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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

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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

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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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PFAS in Food Packaging – State Compliance Deadlines and Requirements (2026 Update)

FDA /

PFAS in food packaging is now regulated by law in a growing number of states, and several of the compliance dates that once looked distant have already arrived. Food manufacturers, distributors, and retailers who have not revisited their packaging since these laws passed may be out of step with rules already in force in California,

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FDA’s Focus on Cybersecurity Creates Avoidable Risk for Management

Medical Devices, FDA, Uncategorized /

The U.S. Food and Drug Administration (FDA) has been actively working to address cybersecurity concerns related to medical devices. On March 29, 2023, FDA published a much-anticipated cybersecurity final guidance regarding cybersecurity requirements for medical device pre-market submissions. Medical devices, like many other modern technologies, are susceptible to cybersecurity vulnerabilities that could potentially compromise patient

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How will FDA and USDA operate during a Government Shutdown?

FDA, USDA /

Will we wake up to a federal government shutdown on October 1st? Many of the ingredients required for a shutdown are present. There may be a breakthrough that will allow Congress to coalesce around an approach to appropriations. However, Congress may not get on track to pass all of the appropriations packages by the end

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OFW and AFI Invite You to a Food Industry Update: Trends in Customs and Trade and Litigation

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

Thursday, September 21 from 12:00 – 1:00 p.m. Click here to register for this event.  Space is limited. In today’s global economy, the regulatory and legal landscape can change quickly.  OFW will provide a high-level review of customs and trade and litigation trends that could affect product compliance and liability, and the ability to market

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June Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, FDA, Government Relations /

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

June Food and Agriculture Regulatory Recap Read More »

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

Agriculture & Agribusiness, Cannabis, FDA, Government Relations /

On Friday, U.S. Food and Drug Administration (FDA) released its first draft guidance on the conduct of clinical trials for psychedelic drugs. The Draft Guidance for Industry, Psychedelic Drugs: Considerations for Clinical Investigations, if finalized, will guide researchers investigating psychedelics as potential treatments for medical conditions.  There has been significant media, marketing, and legislative interest

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Tattoo Ink Safety – A Reinvigorated Agency Concern

FDA /

On June 12, 2023, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance for tattoo ink manufacturers and distributors entitled, “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination,” to assist manufacturers and distributors of such products in recognizing when tattoo ink may pose contamination

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Cannabis Regulatory Update: CBD, The Farm Bill, and The Punt from FDA to Congress

Cannabis, FDA /

Earlier this year, the U.S. Food and Drug Administration (FDA) concluded that existing regulatory frameworks for food and supplements are not appropriate for cannabidiol” (CBD) and the agency will “work with Congress on a new way forward.” Since this announcement, speculation on how FDA and Congress will work to handle the ever-evolving over $9.1 billion

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January Food and Agriculture Regulatory Recap

Agriculture & Agribusiness, Cannabis, FDA /

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

January Food and Agriculture Regulatory Recap Read More »

The FDA Concludes “Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate” for CBD

FDA, Cannabis /

Today, the United States Food and Drug Administration (FDA) announced their conclusion “that existing regulatory frameworks for food and supplements are not appropriate for cannabidiol,” and the agency will “work with Congress on a new way forward.” This position was announced in a Statement by Dr. Janet Woodcock, Principal Deputy Commissioner, who chairs FDA’s cannabis

The FDA Concludes “Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate” for CBD Read More »

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