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This Regulatory Update covers information from August 2025. Please contact <a href="mailto:pebenson@michaelbest.com">Paul Benson</a>, <a href="mailto:ttfritsch@michaelbest.com">Taylor Fritsch</a>, or <a href="http://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/">michaelbest.com</a>.

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FDA Proposes Updates to Orange Juice Identity Standards

August 6: In response to a citizen petition submitted by the Florida Citrus Processors Association Inc. and Florida Citrus Mutual Inc., the FDA is proposing to amend the standard of identity for pasteurized orange juice by lowering the minimum required soluble solids content from 10.5° to 10° Brix. This adjustment reflects the declining natural sugar levels in Florida oranges due to citrus greening disease and would provide industry greater flexibility in the manufacture of pasteurized orange juice. Public comments on the proposed rule are accepted until November 4, 2025. More information can be found <a href="http://New Additions to FDA’s Post-Market Chemical Watchlist August 19: The FDA updated its list of select chemicals currently under the agency’s review to provide more insight on the status of the FDA’s post-market assessments of chemicals in the food supply. This update adds several new substances to the agency’s watchlist including butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), azodicarbonamide (ADA), FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, FD&amp;C Green No. 3, FD&amp;C Red No. 40, FD&amp;C Yellow No. 5, and FD&amp;C Yellow No. 6. The FDA is also reviewing the presence of opiate alkaloids on poppy seeds. More information can be found here. FDA Confirms Natural Color Additives for Food Use August 21: The FDA published final orders confirming June 26, 2025, as the effective date for amendments to its color additive regulations and expanding the list of substances exempt from certification. These orders authorize the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. Galdieria extract blue is authorized as a color additive in a wide array of beverages, dairy products, desserts, and confections. Butterfly pea flower extract is authorized as a color additive in ready-to-eat cereals, chips, crackers, pretzels, and snack mixes. Each additive is approved for use at levels consistent with good manufacturing practices. The final order on calcium phosphate can be found here. The final order on Galdieria extract blue can be found here. And the final order on butterfly pea flower extract can be found here.">here</a> and <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-issues-proposed-rule-amend-standard-identity-pasteurized-orange-juice">here</a>.

FDA Proposes to Extend Food Traceability Compliance Deadline to July 2028

August 7: In response to industry concerns, the FDA is proposing a 30-month extension to the compliance deadline for its Food Traceability Rule, shifting the compliance date from January 20, 2026, to July 20, 2028. The rule, originally finalized in 2022, requires additional recordkeeping for high-risk foods to prevent or mitigate foodborne illness outbreaks and protect public health. However, many supply chain entities have struggled to implement the necessary data systems, prompting the FDA to reconsider the timeline. The deadline for submitting comments on the proposed extension is September 8, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/08/07/2025-14967/requirements-for-additional-traceability-records-for-certain-foods-compliance-date-extension">here</a> and <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-proposes-extend-compliance-date-food-traceability-rule-and-issues-new-faqs-and-other-resources">here</a>.

Save the Date: FDA to Host Public Meetings on Food Allergen Thresholds

August 18: The FDA will host a three-day virtual public meeting from November 18–20, 2025, to discuss food allergen thresholds and their potential applications. FDA is exploring how these thresholds can improve food safety and enhance labeling practices. The event will feature expert presentations and panel discussions on November 18, followed by listening sessions on November 19–20 to gather public input. Public feedback will help the FDA determine the next steps in developing food allergen threshold approaches that benefit public health. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-hold-virtual-public-meeting-and-listening-sessions-food-allergen-thresholds-and-their-potential">here</a>.

New Additions to FDA’s Post-Market Chemical Watchlist

August 19: The FDA updated its list of select chemicals currently under the agency’s review to provide more insight on the status of the FDA’s post-market assessments of chemicals in the food supply. This update adds several new substances to the agency’s watchlist including butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), azodicarbonamide (ADA), FD&amp;C Blue No. 1, FD&amp;C Blue No. 2, FD&amp;C Green No. 3, FD&amp;C Red No. 40, FD&amp;C Yellow No. 5, and FD&amp;C Yellow No. 6. The FDA is also reviewing the presence of opiate alkaloids on poppy seeds. More information can be found <a href="https://www.fda.gov/food/hfp-constituent-updates/fda-update-post-market-assessment-chemicals-food-supply-0">here</a>.

FDA Confirms Natural Color Additives for Food Use

August 21: The FDA published final orders confirming June 26, 2025, as the effective date for amendments to its color additive regulations and expanding the list of substances exempt from certification. These orders authorize the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. Galdieria extract blue is authorized as a color additive in a wide array of beverages, dairy products, desserts, and confections. Butterfly pea flower extract is authorized as a color additive in ready-to-eat cereals, chips, crackers, pretzels, and snack mixes. Each additive is approved for use at levels consistent with good manufacturing practices. The final order on calcium phosphate can be found <a href="https://www.federalregister.gov/documents/2025/08/21/2025-16047/listing-of-color-additives-exempt-from-certification-calcium-phosphate-confirmation-of-effective">here</a>. The final order on Galdieria extract blue can be found <a href="https://www.federalregister.gov/documents/2025/08/21/2025-16046/listing-of-color-additives-exempt-from-certification-galdieria-extract-blue-confirmation-of">here</a>. And the final order on butterfly pea flower extract can be found <a href="https://www.federalregister.gov/documents/2025/08/21/2025-16045/listing-of-color-additives-exempt-from-certification-butterfly-pea-flower-extract-confirmation-of">here</a>.

Imported Pastries: The FDA issued a warning letter to Eurobread Inc., following a Foreign Supplier Verification Program inspection that revealed significant violations related to imported ready-to-eat Mini Patisseries. The inspection was prompted by an outbreak of Salmonella Enteritidis infections linked to the pastries, which led to a recall and placement of the products on Import Alerts for contamination and unsanitary conditions. The FDA cited Eurobread for failing to properly evaluate foreign supplier risks and document verification activities.

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Adulterated Gummies: The FDA issued a warning letter to TKO Distribution, LLC for marketing adulterated food products containing Delta-8 THC which is not approved for use in conventional foods. The agency determined several gummy products are adulterated because they contain unsafe food additives and emphasized that Delta-8 THC does not meet the criteria for Generally Recognized as Safe status.

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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">here</a>.

FSIS Moves Toward Visual-Only Post-Mortem Swine Inspections

August 28: The USDA’s Food Safety and Inspection Service (FSIS) proposed a rule to eliminate mandatory mandibular lymph nodes incision and viscera palpation of swine carcasses in swine slaughter establishments. This change applies to both traditional inspection systems and the New Swine Slaughter Inspection System, based on findings that such procedures are not needed to ensure food safety. FSIS data shows that swine condemnation rates are low, and that visual inspection alone is sufficient to detect disease conditions. FSIS also proposes to amend the post-mortem swine inspection staffing standards table for swine slaughter establishments operating under traditional inspection to allow FSIS greater flexibility in assigning inspection personnel based on operational needs. Public comments on the proposed rule are due by October 20, 2025. More information can be found <a href="https://www.federalregister.gov/documents/2025/08/19/2025-15749/visual-post-mortem-inspection-in-swine-slaughter-establishments">here</a>.

Regulating the Rise of THC-Infused Drinks

August 11: As the popularity of THC-infused beverages grows, the legal framework surrounding them remains inconsistent and rapidly changing. States are taking varied approaches to regulation, with some allowing sales through licensed cannabis dispensaries and others permitting hemp-derived THC drinks in general retail. Recent federal court decisions, such as Bio Gen LLC v. Huckabee, affirm that states may restrict or ban intoxicating hemp products without violating federal law, adding uncertainty to the market. Manufacturers should closely monitor both federal and state developments, given newly proposed federal legislation that seeks to redefine hemp under the Farm Bill. The bill, approved by the House Committee on Appropriations, would exclude synthetic and non-naturally occurring cannabinoids from the definition of hemp, impose stricter THC limits based on total THC content, and distinguish industrial hemp from hemp-derived cannabinoid products. If enacted, the bill could restrict synthetic or intoxicating hemp-derived products while continuing to allow industrial and nonintoxicating cannabinoid products with trace THC.

FDA Litigation Uncertain After DOJ Consumer Protection Branch Dissolves

August 11: The U.S. Department of Justice’s decision to dissolve its Consumer Protection Branch (CPB) by September 30th has raised concerns about the future of FDA-related litigation and enforcement. The branch, which played a key role in prosecuting cases involving food, drug, and consumer product safety, will have its responsibilities absorbed into other DOJ divisions. Legal experts worry this shift could slow regulatory actions and create uncertainty around how aggressively the DOJ will pursue violations tied to FDA oversight. Companies regulated by the FDA are advised to strengthen compliance and monitoring efforts to navigate the evolving regulatory landscape and mitigate any risks associated with the closure of the CPB.

Florida Bans Potent Kratom Compound Under Emergency Rule

August 14: Florida has enacted an emergency rule banning 7-hydroxymitragynine (7-OH), a powerful compound found in kratom, classifying it as a Schedule I controlled substance. The move targets fruit flavored 7-OH products marketed to youth, such as gummies and candies, and aligns with federal efforts to regulate the substance due to its high abuse potential and lack of medical use. More information can be found <a href="https://www.foodsafetynews.com/2025/08/kratoms-7-oh-made-illegal-in-florida-under-emergency-rule/">here</a>.

FDA Launches Tracker of Companies Pledging to Eliminate Petroleum-Based Food Dyes

August 18: In response to the FDA’s initiative announced on April 22, 2025 to phase out petroleum-based food dyes from the American food supply, dozens of companies have pledged to reformulate their products with safer, naturally derived alternatives. To monitor progress and encourage transparency and accountability across the food industry, the FDA compiled a tracker of industry commitments highlighting a coalition of manufacturers, retailers, and trade associations working to eliminate six certified color additives, including FD&amp;C Red No. 40 and FD&amp;C Yellow No. 5, by the end of 2027. The tracker and more information can be found <a href="https://www.fda.gov/food/color-additives-information-consumers/tracking-food-industry-pledges-remove-petroleum-based-food-dyes">here</a>.

Gallup Poll Reveals Shifting Priorities Toward Nutrition and Food Safety

August 20: According to the latest Gallup Consumption Habits poll, American consumers are more engaged than ever with the health and safety of their food. Three-quarters now read nutrition labels, with sugar and calorie content primarily driving purchase decisions. Secondary considerations include sodium or salt, carbohydrates, protein content, and fat levels. Label engagement is highest among higher-income and health-conscious shoppers. Meanwhile, trust in government food safety oversight has dropped to 53%, prompting brands to rely on third-party certifications and transparent labeling to build consumer confidence. More information can be found <a href="https://foodindustryexecutive.com/2025/08/navigating-health-priorities-and-food-safety-concerns-consumer-consumption-habits-from-gallup/">here</a>.

EU Holds the Line on Food Safety Standards in U.S. Trade Deal

August 25: In a recent trade agreement with the United States, the European Union reaffirmed its commitment to maintaining strict food safety standards, drawing a firm line around its sanitary and phytosanitary rules. While the EU agreed to streamline sanitary certificate requirements and expand market access for select U.S. agricultural products such as seafood, dairy, and tree nuts, it maintained bans on hormone-treated beef and chlorine-washed poultry. More information can be found <a href="https://www.foodsafetynews.com/2025/08/eu-protects-food-standards-in-agreement-with-u-s/">here</a>.

CDC Scales Back Foodborne Pathogen Tracking Efforts Amid Budget Constraints

August 29: The CDC confirmed major cuts to its Foodborne Diseases Active Surveillance Network (FoodNet), narrowing its focus to just two pathogens - Salmonella and shiga-toxin producing E. coli (STEC) - and dropping surveillance of six others, including Listeria, Campylobacter, and Cyclospora. The cuts stem from inadequate funding. Experts warn the cuts to FoodNet could put the nation in danger of more foodborne illnesses, especially since some of the dropped pathogens are linked to hospitalizations and deaths. Some state health departments have pledged to continue full surveillance independently. More information can be found <a href="https://www.foodsafetynews.com/2025/08/cdc-confirms-cuts-to-program-that-tracks-foodborne-pathogens/">here</a>.

Capri-Sun Faces Lawsuit Over “100% Juice” Labeling

August 12: A proposed class action lawsuit filed in the U.S. District Court for the Northern District of California accuses Kraft Heinz of misleading consumers by labeling its Capri-Sun "100% Juice" Fruit Punch as entirely juice-based, while it contains synthetic citric acid which is a preservative and flavor additive. The plaintiff argues that the product’s labeling violates consumer protection laws and FDA regulations by falsely suggesting it contains only fruit-derived ingredients, leading buyers to pay more under false pretenses. The suit seeks damages, restitution, and an injunction to stop Kraft Heinz from marketing the product as purely juice. A copy of the complaint can be found <a href="https://casefilingsalert.com/wp-content/uploads/2025/08/Kraft-Heinz.pdf">here</a>.

Food Producers Beats Addiction Lawsuit Over Ultra-Processed Products

August 26: A federal judge dismissed a lawsuit accusing major food companies, including Kraft Heinz, PepsiCo, and General Mills, of deliberately engineering ultra-processed foods (UPFs) to be addictive to children. The U.S. District Court for the Eastern District of Pennsylvania ruled that the complaint did not have enough allegations specific to the plaintiff and instead focused on the science demonstrating the addictiveness of UPFs. While the court acknowledged concerns about the marketing and health impacts of UPFs, the judge said the plaintiff failed to state a claim upon which relief may be granted because he did not identify specific products he consumed or the timeline between the product consumption and his diagnoses. More information can be found <a href="https://www.reuters.com/sustainability/boards-policy-regulation/kraft-other-companies-defeat-test-lawsuit-over-ultra-processed-foods-2025-08-25/">here</a>.

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

Rows of clear plastic water bottles with blue caps on a production line.

Food & Beverage Regulatory Update – August 2025

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