: On October 13, 2026, FDA issued a final rule to permit the use of salt substitutes in foods with standards of identity (SOI) that specify salt (sodium chloride) as a required or optional ingredient. The final rule does not enumerate specific salt substitutes but instead generally allows ingredients to be used as salt substitutes in standardized foods. The final rule is intended to support “efforts to reduce sodium content in standardized foods and may help to improve consumer dietary patterns by reducing sodium consumption.” FDA explained that the rule will provide the potential for ingredient flexibility to reduce sodium content in the food supply, which will in turn serve as a step to reduce diet-related chronic disease risk, including hypertension, heart disease, and stroke. In FDA's responses to comments on the proposed rule, the Agency explains that the final rule amends 80 SOI directly, as well as an additional 59 SOI through cross-reference for a total of 139 SOI foods that will now be permitted to us[...]
: Earlier this month FDA announced ten planned activities to mitigate and prevent future Cyclospora outbreaks. The announcement coincides with the conclusion of the investigation of a multistate outbreak of Cyclospora infections linked to iceberg lettuce. The activities include the planned publication of an outbreak investigation report regarding the recent Cyclospora outbreak in iceberg lettuce, which will include factors contributing to the contamination and recommendations to prevent future outbreaks; increased surveillance of commodities historically associated with Cyclospora ; increased public outreach to educate growers on practices to comply with food safety requirements and reduce the risk of Cyclospora contamination; increased collaboration with food regulatory authorities in Mexico; and leveraging foreign supplier verification program (FSVP) inspections to ensure that importers are considering Cyclospora contamination as part of their hazard analysis and supplier verification. Most cyclospora outbre[...]
: Pennsylvania's H.B. 507 , known as the “Baby Food Protection Act,” has advanced to the Pennsylvania Senate for review. The bill sets enforceable limits on the following heavy metals in baby foods: total arsenic at 10 parts per billion (ppb), lead at 5 ppb, cadmium at 5 ppb, and mercury at 2 ppb. The bill applies to “food that is pureed or minced to be easily consumed by babies or toddlers under two years of age.” If passed, H.B. 507 would be effective one year after being enacted into law. The bill also requires the Pennsylvania Department of Agriculture to test representative samples of each batch of baby food manufactured in the state for heavy metals. Manufacturers of baby foods tested by the Department of Agriculture would be required to label their products with the detected levels of the four specified heavy metals stated above, as well as the presence of other heavy metals identified through testing. H.B. 507 would join several states that have passed laws enforcing heavy metals testing in baby foods,[...]
: On October 19, 2026, FDA released a final guidance document titled “ New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI ” (Safety Guidance). The Safety Guidance finalizes various sections of the general revised draft guidance on NDI Notifications (General Guidance) (updated in October 2026 to reflect the Safety Guidance). The Safety Guidance is in a question-and-answer format and details the information that manufacturers and distributors should provide in a new dietary ingredient notification (NDIN) and specifically finalizes the following sections of the General Guidance: General Guidance Section VI.A, Identity Information about the NDI and the Dietary Supplement: Finalized as Section IV in the Safety Guidance, this section details the type of identity information that should be included in an NDIN, including the name of the ingredient and its specifications. The Safety Guidance provides further information on what is needed to identify certain ingr[...]
: On October 13, 2026, a California District Court stayed USDA's planned reorganization, holding that the plans, which shut down program offices and relocate personnel, constituted unlawful “reprograming” of appropriated funds and exceeded USDA's current statutory authority. We previously blogged about the filing of this case as well as certain elements of UDSA's reorganization plan . The Court held that several provisions in the relevant appropriations bills prohibited USDA's reorganizational efforts. For example, Section 716 of Pub. L. No. 119-37 barred reprogramming of funds. “Reprogramming” was defined as the “the utilization of funds in an appropriations account for purposes other than those contemplated at the time of appropriation.” Specific examples of such prohibited reprogramming included reduction in personnel (by at least 10%), reorganizing to establish new offices (with at least 5 personnel), or the closing of any existing Agricultural Research Service laboratories. Another appropriations statute [...]
: On October 8, 2026, the U.S. Food and Drug Administration (FDA) issued draft guidance addressing the exemption for small retail food establishments (RFEs) and restaurants under Section 1.1305(i) of the Food Traceability Rule. Established under the Food Safety Modernization Act (FSMA), the Food Traceability Rule imposes additional recordkeeping requirements for establishments that manufacture, process, pack, or hold foods on FDA's Food Traceability List (FTL). Congress has pushed enforcement of the final rule to July 2028 following concerns raised by industry stakeholders about the time needed to implement the rule's requirements. Under the current rule, small RFEs and restaurants with average annual food sales of no more than $250,000 over the prior three years are exempt from the Food Traceability Rule's additional traceability record requirements. If finalized, the guidance provides FDA with “enforcement discretion for all requirements in the Food Traceability Rule for RFEs and restaurants that have an ave[...]
: The U.S. Food and Drug Administration's (FDA) proposed rule on infant formula nutrient requirements has advanced to the White House Office of Information and Regulatory Affairs (OIRA) for review. According to the OIRA docket, the proposal, titled “Infant Formula Nutrient Requirements,” was received for review on October 14, 2026, and is being developed as an economically significant proposed rule. The proposed rule is a key component of the Trump Administration's Operation Stork Speed initiative , launched in 2025 to reevaluate the nutrient composition of infant formula marketed in the United States. As part of that effort, FDA issued a request for information ( RFI ) seeking data on infant health outcomes, the adequacy of existing nutrient requirements, and whether adjustments to current minimum and maximum nutrient levels may be warranted. Although the contents of the proposed rule have not yet been released publicly, administration officials have previously identified infant formula composition as an area[...]
: On July 20, 2026, Congressman Josh Gottheimer (D-NJ) announced a series of bipartisan federal initiatives aimed at strengthening the nation's response to foodborne illness outbreaks amid a record-setting surge in Cyclospora infections . According to Gottheimer, nearly 7,000 cases and more than 140 hospitalizations have been reported across at least 34 states, representing a significant increase compared to the same period last year. While the source of the current outbreak remains under investigation, the situation has renewed attention on federal food safety surveillance and outbreak response capabilities. Central to the announcement is the bipartisan Foodborne Illness Rapid Response Act , introduced with Rep. Don Bacon (R-NE). The legislation would prohibit staffing reductions and hiring freezes within CDC divisions responsible for foodborne illness surveillance for one year following the declaration of an outbreak. The bill would also seek to restore mandatory federal surveillance for Cyclospora and other[...]
: FDA Deputy Commissioner for Food Donald Prater recently explained that FDA is focusing on projects to use artificial intelligence (AI) and shift inspections to states, along with reviewing food additives and addressing concerns around ultra-processed foods. FDA's Human Foods Program began pivoting inspections to state authority in 2025, following a mass departure of employees, as we previously blogged . According to Prater, the Better Regulatory Inspections for Dynamic Government Efficiency (BRIDGE) Project is intended to “further enhance the integrated federal-state food safety system that relies more heavily” on states to conduct routine domestic inspections and sampling. FDA will continue to conduct foreign, non-routine, and high-risk inspections. Prater also discussed FDA's efforts to use AI to “ensure safety in the food supply,” stating that the Agency is partnering with universities and industry associations to feed data and research into AI models to better predict foodborne illnesses. Current partner[...]
: Today FDA announced fiscal year 2027 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and for accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program (TPP). The Federal Food, Drug, and Cosmetic Act authorizes FDA to assess and collect fees from participants in these programs to cover the costs of administration. VQIP expedites the review and import of human and animal food products for participating importers (e.g., through reduced examination and sampling). Participating importers must, among other requirements, have in place a plan to control the safety and security of the food they import (VQIP Quality Assurance Program) and a history of compliance. The detailed requirements for participating in the program can be found on FDA's VQIP page . TPP is a voluntary program through which FDA recognizes “accreditation bodies” responsible for accrediting third party “certification bodies” which con[...]
: On July 30, 2026, the U.S. Food and Drug Administration (FDA) announced that in response to stakeholder requests for an extension, they will be reopening the comment period for Butylated Hydroxytoluene (BHT) for 30 days The new deadline for submission of comments is August 31, 2026. The original request for information was opened for comment May 13, 2026 and closed July 13, 2026. The FDA is requesting information on the current uses and safety data for BHT in human food and as a food contact substance as part of their post-market assessment of chemicals in food . FDA intends to use the information received and any other available, relevant information to determine if BHT remains safe under its current conditions of use in food and as a food contact substance. Electronic comments may be submitted to www.regulations.gov docket number FDA-2026-N-2526 . Written comments should be submitted to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 a[...]
: On July 29, 2026, U.S. Senators Richard Blumenthal (D-CT) and Cory Booker (D-NJ) announced the introduction of the Senate companion to H.R. 8385 , the Food Labeling Modernization Act of 2026, which was introduced in the House on April 20, 2026, by Representatives Frank Pallone Jr. (D-NJ) and Rosa DeLauro (D-CT). The legislation seeks to update federal food labeling requirements and expand nutrition disclosure obligations. The bill would direct the Secretary of Health and Human Services to establish a single, standardized front-of-package nutrition labeling system for foods that are required to bear nutrition information. Supporters argue that a uniform labeling approach could make it easier for consumers to compare products and understand nutritional content at a glance. The proposal also seeks to address marketing practices that may be perceived as confusing or misleading by consumers. Among other provisions, the legislation would require definitions for terms such as “ultraprocessed” and “not ultraprocesse[...]
: A Ninth Circuit panel has partially revived (Law360 subscription required) a lawsuit alleging that FDA and USDA nutrient content claim regulations violate First Amendment rights by preventing the inclusion of certain information about fermentable oligosaccharides, disaccharides, monosaccharides, and poloyols (FODMAPs) on food labels. The lawsuit was initially filed against FDA, USDA, and USDA's Food Safety Inspection Service (FSIS) in March 2023 after one plaintiff submitted a label to FSIS for approval. FSIS denied the approval, telling the company that it must “remove all references to digestible, gut loving, and fodmap.” According to the plaintiff, FDA had never raised concerns about the claims on labels of FDA-regulated foods. According to the Ninth Circuit, FSIS told the company that it discussed the proposed label with FDA, and FDA agreed that the FODMAP claims were impermissible nutrient content claims. The company modified the label, then filed the lawsuit along with a consumer plaintiff. The plainti[...]
: Today FDA rejected an objection and request for a public hearing on the Agency's final order to repeal the color additive regulations for FD&C Red No. 3 when used in food (21 CFR 74.303) and in ingested drugs (21 CFR 74.1303). The objection and request was submitted on behalf of Micro-Tracers, a company that uses tracers containing Red 3 in medicated feeds to verify the presence and uniform mixing of components of the feed. We have previously blogged on FDA's revocation of the color additive listings for Red 3. The revocation was based on studies showing that high doses of Red 3 can cause cancer in rats through a mechanism of action not applicable to humans. Thus, although FDA did not find a safety issue with the authorized uses of Red 3, it revoked the authorizations as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. The objection and hearing request raised objections to: (1) the scientific basis for the revocation of the Red 3 authorizations, (2) FDA's failure to c[...]
: On July 31, 2026, the White House Office of Information and Regulatory Affairs (OIRA) completed its review of FDA's proposed rule addressing GRAS substances. The OIRA review included the following noteworthy topics: “Consistent with Change” designation : OIRA cleared the proposal as “Consistent with Change,” indicating that revisions were made during interagency review or will be incorporated by FDA before publication, though the substance of those changes is not yet publicly available. Major Rule designation : OIRA classified the proposal as a “major rule” under the Congressional Review Act. This designation is generally reserved for rules expected to have significant economic impacts, such as annual economic effects exceeding $100 million or other substantial impacts on industry, competition, costs, or investment. Unfunded Mandates Reform Act (UMRA) : OIRA changed the proposal's UMRA status from “Undetermined” to “Private Sector.” This suggests FDA anticipates the rule could impose significant compliance c[...]
: On August 10, 2026, HHS Secretary Robert F. Kennedy Jr., announced that FDA's long-anticipated proposed GRAS rule has been released. The proposed rule seeks to fundamentally reform FDA's oversight of food ingredients by converting the current voluntary GRAS notification program into a mandatory system. Key Takeaways from the Proposed Rule: Mandatory GRAS notifications : FDA would replace the existing voluntary notification framework with a mandatory notification requirement for most substances introduced into commerce under the GRAS exemption. New transparency measures : FDA would continue publicly posting filed GRAS notices and agency response letters and would also establish a public inventory for certain existing substances submitted through a new transitional process. Expanded FDA oversight : FDA would expressly reserve the ability to revisit prior GRAS conclusions, ask follow-up questions concerning previously submitted notices, and update or rescind prior “no questions” letters. The proposal includes s[...]
: On August 5, 2026, FDA posted a Citizen Petition from The Food Foundations Project requesting that the Agency initiate rulemaking to require caffeine disclosures on caffeine-containing dietary supplements. The Petition defines “caffeine-containing dietary supplement” as “a product labeled as a dietary supplement in which caffeine is present in the finished product, whether added directly or contributed by caffeine anhydrous, a botanical, a botanical extract, a proprietary blend, or another ingredient.” The Petition proposes a new section in FDA's dietary supplement labeling regulations at 21 CFR 101.36 to require: Disclosure of the total caffeine per serving, reflecting the aggregate caffeine in the finished product from every source, including directly added caffeine, caffeine anhydrous, botanicals, botanical extracts, proprietary blends, and other caffeine-contributing ingredients; Disclosure of the total caffeine per container for a single-use container when the unrounded caffeine amount meets or exceeds [...]
: A bill ( H.R.9988 ) was introduced into the House on July 30 th which would amend the definition of “major food allergen” in Federal Food, Drug, and Cosmetic Act (21 U.S.C 321(qq)) by replacing “wheat” with “gluten-containing grain.” The term “gluten-containing grain” is defined in the bill to include wheat, rye, barley, oats and crossbreeds of such grain (e.g. triticale). Major food allergens are subject to allergen labeling requirements. The bill would also require the Department of Health and Human Services to prepare a report addressing various issues related to celiac disease, including the collection of data related to its prevalence and severity, the development of effective diagnostics and treatments, and methods for preventing its onset and reducing risks related to the disease. Symptoms of celiac disease are triggered by ingestion of gluten proteins. Celiac disease affects an estimated 1% of the U.S. population, and, if not diagnosed and treated, can have devastating effects, including damage to th[...]
: On August 11, 2026, the Food and Drug Administration (FDA) released “ Guidance for Industry: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce .” The final guidance document is intended to help manufacturers and processors of ready-to-eat (RTE) fresh-cut produce comply with the FSMA Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls (PCHF) rule . The guidance highlights the association of RTE fresh-cut produce with numerous foodborne illness outbreaks. The 80-page document identifies requirements that are most relevant to fresh-cut processing establishments and aims to provide specific recommendations for each identified requirement. The final guidance reflects public comments received on the October 2018 draft guidance and replaces the 2008 FDA fresh-cut produce guidance. In light of recent produce recalls, during an interview the day the guidance was finalized, FDA Commissioner Kyle Diamantas stated, “Americans should feel confident in eating fresh [...]
: Food manufacturers have been given until January 1, 2028, to comply with changes to the National Bioengineered Food Disclosure Standard after a federal district court ordered the prospective vacatur of three key USDA regulations governing bioengineered food disclosures. The court rejected the USDA's request to extend certain provisions until 2029, finding that further delay would perpetuate inadequate consumer access to bioengineering disclosures. The National Bioengineered Food Disclosure Standard ( NBFDS ) is the federal labeling program established by Congress in 2016 that requires certain foods containing bioengineered ingredients to disclose that fact to consumers. Under USDA regulations implementing the law, manufacturers have been permitted to use on-package text, a USDA symbol, or electronic and digital disclosures such as QR codes. The regulations also exempted certain highly refined foods from disclosure when modified genetic material was not detectable in the finished product. Those digital disclo[...]
: The Safe Food Coalition—a group of non-governmental organizations— sent a letter to Congress asking it to rescind an appropriations rider preventing FDA from implementing the final food traceability rule, which the Agency issued in 2022 . The final rule, “Requirements for Additional Traceability Records for Certain Foods,” establishes additional traceability recordkeeping requirements for entities that manufacture, process, pack, or hold certain types of foods. FDA proposed to extend the compliance date to January 2028 last year, as we blogged , and the appropriations rider prevents the Agency from implementing the rule until July 2028. The letter references the current Cyclosporiasis outbreak, stating that consumers are currently avoiding fresh produce altogether due to “a crisis in consumer confidence.” However, according to the Coalition, compliance with FDA's traceability rule “would prevent illness and support healthier diets.” The letter also notes that the delay in implementing the rule undermines foo[...]
: It has widely been reported this morning that President Trump is expected to nominate Dr. Heidi Overton for FDA Commissioner. Dr. Overton is a physician who currently serves as the deputy assistant to the president for domestic policy. A profile of her in The Atlantic last month described her as “one of the most powerful public health officials in Trump's orbit” and reported that she has coordinated almost all of the White House's major health policies in President Trump's second term. If nominated by President Trump and confirmed by the Senate, Dr. Overton would succeed Dr. Marty Makary who resigned in May. Kyle Diamantas is currently Acting FDA Commissioner and will continue in that role until an FDA Commissioner is confirmed. Keller and Heckman will continue to monitor and report on the FDA commissioner
: On June 25, 2026, the U.S. House Oversight Committee held a hearing on “Combating Waste, Fraud, and Abuse in SNAP,” where House Republicans questioned the alleged influence of the food and beverage industry on the nutritional policies under the Supplemental Nutrition Assistance Program ( SNAP ). SNAP is the federal government's anti-hunger program that serves more than 40 million low-income Americans in providing electronic benefits that can be used like cash to purchase food. Under SNAP, all foods for human consumption, except alcoholic beverages and hot foods prepared for immediate consumption are eligible under federal law. During the hearing, Committee Chair Tim Burchett (R-Tenn.) raised questions about SNAP, stating that while “every SNAP dollar is intended to help feed eligible individuals in need... that's not where every dollar goes.” House Republicans also argued that SNAP benefits were improperly paid out by states and that the program has experienced different types of fraud such as SNAP card skim[...]
: On June 22, 2026, FDA posted a Response Letter denying a citizen petition brought by the Tucson Environmental Justice Task Force and two other individuals requesting that FDA set New Temporary Tolerances at the method detection limit (MDL) for various per-fluoroalkyl substances (PFAS). The petition specifically requested limits be established for 30 different PFAS substances that may be inadvertently transferred to foods including lettuce, blueberries, ready-to-eat bread, milk, eggs, salmon, clams, corn silage, and corn snaplage. The requested tolerances were generally based on an MDL of 0.05 micrograms/kg (0.05 ppb) for the relevant PFAS analytes in these food matrices. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), food may be deemed adulterated if it contains a poisonous or deleterious substance that may render it injurious to health. For unavoidable environmental contaminants, FDA may establish action levels, tolerances, or other regulatory limits. FDA has not established broad regulatory limits[...]
: On July 13, 2026 , FDA issued a letter to infant formula manufacturers and their supply chain partners in response to several serious public health events, calling on the industry to increase vigilance to “ensure ingredient and infant formula safety.” The letter details FDA's investigation into two multistate outbreaks of infant botulism that led to voluntary recalls of powdered infant formula, as we previously reported . The investigation identified Clostridium botulinum contamination in a dairy-based ingredient, which FDA linked to both affected formulas. In addition, the letter discusses a global outbreak of cereulide intoxication, which resulted in an ingredient supplier being placed on an FDA Import Alert. In the letter, FDA emphasizes that these incidents reflect a pattern of risks entering through the supply chain. The letter outlines FDA's expectation for manufacturers to conduct supplier audits and verification activities, as well as monitor recalls, outbreak investigations, and FDA Import Alerts. T[...]
: On July 9, 2026, USDA's Food Safety and Inspection Service (FSIS), FDA, and EPA announced a Memorandum of Understanding (MOU) coordinating agency efforts to address drug residues, pesticide residues and other chemical contaminants in meat, poultry, and egg products under FSIS jurisdiction, food-producing animals while under FSIS or FDA jurisdiction, and food for food-producing animals. The MOU aligns with FSIS's efforts to modernize heavy metal testing in food products and further MAHA's goals of reducing children's exposure to harmful contaminants. As the MOU notes, evaluating chemical residues and contaminants in agriculture products is a shared responsibility among agencies. USDA is responsible for the safety and regulation of meat, poultry, and egg products, FDA is responsible for investigating residues reported by FSIS, and EPA is responsible for sale, distribution, and use of pesticides. To foster interagency cooperation, the MOU requires FSIS to provide FDA with weekly residue reports and keep FDA and[...]
: On July 9, 2026, USDA's Food Safety and Inspection Service (FSIS), FDA, and EPA announced a Memorandum of Understanding (MOU) coordinating agency efforts to address drug residues, pesticide residues and other chemical contaminants in meat, poultry, and egg products under FSIS jurisdiction, food-producing animals while under FSIS or FDA jurisdiction, and food for food-producing animals. The MOU aligns with FSIS's efforts to modernize heavy metal testing in food products and further MAHA's goals of reducing children's exposure to harmful contaminants. As the MOU notes, evaluating chemical residues and contaminants in agriculture products is a shared responsibility among agencies. USDA is responsible for the safety and regulation of meat, poultry, and egg products, FDA is responsible for investigating residues reported by FSIS, and EPA is responsible for sale, distribution, and use of pesticides. To foster interagency cooperation, the MOU requires FSIS to provide FDA with weekly residue reports and keep FDA and[...]
: USDA recently published its 2026 Unified Agenda , which includes an August 2026 target date for a Notice of Proposed Rulemaking (NPRM) to revise the bioengineered (BE) foods disclosure regulations and address the deficiencies identified by the Ninth Circuit, which held that the absence of detectable modified genetic material is not legally equivalent to a food not containing such material, and invalidated the rule's detectability exemption as well as its digital and text-message disclosure provisions. The 2016 National Bioengineered Food Disclosure Standard introduced federal disclosure requirements for BE foods, requiring manufacturers to disclose foods that contain BE ingredients. In December 2018, the USDA published its final regulations , which added a detectability exemption and text-message option. The detectability exemption excluded certain foods from the definition of a BE food if “the genetic material is not detectable,” and USDA added an additional disclosure option of text messaging to “provide a[...]