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This Regulatory Update covers information from September 2025. Please contact <a href="mailto:pebenson@michaelbest.com">Paul Benson</a>, <a href="mailto:ttfritsch@michaelbest.com">Taylor Fritsch</a>, or <a href="mailto:lhziemba@michaelbest.com">Leah Ziemba</a> for additional information on regulatory issues that may affect your business. For access to articles and resources from our Premium Member law firm, Michael Best &amp; Friedrich, visit <a href="https://www.michaelbest.com/" target="_blank" rel="noopener">michaelbest.com</a>.

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FDA Releases Findings on Short-Weighting in Frozen Seafood Imports

September 2: The U.S. Food and Drug Administration (FDA) released the results from its 2022 – 2024 testing on frozen seafood products for short weighting. Short weighting can occur when excess ice glaze is included in the net weight. Overstating the net weight of frozen seafood by including the weight of ice glazing is not permitted by the FDA and is a form of economically motivated adulteration. Of the 28 samples of retail packaged frozen seafood products imported from four different countries, 36% were found to be in violation with 2.3 to 9.9% short weight. These shipments were refused entry into the U.S., and the responsible firms were placed on Import Alert 99-47. More information can be found <a href="https://www.fda.gov/food/economically-motivated-adulteration-food-fraud/sample-collection-and-analysis-imported-frozen-seafood-economically-motivated-adulteration-year-2022" target="_blank" rel="noopener">here</a>.

FDA Amends Hydrogen Peroxide Use in Food Processing

September 3: The FDA amended its food additive regulations to provide for the safe use of hydrogen peroxide in food as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide from approved uses. The FDA took this action in response to a food additive petition filed by Cargill, Inc. More information can be found <a href="https://www.federalregister.gov/documents/2025/09/03/2025-16898/secondary-direct-food-additives-permitted-in-food-for-human-consumption-hydrogen-peroxide" target="_blank" rel="noopener">here</a>.

FDA Approves Higher Vitamin D3 Levels in Cultured Dairy Products

September 4: The FDA amended the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in yogurt and other cultured dairy products fermented with Lactobacillus delbrueckii, subspecies bulgaricus (L. delbrueckii, subsp. bulgaricus), and Streptococcus thermophilus (S. thermophilus) at a level higher than previously permitted. The agency took this action in response to a food additive petition filed by General Mills, Inc. The FDA also updated the reference for the vitamin D3 specifications. More information can be found <a href="https://www.federalregister.gov/documents/2025/09/04/2025-16946/food-additives-permitted-for-direct-addition-to-food-for-human-consumption-vitamin-d3-in-yogurt-and" target="_blank" rel="noopener">here</a>.

FDA Proposes Removing Orange B Color Additive Rule

September 17: The FDA proposed removing the regulation that permits the use of Orange B as a color additive on the casings of frankfurters and sausages. Records show Orange B has not been certified for food use in the U.S. since 1978, indicating its authorized use has been abandoned. The FDA considers the regulation outdated and unnecessary and invites public comments on the proposal until October 17, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/09/17/2025-18023/proposal-to-remove-the-color-additive-listing-for-use-of-orange-b-on-casings-or-surfaces-of" target="_blank" rel="noopener">here</a>.

FDA and USDA Extend Comment Period on Ultra-Processed Foods Definition

September 19: The FDA and USDA extended the comment period for their July 25, 2025, Federal Register notice requesting data and information to help develop a uniform definition of ultra-processed foods. In response to requests for an extension, the agencies extended the comment period to October 23, 2025, to allow additional time to submit comments. More information can be found <a href="https://www.federalregister.gov/documents/2025/09/19/2025-18169/ultra-processed-foods-request-for-information-extension-of-comment-period" target="_blank" rel="noopener">here</a>.

FDA Finalizes Updates to Prior Notice Rules for Imported Food

September 25: The FDA issued a <a href="https://www.federalregister.gov/documents/2025/09/25/2025-18655/prior-notice-adding-requirement-to-submit-mail-tracking-number-for-articles-of-food-arriving-by" target="_blank" rel="noopener">final rule</a> amending its prior notice regulations for imported human and animal food to enhance tracking and safety. The rule now requires prior notice for food shipped by international mail to include the mail service name and tracking number, improving coordination with the U.S. Postal Service and U.S. Customs and Border Protection for inspections. It also establishes deadlines for submitting prior notice and facility registration information after refusal or hold notices, reducing delays at ports and preventing duplicate filings. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-updates-amendments-its-regulation-prior-notice-imported-human-and-animal-food" target="_blank" rel="noopener">here</a>.

FDA Confirms Revocation of 11 Obsolete Food Standards

September 26: The FDA confirmed the effective date of September 22, 2025, for its direct final rule originally published on July 17, 2025, revoking 11 obsolete standards of identity for canned fruits and vegetables no longer sold in the U.S. The FDA took this action to reduce unnecessary requirements. More information can be found <a href="https://www.federalregister.gov/documents/2025/09/26/2025-18730/revocation-of-food-standards-for-11-products-not-currently-sold-confirmation-of-effective-date" target="_blank" rel="noopener">here</a>.

FDA Releases FAQs on Pre-Harvest Agricultural Water Requirements

September 30: The FDA released new <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/frequently-asked-questions-agricultural-water-requirements-under-fsma-produce-safety-rule" target="_blank" rel="noopener">frequently asked questions (FAQs)</a> and updated guidance on implementing pre-harvest agricultural water requirements under the FSMA Produce Safety Rule. These FAQs were developed to provide information about the agricultural water requirements including water system inspections, risk assessments, corrective measures, and treatment options. FDA is also collaborating with industry on the development of a best practices document for managing agricultural water. Compliance dates for the pre-harvest agricultural water requirements for covered produce (other than sprouts) begin April 7, 2025, for large farms, with staggered deadlines for smaller operations. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-publishes-agricultural-water-faqs-and-information-fdas-implementation-pre-harvest-agricultural" target="_blank" rel="noopener">here</a>.

FDA Warning Letters

Adulterated Gummies: The FDA issued a warning letter to STNR Creations LLC for marketing inhalable hemp-derived products containing Delta-8 THC and other cannabinoids as dietary supplements and conventional foods. The agency cited violations including the sale of unapproved new drugs, misbranding, and failure to meet safety standards.

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Amanita Muscaria: The FDA issued a warning letter to Blue Forest Farms LLC for marketing products containing Amanita muscaria, including microdose capsules, tinctures, and chocolate, as dietary supplements and conventional foods. The agency determined these products are adulterated under the Federal Food, Drug, and Cosmetic Act because Amanita muscaria and its components are new dietary ingredients lacking adequate safety data.

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A database of warning letters can be found <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters" target="_blank" rel="noopener">here</a>.

FSIS Publishes Food Standards and Labeling Policy Book

September 8: The USDA Food Safety and Inspection Service (FSIS) published Guideline 2005-0003, known as the <a href="https://www.fsis.usda.gov/sites/default/files/import/Labeling-Policy-Book.pdf" target="_blank" rel="noopener">Food Standards and Labeling Policy Book</a>, which serves as a reference for labeling meat, poultry, and egg products. It outlines standardized definitions and labeling policies to ensure labels are truthful and not misleading. This guidance also helps establishments comply with FSIS regulations and supports accurate, consumer-friendly labeling practices. More information can be found <a href="https://www.fsis.usda.gov/guidelines/2005-0003" target="_blank" rel="noopener">here</a>.

FSIS Adds Gluten to Allergen Monitoring in New Directive

September 11: FSIS released Revision 4 of Directive 7230.1 titled <a href="https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/7230.1.pdf" target="_blank" rel="noopener">Ongoing Verification of Product Formulation and Labeling Targeting the Nine Most Common (“Big 9”) Food Allergens and Gluten</a>. This Directive updates inspection guidance for allergen labeling in meat, poultry, and egg products. It adds gluten to the list of monitored allergens, aligns with FDA changes, and clarifies monthly verification tasks to help prevent undeclared allergens from entering commerce. More information can be found <a href="https://www.fsis.usda.gov/policy/fsis-directives/7230.1" target="_blank" rel="noopener">here</a>.

FSIS Releases Guidance on Applying for USDA Inspection

September 15: FSIS released a new guideline titled “<a href="https://www.fsis.usda.gov/policy/fsis-notice/28-25" target="_blank" rel="noopener">Applying for USDA FSIS Inspection</a>” and is seeking public comments. The guidance is designed to help businesses understand whether they need FSIS inspection, identify products exempt from routine inspection, navigate the application process, and learn about FSIS verification activities and available resources for new applicants. Public comments on the new guidelines are due November 14, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/09/15/2025-17737/availability-of-guideline-for-applying-for-food-safety-and-inspection-service-inspection" target="_blank" rel="noopener">here</a>.

Other Articles of Interest

FDA To Propose New Rule That Could End Self-Affirmed GRAS Determinations

September 9: The FDA added a proposed new rule to its spring 2026 agenda that would revise how food ingredients are deemed Generally Recognized as Safe (GRAS), potentially ending the current system where companies can self-affirm safety status without federal review. The proposed rule would require mandatory submission of GRAS notices for substances used in human and animal food, including both direct ingredients and indirect additives such as those from packaging. Substances already affirmed by regulation or previously reviewed with a “no questions” response would be exempt. The proposed rule would require FDA to maintain a public GRAS notice inventory and clarify how it determines when a substance is not considered GRAS. The proposed rule is expected to be released in October 2025. The Unified Agenda referencing the upcoming proposed rule can be found <a href="https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&amp;RIN=0910-AJ02" target="_blank" rel="noopener">here</a>.

MAHA Commission Launches Strategy to Make Children Healthy Again

September 9: The Make America Healthy Again (MAHA) Commission unveiled its “<a href="https://www.whitehouse.gov/wp-content/uploads/2025/09/The-MAHA-Strategy-WH.pdf?utm_medium=email&amp;_hsenc=p2ANqtz-_GMxz3Q2eSGBiYqUtwIlTXiscCnOQHScHbY-YJQCm9sGLJ-wWp_UAAxXQfBT5coptlbN7kYZ4mxBPTtROsojvfYnTJbQ&amp;_hsmi=379805471&amp;utm_content=379805471&amp;utm_source=hs_email" target="_blank" rel="noopener">Make Our Children Healthy Again Strategy</a>” to combat childhood chronic disease, featuring over 120 initiatives to reform food and health systems, with input from food and agricultural groups. The strategy features advancing research, realigning incentives, private-sector collaboration and boosting public awareness. Agricultural recommendations include pesticide research, soil health, and innovation, with deregulatory measures for organics and small farms. The first report, issued in May, questioned pesticides, seed oils, high-fructose corn syrup, and ultra-processed foods. Following industry backlash, the commission shifted its approach, held meetings with farm and food leaders and softened its stance in the latest report which omitted calls to restrict pesticide use and avoided mention of controversial ingredients. While the agriculture community welcomed the report, some MAHA-affiliated groups criticized it as favoring “big agriculture.” More information can be found <a href="https://www.usda.gov/about-usda/news/press-releases/2025/09/09/maha-commission-unveils-sweeping-strategy-make-our-children-healthy-again" target="_blank" rel="noopener">here</a> and <a href="https://www.grainjournal.com/article/1108681/make-america-healthy-again-maha-strategy-released" target="_blank" rel="noopener">here</a>.

Campbells to Eliminate Synthetic Colors from Remaining Products

September 9: The Campbell Soup Co. announced it will eliminate FD&amp;C synthetic colors from its remaining products by the second half of fiscal 2026. Brands like Lance crackers, V8 Splash, and regional snacks such as Jay’s and Tom’s will transition to colors derived from plant-based sources like annatto and purple carrot juice. Campbells began using plant-based colors in its Goldfish crackers more than 15 years ago. More information can be found <a href="https://www.foodbusinessnews.net/articles/28981-campbells-taking-steps-to-remove-fd-and-c-colors" target="_blank" rel="noopener">here</a>.

Tyson Foods to Remove High Fructose Corn Syrup from Popular Brands

September 15: Tyson Foods announced it will stop using high-fructose corn syrup, as well as artificial sweetener Sucralose, the preservative BHA/BHT and the color additive Titanium Dioxide in its brands such as Jimmy Dean and Hillshire Farm by the end of the year. More information can be found <a href="https://www.msn.com/en-us/health/nutrition/tyson-foods-to-eliminate-high-fructose-corn-syrup-in-brands-like-jimmy-dean-and-hillshire-farm/ar-AA1MCBGN" target="_blank" rel="noopener">here</a>.

California Advances Ban on Ultra-Processed Foods in School Meals

September 15: California is set to become the first state in the U.S. to ban ultra-processed foods (UPFs) from public school meals under Assembly Bill 1264, which awaits the governor’s signature. The law defines UPFs as foods high in saturated fat, added sugar, or sodium, and containing industrial additives like artificial colors, sweeteners, and emulsifiers. The California Department of Public Health will identify the most harmful UPFs to be phased out by 2035. More information can be found <a href="https://www.foodsafetynews.com/2025/09/california-law-will-ban-ultra-processed-foods-in-school-meals/" target="_blank" rel="noopener">here</a>.

California Cheesemaker Files for Chapter 11 Amid Listeria Contamination

September 17: Rizo-López Foods Inc., a family-owned California cheesemaker, filed for Chapter 11 bankruptcy after a 16-month shutdown caused by listeria contamination left the company facing over $74 million in legal claims and $10 million in defaulted secured debt. The Modesto-based producer of cheese, yogurt, and sour cream for retail sale and commercial customers like Sargento and Amy’s Kitchen, issued a full product recall in February 2024 and entered an FDA consent decree before resuming limited operations in August 2025. The company plans to restructure debt and address claims from commercial customers and personal injury suits, supported by $3.8 million in debtor-in-possession financing from its owners.

FDA Boosts Transparency with Foodborne Outbreak Investigation Summaries

September 24: The FDA announced new initiatives to increase transparency about foodborne illness outbreaks and investigations by publishing Executive Incident Summary Abstracts of completed outbreak investigations and publishing Foodborne Outbreak Overview of Data (FOOD) Reports. These summaries provide key findings, contributing factors, and recommendations for preventing future outbreaks, offering the public a better understanding of the outcomes of each investigation. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-provides-additional-transparency-around-foodborne-outbreaks-and-investigations-sharing-executive" target="_blank" rel="noopener">here</a>.

California Food Companies Sue Texas Over Ban on Lab-Grown Meat

September 4: A lawsuit filed in the U.S. District Court for the Western District of Texas is challenging the state’s new ban on cell-cultured protein, arguing that it may violate federal law by restricting interstate commerce. The plaintiffs, California-based companies Wild Type and Upside Foods, claim that Senate Bill 261 unfairly blocks the sale of federally approved lab-grown meat products and could limit innovation and market access. The case raises broader questions about state-level regulation of emerging food technologies and its impact on national trade. A copy of the complaint can be viewed <a href="https://ij.org/wp-content/uploads/2025/09/Doc-1-Complaint.pdf" target="_blank" rel="noopener">here</a>. More information can be found <a href="https://reason.com/2025/09/04/the-new-texas-ban-on-cell-cultured-protein-is-an-unconstitutional-interstate-trade-barrier-a-lawsuit-says/" target="_blank" rel="noopener">here</a>.

Coca-Cola Wins Dismissal of PFAS Lawsuit Over Simply Tropical Juice

September 30: A judge for the US District court for the Southern District of New York dismissed a proposed class action against Coca-Cola Co. over claims that its Simply Tropical juice contained PFAS. The court ruled that the lead plaintiff failed to demonstrate harm or establish a clear link between third-party testing and his own purchases. Allegations that Coca-Cola misrepresented the product as “all-natural” were deemed conclusory and unsupported by any accompanying facts. The decision ends a case that involved multiple complaints and attempts to prove contamination through independent lab tests, which the judge found lacked specific details and credibility.

Rows of clear plastic water bottles with blue caps on a production line in a beverage manufacturing facility.

Food & Beverage Regulatory Update – September 2025

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