Manufacturing, Processing, and Marketing, Government Relations, USDA /

As generative artificial intelligence (AI) systems become increasingly powerful and widespread, the United States Patent and Trademark Office (USPTO) is beginning to evaluate the legal implications for intellectual property rights and protection. On March 27th, the USPTO and the U.S. Copyright Office jointly held a public symposium to explore the emerging challenges AI presents across

The Emerging Legal Impacts of Generative AI on Patents and Trademarks: A Symposium with the USPTO and U.S. Copyright Office Read More »

Association Events Targeted for Scams

USDA, FDA /

Since the beginning of 2024, our Trade Association professionals have seen an increase in scammers targeting persons who may be attending or have registered to attend trade association events such as meetings, shows, and conferences. These scammers email potential attendees and offer to sell, for a hefty cost, the attendee list and their contact information.

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Small Businesses Face Reporting Obligations Under The U.S. Corporate Transparency Act

FDA, USDA /

Beginning January 1, 2024, the U.S. Corporate Transparency Act (CTA) will expect a wide range of small companies to begin filing reports identifying “beneficial owners.” These “Beneficial Ownership Information” reports (BOI Reports) include name, birthday, address, and a unique identifying number and issuing jurisdiction from an acceptable identification document. All companies with fewer than 20

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CBD AND DELTA-8 THC – UPDATE ON FDA ENFORCEMENT

FDA, Cannabis /

As part of its ongoing enforcement against unlawful cannabis-containing foods and dietary supplements, the U.S. Food and Drug Administration (FDA) has recently posted two new Warning Letters against cannabis marketers: Both Warning Letters cite the marketers for promoting and distributing human and animal foods and dietary supplements containing (or that purport to contain) the cannabinoids

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November Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, FDA, USDA /

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 November that should be highlighted. If you have any questions or would like more information, please do

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Upcoming State Effective Dates for PFAS in Food Packaging

FDA, Food Distribution & International Trade, Food Manufacturing, Processing, and Marketing /

Food manufacturers should be aware of some upcoming compliance deadlines in various states that have banned Per- and polyfluoroalkyl substances (“PFAS”) in food packaging.  Although federal regulators, like the U.S. Environmental Protection Agency (“EPA”) and the U.S. Food and Drug Administration (“FDA”), are focused on individual PFAS chemicals (like PFOA and PFOS) due to health

Upcoming State Effective Dates for PFAS in Food Packaging Read More »

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