Regulatory Update: July 1 – July 31, 2026

This update includes FDA and USDA updates, warning letters, lawsuits, and other articles of interest, including FDA’s planned 2026 guidance agenda, proposed changes to bioengineered food disclosure and GRAS notifications, and ongoing Cyclospora outbreak investigations.

FDA Updates

FDA Lists Food Program Guidance Planned for 2026
July 1: The U.S. Food and Drug Administration (FDA) updated its list of Foods Program guidance documents under development, which it expects to publish by the end of 2026. Key topics include action levels for contaminants in foods for babies and young children, new dietary ingredient notifications, preventive controls for chemical hazards, pathogen prevention in ready-to-eat foods, food facility registration requirements, online grocery labeling, caffeine content labeling, olive oil standards, and implementation of the updated “healthy” claim. FDA noted that priorities may change based on emerging public health issues and agency needs. More information can be found here.

FDA to Host Public Meetings on Listeria Prevention
July 8: The FDA will hold a public meeting on August 18-19, 2026, to discuss new approaches for preventing Listeria monocytogenes contamination and reducing listeriosis cases. The meeting is the first in a series of planned stakeholder engagements and will explore current science, best practices, food safety management strategies, and consumer outreach efforts, with participation from industry, academia, consumer groups, and public health professionals. More information can be found here.

FDA Signals Broader Push on Food Safety and Chronic Disease Prevention
July 15: FDA Commissioner Kyle Diamantas said the FDA is renewing its focus on food safety, nutrition, product oversight, and consumer transparency. The agency is strengthening its food safety and post-market oversight programs while advancing science-based policies designed to reduce health risks and support long-term public health. More information can be found here.

FDA Modernizes Pasteurized Orange Juice Standard
July 20: The FDA issued a final rule modernizing the standard of identity for pasteurized orange juice by lowering the minimum soluble solids requirement from 10.5° to 10° Brix and allowing up to 15% Citrus reticulata juice or Citrus reticulata hybrid juice by volume, up from the previous limit. The agency said the changes respond to industry petitions and are intended to provide manufacturers with greater flexibility while maintaining product quality and consumer expectations. The rule takes effect August 19, 2026. More information can be found here.

FDA Revokes Orange B Approval for Frankfurter and Sausage Casings
July 23: The FDA issued an order to repeal the color additive regulation that permitted the use of Orange B for coloring on the casings or surfaces of frankfurters and sausages.  The agency determined that the additive’s authorized use has been abandoned and the regulation is no longer necessary. The order takes effect September 8, 2026. Objections and requests for a hearing are due by August 24, 2026.  More information can be found here.

FDA Proposes Ending Approval for Citrus Red No. 2 on Oranges
July 23: The FDA is proposing to issue an order repealing the color additive regulation that allows for the use of Citrus Red No. 2 for coloring the skins of mature oranges. Based on certification data, it appears that Citrus Red No. 2 is no longer used for coloring the skins of oranges and has not been certified for use as a color additive in food marketed in the U.S. since 2020. Because the authorized use of Citrus Red No. 2 appears to have been abandoned, FDA has tentatively concluded that this color additive regulation is outdated and unnecessary. FDA is accepting public comments on the proposed order through August 24, 2026. More information can be found here.

FDA Extends Comment Period for BHT Request for Information
July 30: The FDA reopened the public comment period for its request for information on butylated hydroxytoluene (BHT), a food additive and antioxidant used in foods and food-contact materials, in response to stakeholder requests for additional time to prepare submissions. The agency is seeking data on BHT’s uses, exposure, and safety as part of its broader post-market review of food chemicals. Comments, originally due in July, will now be accepted through August 31, 2026.  More information can be found here.

FDA Announces FY 2027 FSMA User Fees
July 30: The FDA released several Fiscal Year (FY) 2027 user fee updates under the Food Safety Modernization Act (FSMA), affecting food importers, accredited third-party certification participants, and facilities subject to reinspection and recall-related enforcement activities. The FY 2027 user fee for the Voluntary Qualified Importer Program (VQIP) is $9,994 per importer and is effective August 1, 2026, through September 30, 2027. Effective October 1, 2026, through September 30, 2027, hourly rates for domestic and foreign reinspection and recall activities are $354 per hour for activities requiring domestic travel and $414 per hour for activities requiring foreign travel.  FY 2027 fees for the Third-Party Certification Program, include a $56,272 initial application fee for accreditation bodies seeking recognition, annual fees of $2,612 for recognized accreditation bodies and $3,266 for accredited certification bodies, and a $34,311 renewal application fee for recognized accreditation bodies.

FDA Warning Letters

Unapproved New Drug: FDA issued a warning letter to Mineral BioSciences, LLC after inspecting its Arizona facility and reviewing the company’s websites and social media content. The agency alleged that claims for the company’s Totala Fulvic Ionic Mineral Complex and Ionicell products promoted them for treating disease, making them unapproved new drugs. FDA also cited dietary supplement current good manufacturing practice violations, including poor sanitation and facility maintenance, inadequate pest control, incomplete batch records, and weak quality control oversight, which caused the products to be considered adulterated.

A database of warning letters can be found here.

Ten More Companies Adopt USDA’s Product of USA Label
July 10: The U.S. Department of Agriculture (USDA) announced that 10 additional meat and poultry companies have adopted its voluntary “Product of USA” label, which is intended to help consumers identify products from animals born, raised, harvested, and processed in the U.S., while supporting U.S. farmers, ranchers, processors, and rural communities. USDA also highlighted efforts to strengthen the U.S. meat supply chain, including its new Strengthening Processing for U.S. Ranchers (SPUR) program, for small and mid-sized beef processors. More information can be found here.

FSIS Launches New Online Appeal Process for Small Processors
July 24: The USDA Food Safety and Inspection Service (FSIS) created a new web form to make it easier for small and very small processors to appeal FSIS noncompliance decisions outside of the Public Health Information System, as part of the USDA’s Small Processors Action Plan. Processors can submit appeals through an appeal web form and FSIS will direct the appeals to the appropriate officials for response. Submitters must log in to the appeal web form through USDA eAuthentication and provide details such as the establishment involved, the noncompliance number, the reason for the appeal, and contact information. More information can be found here.

USDA Bioengineered Food Disclosure Rules to be Revised
July 28: According to the USDA 2026 Unified Agenda, the USDA plans to publish a Notice of Proposed Rulemaking in August 2026 to revise its bioengineered food disclosure regulations under the 2018 Bioengineered Food Disclosure Standard (2018 Rule). This action follows a Ninth Circuit Court of Appeals decision in Natural Grocers et al. v. Rollins, which directed USDA to issue a new final rule by January 1, 2028. The court rejected parts of the 2018 rule, including the detectability exemption for refined foods with no detectable genetic material and provisions allowing disclosure through QR codes and text messages that may not be easily accessible to consumers. USDA is expected to address those issues in the proposed rule. Until a new rule is finalized, the current 2018 rule remains in effect.

FDA Food Labeling and Ingredient Oversight Rules Face Delays Under White House Agenda
July 3: The Trump administration is now targeting December 2026 for a final front-of-package nutrition labeling rule that would require packaged foods to disclose sodium, saturated fat, and added sugars on the front of the package. However, discussion of a possible traffic-light-style approach could further delay the effort.

California Sets First Statewide Standard for Food Date Labels
July 8: California became the first state to standardize date labels on food packaging, a move intended to reduce consumer confusion and food waste and potentially shape labeling practices nationwide. Similar bills have been proposed in Illinois, Maryland, Massachusetts, New Jersey, South Carolina, and New York. The law comes as state and federal lawmakers seek consistent labeling standards, with more than 50 different date-label terms currently used on packaged foods. Grocers generally support the change. More information can be found here. (Subscription required.)

GLP-1 Claims Surge Across Food and Supplement Markets
July 13: Products marketed with GLP-1-related claims are rapidly expanding across the food and dietary supplement sectors, fueled by growing consumer interest in weight-loss medications and changing eating habits. However, federal regulators have not established a standard definition for terms such as “GLP-1 Friendly,” and oversight of many related claims remains limited. The trend has prompted consumer lawsuits alleging deceptive marketing of supplements and foods that claim to support GLP-1 activity. Industry groups, health experts, and consumer advocates are calling for clearer standards and stronger regulatory guidance. More information can be found here. (Subscription required.)

Codex Updates Chicken Meat and Allergen Labeling Guidance
July 14: The Codex Alimentarius Commission (Codex) adopted several new and revised international food safety and labeling standards, including updated guidelines for controlling Campylobacter and Salmonella in chicken, Listeria monocytogenes in certain ready-to-eat foods, and foodborne parasites. The commission also approved new guidance on precautionary allergen labeling (PAL) to provide consumers with access to accurate information on allergens in food. The guidance states that the decision to use PAL should be based on findings from a risk assessment. Additional actions addressed food labeling during emergencies and emerging food safety issues. More information can be found here. (Subscription required.)

FDA Outlines Food Safety Priorities
July 14: Donald Prater, the FDA’s acting deputy commissioner for food, outlined the agency’s key food safety priorities, including modernization of the Human Foods Program, stronger oversight of food ingredients and additives, expanded use of artificial intelligence and data analytics, and efforts to reduce diet-related disease. He also highlighted the FDA’s new BRIDGE initiative, which would shift routine food inspections to state partners while allowing the agency to focus resources on higher-risk activities. The agency’s broader strategy is intended to improve efficiency, strengthen food safety oversight, and support science-based regulatory decisions. More information can be found here.

FDA Grapples with Defining Ultra-Processed Foods
July 15: As the FDA continues to work on a formal definition of ultra-processed foods, agency officials acknowledged the effort is challenging due to evolving science and the lack of a widely accepted standard. FDA Acting Deputy Commissioner for Food, Donald Prater, said a definition could support future policy decisions and help consumers make healthier choices. The agency is also moving forward with related nutrition efforts, including front-of-package labeling, as part of its broader work to address diet-related chronic disease. More information can be found here.

FDA Considers Clearer Caffeine Labeling for Foods and Beverages
July 15: The FDA has identified caffeine-content labeling as a 2026 priority as sales of energy drink and other caffeinated products continue to grow. The agency is considering new guidance that would encourage food and beverage companies to provide clearer caffeine disclosures on food and beverage labels. The move follows increased scrutiny of highly caffeinated beverages and growing concerns about health risks, particularly for younger consumers.  Current rules generally do not require companies to disclose the amount of caffeine in products, making comparisons difficult for consumers. The potential guidance, which would be nonbinding, comes amid lawsuits and investigations, and reflects a broader push for greater transparency in food labeling. More information can be found here and here.

Michigan Reports Sharp Rise in Cyclospora Infections
July 15: Michigan reported 3,762 confirmed cases of Cyclospora infections as of July 15, up more than 400 cases from the previous day. Investigators believe lettuce and salad mixes may be linked to the outbreak, although no specific grower, supplier, or brand has been identified. Federal and state agencies are investigating multiple outbreak clusters across several states and conducting traceback efforts on various produce items. The rise in cases, which far exceeds reported levels from the same period in 2025, has renewed attention on produce safety and outbreak response efforts. More information can be found here. (Subscription required.)

FDA Plans December Rulemaking on GRAS Notifications
July 30: The FDA is expected to propose a rule in December 2026 that would require companies to notify the agency before marketing ingredients as Generally Recognized as Safe (GRAS), potentially ending the practice of self-affirmed GRAS determinations. Currently, that notification is voluntary. The proposal would still need to move through the rulemaking process and would not take effect right away, but food manufacturers should start reviewing their ingredients and safety records now. Companies that rely on self-affirmed GRAS conclusions may need to inventory affected ingredients, update safety data, and assess whether voluntary FDA notification is warranted ahead of a future mandate. More information can be found here.

Cyclospora Infections Continue to Rise in the U.S.
July 31: The FDA and Centers for Disease Control and Prevention continue to investigate three Cyclospora outbreaks nationwide, including a 15-state outbreak linked to iceberg lettuce from Taylor Farms de Mexico. As of July 24, 2026, investigators had traced the outbreak to the recalled lettuce, prompting a July 17 recall of products sent to foodservice customers, Taco Bell restaurants, and select Walmart stores. The outbreak has grown to 1,947 confirmed illnesses across 9 states, with 98 hospitalizations, and continues to climb.  Two additional Cyclospora outbreaks remain under investigation and have not yet been linked to specific products. More information about the Cyclospora outbreak can be found here.

FDA Announces Agency-Wide Reorganization Effective October 1
July 31: The FDA is set to implement its “Simple Reform” reorganization on October 1, 2026, which shifts field inspectors from specialized product areas back to generalist investigators and centralizes administrative functions. The Human Foods Program is not affected by the changes. While the reorganization does not change existing food safety or compliance requirements, it may alter how inspections are conducted, with greater emphasis on broad quality systems rather than highly specialized technical issues. More information can be found here.

Court Blocks California’s Truth-in-Recycling Law
July 15: A judge for the US District Court for the Southern District of California preliminarily blocked enforcement of California’s Senate Bill 343, the state’s “Truth in Recycling” labeling law, which was scheduled to take effect in October 2026. The law would restrict the use of recycling-related symbols on packaging unless specified recyclability criteria are met. The court found that industry trade associations are likely to succeed in their challenge that the law unlawfully restricts commercial speech and imposes significant compliance burdens on manufacturers. The ruling temporarily prevents enforcement while litigation continues.

Despite Early Setbacks, Ultra-Processed Foods Lawsuits Continue to Expand
July 15: Litigation targeting ultra-processed foods (UPFs) continues to expand, with more than 10 consumer lawsuits filed against major food and beverage companies alleging they failed to warn consumers about potential health risks associated with highly processed products. While a federal court recently dismissed a leading case, citing a lack of proof that the products caused the plaintiff’s injuries, additional lawsuits and a public enforcement action remain active. The litigation surge comes as federal officials work toward a standardized definition of UPFs and states pursue their own regulatory approaches. Uncertainty over how to define UPFs and assess related health risks further complicates the litigation.

Seventh Circuit Revives Chobani “Sugar Free” Labeling Lawsuit
July 27: The U.S. Court of Appeals for the Seventh Circuit revived a proposed class action alleging that Chobani misled consumers by labeling certain yogurt products as “sugar free” despite containing allulose, a naturally occurring sweetener. The court reversed a lower court’s dismissal and held that allulose falls within the federal regulatory definition of sugar and found that the plaintiffs plausibly alleged consumer deception. A copy of the decision can be found here.

This Regulatory Update covers information from July 2026. Please contact Paul Benson, Taylor Fritsch, or Leah Ziemba 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 & Friedrich, visit michaelbest.com.

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