• The U.S. Food and Drug Administration (FDA) recently updated its Frequently Asked Questions accompanying the agency’s fifth edition Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act guidance, originally finalized in January 2025. The October 29, 2026 updates provide additional clarification regarding major food allergen labeling, manufacturing controls, allergen-free claims, and the agency’s revised interpretations of certain allergen categories.
  • Consistent with the January 2025 guidance, FDA reiterated that milk from ruminants other than cows (such as goats and sheep) and eggs from birds other than chickens (such as ducks, geese, and quail) are considered major food allergens. FDA also confirmed that ingredient declarations and “Contains” statements should identify the specific animal source, such as “goat milk” or “duck eggs.”
  • FDA also provided additional clarification regarding tree nuts. The agency confirmed that coconut and several other tree nuts, including chestnut, pili nut, shea nut, ginkgo nut, and kola nut, are no longer considered major food allergens for labeling purposes. As a result, these ingredients should no longer be declared in a “Contains” statement, although they must still appear in the ingredient list by their common or usual names when used as ingredients.
  • Several new FAQs focus on allergen labeling statements and FDA’s expectations regarding potentially inconsistent claims. FDA stated that it is generally not appropriate to use a “wheat-free” claim together with a “may contain wheat” advisory statement, or to pair a “Contains peanuts” statement with a “may contain peanuts” statement. According to FDA, such combinations may provide inconsistent allergen information and raise concerns under the prohibition against false or misleading labeling.
  • Keller and Heckman will continue to monitor FDA guidance and policy developments relating to food allergen labeling and food safety compliance and will provide updates on significant developments.
  • On October 29, 2026, Health Canada expanded the permitted use of silicon dioxide as an anticaking agent in nutrient pre-mixes for use in infant formula. The change was implemented through the addition of paragraph S.1(h) to the List of Permitted Anticaking Agents.
  • Silicon dioxide is not intended to perform a technical function in the finished infant formula. Instead, its presence results from carry-over from the nutrient premix, where it helps prevent ingredients from clumping together during manufacturing and handling.
  • Silicon dioxide may be used in nutrient premixes at levels consistent with Good Manufacturing Practice, meaning manufacturers may only use the amount necessary to achieve the intended anticaking function. Any residue in infant formula as consumed must not exceed 10 parts per million (ppm).
  • The authorization follows Health Canada’s premarket safety assessment, which evaluated dietary exposure, allergenicity, chemistry, nutrition, toxicology, and technical efficacy. Health Canada concluded that the requested use is supported from both safety and technical perspectives, and noted that the 10 ppm residue limit is recognized internationally.
  • A study commissioned by Blendtek and conducted independently by Dalhousie University on the impact of Canadian front of pack (FOP) nutrition labels found that FOP labels are significant to Canadian purchasing decisions, but that taste and price are still generally more important. Canadian FOP regulations requiring warnings for most foods “high in” (as defined by regulation) saturated fat, sugar, and/or sodium were published in 2022, but only began to be enforced this year (FOP Guidance). The study is available for download here.
  • The study was conducted on a sample of 1,000 Canadian consumers. The study’s findings included the following:
    • Awareness of FOP labeling was very high (e.g., 94% of consumers were aware that some foods had FOP labels and 97% said they understood them at least somewhat well).
    • More than half of consumers reported changing their behaviors because of an FOP label (e.g., 50% switched from one product to another in the same category because of an FOP label and 64% said that FOP labels were at least somewhat likely to influence future decisions).
    • Household characteristics and food category were reported to impact the degree of importance of FOP labels. For example, the study results indicate that households in which someone was following a specific diet were most likely to avoid FOP-labeled foods, while financially strained households were the least likely to avoid them. Snack purchases were the most likely to be influenced by FOP labels.
    • Consumers were slightly more responsive to sugar FOP labels than fat or sodium, but no symbol dominated.
    • Price and taste remain the most important considerations (taste, price, and nutrition were rated as very or extremely important by 86.2%, 61.4%, and 58.4% of respondents, respectively). Only a small portion of consumers said they will pay more for a comparable product without an FOP label.  
  • FDA’s 2025 proposed FOP rule would, if finalized, also provide information on saturated fat, sodium, and added sugar content, although it would provide “low,” “medium,” and “high” criteria. There is no timetable for finalizing FDA’s FOP rule, but it is on the Human Foods Program 2026 Priority Deliverables.

  • The University of North Carolina at Chapel Hill’s Global Food Research Program and Harvard Law School’s Food Law and Policy Clinic (FLPC) have joined to launch an initiative “intended to provide policymakers and advocates with scientific research, food supply data, and legal expertise to support the development of policies addressing ultra-processed foods (UPFs).” The initiative—the Food Policy Accelerator—will use nutrition science along with legal and policy analysis to aid in developing food labeling, procurement, and nutrition policies.
  • Specifically, the Food Policy Accelerator will conduct work including:
    • Food supply analysis and nutrition profiling to determine what foods are affected by certain regulations, including availability, affordability, and purchasing patterns, as well as establishing nutritional criteria;
    • Policy development and technical assistance, including scientific guidance and feedback on proposed legislation and regulations;
    • Legal research and support to help state and local governments navigate legal questions; and
    • Developing resources for policymakers to inform regulatory and legislative decisions.
  • The initiative was developed amid ongoing federal and state efforts to define and regulate UPFs, including a proposed UPF definition that is in the works and a recent California law establishing a non-UPF certification seal. According to the FLPC Director, “developing effective regulations requires navigating complex legal and scientific questions,” and the initiative is intended to provide that support.
  • Keller and Heckman will continue to monitor developments related to UPF policies.
  • The U.S. Department of Justice Office of Legal Counsel (OLC) recently issued an opinion concluding that the Food and Drug Administration (FDA) has authority under existing law to amend its regulations to permit broader disclosure of supply chain information during certain food safety events. The opinion addresses circumstances involving foodborne illness outbreaks, recalls, and other situations that may present risks to public health.
  • According to the OLC, current FDA regulations generally treat supply chain information, such as the identities and locations of entities within a product’s distribution chain, as confidential commercial information. As a result, FDA’s ability to disclose this information publicly or share it with state and local partners is currently limited except in specific circumstances, such as when disclosure is necessary to effectuate an enforcement action or recall.
  • The opinion explains that these regulatory limitations arise primarily from FDA regulations rather than from a statutory prohibition in the Federal Food, Drug, and Cosmetic Act (FDCA). While the Trade Secrets Act generally restricts federal employees from disclosing certain confidential business information, it permits disclosures that are “authorized by law.”
  • The OLC concluded that FDA possesses authority under Section 705(b) of the FDCA (21 U.S.C. § 375(b)) to promulgate regulations allowing broader disclosure of information regarding regulated products in situations involving “imminent danger to health” or “gross deception of the consumer.” If FDA were to adopt such regulations, disclosures made pursuant to them would be considered legally authorized and therefore would not violate the Trade Secrets Act.
  • Although the opinion does not itself change FDA policy, it provides legal support for future regulatory changes that could expand information sharing during public health emergencies. Any such changes would require FDA to revise its regulations and would remain subject to the statutory limitations set forth in 21 U.S.C. § 375(b), including the requirement that disclosure relate to circumstances involving an imminent danger to health or gross deception of consumers.
  • Keller and Heckman will continue to track developments in this area, including any FDA rulemaking or policy changes related to the disclosure of supply chain information during food safety events.
  • 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.