This update includes FDA and USDA updates, warning letters, lawsuits, and other articles of interest, including new dietary guidelines for Americans, a proposed extension of the FSMA Traceability compliance date, early success of the ImportShield Program at U.S. ports, a false advertising claim against Smartfood, and more.
FDA Updates
FDA Details Food Traceability Requirements Under FSMA
January 2: FDA updated its webpage detailing the Food Safety Modernization Act (FSMA) Final Rule on Requirements for Additional Traceability Records for Certain Foods, which establishes new recordkeeping requirements for foods on the Food Traceability List. The rule requires covered entities that manufacture, process, pack, or hold these foods to maintain specific records tied to key points in the supply chain, allowing FDA to more quickly trace and remove potentially contaminated foods from the market. FDA has proposed extending the compliance date to July 20, 2028, to give industry more time to implement necessary systems and processes. More information can be found on FDA’s webpage here.
HHS & USDA Announce New Dietary Guidelines for Americans
January 7: The U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) released 2025-2030 Dietary Guidelines for Americans as part of the Make America Healthy Again (MAHA) initiative. The guidelines encourage prioritizing proteins and healthy fats while limiting highly processed foods, refined carbohydrates, and added sugars. More information can be found here and in this Michael Best Client Alert.
FDA Reports Early Success of ImportShield Program at U.S. Ports
January 21: FDA announced early results from its ImportShield Program, a centralized import review initiative launched in August 2025 to strengthen oversight of FDA‑regulated products at U.S. ports of entry. FDA stated that the program has improved efficiency and consistency by consolidating import reviews into a single national operation, increasing processing speed and review capacity while enabling real‑time alerts to stop contaminated foods, from entering the U.S. market. More information can be found here.
FDA Opens Information Request on Gluten Labeling and Cross‑Contact
January 22: The FDA announced a Request for Information (RFI) focused on gluten labeling and preventing cross-contact of gluten in packaged foods. The RFI responds to a citizen petition asking FDA to require clearer identification of all gluten‑containing ingredients and stronger controls to prevent cross‑contact with gluten‑containing grains. FDA is seeking comments and data on these issues to help assess potential risks to consumers with celiac disease and to inform possible future regulatory actions related to gluten disclosure and cross‑contact practices. The deadline for comments is March 23, 2026. More information can be found here and here.
FDA Outlines 2026 Priorities for Human Foods Program
January 23: FDA released its 2026 deliverables for the Human Foods Program, outlining the agency’s planned food safety and nutrition priorities for 2026. According to FDA, the program will focus on advancing food chemical safety, improving nutrition, and strengthening microbiological food safety as part of broader efforts to modernize food oversight and protect public health. More information can be found here.
FDA Unveils Interactive Tool for Total Diet Study Findings
January 27: The FDA released a new interactive web‑based tool that provides streamlined public access to results from the agency’s Total Diet Study, along with newly released data. The tool allows users to analyze findings on nutrients and chemical contaminants in foods representing the average U.S. diet and includes data collected from 2018 through 2022. FDA stated that the new platform is intended to improve transparency and accessibility of food safety and nutrition data and support the agency’s ongoing monitoring of dietary exposure. More information can be found here.
FDA Warning Letters
Imported Foods: The FDA recently issued warning letters to four food importers for failing to meet required food safety oversight obligations. FDA alleged the food importers did not follow required foreign supplier verification programs. The violations covered a wide range of products, including truffle products, olive oils, chocolates, teas, mushrooms, frozen fruits, baked goods, dairy products, and prepared foods. FDA also noted that some importers failed to provide adequate documentation or perform corrective actions after earlier inspections, and in some cases did not respond at all to FDA’s findings.
A database of warning letters can be found here.
USDA Updates
FSIS Updates Enforcement Letters to Highlight Small Business Rights
January 2: The U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) is updating how the agency communicates enforcement actions to regulated establishments, using a Notice of Intended Enforcement (NOIE) letter to highlight small business rights. FSIS Notice 01-26 requires that enforcement letters clearly inform small establishments about the option to contact the Small Business Administration’s National Ombudsman if they have concerns about regulatory enforcement, while clarifying that existing FSIS appeal and hearing processes still apply. More information can be found here.
FSIS Leadership Changes
January 9: FSIS announced several leadership changes. Robert Bane will join the Office of the Administrator as Deputy Administrator of Field Operations, bringing decades of FSIS leadership experience while continuing to work from the Springdale District Office. He will serve alongside Deputy Administrator Dr. Denise Eblen, who will focus on FSIS’ science and policy efforts. FSIS also named Melissa Moore as Assistant Administrator of the Office of Field Operations, Natalie Duncan as Assistant Administrator of the Office of Management, and Karen Hunter as Assistant Administrator of the Office of Public Affairs and Consumer Education. In addition, Dr. Hany Sidrak was named FSIS’ Chief Public Health Veterinarian and Robert Witte was named Acting Assistant Administrator for investigations and enforcement. Dr. Sheryl Shaw returns to a public health science leadership role, and Christine Turner was appointed Deputy Chief Financial Officer. More information can be found here.
Brashears Returns to USDA as Under Secretary for Food Safety
January 16: Dr. Mindy Brashears returned to the USDA as Under Secretary for Food Safety, following her swearing-in on January 14. She previously served in the same role from 2020 to 2021 and brings experienced leadership and understanding in food safety science, policy, and operations from her earlier USDA service and her recent work at Texas Tech University. More information can be found here.
USDA Sets 24‑Hour Evidence Requirement for “Product of USA” Claims
January 27: The USDA issued new guidance strengthening the rules for using the “Product of USA” label and requiring producers to have documentation ready to prove the claim within 24 hours of an agency request. The guidance, enforced by the FSIS, limits the claim to products made from animals born, raised, slaughtered, and processed in the United States, with limited exceptions for spices and flavorings. While the rule applies only to USDA‑regulated products, it signals a broader labeling trend that affects products of all types and manufacturers should have clear evidence to support any label claim before it is challenged. More information can be found at this Michael Best Client Alert and FSIS Directive 7221.1.
Other Articles of Interest
GAO Report Finds FDA Falling Short on FSMA Requirements
January 8: A new Government Accountability Office (GAO) report finds that FDA continues to fall short of several key requirements under the 2011 Food Safety Modernization Act (FSMA), including establishing a food‑tracing system central to identifying and containing foodborne illness outbreaks. Although FDA has issued nine rules designed to prevent foodborne illness, GAO notes the agency has not completed five major mandates such as issuing guidance on preventive controls, intentional adulteration, and updated produce safety practices. The agency also lacks performance measures to assess whether industry is meeting the rule requirements. FDA officials cited competing priorities and recent organizational changes as reasons for the delays, acknowledging that a functional food‑tracing system will not be in place until 2028, 17 years after FSMA became law. GAO issued seven recommendations to help FDA meet its statutory obligations. More information can be found here.
Lawmakers Renew Push for a Single U.S. Food Safety Agency
January 13: Lawmakers Rosa DeLauro and Dick Durbin reintroduced the Federal Food Administration Act, a bill that would consolidate FDA’s food oversight programs into a single agency to better protect consumers and reduce foodborne illness. The new Federal Food Administration, led by a Senate-confirmed Commissioner, will strengthen regulatory accountability, improve public health, and ensure that companies failing to meet food safety standards are held responsible. More information can be found here.
President Trump Signs Whole Milk for Healthy Kids Act
January 14: President Trump signed the Whole Milk for Healthy Kids Act, restoring access to whole milk in schools and aligning federal school meal standards with the newly released Dietary Guidelines for Americans, 2025–2030, which reintroduced full‑fat dairy as part of a healthy diet. The law expands milk options for students and supports American dairy farmers. USDA has begun immediate implementation, issuing guidance to school nutrition officials and preparing rulemaking to enable schools to offer whole milk as soon as possible. More information can be found here.
Michigan and Oklahoma Move to Expand Raw Milk Sales
January 30: Lawmakers in Michigan and Oklahoma are advancing bills that would ease state restrictions on the sale of unpasteurized (raw) milk. In Michigan, House Bills 5217, 5218 and 5219 would allow farmers to sell raw milk directly to consumers under new labeling and waiver requirements, replacing the current ban that limits raw milk access to herdshare arrangements. In Oklahoma, proposed Senate Bill 2107 would expand raw milk sales beyond farms to farmers markets and produce stands and allow advertising, while exempting sellers from certain state food safety laws. Public health officials and the FDA continue to warn that raw milk carries a much higher risk of foodborne illness than pasteurized milk and offers no proven health benefits. Supporters argue the bills would give consumers more choice and create new opportunities for small farms.
Lawsuits
Judge Allows Texas to Keep Lab‑Grown Meat Ban in Place as Lawsuit Continues
January 21: A federal judge for the Western District of Texas ruled that Texas can continue to enforce its ban on the sale of lab‑grown meat and fish for human consumption, rejecting a challenge for now from two California startups seeking to enter the state’s market. The judge denied the companies’ request to block the law (S.B. 261), which took effect September 1, 2025, but allowed part of their lawsuit to move forward involving a claim that the ban may unlawfully restrict interstate commerce. Texas lawmakers say the law is based on concerns about long‑term health effects of lab‑grown products, while the companies argue the law is meant to shield the state’s agriculture industry from competition. More information can be found here.
Supplement Companies Sue FDA Over Rejected Health Claims
January 22: Dietary supplement makers Living Fuel International, Health Ranger Store, and Cardio Miracle, joined by the Alliance for Natural health USA, sued the FDA in Washington, D.C. federal court, challenging the agency’s December 2025 decision to block 114 proposed health claims for their products, including statements about reducing the risk of conditions such as high cholesterol, memory loss and cancer. The companies argue the FDA failed to consider supporting evidence, misapplied the standard for “authoritative statements,” and improperly ignored First Amendment considerations involving commercial speech. The plaintiffs are seeking to have the FDA’s denial set aside and discontinue censorship of their product labeling and marketing claims.
Smartfoods Faces False Advertising Lawsuit Over “No Artificial” Claims
January 29: PepsiCo is facing a proposed class action alleging the company falsely advertised its Smartfood White Cheddar Popcorn as containing no artificial flavors or preservatives. The lawsuit Flexer v. Smartfoods Inc, filed in the U.S. District Court for the Eastern District of New York, claims the product contains maltodextrin, which is a synthetic flavor and preservative. The suit alleges these front‑label claims misled shoppers seeking more natural snack options and caused consumers to pay a premium they otherwise would not have paid. The plaintiff is seeking class certification, monetary damages, and changes to Smartfood’s labeling and marketing practices.
This Regulatory Update covers information from January 2026 Please contact Paul Benson, Taylor Fritsch, or Leah Ziembafor 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.