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US FDA & USDA Food Regulation Updates

| Food News
Posted By: Sandhya Sashikumar

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. 

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In this post, we break down the most important regulatory developments reshaping food safety and labeling in the U.S.

 

 

US Updates General Food Labeling Compliance Program – June 24, 2025

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.

What’s Changed

  • Modernized Label Review Criteria: The revised program aligns with current FDA labeling regulations, including mandatory Nutrition Facts label updates finalized in 2016.
  • Sesame Now Scrutinized as a Major Allergen: As the ninth major allergen under the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, sesame must be clearly declared on packaging and is now a key focus in compliance reviews.
  • Gluten-Free Labeling Under Review: The program will verify if products bearing “gluten-free” claims comply with FDA's strict criteria.
  • Applies to Both Domestic and Imported Foods: The scope now explicitly covers foods produced in the U.S. and those entering from abroad, signaling intensified oversight across supply chains.

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

 

EPA Finalizes Sulfentrazone Tolerances for Popcorn – May 19, 2025

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.

Final Tolerances Set Under 40 CFR 180

Published in the Federal Register on May 19, 2025, the rule establishes the following maximum residue limits:

  • Corn, pop, grain: 0.15 parts per million (ppm)
  • Corn, pop, stover: 0.3 ppm

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).

Risk Assessment & International Standards

  • Toxicological Classification: Sulfentrazone is deemed “not likely to be carcinogenic to humans.”
  • Cancer Risk Assessment: Not required.
  • International Harmonization: No Codex MRLs exist for sulfentrazone on popcorn.

Comment Period Open

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

 

FDA Approves Three New Natural Color Additives - May 9, 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.

Key Approvals

  • Galdieria Extract Blue
    • Derived from Galdieria sulphuraria, a species of red algae, this blue colorant is now permitted for use in a wide range of foods, including:
      • Beverages
      • Yogurts
      • Candies
      • Frozen desserts
  • Butterfly Pea Flower Extract
    • Already used in some food categories, butterfly pea flower extract is now approved for use in additional products such as:
      • Chips
      • Breakfast cereals
      • Crackers
  • Calcium Phosphate
    • Traditionally used in supplements and fortification, calcium phosphate has been approved as a white coloring agent for:
      • Ready-to-eat chicken
      • Confectionery
      • Food coatings

Petition Origins and Legal Basis

These approvals follow color additive petitions submitted by:

  • Fermentalg (France)
  • Sensient Colors LLC (St. Louis, USA)
  • Innophos Inc. (USA)

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.

What This Means for Food Manufacturers

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

 

 

FDA Detects PFAS in Bottled Water Below EPA Limits - April 16, 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.

Key outcomes include:

  • 10 samples contained detectable PFAS, all below the EPA's new MCLs.
  • 18 PFAS compounds were tested in total.
  • Four compounds were detected at levels within the new limits.
  • Two PFAS compounds were detected that do not currently have MCLs established by the EPA.

A First in FDA Testing History

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.

Regulatory Background

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.

What This Means for Industry and Consumers

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

 

 

EPA Grants Tolerance Exemption for Biopesticide Strain SYM23945 - March 27, 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.

Safety Evaluation Findings

EPA’s scientific review determined that Pseudomonas oryzihabitans SYM23945:

  • Poses no significant health risk to the general population, including infants and children;
  • Meets the Federal Food, Drug, and Cosmetic Act (FFDCA) safety standard for pesticide residues in or on food;
  • Has no anticipated adverse environmental impacts, aligning with EPA’s biopesticide risk assessment framework.

Regulatory Significance

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.

Stakeholder Action Required

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

 

 

FDA Extends Compliance Deadline for Food Traceability Rule to July 2028 - March 20, 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.

Rule Requirements Stay the Same

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:

  • Leafy greens
  • Fresh-cut fruits and vegetables
  • Soft cheeses
  • Seafood
  • Nut butters

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.

Why the Extension Was Granted

The FDA cited multiple reasons for the extension:

  • Supply chain complexity: Time is needed for food businesses—especially small and mid-sized entities—to build or upgrade digital traceability systems.
  • Coordination across industry: Extra time will help align practices among growers, processors, distributors, and retailers.
  • Stakeholder support: Broad industry feedback emphasized the need for a longer timeline to ensure compliance without operational disruptions.

Continued Support from FDA

The agency emphasized its commitment to collaboration and education by pledging to:

  • Provide technical assistance and updated guidance documents
  • Facilitate engagement with stakeholders to promote understanding and adoption
  • Maintain enforcement consistency in line with public health priorities

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

 

 

FDA Bans Red No. 3 in Food Products - January 16, 2025

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. 

Why is Red No. 3 banned? 

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. 

Key compliance takeaways:

  •  Red No. 3 must no longer be used in food or drug formulations after January 15, 2027. 
  • Food manufacturers using this additive must reformulate their products to comply with the updated regulation. 
  • Continued use of FD&C Red No. 3 beyond its certificate expiration will render products adulterated under federal law. 
  • A specific amendatory instruction will take effect slightly later, on January 18, 2028.

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

 

 

FDA Updates Definition of “Healthy” Nutrient Claim Under 2025 Dietary Guidelines - December 27, 2024

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.

Key elements of the FDA Healthy claim update:

  • Establishes food group equivalents (FGEs) to determine qualifying levels of vegetables, fruits, grains, seafood, nuts, and other whole foods based on nutritional content.
  • Products must meet new limits for added sugars, saturated fat, and sodium, tied to their Daily Value (DV) thresholds.
  • Whole foods such as fruits, vegetables, whole grains, seafood, and unsalted nuts or seeds automatically qualify when presented without added ingredients (excluding water).
  • Water, tea, and coffee with fewer than 5 calories per serving are also eligible for the “healthy” label.
  • Emphasizes manufacturer recordkeeping to verify compliance with the updated criteria.

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

 

 

EPA Grants Tolerance Exemption for Fragrance Components in Pesticide Formulations - November 25, 2024

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.

Scope of the Tolerance Exemption

Under the new regulation, specific fragrance substances may be included in antimicrobial pesticide formulations applied to:

  • Food-processing equipment
  • Dairy-processing equipment
  • Utensils and public eating area surfaces

The exemption permits usage up to 33 parts per million (ppm), a level determined to be safe under EPA’s food contact surface guidelines.

Risk Assessment and Safety Review

EPA's risk evaluation concluded that:

  • These fragrance components do not pose health risks to consumers, including infants and children.
  • Exposure via food-contact surfaces remains within acceptable limits under standard use conditions.

This rule supports both public health protection and product formulation flexibility, allowing manufacturers to use specific fragrances without violating residue thresholds.

Industry Implications

This decision offers critical regulatory clarity for formulators of antimicrobial products used in food-related environments, enabling:

  • Improved product appeal via added fragrance
  • Compliance assurance with federal food safety regulations
  • Streamlined approvals for food-contact pesticide ingredients

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

 

 

EPA Extends Temporary Pesticide Residue Limits on Key Crops - October 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.

Key Tolerance Updates

The EPA has extended the following residue limits:

  • Sodium salt of Acifluorfen
    • Crop: Sugar beet roots and leaves
    • Tolerance: 0.1 parts per million (ppm)
    • Purpose: Control of glyphosate-resistant pigweed
  • Thiamethoxam
    • Crop: Rice grain – 6 ppm; Rice straw – 2 ppm
    • Metabolite (Clothianidin): Rice – 5 ppm
    • Use Context: Emergency exemption uses

Safety and Legal Context

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:

  • These temporary tolerances pose no unreasonable risks to public health or the environment.
  • They address urgent agricultural needs while ensuring consumer safety remains protected.

Industry Implications

This update offers critical support for U.S. growers facing pest resistance and climate-driven pressures:

  • Sugar beet producers benefit from an effective herbicide tool against aggressive pigweed strains.
  • Rice growers are supported by extended access to neonicotinoid-based insecticides during pest outbreaks.

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

 

 

EPA Establishes Flazasulfuron Residue Limit for Avocados - October 7, 2024

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.

New Flazasulfuron Tolerance:

  • Crop: Avocados
  • Residue Limit: 0.01 parts per million (ppm)

The EPA established this tolerance following a scientific risk assessment that concluded:

  • Aggregate exposure to Flazasulfuron is safe for the general population, including infants and children.
  • The compound is classified as “not likely to be carcinogenic to humans.”

International Alignment

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.

Objection Window and Industry Considerations

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:

  • Providing a regulatory framework for lawful Flazasulfuron use
  • Supporting the management of weed pressures in avocado cultivation
  • Ensuring compliance with U.S. food safety regulations

Announcement Date: October 7, 2024
Link to Regulation
Food & Ingredients Impacted: Avocados
Deadline for Public Comments: December 6, 2024
Effective Date: October 7, 2024

 

 

EPA Sets New Residue Limit for Ethaboxam - August 23, 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.

New Ethaboxam Tolerance Limit

  • Commodity Group: Leaf petiole vegetable subgroup 22B (e.g., celery, rhubarb, cardoon)
  • Tolerance Level: 0.15 parts per million (ppm)

This action allows for lawful use of Ethaboxam on crops within this subgroup, aligning pesticide regulation with evolving agricultural practices and pest management needs.

Safety and Risk Evaluation

EPA’s scientific review found that:

  • Ethaboxam and its metabolites and degradates do not pose a health risk at or below the new limit.
  • Long-term dietary exposure is considered safe, including for sensitive populations such as infants and children.
  • No significant cumulative or residential risks were identified.

Regulatory Impact

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

 

 

USDA Proposes New Salmonella Safety Standards for Raw Poultry Products - August 7, 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.

Scope of the Proposed Rule

The rule applies to the following raw poultry categories:

  • Whole chicken carcasses
  • Chicken parts
  • Comminuted chicken and turkey

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.

Key Regulatory Provisions

The proposed Salmonella rule introduces several significant updates:

  • Microbial Testing & Sampling: Mandates enhanced sampling at both rehang and post-chill stages in poultry processing.
  • Statistical Process Control (SPC): Requires implementation of validated SPC methods to monitor process performance.
  • Digital Recordkeeping: Establishes requirements for electronic documentation to support traceability and compliance.
  • Food Safety Readiness: All products must meet microbial limits prior to market distribution.

Public Health and Industry Impact

The framework is a central component of the USDA’s broader Salmonella reduction strategy and aims to:

  • Lower the burden of foodborne illness from poultry consumption;
  • Hold producers accountable for contaminated products at the point of production;
  • Modernize oversight by aligning microbiological standards with public health outcomes.

Public Comment Period

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

 

 

FDA Bans Brominated Vegetable Oil (BVO) in Food Products - July 3, 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.

Why is BVO prohibited?

Following a comprehensive scientific review, the FDA concluded that BVO is no longer "Generally Recognized as Safe" (GRAS) due to:

  • Potential adverse health effects, including concerns about its impact on the thyroid and other organs from long-term exposure.
  • New toxicological data indicating insufficient safety margins at previously accepted use levels.

Key Regulatory Details

  • Revoked Use: BVO used as an emulsifier in beverages at levels up to 15 parts per million (ppm).
  • Scope: Applies to all food and beverage categories—no remaining approved uses for BVO.
  • Common Sources: BVO is typically derived from soybean, corn, cottonseed, or olive oil, and often labeled as brominated soybean oil.

Industry Implications

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

 

 

EPA Grants Emergency Tolerance for Afidopyropen Use on Strawberries - June 20, 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.

Target Pest and Use Context

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.

Approved Residue Level

  • Crop: Strawberries
  • Afidopyropen Tolerance: 0.3 parts per million (ppm)

EPA’s dietary risk assessment confirms that the specified use:

  • Does not pose a risk to the general population
  • Is safe for infants, children, and other sensitive subgroups

Stakeholder Impact

This rule applies across the strawberry supply chain, including:

  • Growers utilizing Afidopyropen under the exemption
  • Processors handling treated berries
  • Food handlers and retailers ensuring compliance with tolerance levels

Timeline and Compliance

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

 

 

FDA Issues Post-Market Assessment Update on Tara Flour Safety - May 15, 2024

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.

Key findings from the FDA Tara Flour update:

  • Tara flour is not GRAS: The ingredient lacks Generally Recognized as Safe (GRAS) status, and no food additive regulation has been issued to permit its legal use.
  • No confirmed outbreaks but concerns remain: Although no foodborne illness outbreaks have been directly linked to Tara flour, its regulatory status remains under review due to insufficient safety data.
  • Increased import oversight: The FDA has initiated screening at U.S. ports of entry to prevent unauthorized imports of Tara flour-containing products.

Manufacturer Guidance

Food companies using or considering the use of Tara flour are strongly advised to:

  • Verify safety and regulatory status through internal review or direct FDA consultation.
  • Avoid including Tara flour in consumer products unless supported by an approved food additive petition or GRAS determination.
  • Monitor supply chains to prevent noncompliant materials from entering production.

Announcement Date: May 15, 2024
Link to Regulation
Food & Ingredients Impacted: Tara flour and products containing it
Effective Date: May 15, 2024

 

 

USDA Releases Updated Guidelines on Label Approval for FSIS-Regulated Products - March 11, 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.

What’s New in the 2024 FSIS Label Approval Guidelines

This reissued guidance clarifies and expands upon several essential areas:

  • Label Submission Requirements: Outlines which labels must be submitted to the FSIS Labeling and Program Delivery Staff (LPDS) for approval and which are eligible for generic approval.
  • Uniform Compliance Date: Establishes January 1, 2026 as the next uniform compliance date for all new labeling regulations, giving industry time to adjust practices accordingly.
  • Voluntary U.S. Origin Claims: Provides detailed standards for “Product of USA” and “Made in the USA” claims, ensuring they reflect accurate sourcing and processing disclosures in line with the final rule.
  • Updated Appendices: Incorporates revised appendices to help establishments understand both new labeling obligations and existing regulatory frameworks.

Compliance Impact

This guidance is a cornerstone for navigating labeling changes tied to origin transparency and consumer trust. It helps:

  • Prevent misleading or unsupported origin statements
  • Standardize label review practices
  • Support compliance in the transition to updated labeling protocols

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

 

 

US Establishes Maximum Residue Limits for Saflufenacil in Corn Products - February 2, 2024

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.

Updated Saflufenacil Tolerances

The newly established maximum residue limits (MRLs) apply specifically to corn and associated by-products:

  • Corn field forage: 0.4 parts per million (ppm)
  • Corn milled by-products: 0.2 ppm

The regulation also makes a notable revision to crop group definitions:

  • Crop Group 16 is updated to Crop Group 16–22.
  • The existing 0.1 ppm tolerance for cereal grain group (excluding barley and wheat straw) has been removed.

Health and Safety Assessment

EPA’s dietary risk assessment confirms:

  • No adverse health effects from consuming crops treated with Saflufenacil at or below the new limits.
  • Safety is assured for vulnerable populations, including infants and children.

Regulatory Implications

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

 

 

EPA Extends Emergency Pesticide Tolerance for Kasugamycin on Almonds - December 18, 2023

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.

Key updates under the EPA Kasugamycin extension:

The updated rule sets the following tolerances:

  • Almonds: 0.04 parts per million (ppm)
  • Almond hulls: 0.4 ppm

These values reflect EPA's safety assessments and remain consistent with previous temporary tolerances issued to address agricultural emergencies.

Timeline and Scope

  • The emergency exemption is extended for three years and will now expire on December 31, 2026.
  • This update applies to all stakeholders across the almond supply chain, including growers, handlers, processors, and distributors working with Kasugamycin-treated crops.

Compliance and Safety Considerations

EPA’s risk analysis confirms that:

  • Short-term dietary exposure to Kasugamycin residues at these levels poses no health risks, including for infants and children.
  • The exemption maintains alignment with Federal Food, Drug, and Cosmetic Act (FFDCA) requirements for food pesticide residues.

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

 

 

EPA Establishes Maximum Residue Limits for Cypermethrin in Food Commodities - October 4, 2023

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.

Newly Established Cypermethrin Tolerances

The final rule sets the following food-specific MRLs for Cypermethrin:

  • All spices and fruits: 0.5 parts per million (ppm)
  • Tea: 15 ppm
  • Select root vegetables: 0.2 ppm

These tolerances are based on a comprehensive dietary exposure analysis, which evaluated both acute and chronic intake scenarios.

Safety and Risk Findings

EPA’s assessment concluded that:

  • Cypermethrin residues at the specified levels do not present a health risk to the general population.
  • Vulnerable groups, including infants and children, are adequately protected under the established limits.
  • The tolerances are supported by current data on toxicological thresholds and residue behavior in treated crops.

Regulatory and Industry Impact

This update:

  • Enables regulated use of Cypermethrin across expanded food categories;
  • Supports domestic and international trade by providing clear regulatory thresholds;
  • Reinforces EPA’s commitment to science-driven pesticide approvals under the Federal Food, Drug, and Cosmetic Act (FFDCA).

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

 

 

USDA Updates Official Standards for Soybeans - July 14, 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.

Key Revisions to Soybean Grading

The revised rule includes the following critical updates:

  • Removal of Soybeans of Other Colors (SBOC) as a grading factor
    • Based on scientific studies showing no significant impact on quality, SBOC is no longer considered when determining soybean grade classifications.
  • Revised Grades and Requirements
    • AMS has updated grade definitions and tolerances to reflect the realities of modern production, processing, and export demands, ensuring greater consistency and clarity across the supply chain.

Industry Impact

These regulatory updates are designed to:

  • Enhance transparency in how soybeans are evaluated for trade and inspection purposes
  • Promote efficiency and consistency across domestic and international grain markets
  • Support enforceable safety and quality guidelines aligned with evolving scientific understanding

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

 

 

EPA Sets Pesticide Residue Limits for Cyflufenamid and Fomesafen - May 10, 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.

Cyflufenamid Residue Limits

  • Crop: Sugar beet roots
  • New MRL: 0.15 parts per million (ppm)
  • Effective Date: May 10, 2023

Fomesafen Residue Limits

  • Crop Group: Vegetable bulb crops (e.g., onions, garlic)
  • New MRL: 0.02 ppm
  • Effective Date: May 9, 2023

Health and Safety Findings

EPA’s dietary exposure assessments determined that:

  • Both pesticides meet the Federal Food, Drug, and Cosmetic Act (FFDCA) safety standards
  • Short- and long-term exposures at or below the specified limits are not expected to cause health risks, including for infants, children, and other sensitive populations

Regulatory and Industry Implications

These new residue tolerances are now enforceable across applicable food commodities and offer updated guidance for:

  • Growers and pesticide applicators using Cyflufenamid and Fomesafen
  • Food processors and distributors managing treated crops
  • Compliance teams monitoring product safety and import/export adherence

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)

 

 

EPA Sets Deltamethrin Tolerances for Agricultural Commodities - April 4, 2023

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.

Deltamethrin Residue Limits

  • Covered Crops: Legume and pulse crops, including beans
  • Maximum Residue Limit (MRL): 0.07 parts per million (ppm)

Safety and Risk Assessments

The EPA’s toxicological review determined that:

  • Short- and intermediate-term dietary exposure to Deltamethrin residues at the 0.07 ppm level is unlikely to pose any health risk.
  • The regulation complies with the Federal Food, Drug, and Cosmetic Act (FFDCA) requirements.
  • Safety standards are adequate for all population groups, including infants and children.

Regulatory and Industry Impact

This rule is part of the EPA’s ongoing commitment to modernize pesticide tolerances and ensure:

  • Effective pest control options remain available to farmers;
  • Consumers are protected through data-driven residue limits;
  • Compliance clarity for domestic producers and international importers.

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

 

 

USDA Proposes Voluntary U.S. Origin Labeling for Meat, Poultry & Egg Products - March 13, 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.

Key elements of the USDA origin labeling proposal:

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:

  • The product is derived from animals born, raised, slaughtered, and processed in the United States
  • All major processing steps occur within the U.S.

This eliminates the possibility of imported meat being labeled “Product of USA” based solely on packaging or minor processing steps conducted domestically.

Regulatory Objectives

  • Prevent misleading origin claims in the marketplace
  • Support consumer trust with more truthful labeling practices
  • Modernize the FSIS labeling approval process for origin-based claims

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

 

 

FDA Expands Use of Vitamin D3 in Food Products for Nutritional Fortification - January 5, 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.

Updated Vitamin D3 Fortification Guidelines

The rule allows Vitamin D3 (cholecalciferol) to be added to:

  • Breakfast cereals at levels up to 560 International Units (IU) per 100 grams
  • Grain-based bars at levels up to 400 IU per 100 grams

These newly approved limits reflect the FDA’s efforts to increase dietary vitamin D intake through commonly consumed foods.

Scientific Basis and Safety Review

The FDA based its decision on:

  • Toxicological evaluations
  • Dietary exposure analyses confirming that vitamin D3 use at these levels is safe for all age groups, including children and pregnant individuals

The rule supports public health objectives focused on preventing vitamin D deficiency, which has been linked to bone health issues and immune function concerns.

Regulatory and Industry Implications

This update:

  • Expands food fortification options for manufacturers
  • Aligns with national nutrition strategies promoting functional foods
  • Reinforces the importance of science-based additive regulation

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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