There is mounting federal and state pressure to ban various food additives and artificial colors in foods and beverages. The elimination of artificial colors is a high priority for Secretary Kennedy, though the precise means by which HHS would accomplish this are unclear. As artificial colors are permitted only by regulation, absent Congress changing the
March Food and Agriculture Regulatory Recap Read More »
On February 27-28, 2025, USDA hosted its 101st Agricultural Outlook Forum in Arlington, VA. The 2025 Outlook Forum focused on the latest outlook for agricultural markets and trade as well as a range of agricultural, food market, and environmental issues. Additional details and messages regarding the impact of Outlook Forum discussions will be available in
February Food and Agriculture Regulatory Recap 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 January. If you have any questions or would like more information, please do not hesitate to
January Food and Agriculture Regulatory Recap Read More »
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
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 December that should be highlighted. If you have any questions or would like more information, please do
December Food and Agriculture Regulatory Recap 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 November. If you have any questions or would like more information, please do not hesitate to
November Food and Agriculture Regulatory Recap Read More »
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 help
Food, Ag, & Trade Outlook in the Incoming Trump Administration Read More »
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
Priority Deliverables For 2025 Under the New Unified Human Foods Program Read More »
OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients appraised 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 September 10, 2024, USDA’s Food Safety and Inspection Service (FSIS) announced the availability of an updated version of “FSIS Guideline on Substantiating Animal-Raising or Environmental-Related Claims.” The guideline is final and provides establishments with information on how to use and substantiate animal-raising claims(ex. “Raised Without Antibiotics,” “Grass Fed,” “Free-Range,” “Raised Without the Use of
September Food and Agriculture Regulatory Recap Read More »
On August 23, 2024, FSIS reminded stakeholders that starting September 1, 2024, FSIS will begin the allergen verification sampling (additional information in FSIS Directive 7000.6). In response to questions, FSIS is posting questions and answers for a few commonly asked questions. On August 13, 2024, USDA’s Food Safety and Inspection Service (FSIS) issued FSIS Notice
August Food and Agriculture Regulatory Recap Read More »
FSIS Directive 7000.6: “Allergen Verification Sampling Program,” provides instructions to IPP to collect samples for the allergen verification sampling program conducted at establishments that RTE products with labeling claims for 14 food allergens and gluten. On July 29, 2024, the USDA’s Food Safety and Inspection Service (FSIS) released an advance copy of its proposed rule
July Food and Agriculture Regulatory Recap Read More »
Agencies may rely less on general authorities in rulemaking and more on clear and specific instructions from Congress as to the matter to be regulated. Agencies may slow or abandon rulemaking, with heightened scrutiny to lessen the risk of legal challenges when they do issue rules. A surge in litigation is likely as regulated entities
On June 25, 2024, USDA’s Food Safety and Inspection Service (FSIS) announced the availability of its updated “FSIS Guideline for Residue Prevention” to prevent violative residues in meat and poultry slaughter establishments. Simultaneously, FSIS also released FSIS Notice 21-24, “Availability of Updated Guideline for Residue Prevention” to provide instructions to inspection program personnel. Other On
June Food and Agriculture Regulatory Recap Read More »
On May 23, 2024, USDA-FSIS published the revised “FSIS Guideline to Assist with Donation of Eligible Meat, Poultry & Egg Products to Non-profit Organizations.” The Guideline is final and provides information to meat, poultry, and egg products establishments interested in donating products to non-profit organizations in compliance with the Federal Meat Inspection Act (FMIA), the
May Food and Agriculture Regulatory Recap Read More »
On April 26, 2024, USDA-FSIS announced its final determination to declare Salmonella an adulterant in raw breaded stuffed chicken products when they exceed a specific threshold (1 colony forming unit (CFU) per gram or higher) for Salmonella contamination. On April 10, 2024, USDA’s Agriculture Marketing Service (AMS) released a notice and request for information, “National
April Food and Agriculture Regulatory Recap Read More »
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
On March 18, 2024, USDA’s Food Safety and Inspection Service (FSIS) published the Final Rule, “Voluntary Labeling of FSIS-Regulated Products with U.S.- Origin Claims.” The Final Rule establishes new regulatory requirements under 9 C.F.R. Part 412 for voluntary “Product of USA” or “Made in the USA” (the labeling claims for meat, poultry, and egg products)
March Food and Agriculture Regulatory Recap Read More »
On February 16, 2024, USDA-FSIS announced that in the coming weeks, the agency will be soliciting feedback from small and very small establishment owners through a survey. The agency says the purpose of the survey is to understand how FSIS can better serve the needs of small establishments and improve outreach. The survey is tentatively scheduled
February Food and Agriculture Regulatory Recap Read More »
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.
Association Events Targeted for Scams Read More »
On January 16, 2024, USDA’s Food Safety and Inspection Service (FSIS) published a Directive entitled, “Ongoing Verification of Product Formulation and Labeling Targeting the Nine Most Common A (”Big 9”) Allergens. This Directive provides instructions on performing the “Big 9” Formulation Verification Task. The Directive has been updated to include sesame as a major allergen,
January Food and Agriculture Regulatory Recap Read More »
Cosmetics – On December 20, 2023, FDA’s Office of the Chief Scientist (OCS) introduced new proposed guidance documents under development. Over the years, OCS has issued a number of guidance on cosmetics. Registration and Listing of Cosmetic Product Facilities and Products; Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk
December Food and Agriculture Regulatory Recap Read More »
Securities reporting issuer; Governmental authority; Bank; Credit union; Depository institution holding company; Money services business; Broker or dealer in securities; Securities exchange or clearing agency; Investment company or investment adviser; Venture capital fund adviser; Insurance company; Commodity Exchange Act-registered entity; Accounting firm; Public utility; Financial market utility; Pooled investment vehicle; Tax-exempt entity; Entity assisting a
Small Businesses Face Reporting Obligations Under The U.S. Corporate Transparency Act Read More »
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:
CBD and Delta-8 THC: FDA Enforcement Update Read More »
FSIS currently has two other rulemakings under review at OMB. Both are slated to be finalized in early 2024: Salmonella in Not-Ready-to-Eat Breaded Stuffed Chicken Products Voluntary Labeling of FSIS-Regulated Products with U.S.-Origin Claims Other This month, USDA’s Food Safety and Inspection Service (FSIS) noted that a proposed rule addressing Salmonella in poultry is
November Food and Agriculture Regulatory Recap Read More »
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,
PFAS in Food Packaging – State Compliance Deadlines and Requirements (2026 Update) Read More »
On October 25, 2023, USDA’s Agriculture Marketing Service (AMS) Secretary Vilsack previewed the Organic Livestock and Poultry Standards (OLPS) Final Rule. The Final Rule will amend the National Organic Program (NOP) regulations by adding new provisions for livestock handling and transport for slaughter and avian living conditions. The Final Rule will also expand existing requirements
October Food and Agriculture Regulatory Recap Read More »
Food Waste – On September 20, 2023, USDA announced an additional $25 million in investments (funded under the American Rescue Plan Act (ARPA)) to expand efforts to prevent and reduce food loss and waste. This is a joint agency initiative between USDA’s National Institute of Food and Agriculture (NIFA) and USDA’s Office of the Chief
September Food and Agriculture Regulatory Recap Read More »
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
FDA’s Focus on Cybersecurity Creates Avoidable Risk for Management Read More »
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
On August 30, 2023, The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) – an advisory committee originally established in 1988 by USDA – hosted a subcommittee Plenary Public Meeting. The 2021-2023 current NACMCF subcommittee work can be found here. During the meeting, NACMCF focused on two FDA subcommittee charges: Cyclospora cayetanensis in Produce
August Food and Agriculture Regulatory Recap Read More »
On July 5, 2023, FDA and the Federal Trade Commission (FTC) jointly sent six (6) cease and desist letters to companies marketing and selling edible products containing Delta-8 tetrahydrocannabinol (THC) in packaging similar to snacks and candy ordinarily eaten by children On July 27, 2023, the House Oversight and Accountability Subcommittee on Health Care and
July Food and Agriculture Regulatory Recap Read More »
On June 21, 2023, USDA issued Grants of Inspection (GOI) to two companies that intend to manufacture cell-cultured chicken products, Upside Foods and Good Meat Company (as well as a Good Meat co-packer, Joinn Biologics). Along with the GOI, FSIS released FSIS Directive 7800.1, “FSIS Responsibilities in Establishments Producing Cell-Cultured Meat and Poultry Food Products,”
June Food and Agriculture Regulatory Recap Read More »
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
FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs Read More »
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
Tattoo Ink Safety – A Reinvigorated Agency Concern Read More »
