As consumer demand for transparency grows and U.S. food safety regulations evolve, staying ahead of FDA compliance is more critical than ever. From ingredient bans like the FDA’s Red Dye No. 3 ruling to new food labeling requirements and enhanced pesticide residue limits, food manufacturers must act fast to remain compliant.
These sweeping regulatory changes from the FDA and USDA are reshaping how products are formulated, labeled, and marketed. Leveraging regulatory compliance software can help brands monitor and adapt to new food safety rules efficiently, avoiding costly recalls and protecting consumer trust.
In this post, we break down the most important regulatory developments reshaping food safety and labeling in the U.S.
The U.S. Food and Drug Administration (FDA) has updated its food labeling compliance framework, issuing a revised version of Compliance Program 7321.005: General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import on June 24, 2025. This update replaces the previous 2010 version and reflects the latest federal labeling requirements and enforcement priorities.
The revised compliance program serves as an enforcement guide for FDA investigators and analysts, helping ensure that food labeling remains truthful, not misleading, and consistent with federal law.
Announcement Date: June 24, 2025
Link to Regulation
Food & Ingredients Impacted: All Food Categories
The U.S. Environmental Protection Agency (EPA) has finalized residue tolerances for the herbicide sulfentrazone on popcorn grain and stover, addressing a regulatory gap that arose during previous registration.
Published in the Federal Register on May 19, 2025, the rule establishes the following maximum residue limits:
These tolerances correct an earlier oversight in which sulfentrazone use on popcorn was approved, but no residue limits were defined. The EPA has now confirmed that these levels pose no health risk to any population group, including infants and children, under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Stakeholders may file objections or request hearings on this regulation through July 18, 2025.
Announcement Date: May 19, 2025
Link to Regulation
Food & Ingredients Impacted: Corn and corn products
Deadline for Public Comments: July 18, 2025
Effective Date: May 19, 2025
The U.S. Food and Drug Administration (FDA) has amended its color additive regulations to allow the use of three new natural colorants in food, expanding opportunities for manufacturers seeking clean label ingredients.
These approvals follow color additive petitions submitted by:
Under Section 721 of the Federal Food, Drug, and Cosmetic Act, the FDA authorizes the use of color additives following a safety review and rulemaking process. Once finalized, manufacturers may legally incorporate these colorants in food products as specified.
This update supports growing demand for naturally derived ingredients and clean-label formulations. The expanded list of approved uses for these colorants offers flexibility for innovation across diverse product categories.
Announcement Date: May 9, 2025
Link to Regulation
Food & Ingredients Impacted: Beverages, yogurts, candies, frozen desserts, chips, cereals, crackers, ready-to-eat chicken, coatings
Effective Date: May 9, 2025
In a pivotal update reflecting heightened concern over drinking water safety, the U.S. Food and Drug Administration (FDA) has published new findings on per- and polyfluoroalkyl substances (PFAS) levels in bottled water. The April 16 report aligns with the Environmental Protection Agency’s (EPA) revised maximum contaminant levels (MCLs) under the Safe Drinking Water Act.
Between 2023 and 2024, the FDA tested 197 samples of bottled water.
This is the first time FDA testing has detected PFAS in bottled water. Previous evaluations, including the 2016 FDA study and data from the agency’s Total Diet Study, reported no detectable PFAS in bottled water samples.
The update reflects FDA’s obligation under Section 410 of the Federal Food, Drug, and Cosmetic Act, which mandates that FDA either adopt EPA's drinking water standards or explain any deviation. The agency has reaffirmed its commitment to continued monitoring and will publish additional PFAS testing updates as data becomes available.
While PFAS were detected in a limited number of samples, the findings are currently within safety thresholds established by EPA. This reinforces regulatory efforts to identify and mitigate emerging contaminants and provides early transparency for manufacturers and consumers alike.
Announcement Date: April 16, 2025
Link to Regulation
Food & Ingredients Impacted: Bottled water
Effective Date: April 16, 2025
The U.S. Environmental Protection Agency (EPA) has officially amended 40 CFR 180 to exempt Pseudomonas oryzihabitans strain SYM23945 from tolerance requirements. This action, published in the Federal Register on March 27, supports expanded use of microbial biopesticides in agriculture under strict safety assurances.
EPA’s scientific review determined that Pseudomonas oryzihabitans SYM23945:
The rule amends 40 CFR 180, removing the need for a specific tolerance level when this strain is used as directed. It reflects EPA’s continued support for biological alternatives to synthetic pesticides and reinforces its commitment to science-based exemptions that do not compromise food safety.
Stakeholders wishing to object or request a hearing must submit filings by May 27, 2025, per procedural requirements outlined in the Federal Register notice.
Announcement Date: March 27, 2025
Link to Regulation
Food & Ingredients Impacted: Food crops treated with SYM23945
Deadline for Public Comments: May 27, 2025
Effective Date: May 27, 2025
In a significant timeline shift, the U.S. Food and Drug Administration (FDA) has granted a 30-month extension for compliance with the Food Traceability Rule under the Food Safety Modernization Act (FSMA). Originally set for January 2026, the new deadline is now July 2028, giving companies extended time to implement traceability systems without compromising public health objectives.
While the deadline has changed, the requirements of the Food Traceability Rule remain fully intact. These include recordkeeping and tracking mandates for foods listed on the Food Traceability List, covering high-risk items such as:
The rule aims to improve the speed and precision of foodborne illness outbreak response through standardized data capture and sharing practices across the supply chain.
The FDA cited multiple reasons for the extension:
The agency emphasized its commitment to collaboration and education by pledging to:
This delay reflects the FDA’s strategy to balance enforcement with readiness, recognizing the rule’s long-term impact on food safety modernization.
Announcement Date: March 20, 2025
Link to Regulation
Food & Ingredients Impacted: Foods listed on the Food Traceability List
Effective Date: July 2028
On January 16, 2025, the U.S. Food and Drug Administration (FDA) finalized its decision to revoke the use of FD&C Red No. 3 (also known as Erythrosine or E127) in food and ingested drug products. This update, published in the Federal Register, officially amends 21 CFR Part 74, marking a major shift in food dye regulation.
This synthetic cherry-red dye has long been under scrutiny due to its potential carcinogenicity. The FDA invoked the Delaney Clause, a zero-tolerance policy for additives shown to cause cancer in animal studies, mandating its removal.
This decision reinforces growing food dye safety concerns and signals a shift toward tighter ingredient regulations. Brands should act now to ensure reformulations are complete ahead of the compliance deadline.
Announcement Date: January 16, 2025
Link to Regulation
Food & Ingredients Impacted: FD&C Red No. 3 (also known as Erythrosine or E127)
Effective Date: January 15, 2027
On December 27, 2024, the U.S. Food and Drug Administration (FDA) finalized a rule redefining the use of “healthy” as a nutrient content claim under 21 CFR Part 101, aligning it with the Dietary Guidelines for Americans, 2020–2025.
This rule takes effect on February 25, 2025, with a final compliance deadline of February 25, 2028, giving brands time to align with the revised Dietary Guidelines 2025 Healthy definition.
Announcement Date: December 27, 2024
Link to Regulation
Food & Ingredients Impacted: Multiple categories
Effective Date: February 25, 2025 & February 25, 2028
The U.S. Environmental Protection Agency (EPA) has finalized a rule exempting certain fragrance components used in pesticide formulations from residue tolerance limits, as published in the Federal Register on November 25, 2024. This amendment to 40 CFR 180.940(a) facilitates the continued use of antimicrobial products on food-contact surfaces, such as in commercial kitchens and food processing facilities.
Under the new regulation, specific fragrance substances may be included in antimicrobial pesticide formulations applied to:
The exemption permits usage up to 33 parts per million (ppm), a level determined to be safe under EPA’s food contact surface guidelines.
EPA's risk evaluation concluded that:
This rule supports both public health protection and product formulation flexibility, allowing manufacturers to use specific fragrances without violating residue thresholds.
This decision offers critical regulatory clarity for formulators of antimicrobial products used in food-related environments, enabling:
Stakeholders wishing to file objections or request a hearing must do so by January 24, 2025.
Announcement Date: November 25, 2024
Link to Regulation
Food & Ingredients Impacted: Fragrance components used in pesticide formulations
Deadline for Public Comments: January 24, 2025
Effective Date: November 25, 2024
On October 25, 2024, the U.S. Environmental Protection Agency (EPA) issued updated time-limited pesticide tolerances for certain crops under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The changes, published in the Federal Register, authorize continued emergency use of specific chemical treatments on rice and sugar beet crops through December 31, 2027.
The EPA has extended the following residue limits:
All extensions are compliant with residue safety limits under the Federal Food, Drug, and Cosmetic Act (FFDCA). The EPA’s risk assessments have confirmed that:
This update offers critical support for U.S. growers facing pest resistance and climate-driven pressures:
These tolerances are time-limited and will expire on December 31, 2027, unless further extended or revised by EPA action.
Announcement Date: October 25, 2024
Link to Regulation
Food & Ingredients Impacted: Sugar beet roots and leaves, rice grain and straw
Effective Date: October 25, 2024
Expiration Date: December 31, 2027
On October 7, 2024, the U.S. Environmental Protection Agency (EPA) finalized a new pesticide residue tolerance for Flazasulfuron on avocados, formalized under 40 CFR Part 180. This regulation introduces a defined limit for Flazasulfuron residues on imported or domestically produced avocados in the United States.
The EPA established this tolerance following a scientific risk assessment that concluded:
Notably, there are no established Maximum Residue Limits (MRLs) for Flazasulfuron on avocados by the Codex Alimentarius Commission or Canada. This makes the EPA's action non-disruptive to global trade and consistent with existing international residue standards.
Stakeholders wishing to file objections or request a public hearing must submit by December 6, 2024, per the procedures outlined in the Federal Register.
This new tolerance supports avocado producers and importers by:
Announcement Date: October 7, 2024
Link to Regulation
Food & Ingredients Impacted: Avocados
Deadline for Public Comments: December 6, 2024
Effective Date: October 7, 2024
On August 23, 2024, the U.S. Environmental Protection Agency (EPA) finalized a new pesticide residue tolerance for Ethaboxam under Section 408(b)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation, now codified under 40 CFR Part 180, updates U.S. standards for chemical residues on produce.
This action allows for lawful use of Ethaboxam on crops within this subgroup, aligning pesticide regulation with evolving agricultural practices and pest management needs.
EPA’s scientific review found that:
This new tolerance supports both crop protection and food safety, offering growers additional tools for disease management while ensuring that U.S. produce remains within safe residue thresholds. The rule enhances EPA’s broader strategy to update chemical use standards based on current scientific data.
Announcement Date: August 23, 2024
Link to Regulation
Food & Ingredients Impacted: Leaf petiole vegetable subgroup 22B
Effective Date: August 23, 2024
On August 7, 2024, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) proposed a landmark rule to reduce Salmonella-related foodborne illnesses linked to raw poultry. This proposed framework targets contaminated chicken and turkey products, introducing new criteria for classification, testing, and recall readiness.
The rule applies to the following raw poultry categories:
Under the proposed framework, any product testing positive for ≥10 colony-forming units (cfu) per gram or milliliter of Salmonella, or containing virulent serotypes such as S. Enteritidis or S. Typhimurium, would be considered adulterated and potentially subject to recall.
The proposed Salmonella rule introduces several significant updates:
The framework is a central component of the USDA’s broader Salmonella reduction strategy and aims to:
Stakeholders are invited to submit feedback on the proposed rule by October 7, 2024. FSIS will review all comments before finalizing the regulation.
Announcement Date: August 7, 2024
Link to Regulation
Food & Ingredients Impacted: Raw chicken and turkey (whole, parts, comminuted)
Deadline for Public Comments: October 7, 2024
On July 3, 2024, the U.S. Food and Drug Administration (FDA) issued a final rule banning brominated vegetable oil (BVO) as a food ingredient, marking a significant shift in food safety oversight. Long used in fruit-flavored beverages as an emulsifier to prevent separation, BVO will no longer be permitted in any food product marketed in the United States.
Following a comprehensive scientific review, the FDA concluded that BVO is no longer "Generally Recognized as Safe" (GRAS) due to:
The FDA’s final rule compels manufacturers to reformulate products that still use BVO, reinforcing a growing regulatory trend to phase out food additives associated with long-term health risks. Companies are expected to comply by the effective date of August 2, 2024.
The ruling aligns with actions already taken by major U.S. beverage makers and international regulators, many of whom have voluntarily removed BVO from their products in recent years.
Announcement Date: July 3, 2024
Link to Regulation
Food & Ingredients Impacted: Fruit-flavored beverages, emulsified drinks containing BVO
Effective Date: August 2, 2024
On June 20, 2024, the U.S. Environmental Protection Agency (EPA) issued a time-limited pesticide tolerance for Afidopyropen residues on strawberries, in response to an emergency exemption request from the California Department of Pesticide Regulation (CDPR). This rule, issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), aims to protect strawberry crops from rising pest threats while ensuring consumer safety.
This emergency exemption specifically addresses lygus bugs (Western Tarnished Plant Bugs), which have increasingly impacted California's high-value strawberry production. Afidopyropen is a targeted insecticide approved for use under controlled conditions to manage this pest.
EPA’s dietary risk assessment confirms that the specified use:
This rule applies across the strawberry supply chain, including:
This time-limited tolerance is effective immediately and will expire on December 31, 2027, unless extended or superseded by a permanent rule. It reflects EPA’s approach to pest crisis response while upholding stringent residue safety standards.
Announcement Date: June 20, 2024
Link to Regulation
Food & Ingredients Impacted: Strawberries
Effective Date: June 20, 2024
Expiration Date: December 31, 2027
On May 15, 2024, the U.S. Food and Drug Administration (FDA) released a post-market safety assessment declaring Tara flour an unapproved food additive not recognized as safe for human consumption. This regulatory update intensifies scrutiny on novel plant-based ingredients and reinforces FDA’s commitment to ingredient safety and compliance.
Food companies using or considering the use of Tara flour are strongly advised to:
Announcement Date: May 15, 2024
Link to Regulation
Food & Ingredients Impacted: Tara flour and products containing it
Effective Date: May 15, 2024
On March 11, 2024, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) reissued its label approval guidance, incorporating key updates tied to the final rule on voluntary U.S. origin claims. This revised document replaces the January 2023 version and provides critical compliance direction for meat and poultry establishments.
This reissued guidance clarifies and expands upon several essential areas:
This guidance is a cornerstone for navigating labeling changes tied to origin transparency and consumer trust. It helps:
Establishments should begin reviewing current product labels and prepare for necessary adjustments ahead of the 2026 compliance deadline.
Announcement Date: March 11, 2024
Link to Regulation
Food & Ingredients Impacted: Meat and poultry products with voluntary origin claims
Effective Date: January 1, 2026
On February 2, 2024, the U.S. Environmental Protection Agency (EPA) finalized new pesticide residue tolerances for Saflufenacil, marking a significant update under 40 CFR Part 180.649. This rule revision is part of EPA’s continued effort to align chemical use regulations with modern food safety standards and evolving agricultural practices.
The newly established maximum residue limits (MRLs) apply specifically to corn and associated by-products:
The regulation also makes a notable revision to crop group definitions:
EPA’s dietary risk assessment confirms:
This rule enables growers to continue using Saflufenacil-based herbicides while ensuring that food products meet updated residue safety thresholds. It also modernizes crop definitions and residue classifications in line with international standards and scientific data.
Announcement Date: February 2, 2024
Link to Regulation
Food & Ingredients Impacted: Corn forage, corn stover, corn milled by-products
Effective Date: February 2, 2024
On December 18, 2023, the U.S. Environmental Protection Agency (EPA) issued a final rule extending time-limited pesticide residue tolerances for Kasugamycin in almonds. This extension, granted under an emergency exemption, supports California almond growers in managing ongoing pest pressures while preserving compliance with federal food safety standards.
The updated rule sets the following tolerances:
These values reflect EPA's safety assessments and remain consistent with previous temporary tolerances issued to address agricultural emergencies.
EPA’s risk analysis confirms that:
This rule provides regulatory flexibility for almond production during a period of heightened pest vulnerability while safeguarding consumer health through clearly defined limits.
Announcement Date: December 18, 2023
Link to Regulation
Food & Ingredients Impacted: Almonds and almond hulls
Effective Date: December 18, 2023
Expiration Date: December 31, 2026
On October 4, 2023, the U.S. Environmental Protection Agency (EPA) finalized new maximum residue limits (MRLs) for Cypermethrin under 40 CFR 180.418, introducing updated pesticide tolerances for a range of agricultural commodities. This rule is part of EPA’s broader effort to harmonize chemical residue standards with current food safety data and risk assessment methodologies.
The final rule sets the following food-specific MRLs for Cypermethrin:
These tolerances are based on a comprehensive dietary exposure analysis, which evaluated both acute and chronic intake scenarios.
EPA’s assessment concluded that:
This update:
All producers, processors, and food handlers working with commodities treated with Cypermethrin must now comply with these new residue limits.
Announcement Date: October 4, 2023
Link to Regulation
Food & Ingredients Impacted: Spices, fruits, tea, root vegetables
Effective Date: October 4, 2023
On July 14, 2023, the U.S. Department of Agriculture’s Agriculture Marketing Service (AMS) issued a final rule updating soybean grading criteria under the United States Grain Standards Act (7 CFR Parts 800 and 810). The changes, effective September 1, 2023, aim to bring soybean quality assessments in line with current industry practices and global market expectations.
The revised rule includes the following critical updates:
These regulatory updates are designed to:
Soybean producers, handlers, and exporters are strongly encouraged to review the updated standards and ensure their operations are aligned with the new grading framework ahead of the compliance date.
Announcement Date: July 14, 2023
Link to Regulation
Food & Ingredients Impacted: Soybeans
Effective Date: September 1, 2023
The U.S. Environmental Protection Agency (EPA) has issued final rules establishing new maximum residue limits (MRLs) for two key agricultural pesticides, Cyflufenamid and Fomesafen. These updates reflect the agency’s ongoing review of pesticide tolerances to align with modern risk assessments and global food safety standards.
EPA’s dietary exposure assessments determined that:
These new residue tolerances are now enforceable across applicable food commodities and offer updated guidance for:
Announcement Date: May 10, 2023
Link to Regulation Cyflufenamid and Link to Regulation Fomesafen
Food & Ingredients Impacted: Sugar beet roots, vegetable bulb crop group
Effective Date: May 9, 2023 (Fomesafen), May 10, 2023 (Cyflufenamid)
On April 4, 2023, the U.S. Environmental Protection Agency (EPA) finalized a rule establishing new pesticide residue tolerances for Deltamethrin under 40 CFR 180.435. This action sets maximum allowable residue levels for Deltamethrin on legumes and pulse crops, including various types of beans, to ensure safe use while maintaining food safety standards.
The EPA’s toxicological review determined that:
This rule is part of the EPA’s ongoing commitment to modernize pesticide tolerances and ensure:
Producers, processors, and retailers handling legumes and beans treated with Deltamethrin must now ensure their products meet this new tolerance threshold.
Announcement Date: April 4, 2023
Link to Regulation
Food & Ingredients Impacted: Legumes and pulse crops (including beans)
Effective Date: April 4, 2023
On March 13, 2023, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a proposed rule to strengthen voluntary origin labeling standards for meat, poultry, and egg products. This initiative is part of the USDA’s broader push to enhance labeling transparency and ensure that U.S. origin claims accurately reflect the product’s journey from farm to label.
The proposal would revise labeling regulations under 9 CFR Part 412, outlining strict conditions under which voluntary origin claims like “Product of USA” and “Made in the USA” may be used. Specifically, such claims would only be allowed if:
This eliminates the possibility of imported meat being labeled “Product of USA” based solely on packaging or minor processing steps conducted domestically.
The rule is a response to consumer demand for greater clarity and accountability in food labeling and builds on long-standing FSIS efforts to ensure that regulated products are safe, wholesome, and accurately described.
The proposed rule is open for public comment until May 12, 2023. Stakeholders, including producers, retailers, and advocacy groups, are encouraged to submit feedback through the Federal Register.
Announcement Date: March 13, 2023
Link to Regulation
Food & Ingredients Impacted: Meat, poultry, and egg products regulated by FSIS
Deadline for Public Comments: May 12, 2023
On January 5, 2023, the U.S. Food and Drug Administration (FDA) issued a final rule authorizing the direct addition of Vitamin D3 to select food products under revised food additive regulations. This amendment enhances the scope of vitamin D fortification in response to widespread nutritional deficiencies in the American diet.
The rule allows Vitamin D3 (cholecalciferol) to be added to:
These newly approved limits reflect the FDA’s efforts to increase dietary vitamin D intake through commonly consumed foods.
The FDA based its decision on:
The rule supports public health objectives focused on preventing vitamin D deficiency, which has been linked to bone health issues and immune function concerns.
This update:
Manufacturers can begin incorporating Vitamin D3 under these specifications immediately, as the rule took effect on the day of publication.
Announcement Date: January 5, 2023
Link to Regulation
Food & Ingredients Impacted: Breakfast cereals, grain-based bars
Effective Date: January 5, 2023
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