• Today, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) issued the first of three proposed rules that aim to update infant formula nutrient requirements.  While the formal rulemaking process commences, FDA has also released new chemical contaminant testing data demonstrating that most infant formula samples showed low or non-detectable levels of contaminants, according to HHS’ press release. 
  • FDA intends to conduct a comprehensive review of the 30 nutrients currently required in infant formula marketed in the United States.  The FDA intends to consolidate final changes to infant formula nutrient requirements into a single comprehensive final rule.
  • Today’s proposed rule (phase 1 of three) would update requirements for iodine, manganese, vitamin A, and vitamin D and reaffirm existing requirements for chloride, potassium, selenium, and sodium.  It would also change the units of measure for two nutrients and request public input on potential requirements for ingredients that are currently not required in infant formula but commonly added by manufacturers due to their nutritional value (e.g., arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine).
  • FDA is accepting comments on the proposed rule until February 26, 2027.  Keller and Heckman LLP will provide updates throughout the rulemaking process.
  • Earlier this month FDA released results of testing conducted on lemon juice samples for economic adulteration (i.e., food fraud). The tests were taken on 195 lemon juice samples between 2022 and 2025.
  • Lemon juice is subject to a standard of identity at 21 CFR 146.114, which defines standards for lemon juice and only allows for the following optional ingredients when added consistent with the defined standards: (1) concentrated lemon juice, (2) water and lemon juice (to reconstitute lemon juice from concentrate), and (3) preservatives. Additives like citric acid and sweeteners are not permitted.
  • None of the 38 domestic samples indicated the presence of economic adulterants while 7 of the 157 imported samples did (4.5% economic adulteration rate amongst imported samples). All imported samples were collected at the ports of entry prior to release into interstate commerce. Those that tested positive for an economic adulterant were refused entry and placed on Import Alert 99-47 (“Detention Without Physical Examination of Human Food Products That Appear to be Adulterated for Economic Gain”).
  • On October 27, 2026, FDA released a draft guidance document providing examples of U.S. origin statements that the Agency considers to be truthful and not misleading when used on seafood products.
  • The draft guidance, titled “U.S.-Origin Statements on Seafood: Guidance for Industry,” explains that it may be difficult to establish where certain wild-caught fish originate due to, for example, open waters and fish migrations. The draft guidance is specific to U.S. origin statements and does not address more specific origin statements like states, territories, or localities.
  • According to the draft guidance, the following statements are considered truthful and not misleading:
    • “U.S-Caught” is appropriate for wild-caught seafood caught in the U.S. or by U.S. flagged vessels under U.S. jurisdiction.
    • “U.S. Farm-Raised” is appropriate for seafood cultivated in aquaculture facilities in the U.S. and exported for processing.
    • “Processed in the United States” is appropriate for seafood caught or raised outside of the U.S. and processed entirely in the U.S.
    • “USA Seafood” is appropriate in the labeling of (a) “U.S.-Caught” seafood as described above that is harvested, processed in its entirety, and offered for sale in the U.S.; or (b) U.S. spawned and farm-raised seafood that is harvested, processed in its entirety, and offered for sale in the U.S.
    • “Made with U.S. Seafood” is appropriate in the labeling of products, including multi-ingredient products, in which all seafood that otherwise meets the requirements for “USA Seafood” described above.
  • The draft guidance further states that graphics, such as the American flag, may be used to convey a U.S. origin statement. These graphics should be accompanied by qualifying statements describing what product aspects are connected to the U.S. when appropriate.
  • Finally, the draft guidance emphasizes that manufacturers and distributors must be able to substantiate all U.S. origin claims on seafood products. This could be in the form of standard recordkeeping showing that the claim is truthful and not misleading.
  • Keller and Heckman will continue to update on new guidance from FDA.
  • On October 22, 2026, the U.S. Food and Drug Administration (FDA) announced several new actions under its Closer to Zero initiative, a multi-year effort aimed at reducing dietary exposure to heavy metals in foods consumed by babies and young children.
  • As part of the announcement, FDA issued draft guidance proposing action levels for cadmium in processed foods intended for children under two years of age. Cadmium is a naturally occurring heavy metal that can enter the food supply through soil, water, and environmental contamination. While low-level exposure is common, excessive exposure over time may be associated with adverse health effects, and infants and young children are considered particularly vulnerable due to their smaller body size and developmental stage.
  • Specifically, FDA has proposed action levels of 10 parts per billion (ppb) for fruits, vegetables (excluding single-ingredient carrots), and mixed foods; 25 ppb for single-ingredient carrots; 45 ppb for dry infant cereals; 20 ppb for yogurts, puddings, and custards; and 25 ppb for single-ingredient meat products.
  • The draft guidance emphasizes that the proposed action levels are recommendations rather than legally binding requirements. However, FDA notes that it may consider the action levels, along with other factors, when evaluating whether enforcement action is warranted.
  • In addition to the cadmium proposal, FDA released draft guidance addressing the control of chemical hazards under the Food Safety Modernization Act’s Preventive Controls for Human Food regulation. The guidance is intended to help manufacturers identify, assess, and mitigate chemical hazards, including heavy metals, through preventive controls, current good manufacturing practices (CGMPs), and supply-chain management measures.
  • FDA also updated its Closer to Zero website to provide information on ongoing activities related to heavy metals in food and announced a public webinar scheduled for November 16, 2026, to discuss the new proposals and other food chemical safety initiatives.
  • Comments on the draft cadmium action levels may be submitted through December 22, 2026, while comments on the chemical hazards guidance will be accepted through January 21, 2027.
  • Keller and Heckman will continue to monitor for developments realted to FDA’s Closer to Zero initiative and the regulation of heavy metals in baby food.
  • 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, including Bill H.536 in Vermont, which was enacted in May 2026 and similarly sets product testing requirements for baby food and requires manufacturers to place a QR code on the product’s label linking back to the test results.
  • Keller and Heckman will continue to report on state legislative developments impacting product testing and labeling.
  • 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 (Pub. L. No. 199-74), which applied to USDA’s Forest Service, similarly restricted “reprogramming.” The term was similarly defined as “any significant departure from the program described in the agency’s budget justifications,” and included “all proposed reorganization or other workforce actions [affecting 10 staff or 10% of the staffing of a program].”
  • The Court reviewed the record of USDA’s reorganizational actions and held that under both statutes USDA’s actions constituted reprogramming of funds. Both statutes did in fact permit reprogramming where permission for the reprogramming activity was granted from the House and Senate Appropriations Committees, but this statutory language was held to be unconstitutional, a position that was not contested by either side (it proposed in essence a legislative amendment that did not go through the legislative process). 
  • It should be noted that “reprograming,” defined slightly differently in different statutes, but essentially reallocating funds from a single account for a purpose other than those contemplated by Congress, is generally permitted (in contrast with transferring funds to different appropriations accounts). However, the specific statutes at issue prohibited them.
  • The Court also rejected the argument that it had authority to offer only relief to the Plaintiffs and not everyone affected by the challenged government action (universal relief). It held that Section 706 of Administrative Procedure Act (APA) was not so limited and authorizes a court to “hold unlawful and set aside agency action,” when it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law.” The Court reasoned that a universal stay was necessary to ensure that final relief under Section 706 could ultimately be granted.
  • We will continue to monitor and report on this case and USDA’s reorganization efforts.
  • 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 ingredients such as salts, covalently modified derivatives of dietary ingredients, botanicals, metabolites, enzymes, ingredients produced by fermentation, and live microbial ingredients.
    • General Guidance Section VI.B, History of Use or Other Evidence of Safety:
      • Finalized in Sections VI and VII in the Safety Guidance, these sections describe the type of information needed to demonstrate an NDI’s safe history of use. FDA recommends a period of at least 25 years of widespread use when relying on history of safe use alone. The Safety Guidance recommends citing to published articles, providing examples of sufficient documentation to establish history of safe use. Other evidence of safety could include things like genetic toxicity tests, animal studies, and human studies. This type of evidence is needed when there is not sufficient history of safe use to support the NDIN. The Safety Guidance further details characteristics of a quality study.
    • General Guidance Section VI.C, Summary of the Basis for Your Conclusion of Safety:
      • Finalized in Section V in the Safety Guidance, this section explains what safety information is required, including what should be included in the “safety narrative.” The safety narrative should contain an “objective evaluation of the history of safe use or other evidence of safety, along with an explanation of how the evidence of safety provides a basis” to conclude the NDI is reasonably expected to be safe. It should include an estimated daily intake of the substance, as well as describe the function of each non-dietary ingredient.
  • Under the Dietary Supplement Health and Education Act of 1994, dietary supplement manufacturers generally do not need FDA premarket approval before marketing a product. However, unless a limited exception applies, manufacturers must submit an NDIN at least 75 days before marketing a dietary supplement containing a dietary ingredient that was not marketed in the United States before October 15, 1994. The notification must contain information supporting the manufacturer’s conclusion that the ingredient can reasonably be expected to be safe under the recommended conditions of use.
  • FDA issued its last major revision to the General Guidance in 2016. Since then, industry and stakeholders have submitted nearly 2,000 public comments, and FDA has issued a series of guidance documents addressing discrete aspects of the NDIN process, including notification procedures and master files. This new Safety Guidance continues the Agency’s phased approach of finalizing discrete sections of the General Guidance.
  • Keller and Heckman will continue to monitor developments related to FDA’s evolving NDIN framework and will provide updates as additional guidance and policy developments become available.
  • 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 of interest. Public statements by HHS leadership have highlighted concerns around ingredients such as corn syrup solids and seed oils, for example.
  • Any significant revisions to infant formula nutrient requirements could have substantial implications for manufacturers, including potential reformulation efforts, ingredient sourcing considerations, supply chain impacts, and associated costs.
  • While FDA has not announced a publication date, completion of OIRA review is generally one of the final steps before publication of a proposed rule.
  • Keller and Heckman will continue to monitor developments related to FDA’s infant formula modernization efforts and will provide updates as additional information regarding the proposal becomes available.
  • 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 average annual monetary value of food sold or provided during the previous 3-year period of greater than $250,000 but no more than $1,000,000 (on a rolling basis),” adjusted for inflation (emphasis added). The proposed enforcement discretion was written in response to compliance “challenges” brought to FDA’s attention by small RFEs and restaurants following the issuance of the final rule in 2022.
  • FDA also noted in its press release of the draft guidance that it is actively considering additional flexibilities for regulated entities and will hold a public meeting on November 6, 2026, to discuss implementation challenges and potential modifications to lot-level food traceability requirements.
  • Keller and Heckman will continue to monitor updates related to FDA’s Food Traceability Rule.
  • 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 outbreaks originate from imported foods as the disease-causing organism, Cyclospora cayetanensis, is not endemic to the U.S. C. cayetanensis is a single-celled coccidian protozoan parasite, the lifecycle of which requires a human host to grow and reproduce (CDC – DPDx – Cyclosporiasis). Feces containing the organism can contaminate the environment, including food and water, although it is passed in feces in an unsporulated oocyst form which is not infective until it sporulates. The incubation period is typically one week and symptomatic infections typically take the form of watery diarrhea.