This update includes FDA and USDA updates, warning letters, lawsuits, and other articles of interest, including adulteration in honey, concerns regarding the FDA’s “no artificial colors” redefinition, the FY 2025 Summary of Consumer Complaints, and more.
FDA Updates
FDA Reviews Petition to Remove Obsolete Solvents From Color Additive Rules
April 1: The U.S. Food and Drug Administration (FDA) announced the filing of a color additive petition from the International Association of Color Manufacturers requesting amendments to color additive regulations to remove methylene chloride, trichloroethylene, and ethylene dichloride used in preparing certain color additives. The petition states these uses have been permanently abandoned by industry. The proposed changes would affect certain exempt color additives used in foods, as well as related uses in drugs, cosmetics, and inks for marking fruits and vegetables. The petition is open for public comments through June 1, 2026. More information can be found here.
FDA Finds Adulteration in 4% of Honey Samples in FY25 Testing
April 13: The FDA released its fiscal year 2025 sampling results for economically motivated adulteration in honey, showing that 4 percent of the 102 domestic and imported samples tested contained undeclared added sweeteners. The sampling focused on detecting food fraud, where lower-cost sweeteners such as sugarcane and corn syrups are added to honey for economic gain without proper labeling. While the violation rate declined from prior years, the agency noted that honey remains vulnerable to economically motivated adulteration and reaffirmed the need for accurate labeling and continued monitoring to protect market integrity and consumer trust. More information can be found here.
FDA To Hold Public Meeting on Lot-Level Traceability Challenges
April 22: The FDA announced it will hold a public meeting on June 15, 2026, to gather stakeholder input on challenges and potential solutions related to implementing the Food Traceability Rule, with a focus on lot-level tracking and compliance flexibilities. The meeting, which is free and open to the public with advance registration, is part of a series of engagements directed by Congress and is intended to inform FDA’s ongoing work under the Food Safety Modernization Act. More information, including registration, can be found here.
FDA Submits Juice HACCP Information Collection for OMB Review
April 30: The FDA has submitted to the Office of Management and Budget (OMB) for review an information collection request related to Hazard Analysis and Critical Control Point (HACCP) requirements for juice processors and importers. The notice covers recordkeeping and reporting obligations used to verify compliance with food safety standards, including hazard analyses, monitoring, corrective actions, and validation activities. Written comments on the collection of information are due by June 1, 2026. More information can be found here.
FDA Warning Letters
Mushroom Extract Products: The FDA issued a warning letter to Half Hill Farm Inc. following an inspection and review of the company’s website. The agency concluded that several mushroom extract products were marketed with disease-related claims, including references to cancer and other serious conditions, causing the products to be regulated as unapproved new drugs. The FDA also found the products to be misbranded because they lacked adequate directions for safe use.
Dietary Supplements: The FDA sent a warning letter to Nupack Inc. citing violations of current good manufacturing practices for dietary supplements, rendering the products adulterated. The FDA alleges the company failed to set product specifications, keep master manufacturing and batch records, and implement procedures for returned items. Additionally, the FDA determined that some products were misbranded because their labels and website claimed they could treat diseases, categorizing them as unapproved drugs.
A database of warning letters can be found here.
USDA Updates
FSIS Launches New One‑Stop Online Hub for Public Q&A Resources
April 3: The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is rolling out new public Q&A resources through a redesigned website, ask.fsis.usda.gov. As previously announced, public Q&As for askFSIS, the Small Plant Help Desk, and the Meat & Poultry Hotline moved to the new site beginning March 23, 2026. On April 6, FSIS launched a new landing page that serves as a one-stop location for more than 1,200 consumer Q&As and over 800 inspection policy Q&As, as well as direct contact options for FSIS assistance services. Enhanced search and browsing features will be added over time to improve access to inspection, food safety, and regulatory information.
New USDA Portal Centralizes Agency Guidance Documents
April 7: The U.S. Department of Agriculture (USDA) launched a new USDA Guidance Portal, a searchable database that consolidates current guidance issued across the Department and its agencies. According to USDA, the portal improves transparency and access by removing outdated documents and providing a single resource that will be continuously maintained across its agencies. More information can be found here.
USDA Launches New Office to Support U.S. Seafood Industry
April 15: The USDA announced the creation of a new Office of Seafood to improve coordination and access to USDA programs for seafood cultivators, processors, and producers. The office will serve as a central hub within USDA, working with the Department of Commerce and other federal partners to strengthen domestic seafood production, processing, and competitiveness. The initiative supports a broader federal effort to boost the U.S. seafood industry and improve integration of seafood producers into the nation’s food supply system. More information can be found here.
FSIS Releases FY 2025 Summary of Consumer Complaints and Surveillance Data
April 17: FSIS released the FY 2025 Annual Summary of Consumer Complaints from October 1, 2024 to September 30, 2025. The summary presents data from the FSIS Consumer Complaint Monitoring System, which helps the agency monitor and investigate potential food safety issues and track trends. The report includes information on how consumers report complaints to FSIS, the types of complaints reported, and complaint outcomes.
USDA Announces Reorganization of FSIS and Creation of National Food Safety Center
April 23: The USDA announced a reorganization of FSIS to modernize operations and better align with agricultural objectives. A new National Food Safety Center will open in Urbandale, Iowa, and scientific capabilities will expand at the Science Center in Athens, Georgia. Select personnel will relocate to Iowa, Georgia, and other offices. FSIS will also establish a presence in Fort Collins, Colorado, to support international efforts. Headquarters staff will remain in Washington, D.C., for congressional and policy work and frontline staff and food safety operations continue without interruption. No jobs are being eliminated. More information can be found here.
Other Articles of Interest
Consumer Reports Raises Concerns Over FDA’s Redefinition of “No Artificial Colors”
April 9: A Consumer Reports analysis warns that a new FDA policy redefining the claim “no artificial colors” could make food labels more confusing for consumers. Under the updated approach, products may use the claim if they do not contain FD&C certified dyes, such as Red 40, Yellow 5, or Blue 2, even if they include other added colors. Consumer Reports points to substances like titanium dioxide, which is synthetically produced and banned in the European Union, as examples of additives that could now appear in products labeled “no artificial colors.” The FDA says some additives, including titanium dioxide, are under review. Meanwhile, several states have moved ahead with their own restrictions on synthetic dyes. More information can be found here.
RFK Jr. Turns Attention to Whole Milk, Moving Away from Raw Milk Advocacy
April 15: According to the Wall Street Journal, Health and Human Services Secretary Robert F. Kennedy Jr. stepped back from publicly promoting raw milk since taking office and has not pursued changes to existing federal warnings or restrictions. While previously supportive, Kennedy has shifted his public messaging toward whole milk, a less controversial option. FDA and CDC guidance warning of food safety risks associated with raw milk remains unchanged, and federal limits on interstate sales are still in place. More information can be found here. (Requires subscription.)
FDA to Consider Easing Limits on Unapproved Peptides
April 15: The FDA announced it will hold an advisory meeting this summer to consider easing restrictions on several unapproved peptide injections that are popular in wellness and fitness circles, despite limited evidence supporting their safety or effectiveness. The review would examine whether certain peptides should be allowed to be produced by compounding pharmacies. Critics warn that relaxing oversight could undermine FDA’s drug approval framework, while supporters argue existing limits have fueled a gray market for unregulated products. More information can be found here.
Food Industry and Advocates Clash Over FDA’s BHA Safety Review
April 16: The FDA is reevaluating the safety of butylated hydroxyanisole (BHA), a widely used preservative in frozen foods and packaged snacks, prompting mixed responses from industry and public health groups. Food manufacturers and agricultural organizations caution that restricting BHA could disrupt the food supply, noting its use in preventing spoilage. In contrast, public health advocates cite studies linking BHA to cancer in animals and urge a ban under federal law. The review is part of a broader federal effort to examine chemicals in food, with potential implications for food safety standards, supply chains, and regulatory policy.
FDA Tracker Monitors Food Industry Transition from Petroleum-Based Dyes
April 24: The FDA launched a webpage featuring a tracker that lists companies committed to removing petroleum-based food dyes from their products, along with details on their planned updates and progress so far. The site also provides information on how the FDA oversees color additives and includes a complete inventory of approved color additives. You can access the webpage here.
FDA Warning Letters Rise as Enforcement Tightens Under Food Safety Law
April 28: FDA warning letters to food manufacturers and importers are rising as the agency shifts from education to sustained enforcement under the Food Safety Modernization Act. With limited resources, the agency is relying more on formal enforcement earlier in the process, using warning letters to prompt timely corrective action and deter repeat violations. The trend has significant implications for global supply chains, particularly under the Foreign Supplier Verification Program, where deficiencies at foreign facilities can trigger broader consequences for U.S. importers, including shipment delays or import alerts. More information can be found here.
New York Lawmakers Approve Law Targeting Greater Disclosure of Chemicals in Food
April 22: State lawmakers have approved the New York Food Safety and Chemical Disclosure Act (S1239/A1556), which is intended to close the federal GRAS loophole by requiring public disclosure of safety assessments for food chemicals used in the state to the state’s Department of Agriculture and Markets. The law also bans the sale of foods containing Red 3, potassium bromate, and propylparaben, and directs the state to publish a public database to improve transparency for regulators and consumers. The new law will have impact outside of New York because it will force food companies to disclose details about chemicals they use in their products.
Lawsuits
Court Sets June Deadline for FDA Decision on PFAS Limits in Food
April 16: A federal judge for the U.S. District Court for the District of Arizona gave the FDA until June 30, 2026, to determine whether it will set limits for per- and polyfluoroalkyl substances (PFAS) in foods. The Tucson Environmental Justice Task Force sued the agency in January 2025, alleging it moved too slowly on the group’s 2023 petition seeking enforceable tolerances on how much PFAS residue is allowed in food. The case reflects growing pressure to address PFAS exposure through food, which has been linked to cancer, immune effects, and reproductive harm. While plaintiffs now seek PFAS action levels rather than formal tolerances, the FDA has identified PFAS in food as a 2026 priority and plans to release new data on contamination levels.
Trader Joe’s Faces Class Action Over Coffee Labeling Claims
April 29: Four consumers filed a class action lawsuit against Trader Joe’s, alleging that the label on its French Roast Low Acid Whole Bean Coffee is misleading because the coffee contains significantly less caffeine than expected and it is not identified as decaffeinated or reduced-caffeine. The complaint relies on third-party testing, which suggests the product contains notably lower caffeine levels than comparable coffees, potentially influencing purchasing decisions. Plaintiffs also challenge the accuracy of the product’s “low acid” claim. The lawsuit seeks damages, revised labeling, and a product recall.
New Lawsuit Targets Ultra‑Processed Foods as Addictive to Children
April 28: A consumer lawsuit filed in the U.S. District Court for the Eastern District of Wisconsin alleges that major food companies, including Kraft Heinz, Nestlé USA, and PepsiCo, deliberately designed and marketed ultra-processed foods to addict children, using strategies similar to those used by tobacco companies. The complaint links these practices to rising childhood health issues, including type 2 diabetes, and claims the companies knowingly prioritized product appeal and low cost over safety. The case follows similar litigation filed in California and underscores growing scrutiny of ultra-processed foods. The plaintiffs seek damages and assert multiple claims including negligence, deceptive practices, and product design defects.
Court Allows “100% Whole Fish Fillets” Labeling Claims Against Conagra to Proceed
April 30: The U.S. District Court for the Northern District of Illinois declined to dismiss most claims in a proposed class action alleging Conagra Brands misled consumers by labeling certain frozen fish products as “100% Whole Fish Fillets.” Plaintiffs argue the fillets are not entirely whole fish because they contain added sodium tripolyphosphate and water, which are incorporated into the fish itself. The court found both parties’ interpretations of the label plausible, allowing the case to proceed. However, the judge dismissed the request for injunctive relief, finding the plaintiffs could not demonstrate a likelihood of future harm.
Dietary Supplement Groups Sue FDA Over Labeling Restrictions
April 30: A coalition of dietary supplement companies and an advocacy group filed suit against FDA in the U.S. District Court for the District of Columbia, alleging that the agency violated First Amendment commercial speech protections when it blocked product label claims connecting certain nutrients or ingredients to health outcomes. Plaintiffs argue FDA applied stricter standards than what is required by statute when it blocked 114 of the 118 label claims the plaintiffs submitted, all of which were drawn directly from the websites of the National Institutes of Health and Centers for Disease Control and Prevention. The suit also cites a recent Supreme Court decision limiting agency deference, contending FDA’s interpretation of “authoritative statements” is overly narrow and violates commercial speech protections. The case is Health Ranger Store Inc. et al. v. U.S. Food and Drug Administration.
This Regulatory Update covers information from April 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.