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 »
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 »
On July 16, 2024, the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to six companies for illegally selling copycat food products containing delta-8 tetrahydrocannabinol (THC) and introducing them into the marketplace, violating the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA highlighted two primary concerns: the
FDA and FTC Issue Warning Letters to Companies Selling Copycat Delta-8 THC Food Products 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 »
Inadequate disclosure from integrators regarding Additional Capital Investments: The Proposed Rule would require integrators to provide certain information to broiler growers when the integrator requests or requires the grower to make additional capital investments. The Proposed Rule, if finalized, would revise the Packers and Stockyards Act, 1921 (P&S Act or the Act) by amending 9
USDA-AMS Announces Proposed Revision to the Packers and Stockyards Regulations 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 »
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 »
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 »
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 »
On October 17, 2023, Arkansas became the first state to enforce a state law banning certain foreign entities from owning agricultural land (doing so under Act 636, which blocks “prohibited foreign-party-controlled business” from owning public or private land directly or through affiliation). Arkansas Attorney General, Tim Griffin ordered Syngenta Seeds LLC. to sell 160 acres
Arkansas Becomes the First State to Enforce Foreign-Ownership Land Restrictions 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 »
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 August 18, 2023, comments were due to Congress on the bipartisan and bicameral request for information (RFI), which sought written stakeholder comments and analysis to “asses[s] the potential for a regulatory pathway for hemp-derived [cannabidiol (CBD)] products that prioritizes consumer safety and provides certainty to the U.S. market.” By way of background on July
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 »
On May 11, 2023, the U.S. Supreme Court published its opinion in National Pork Producers Council v. Ross. In a 5-4 decision, the justices agreed to uphold provisions of California’s ballot initiative, Proposition 12, that require whole, uncooked cuts of pork sold at retail in California to be produced in accordance with California’s farm animal
May Food and Agriculture Regulatory Recap Read More »
On April 25, 2023, the USDA’s Food Safety and Inspection Service (FSIS) released the anticipated “Salmonella in Not-Ready-To-Eat (NRTE) Breaded Stuffed Chicken Products; Proposed Determination and Request for Comments” (the Proposed Determination), todeclare Salmonella an adulterant in breaded, stuffed raw chicken products when the chicken component tests positive for Salmonella at 1 colony forming unit (CFU) per gram or greater
April Food and Agriculture Regulatory Recap Read More »
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
Cannabis Regulatory Update: CBD, The Farm Bill, and The Punt from FDA to Congress Read More »
On March 17, 2023, FSIS announced it will make “Temporary Allowance for Use of Sodium Nitrite from Natural Sources, ”as a way to handle shortages of synthetic sodium nitrite used to cure meat and poultry products. Establishments interested in using the substitution may submit for temporary label approval under 9 C.F.R. § 412(1)(f). On March
March Food and Agriculture Regulatory Recap Read More »
2022 Achievements – On February 6, 2023, FSIS posted a list of the key achievements in 2022. These include the Agency’s efforts to reduce illnesses linked to Salmonella in poultry, support small and very small establishments, the result of the “Product of the USA” labeling survey, state inspection programs, collaboration, and fostering diversity, equity, and
February Food and Agriculture Regulatory Recap Read More »
On January 4, 2023, the Office of Management and Budget (OMB) released the Semiannual Regulatory Agendas for Fall 2022. All Federal Agency Regulatory Agendas can be found here. On December 20, 2023, the U.S. Federal Trade Commission (FTC) published a regulatory review; request for public comment on “Guides for the Use of Environmental Marketing Claims
January Food and Agriculture Regulatory Recap Read More »
Today, Frank Yiannas announced his resignation, via a letter to Commissioner Califf, as Deputy Commissioner for Food Policy and Response at the United States Food and Drug Administration (“FDA” or “the agency”). Yiannas has been with FDA since December 2018. Previously he was the Vice President for Food Safety at Walmart and Sam’s Club stores.
Frank Yiannas Announces Resignation from FDA Read More »
