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FDA clarifies applicability of food traceability rule with new draft Q&A guidance

The FDA’s new guidance on the food traceability rule covers a range of implementation activities and scenarios, detailing how the rule may apply across the food supply chain, including manufacturers, retail food establishments, restaurants, and farms.

By Jared Rothstein | Feb 23, 2026 12:42 PM EST

Quick background on the food traceability rule

  • The food traceability rule is intended to improve foodborne outbreak responses by establishing recordkeeping requirements for certain facilities that manufacture, process, pack, or hold high risk foods. The rule, finalized in Nov. 2022, was a key output of the FDA Food Safety Modernization Act. Foods the agency has selected for inclusion on the Food Traceability List are subject to the rule. Regulated entities must maintain records for Critical Tracking Events through the supply chain for FTL foods, such as packing, shipping, receiving, and transformation. These CTEs must be associated with key data elements, which encompass descriptive information about the food such as location, quantities, dates, lot codes. Regulated entities must also establish and maintain a traceability plan that details company procedures used to maintain records, identify foods on the FTL, and procedures for the assignment of traceability lot codes. The final rule established Jan. 20, 2026, as the deadline for compliance.
  • Implementation by the food industry is an ongoing challenge. The regulatory impact analysis of the rule estimated that “20-year annualized costs of the rule range from about $63 million to $2.3 billion, with a primary estimate of $570 million per year.” In addition to the cost of investing in new systems and processes, the food industry has faced practical difficulties with navigating compliance including lack of standardization for traceability lot codes, difficulties with receiving accurate data from suppliers, lack of interoperability across traceability technology platforms, and limited familiarity with the rule across the food industry supply chain. The FDA has made efforts to provide clarity and outreach on the rule including by continuously updating its FAQ page, publishing a small entity compliance guide, issuing templates for traceability plans and electronic sortable spreadsheets, and regularly attending industry conferences and events to educate about the rule.
  • In response to implementation challenges, the FDA in August 2025 proposed a 30-month extension for traceability rule compliance. Before finalizing the rule, Congress acted by including the delay provisions in the fiscal year 2026 Ag-FDA funding bill, which prohibited the agency from using its funds “to administer or enforce” the food traceability rule before July 20, 2028. The bill also directed the agency to meet with regulated entities including farms, warehouses, retail food establishments, and restaurants quarterly to identify and implement flexibilities related to the rule’s lot-level tracking requirement and develop guidance on these flexibilities to satisfy rule compliance within 180 days of enactment. The legislation also required the FDA to assist and engage in pilots “regarding how to handle food waste recovery, reclamation, intra-company transfers, customer returns under the rule.” The agency also received a directive to evaluate covered entities’ recordkeeping and management systems and to assist in identifying any technical difficulties for implementation, as its resources may allow.

Overview of FDA’s draft guidance

  • On Feb. 20, the FDA published a Federal Register notice announcing the availability of draft guidance titled “Questions and Answers About Requirements for Additional Traceability Records for Certain Foods.” The notice stated that the guidance, once finalized, will represent the agency’s current thinking on implementation of the rule and will include questions and answers to support industry compliance and understanding of the rule’s requirements. “Topics covered in this draft guidance include additional information on requirements for farms, food obtained from fishing vessels, raw molluscan shellfish, retail food establishments and restaurants, commingling, initial packing of a food, transformation of a food, the traceability plan, recordkeeping, and the [Food Traceability List],” the agency wrote.
  • The 31-page draft guidance covers a wide range of questions and answers about the traceability rule. This includes the applicability of exemptions for certain entities such as farms, farmers’ market stalls, fishing vessels, first land-based receivers, retail food establishments, and restaurants; applicability of the rule to activities such as commingling, initial packing, and transformation; and information related to food traceability plans, the food traceability list, and recordkeeping requirements. The agency emphasized that, as with all guidances issued by the FDA, they “should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.”

Analysis, points of interest, and next steps

  • The guidance clarifies that breaking of pallets is not, in and of itself, a transformation event. The agency distinguished between an event such as the manufacturing, processing, repacking or changing of a food, and removal and separation of a case of food. As an example, “if a distribution center breaks a pallet to remove one case (or breaks a case to remove an item, such as a jar of peanut butter) – for example, because they only need one case to fulfill a customer’s order – this does not constitute transformation. The contents of the pallet are not being repacked or otherwise transformed. In this situation, the transformation KDEs would not need to be maintained, the TLC would not change, and the distribution center would not become the TLC source,” the agency explained.
  • The agency suggested that both suppliers and receivers will be held responsible for inaccurate or incomplete recordkeeping. The guidance emphasizes that each entity has an independent responsibility to adhere to the rule’s requirements for the critical tracking events performed, whether it be maintaining accurate shipping or receiving KDEs, and that relieving receivers of responsibility would undermine the purpose and effectiveness of the rule. “In some situations, FDA might request records from multiple covered entities in one FTL food’s supply chain (e.g., from both you and your supplier). In other situations, we might only request records from one covered entity in the food’s supply chain. When we find that a firm’s data that is required under the Food Traceability Rule is inaccurate or incomplete, we consider the public health impact and any voluntary corrective action by the firm when determining regulatory follow-up. As a practical matter, we routinely allow firms an opportunity to make voluntary corrective actions, which could include working to correct data inaccuracy, including working with the source of inaccurate or incomplete data,” the agency explained, indicating that enforcement circumstances will likely be case dependent.
  • The guidance clarifies the rule’s partial exemption for routine ad hoc purchases of food made by restaurants and retail food establishments. “The RFE (or restaurant) that made the sale is fully exempt, while the RFE or restaurant that made the purchase must only maintain a record documenting the name of the product purchased, the date of purchase, and the name and address of the place of purchase. In many cases, the required KDEs for the ad hoc purchase can be documented by a sales receipt,” the agency explained. The FDA emphasized that this arrangement is due to the impracticality of expecting a cashier to ascertain and exchange key data elements for the food in a situation where the purchaser is operating as a typical consumer such as through the check-out line. However, adding complexity to the circumstances, the FDA noted that certain firms, such as wholesale membership clubs, may be able to provide detailed purchase information to their members upon request. And if such is the case, “the RFE or restaurant that made the ad hoc purchase could consider the wholesale membership club to be the holder of the records that are required under the partial exemption, as long as the purchasing RFE or restaurant can provide the required records to FDA upon request within 24 hours.” The guidance suggests that the initial traceability obligation falls on the purchaser to either provide or establish a means to retrieve the relevant records with such ad hoc purchases.
  • Likewise, ad hoc intracompany shipments of food between RFEs and restaurants are also subject to the partial exemption. Such food must have been intended to be sold directly to consumers before being redirected to another establishment. The agency will “consider factors such as whether the transaction is outside of the receiving entity’s usual practice, and whether the entity selling or providing the FTL food had already placed the food on the shelf for purchase by consumers (in the case of an RFE) or moved it to the area where it could be utilized by the kitchen (in the case of a restaurant)” to determine whether a shipment is considered ad hoc versus a regular practice of sharing inventory. This ad hoc exemption also applies in situations in which a third party utilized by a purchasing entity makes an ad hoc purchase on their behalf from another RFE or restaurant.
  • For continuous processing events, the agency emphasized that rule coverage is dependent on food at the start and end of the processing event. Intermediate FTL foods that may briefly exist during continuous processing would not need traceability records, as transformation KDEs are required when an event leads to a FTL output. Companies would only need to maintain receiving or shipping KDEs when there is an FTL food at the beginning of end of the continuous process. On the flipside, “a single processing event that begins with a food not on the FTL (whole strawberries) and results in a food not on the FTL (frozen sliced strawberries)” would not need to maintain any records under the rule. The same goes for a non-FTL food that is continuously processed into an intermediate FTL food and then is consequently subject to a kill step, though the agency emphasizes that documentation of the kill step is necessary to qualify for that exemption.
  • The use of stickering for internal tracking is not in of itself considered an act of relabeling. The FDA emphasized that relabeling as part of a transformation activity, such as repacking or changing the brand identity of the food product, is what is covered under the rule. On the other hand, stickering a case of food or adding a pallet license plate to assist with internal tracking and management falls outside the context of a transformation activity.
  • The agency clarified the differences between intracompany and intercompany shipments for rule coverage. For intercompany shipments of food between two companies at the same street address, such as a sushi bar that buys FTL ingredients from the grocery store it operates within, shipping and receiving records would need to be maintained by both companies, and the agency notes that many elements of the location description will be the same in both entities’ records. Meanwhile, for intracompany movement of food, shipping and receiving KDEs are only needed when the movement occurs from one street address to another address. The FDA emphasizes that the rule seeks to avoid situations where movement “from one dock at a distribution center to another dock at the same distribution center, which might be a fairly large distance away – could be seen as a shipping and receiving event.”
  • The guidance seeks to distinguish fresh-cut versus trimmed produce for coverage under the FTL. The agency explained that if produce is no longer in its whole state after being chopped, diced, peeled, riced, shredded, sliced, torn, or spiralized, it is considered fresh-cut. More limited alterations however, such as the removal of parsnip root tails or trimming the outer leaves of a head of lettuce, do not alter the produce sufficiently to no longer being in a whole state. Firms would likely need to make a determination based on degree of alteration to determine if a produce item is considered fresh-cut for the purposes of the FTL.
  • The guidance clarifies that the rule’s monetary exemption for farms with average annual sales revenue of less than $25,000 over the past three years relates to the value of all produce sold by the firm, regardless of whether it is on or off the FTL. The monetary threshold also does not include non-produce items, such as for farms that also make other agricultural products such as dairy. The agency also acknowledges that any farm that qualifies for the monetary exemption under the FSMA Produce Safety Rule is also exempt from the traceability rule, which should minimize work by entities to ascertain their compliance obligations. Firms should consider maintaining appropriate documentation and regularly reconfirming that they remain under the monetary threshold to demonstrate they qualify for the exemption.
  • Comments are due on the draft guidance 90 days after the date of publication in the Federal Register – May 21, 2026. Stakeholders should evaluate the guidance closely and identify additional examples, scenarios, and questions the agency should address within the structure of this document.

To contact the author of this item, please email Jared Rothstein ( jrothstein@agencyiq.com)
To contact the editor of this item, please email Karen Early ( kearly@agencyiq.com).

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FDA revokes AOAC methods of analysis policy, affecting food and cosmetic testing

By Xiaolu Wang, Esq.

The FDA has finalized a rule revoking its long-standing policy of defaulting to certain AOAC International methods of analysis in enforcement programs when no method is specified in regulation. The move eliminates a provision incorporated in 21 CFR 2.19 and shifts the agency toward identifying preferred analytical methods through internal guidance and compliance resources.

The decision follows significant industry opposition and raises questions about regulatory predictability, global harmonization, and how manufacturers should evaluate testing methodologies in the absence of AOAC’s default status. While use of AOAC methods is not prohibited, the revocation may alter how analytical standards are selected and defended in enforcement contexts.

This AgencyIQ analysis explores the regulatory rationale, stakeholder concerns, and practical implications for food and cosmetic manufacturers operating domestically and internationally.

Fill out the form to read the full analysis.

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FDA revokes AOAC methods of analysis policy, affecting food and cosmetic testing

The FDA revoked a long-standing agency policy on using certain methods of analysis published by the AOAC International in its enforcement programs, if one is not prescribed in a regulation. This Feb. 19 rule could bring uncertainty to the food and cosmetics industries, both of which rely on AOAC methods of analysis.

By Xiaolu Wang, Esq. | Feb 19, 2026 5:27 PM EST

Background: AOAC International and its Official Methods of Analysis

  • Established in 1884 as the Association of Official Agricultural Chemists, the AOAC is an independent, non-profit membership association of analytical science professionals across government, industry, and academia worldwide. It was part of the FDA for “more than 50 years before it became an independent organization in 1979.” In 2019, the organization refreshed its strategy and officially changed its name to Association of Official Analytical Collaboration International, or AOAC.
  • One of AOAC’s most prominent publications is the Official Methods of Analysis, which contain approved methods that have undergone “rigorous, systematic scientific scrutiny to ensure they are highly credible and defensible.” Its Official Methods of Analysis program assesses methods of analysis, including chemistry methods, microbiology methods, and molecular biology methods, through its expert panels and approves them following the panel’s review and approval. The approved methods must be accurate, precise, fit for purpose and validated. They must also perform consistently in various personnel, equipment, location and laboratory arrangements.
  • The latest edition of the Official Methods of Analysis was published in 2023, and contains more than 3,000 validated methods aimed at ensuring food and product safety. It covers a broad range of products, including agricultural chemicals, food, infant formula, dietary supplements, cosmetics and drugs. These analytical methods are widely recognized internationally and may offer legal defensibility for tested products.

Background: Proposal to revoke the Methods of Analysis Regulations and comments received

  • The FDA issued a draft rule in 2022, proposing to revoke the methods of analysis regulation, which states the agency’s policy to default to certain methods of analysis developed by AOAC in its enforcement programs, if no method of analysis is prescribed in a regulation. Codified in 21 CFR 2.19, the policy limits these analytical methods to those prescribed in the 13th edition of AOAC’s “Official Methods of Analysis of the Association of Official Analytical Chemists” and its supplements, which are published in the annual “Changes in Methods” documents. These methods are incorporated by reference, when available and applicable. In the absence of an AOAC method, the regulations require the FDA to “furnish a copy of the particular method, or a reference to the published method, that the Food and Drug Administration will use in its enforcement program.”
  • In the proposal, the FDA justified the revocation by stating that the regulation is “unnecessary as a general matter.” The agency also indicated that it was “more appropriate, flexible, and efficient to identify the Agency’s preferred methods of analysis in documents such as the Office of Regulatory Affairs Laboratory Procedures Manual, FDA compliance programs, and other resources.” The agency also suggested that maintaining a general reference to the 1980 edition of the Official Methods document is archaic when updated methods of analysis may exist.
  • Following the proposal’s issuance, the FDA opened a public consultation and received 40 comments, most of which were in opposition. The AOAC countered the FDA’s argument that the revocation would afford the agency more flexibility and efficiency to identify its preferred methods of analysis, pointing out that AOAC was better equipped to update these methods and “help solve unexpected analytical problems that may arise,” due to its multiple methods to publish new and updated methods. AOAC also challenged the FDA’s plan to replace the AOAC’s methods, taking issue with the agency’s statement that updated methods simply “may exist,” which could call into question the integrity of these methods due to a lack of rigorous review. The Institute of Food Technologists similarly took issue with the agency’s justification that the Official Methods document was outdated and unnecessary, saying “AOAC has updated and added new methods of analysis numerous times since 1980, and FDA is currently using many of them.”
  • The AOAC also disagreed with the FDA’s cost benefit analysis, pointing out the potential economic cost of revoking the regulation, which had facilitated timely regulatory actions and provided legally defensible methods for the U.S. during international trade disputes. The AOAC also touted the broad reach of its methods of analysis and their cost-saving effects for the federal government, citing OMB Circular A-119, which recognizes that voluntary consensus standards “eliminate the cost to the government of developing its own standards” and “promote efficiency and economic competition through harmonization of standards.”
  • AOAC’s comments were echoed by a host of other companies, nonprofit organizations, and laboratories. MilliporeSigma requested that the FDA clarify the process for “preferred and required test methods and resources for enforcement activities to avoid unnecessary ambiguity for those selecting appropriate test methods for product safety.” Many also stressed the value of AOAC’s methods, focusing on the rigorous reviews products undergo before being approved for use. The American Frozen Food Institute expressed similar concerns, emphasizing the importance for methods used for FDA’s enforcement purposes to “categorically pass the muster of the broader scientific community within and outside the agency.” “We believe that any analytical method and its criteria and specifications for intended use; general process of development of an analytical method; and validation of an analytical method, used specifically for enforcement purposes, need to be scientifically vetted, peer-reviewed, and validated across multiple laboratories,” the Institute said, a sentiment shared by the FMI – The Food Industry Association, the Arizona Department of Agriculture, and the Consumer Brands Association, representing another 12 national trade associations. Laboratories, such as the Eurofins Scientific and the Q Laboratories both strongly opposed the proposal, citing concerns over losing analysis methods that have undergone rigorous, systematic, and independent scientific scrutiny.
  • Many also commented on the potential impact on the harmonization of global analysis methods. The Institute of Food Technologists, for instance, pointed out that Codex Alimentarius Commission references AOAC as an acceptable source for methods of analysis related to global trade regulations on food and agriculture products. The FDA’s revocation would “likely be harmful regarding global regulatory harmonization efforts at Codex, and could potentially create inadvertent trade barriers for the USA with other countries and inhibit economic activity.” Takashi Hirao, president of the AOAC INTERNATIONAL JAPAN SECTION, also highlighted that the Official Methods of Analysis is widely used as “the bible of analytical methods in government, private companies, and analytical laboratories” in Japan, referenced Japanese official methods, further amplifying the influence of these methods and the potential impact of the revocation on global trade. Protein Industries Canada also submitted similar comments addressing the potential global impact on the proposed revocation.
  • There were also comments supporting the proposal from a representative from several Texas state agencies. “Utilizing only AOAC methods to regulate the food industry potentially erects barriers to trade,” Texas State Chemists Tim Herrman wrote. The Association of Public Health Laboratories took issue with AOAC’s official approval process for their methods of analysis, which the organization characterized as “time-consuming and expensive.” It also pointed out that fully approved official methods do not always take advantage of the latest technological advances available. Although the APHL did also stress the importance of access to any unpublished updates for Laboratory Information Bulletin (LIB) methods that are not offered publicly.

Finalized revocation

  • The FDA finalized the proposal on Feb. 19, 2026, officially revoked the default use of the 1980 Official Methods of Analysis of the Association of Official Analytical Chemists, including its supplements, in the agency’s enforcement programs, absent a method of analysis prescribed in a regulation.
  • In the final rule, the FDA noted that the method of analysis regulation is “unnecessary as a general matter.” Instead, the agency believes it is “more appropriate, flexible, and efficient” to identify the agency’s preferred methods of analysis in internal documents, such as compliance program guidance documents, agency methods compendia, and other resources, because it is “not FDA’s preferred policy” to always use the 13th edition of AOAC’s Official Methods of Analysis and its supplements for enforcement programs when the method is not prescribed by statute or regulation, citing the need to update the methods of analysis that the agency uses “more frequently and efficiently as the science and technologies advance while continuing to maintain transparency about FDA analytical methods,” a viewpoint directly disputed by the AOAC in its comments on the proposal.
  • The FDA addressed the concerns over the repeal of this agency policy, focusing on the potential lack of validation of newly developed methods of analysis, loss of credibility of many analytical methods currently used by governments and the industry, and industries’ heavy reliance on these methods.
  • In general, the FDA pointed out that revoking this policy does not preclude anyone from using AOAC’s methods of analysis, including both the FDA and industries. The agency also reassured stakeholders that the analytical methods that it uses “undergo rigorous qualification, validation, and fitness-of-use in accordance with international standards, including the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 accreditation framework” and remains “committed to using the appropriate methods for any given analysis, whether or not the methods are AOAC official methods.”
  • The FDA further cited certain analytical methods used in the foods program, which “have a defined validation status and are currently used by FDA regulatory laboratories.” The validation “may have been established through the FDA Foods Program Method Development, Validation, and Implementation Program using the Foods Program Method Validation Guidelines or by internal FDA Foods Program committees that have established the equivalency of the method validation level to the FDA guidelines,” the agency added. Additionally, the agency confirmed that FDA’s existing manuals and guidelines recommending the use of AOAC official methods of analysis remain valid and are not affected by the final rule.
  • Regarding the revocation’s potential impact on the credibility and standing of the AOAC methods, the FDA stated that the final rule does not create new testing requirements nor prevent industry from using AOAC official methods, suggesting that the impact would be minimal due to the limited scope of the regulatory changes introduced. The FDA also advanced similar responses to concerns over the loss of standing of thousands of methods of analysis used by industry and governments worldwide, arguing that the FDA’s revoked policy has been traditionally applied to its enforcement programs only and “does not address or establish which methods of analysis are used ‘as a basis for trade disputes under [the WTO]’ or any other forum external to FDA.” Additionally, the final rule does not prevent anyone from using these methods, including the WTO.
  • The FDA also responded to comments requesting revision, instead of revocation, of the methods of analysis regulation, arguing that these comments only request language changes to reflect the use of the latest versions of AOAC’s Official Methods of Analysis, but still allow the use of AOAC official methods “at the exclusion of other, potentially more suitable methods.”
  • The FDA also highlighted its public-facing resources that provide analytical methods that it intends to use, addressing concerns that the revocation may increase uncertainty and lower predictability for the industry to determine which methods would be appropriate for use. The agency listed the laboratory methods for food as an example of resources containing “some of the analytical laboratory methods” the FDA uses, along with the Compliance Program 7321.008 Dietary Supplements.
  • Lastly, the agency determined that there are no costs associated with this final rule, as “revocation of § 2.19 will not change Agency current practice.” On the contrary, there may be qualitative benefits because “there will no longer be any inefficiencies due to keeping unnecessary regulations on the books.”

Analysis and next steps

  • The agency described the final rule as eliminating an unnecessary regulation, representing another deregulatory effort from the FDA. This move will give the agency more flexibility in determining which analytical methods to use in its enforcement programs, such as those used for sample testing.
  • The change will likely increase uncertainties for food and cosmetic manufacturers. While use of AOAC’s official analytical methods is not prohibited, AOAC’s standing and credibility will likely take a hit when it is no longer the first choice for the FDA’s enforcement programs when a method of analysis is not otherwise prescribed in the regulation. Manufacturers may switch to other less expensive analytical methods, for instance, especially when the FDA has yet to establish a comprehensive set of analytical methods capable of replacing AOAC’s Official Methods of Analysis.
  • With the increased uncertainty, it’s more crucial to keep up with the FDA’s internal resources on analytical methods, such as the FDA Laboratory Methods for Food, including the Pesticide Analytical Manual (PAM), Chemical Analytical Manual (CAM), and Bacteriological Analytical Manual (BAM), Compliance Policy Guide, and the Food Compliance Programs.
  • Revocation of AOAC’s status in the CFR could create a vacuum for comparable analytical methods to fill. In addition to the FDA’s internal resources, several other organizations’ methods of analysis may now be considered for use in the agency’s enforcement programs, such those of the International Organization for Standardization and the International Dairy Federation.
  • This final rule could have a sizable impact on companies operating internationally. AOAC’s methods of analysis are widely adopted by governments globally, sometimes directly into domestic regulations and standards by reference, as the FDA once did in its methods of analysis regulation, conferring official status to these methods in those markets. As Takashi Hirao’s comments pointed out, Japan’s Food Labeling Standard uses the enzyme-gravimetric method (AOAC 985.29) and enzyme-HPLC method (AOAC 2001.03) for dietary fiber analysis and AOAC 920.97 for lipid analysis of roasted coffee beans.
  • Switching away from these analytical methods could create barriers and compliance challenges for companies that manufacture and market products globally, given the broad reach of the AOAC’s methods of analysis. Additionally, when the FDA conducts inspections of foreign food facilities under the Food Safety Modernization Act, ambiguity may also arise as to whether these inspections rely on AOAC methods that are part of the local standards. This uncertainty is particularly acute considering that FSMA requires importers to verify that foreign food suppliers meet FDA safety standards, including providing an equivalent level of protection as that provided by the agency’s hazard analysis and risk-based preventive controls and current good manufacturing practices rules. The potential for AOAC’s methods to offer legal defensibility in courts around the global, as the organization claimed, could also pose additional challenges when companies move away from these methods, as it’s unclear whether the replacement methods may offer the same legal protection.

To contact the author of this item, please email Xiaolu Wang ( xwang@agencyiq.com).
To contact the editor of this item, please email Karen Early ( kearly@agencyiq.com).

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White House reviewing FDA proposed rule on distributed manufacturing, foreign facility registration

By Laura DiAngelo, MPH and Ned Pagliarulo

The White House is reviewing a proposed FDA rule that could update registration and listing requirements for entities involved in distributed drug manufacturing as well as certain foreign establishments. The proposal comes as regulators increasingly examine how emerging manufacturing models and globalized supply chains fit within existing regulatory frameworks.

The rule could clarify how distributed manufacturing facilities register with the FDA and codify statutory changes affecting foreign establishments involved in producing drugs imported into the United States.

This AgencyIQ analysis examines how the proposed rule could reshape regulatory oversight of distributed manufacturing and international drug supply chains.

Fill out the form to read the full analysis.

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White House reviewing FDA proposed rule on distributed manufacturing, foreign facility registration

The FDA has submitted for White House review a new proposed rule covering registration and listing requirements for entities involved in distributed manufacturing as well as certain foreign firms. The rule could build on recent FDA work around distributed manufacturing, while helping close gaps in the agency’s monitoring of medical supply chains.

By Laura DiAngelo, MPH and Ned Pagliarulo | Mar 6, 2026 1:56 PM EST

Registration and listing of drug products: A quick background

  • Under section 510 of the Federal Food, Drug and Cosmetic Act and the implementing regulations at 21 CFR part 207, the entities that manufacture, prepare, propagate, compound, or process drugs – including human and veterinary drugs, as well as biological products – must register their establishments with the FDA. The requirements apply to establishment owners and operators, known as “registrants.” The registration information must include listing information for all drugs, as defined under the FD&C Act, in commercial distribution. The FDA most recently finalized a comprehensive regulation on drug registration and listing in 2016, following legislative updates under the FDA Amendments Act in 2007 and the FDA Safety and Innovation Act that were codified in that update to the 2016 rule.
  • According to part 207, the term “commercial distribution” means “any distribution of a human drug” except under investigational use regulations, or internal or interplant transfers between registered establishments under common ownership and control. Foreign establishments are also included in these requirements when the product is in commercial distribution in the U.S. In general, all “manufacturers, repackers, relabelers, and salvagers,” as well as private label distributers, must register all foreign and domestic establishments that conduct these activities, unless otherwise exempted. Exempted organizations include pharmacies and public health agencies, for example.
  • Registration should provide information about the establishment’s owner and physical address, registration number and unique facility identifier, and information about the activities performed at the establishment. Foreign registrants also need to provide information about their local U.S. agent, as well as “each importer in the United States of drugs manufactured, repacked, relabeled, or salvaged at the establishment that is known to the establishment; and each person who imports or offers for import such drug to the United States.” Firms must update their registrations biannually and provide the list of products at that time, including updates that “reflect all changes that have occurred since the last annual review and update.” According to provisions of the FDA Amendments Act of 2007, registration and listing information must be provided electronically; use of the Electronic Drug Registration and Listing System is described in 2009 guidance.
  • The FDA uses data from drug establishment registration and listing in several ways, including postmarket surveillance, pharmacovigilance, inspections, importation monitoring, and shortage/supply chain surveillance.

As drug manufacturing evolves, regulations may need to change as well

  • Industry and regulators have increasingly discussed opportunities for advanced manufacturing technologies and methods, including distributed manufacturing and point-of-care manufacturing. Distributed manufacturing is defined by the FDA as “a decentralized manufacturing strategy with manufacturing units that can be deployed to multiple locations.” It is one of four advanced manufacturing technologies prioritized by the Center for Drug Evaluation and Research’s Framework for Regulatory Advanced Manufacturing Evaluation initiative. In 2022, the agency issued a discussion paper and co-hosted a workshop on distributed manufacturing, also updating its action plan on the topic in 2023.
  • The 2022 discussion paper flagged several existing regulatory barriers to distributed manufacturing, including regulations that don’t readily accommodate facilities that are mobile units. The paper highlighted current regulations that require individual evaluations/inspections, application and submission requirements related to site changes, and the impact on pharmaceutical quality systems that may be assessed at the facility level. Registration and listing requirements would likely need to be updated to account for distributed manufacturing methods, including by clarifying how a PQS would account for multiple mobile distributed manufacturing units. The 2023 action plan built on these discussions, folding in stakeholder feedback and zeroing in on the specific regulatory requirements that would apply to a firm seeking to implement a distributed manufacturing strategy. At the same time, the plan cited stakeholder feedback clarifying that not all distributed manufacturing units are mobile, and that conversely, point-of-care manufacturing “describes a manufacturing location, rather than a manufacturing technology,” so not all POC manufacturing would be considered distributed manufacturing.
  • Manufacturing is also increasingly globalized. During the Covid-19 pandemic, lawmakers and regulators both raised concerns about the FDA’s visibility into the drug supply chain, particularly as it relates to foreign establishments and drug components.
  • The PREVENT Pandemics Act, enacted as part of the 2023 Consolidated Appropriations Act, included a provision intended to address these concerns. As noted in the Congressional Research Service report on the legislation, section 2511 seeks to address data gaps by “specifying that the registration requirements stated therein are applicable regardless if the product undergoes further preparation, propagation, compounding, or processing at a separate foreign facility prior to importation or offer for importation within the United States.” The statutory text states that the registration and listing requirements apply “regardless of whether the drug or device undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported or offered for import into the United States.”

A proposed rule under White House review could offer updates

  • The White House’s Office of Information and Regulatory Affairs is now reviewing a new FDA proposed rule on “drug establishment registration and drug listing requirements” for entities involved in distributed manufacturing, as well as “certain foreign establishments.” According to an update on OIRA’s website, the office received the proposed rule from the FDA on March 4, 2026. Once OIRA, which reviews regulations for policy consistency, has cleared the rule, the FDA can make it public. Previous research by AgencyIQ found OIRA takes a median of just over three months to review proposed rules, although timelines vary widely.
  • The rule aims to revise 21 CFR 207 in two ways. According to a description in the Office of Management and Budget’s Unified Agenda, the rule seeks to clarify that registration and listing requirements are applicable to foreign drug manufacturers involved in making drugs imported or offered for import into the U.S., even if the manufacturers don’t directly import or offer those products themselves. This in response to the statutory changes under 2511 of the PREVENT Pandemics Act; the proposed rule might seek to codify these provisions into regulation.
  • The rule will also set registration requirements for “establishments” that engage in distributed manufacturing. As noted previously, the FDA has been conducting a review of existing regulations that would be applicable for firms considering distributed manufacturing, identifying registration and listing as a key concern. This proposed rule might begin to clarify the agency’s thinking about how entities with distributed manufacturing units would register with the agency, and how listing would be considered – potentially including when units are moved.
  • The FDA missed its deadline for developing a rule covering foreign registration requirements, which was due no later than two years after PREVENT Pandemics’ enactment, or December 2024.

Analysis and what’s next

  • For now, the proposed rule is likely to focus on the registration and listing impact for distributed manufacturing. The agency’s discussion paper and action plan list a bevy of regulations that would likely need to see an update, clarification or would otherwise be applicable to distributed manufacturing implementation. While these do include various sections of 21 CFR 207 (registration and listing), many other regulations apply here, including the current good manufacturing practice regulations at 21 CFR 211. For now, this regulation appears focused on amending and clarifying the registration and listing requirements for distributed manufacturing, as well as the codification of the policy updates for foreign establishment registration under PREVENT Pandemics.
  • The agency is moving forward with other distributed manufacturing-related policies via guidance. For example, distributed manufacturing is also the topic of a forthcoming CDER guidance titled “Distributed Manufacturing – Recommendations for Application Content,” added to its recently released regulatory agenda for 2026. [Read AgencyIQ’s full analysis of the agenda here.] The title suggests the FDA may be putting together recommendations on how sponsors can describe distributed manufacturing approaches in relevant submissions to the agency, a topic cited as a barrier in the discussion paper and action plans. CDER is also still developing a separate guidance, “Approaches to Meeting CGMP Requirements for Distributed Manufacturing” that has appeared on prior regulatory agendas.
  • The FDA is also continuing to weigh how to support innovative manufacturing more broadly. The agency finalized a strategy document in December 2025 that indicates it will support “prioritized advanced manufacturing technologies” through means such as guidance and meetings with stakeholders. [Read AgencyIQ’s analysis of the document here.]

Featuring previous research by Amanda Conti.

To contact the authors of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com) or Ned Pagliarulo ( npagliarulo@agencyiq.com).

To contact the editor of this item, please email Kari Oakes ( koakes@agencyiq.com).

Key documents and dates

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Senate TSCA draft redefines conditions of use, adds tiered review system

By Nathaniel Gajasa, Esq.

The Senate has entered the debate over chemical safety reform with draft legislation that would revise key elements of the Toxic Substances Control Act (TSCA). The proposal focuses heavily on redefining “conditions of use,” a critical concept that determines the scope of the EPA’s risk evaluations for chemical substances.

The draft would also introduce a tiered framework for reviewing new chemicals and impose limits on how the EPA considers reasonably foreseen uses during risk evaluations — changes that could significantly alter the agency’s review process and regulatory predictability.

This AgencyIQ analysis explores the Senate proposal’s potential impact on chemical regulation, industry compliance and the broader TSCA reform debate.

Fill out the form to read the full analysis.

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Senate TSCA draft redefines conditions of use, adds tiered review system

The Senate entered the TSCA reform conversation with a draft published last week, focusing heavily on redefining conditions of use and creating a tiered framework for new chemical reviews. This analysis is the first in a series digging into the Senate draft language, focused on the proposed limits to “conditions of use,” which define the scope of the EPA’s risk evaluations under TSCA.

By Nathaniel Gajasa, Esq. | Mar 4, 2026 4:33 PM EST

Background: TSCA and recent push to amend chemical reviews

  • The EPA implements the Toxic Substances Control Act, which provides the basis for much of the chemical regulation in the U.S. TSCA underwent numerous changes in 2016 with the Lautenberg amendments, which were the first truly major changes to the law in 40 years. TSCA covers reporting, recordkeeping, premarket reviews and regulation of thousands of chemical substances listed in the TSCA Chemical Substance Inventory. The inventory contains all existing chemical substances manufactured, processed or imported in the U.S. that do not qualify for an exemption or exclusion under TSCA. The statute excludes certain substances that are governed by other U.S. laws such as pesticides, cosmetics, drugs, food, and food additives.
  • In the years since TSCA was amended, the EPA’s Office of Chemical Safety and Pollution Prevention has struggled to keep up with new mandates and deadlines. There is a significant backlog of new chemical submissions awaiting review and risk evaluation, and risk management rules to regulate existing chemicals undergo frequent reconsiderations and legal challenges. This has amplified the calls for legislative reforms to the act.
  • EPA’s fee collection authority expires at the end of the fiscal year, Sept. 30, unless Congress reauthorizes the fee collection by then. TSCA authorizes the EPA to collect user fees sufficient and not more than reasonably necessary to defray the cost related to chemical substances administered under Sections 4, 5 and 6, along with certain activities relating to confidentiality claims under Section 14. The statute allows the agency to recover no more than 25 percent of its costs of implementing the relevant TSCA program provisions. The funds collected must be deposited into the TSCA Service Fee Fund. The upcoming reauthorization presents an opportunity for stakeholders, such as industry, to examine the implementation of TSCA and advocate for potential changes to the act.
  • On Jan. 15, 2026, the House Committee on Energy and Commerce released a draft bill amending TSCA and renewing EPA’s fee collection authority. The draft legislation introduces major revisions to the nation’s framework chemical safety law, targeting premarket review of new chemicals – a process the industry has long criticized as stalling innovation. The bill also seeks to revise risk evaluation and risk management of existing chemicals, testing, citizen petitions and information disclosure requirements. [Read AgencyIQ’s analysis on the TSCA amendment bill.]

Now the Senate provides its version of a TSCA reform bill: Redefining conditions of use

  • On Feb. 26, the Senate Environment and Public Works committee released its own draft language, the “Toxic Substances Control Act Fee Reauthorization and Improvement Act of 2026,” limiting and clarifying the scope of “conditions of use,” introducing a tiered review process, and creating and expanding exemptions from certain risk evaluation procedures for certain classes of substances.
  • The Senate draft would set new limits for the scope of COUs by further defining when a use is “intended, known, or reasonably foreseen.” Defining COUs can be a make or break issue when the EPA reviews premanufacture notices under TSCA, as COUs determine the scope of the agency’s risk evaluation and, ultimately, whether it permits the use or imposes risk management requirements under Section 5(F).
  • The bill creates a set of restrictions on how the EPA evaluates COUs. The EPA would no longer be able to consider uses that are “merely hypothetical circumstances,” nor would it be able to consider misuse of the substance or other conditions that violate federal laws or regulations as reasonably foreseen. Similarly, submitters would be able to provide information “that demonstrates broadly applied and effective exposure control measures that are routinely used,” creating a “rebuttable presumption that the lack of such measures is not reasonably foreseen.” This would require the EPA to consider both mandatory and voluntary workplace safety controls during risk evaluations.
  • The bill would require the EPA to have a “cognizable basis” before it can determine that a COU is reasonably foreseen and thus within the scope of TSCA review. The term “cognizable basis” refers generally to a reason that courts will recognize as valid, though the draft imposes no additional constraints for a cognizable basis. Instead, the change would put the onus on reviewing courts to define the term over time and within the context of the other limits on COUs.

Analysis and next steps

  • The Senate Environment and Public Works Committee will hold a legislative hearing on the discussion draft March 4, with conditions of use likely to be tied to industry concerns regarding TSCA review predictability. EPW Chair Sen. SHELLEY MOORE CAPITO (R-W.Va.) is expected to lead the session. She has framed the draft as a focused attempt to improve the EPA’s new chemicals program, restore predictability to reviews and address long-standing concerns about review delays. In a statement previewing the hearing, Capito emphasized that “we need to improve our current systems so we can bring better, safer and more innovative chemicals to market – with the predictability and resources to get it right.” This signals a strong intent, at least from the Republican members of the EPW committee, to advance the bill’s updates to the TSCA risk review framework, including the restrictions on COUs.
  • Environmental groups “expect the minority to reject it outright,” according to reporting by POLITICO’s Ellie Borst quoting DANIEL SAVERY, senior legislative representative at Earthjustice. The proposal did not include involvement from either of the top democrats, SHELDON WHITEHOUSE (R.I.) or JEFF MERKLEY (Ore.), each the ranking member of the committee and subcommittees involved, according to reporting by Borst. Their absence from the drafting process suggests a low likelihood of buy-in from Senate Democrats and sets the stage for a potentially highly partisan review process when the committee convenes.
  • While there will likely be significant pushback from Senate Democrats on the bill language, House lawmakers have already demonstrated support for imposing new limits on COUs, having included similar, though notably more stringent, restrictions on the EPA’s authority to define COUs in their discussion draft. Their version would limit COUs to conditions under which a substance is “intended or known to be or reasonably foreseen as more likely than not to be” used (emphasis added), which would exclude real but unlikely use scenarios. The House draft would further restrict the EPA’s risk evaluation only to those COUs identified by the submitter, omitting other equally likely uses.
  • The Senate draft would limit the scope for conditions of use, without going as far as the House version to restrict the EPA’s review. Submitters would still get significant new input into what COUs the EPA considers, allowing them to create a “rebuttable presumption that the lack of such measures is not reasonably foreseen” by demonstrating “broadly applied and effective exposure control measures that are routinely used.” Short of defining the entire universe of COUs for risk evaluation review, as with the House version, the Senate language allows submitters to exclude conditions where users would be exposed but for generally recognized safety measures, including required workplace safety controls and industry safety standards, provided they are common enough to be considered “broadly applied” to a reviewing court. While the House draft language does not explicitly consider the use of voluntary-but-widespread safety practices to limit COUs, industry could invoke their use to argue that certain workplace exposures are not likely to occur, potentially defeating a finding that some exposure is reasonably foreseen for the purposes of the EPA’s review.
  • Both versions also represent a rejection of “whole-of-chemical” approaches, suggesting that, regardless of which version ends up gaining traction, Congress will use COUs to limit comprehensive review of chemical uses and exposures. Despite the differences in approaches, the limits on COUs proposed by both chambers would directly address a core component of the EPA’s Biden-era approach where the agency did not assume that workers wore personal protective equipment when evaluating exposure risks, even where an existing Occupational Safety and Health Administration rule required their use. The Senate draft achieves this by excluding uses that violate “any other Federal law (including regulations) or that represents misuse of a substance” and creating a rebuttable presumption of exposures supported by submitter-provided demonstrations of broadly applied and effective exposure control measures. The House version addresses the issue of overlapping OSHA requirements directly, requiring the agency to both (1) “consider any exposure limits or thresholds relating to the chemical substance developed by another Federal department or agency,” and (2) “not assume noncompliance with any such applicable law or regulation relating to the chemical substance, including any occupational safety and health standard.” Taken together, these directives require the EPA to incorporate the permissible exposure limits and mandatory controls under OSHA’s Subpart Z regulations when it reviews chemicals under TSCA.
  • The “cognizable basis” standard would create major new uncertainty and potentially a high evidentiary bar for the agency’s risk evaluations. The standard is not used for fact-finding under other laws implemented by the EPA and, when used in other administrative law contexts, generally refers to a requirement for verifiable, non-speculative justification for an agency’s action. While this increased burden has the potential to limit the scope of the EPA’s review under Section 5, it could also potentially further slow the new chemical review process. For the EPA, demonstrating a negative – that a particular use is not hypothetical – could be more difficult than modeling worst-case exposure scenarios and could require significant additional time to build an administrative record to justify a reviewed COU. This additional effort could lead the agency to extend review periods past the standard deadlines, which would remain permissible under the tiered review approach, and undermine the predictability sought by industry.

Featuring previous research by Xiaolu Wang.
To contact the author of this item, please email Nathaniel Gajasa ( ngajasa@agencyiq.com).
To contact the editor of this item, please email Karen Early ( kearly@agencyiq.com).

Key documents and dates

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Prevention and treatment a major focus of FDA’s food allergy regulatory push

By Scarlett Salem, MS, MPH

The FDA is expanding its focus on food allergies beyond labeling and allergen thresholds, with agency leadership increasingly emphasizing prevention strategies and new therapeutic approaches. Recent public meetings and expert panels convened by the agency highlight growing scientific consensus around early allergen introduction and the potential role of immunotherapies in managing food allergies.

At the same time, discussions exposed key regulatory tensions — particularly around how prevention-related messaging can appear on food labels without triggering drug claims, as well as the clinical and reimbursement challenges involved in scaling treatment.

This AgencyIQ analysis examines how evolving science, regulatory constraints and policy priorities are shaping the FDA’s broader food allergy agenda.

Fill out the form to read the full analysis.

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Prevention and treatment a major focus of FDA’s food allergy regulatory push

After convening a public meeting and two days of stakeholder listening sessions on allergen thresholds, the FDA turned this week to prevention and treatment, with Commissioner MARTY MAKARY urging earlier allergen introduction and faster therapeutic development as the agency weighs broader changes to labeling and enforcement policy.

By Scarlett Salem, MS, MPH | Feb 27, 2026 2:02 PM EST

Background

  • As the Trump administration and FDA leadership elevate food allergies as a policy priority, the FDA has begun laying groundwork for potential changes to how allergens are labeled, regulated and managed across the food system. On Feb. 18-20, the agency held a virtual public meeting and listening sessions on risk-based thresholds for major food allergens. The event convened industry, clinicians, patient advocates and regulators to gather feedback on how such thresholds might work in practice. Those discussions centered on moving beyond the current binary allergen framework toward a dose-response model grounded in population reference doses such as the FAO/WHO ED05 benchmark. Stakeholders broadly agreed that precautionary allergen labeling should be standardized and reflective of actual risk. Many supported standardized, science-based thresholds, while cautioning that implementation would require education, analytical clarity, and safeguards for highly sensitive individuals.
  • The Feb. 25 expert panel, recorded on YouTube, was positioned as the next step in that process, shifting the focus from food regulation to prevention, etiology and treatment. The session featured FDA Commissioner MARTIN MAKARY opening and closing the event and co-moderation led by GIDEON LACK of King’s College London and RICHARD IORIO, a principal medical advisor to Makary at the FDA, followed by presentations from academic, NIH, and FDA experts and structured discussion.

Overview of the panel discussion

  • Makary opened the session by sharply criticizing past guidance that advised parents to delay allergen introduction. He called it a “tragedy of medical dogma,” arguing that advice to avoid peanut and other allergens until age three ignored oral tolerance, “whereby the body’s developing immune system benefits from exposures to allergens as early as five, six, seven months of age.” He went on to say, “Our job today is not to look back, it’s to look ahead – to talk about prevention, best practices, the latest science, and new therapeutics to help the kids suffering from these allergies.”
  • Panelists focused on Immunoglobulin E mediated food allergies, which can trigger severe life threatening reactions including anaphylaxis, which now affect roughly 8% of U.S. children and about 10% of adults. Epidemiologist RUCHI GUPTA of Northwestern University said approximately 33 million Americans have food allergies and estimated the condition costs nearly $25 billion in annual economic costs, much of it borne by families.
  • A dominant theme was timing and early intervention. Lack, a pediatric allergist, argued that early prevention, early diagnosis and early treatment should anchor policy. “The pendulum has shifted where we’re exposing early to prevent and diagnose early and treat early,” he said. Panelists pointed to the LEAP study, under which high risk infants who consumed peanut regularly beginning in infancy saw about an 80 percent reduction in peanut allergy, with protection persisting into adolescence. CORINNE KEET of the University of North Carolina at Chapel Hill emphasized that eczema is the strongest early life risk factor for food allergy and warned that limiting early introduction guidance to infants with severe eczema misses most children who will develop allergy. In her research, “each month that an infant delayed peanut introduction increased the risk by about 30%” between four and 11 months of age.
  • Discussion then shifted to food allergy treatment strategies. MICHELLE HUFFAKER of Stanford described oral immunotherapy as the only currently available therapy with disease modifying potential, particularly when started in toddlers. In one NIH funded trial, 71 percent of young children receiving daily peanut flour tolerated the equivalent of two tablespoons of peanut butter after treatment, and about one in five maintained tolerance after therapy was stopped for six months. EDWIN KIM of the UNC Food Allergy Initiative cautioned that access remains limited, noting that “only about 15 to 20 percent of U.S. allergists are highly active with OIT.” HUGH SAMPSON of Mount Sinai School of Medicine described biologics as promising but not curative on their own. “If you’re only doing omalizumab, you’ll get benefit while on omalizumab, but when you stop it, it all comes back again,” he said.
  • FDA officials addressed how those therapies move through the regulatory system. RONALD RABIN of the Center for Biologics Evaluation and Research explained that when a food is intended to “treat, mitigate or cure disease,” it is regulated as a drug. He acknowledged the burden of trials but emphasized that “we have erred on the side of safety.”
  • STEFANO LUCCIOLI of the FDA’s Human Foods Program connected the discussion back to labeling policy, reiterating that because prevention language can trigger drug classification, claims must be framed around “reduced risk.” FDA staff and panelists stressed that early-introduction messaging on packaging is constrained by how FDA distinguishes food claims from drug claims. Luccioli noted that “health claims … are voluntary,” and warned that “a health claim is just on a package, and people can’t get a full view of what that means.” Luccioli added that “when you use words such as prevention, that is a drug claim,” framing FDA’s current approach around “reduced risk” language rather than prevention claims. The FDA already permits limited peanut-related health claims. In 2017, the agency acknowledged a qualified health claim allowing language that introducing peanut in certain high-risk infants “may reduce the risk” of developing peanut allergy, based on the LEAP study. In 2021, the FDA completed review of a notification based on authoritative statements in the 2020–2025 Dietary Guidelines for Americans. Under that framework, manufacturers may use specific risk-reduction language, but only if it reflects the full guideline recommendation, including references to severe eczema or egg allergy, age-appropriate peanut-containing foods and consultation with a healthcare provider. Broader statements, simplified language and claims tied to egg were not authorized.
  • SUNG POBLETE, CEO of Food Allergy Research and Education, emphasized the daily burden on families and pushed for stronger implementation of prevention policy. She said, “The newly released 2025, 2030 Dietary Guidelines for Americans reinforce current evidence and strengthen national recommendations for early introduction of food allergens as a population-based prevention strategy, broadly for infants beginning at four to six months of age.” She urged the FDA to align labeling, WIC policy and therapeutic access, adding that regulations must “reflect patient realities and help translate evidence into everyday practice.”

Analysis

  • The sequencing of the week’s events makes clear that the FDA is working on two related – but distinct – fronts. One focuses on risk-based allergen thresholds and regulatory reform in the food space. The other focuses on prevention and treatment science. The Feb. 25 panel did not revisit threshold mechanics in depth, but the scientific discussion underscored how closely dose-response modeling, oral food challenges and immunotherapy development are connected. The same threshold science that could inform precautionary labeling also underpins how clinicians measure treatment response and remission.
  • One of the clearest regulatory tensions surfaced during discussion of early introduction claims. Panelists strongly endorsed early exposure to peanut and egg as preventive. But FDA officials emphasized statutory limits on how that message can appear on packaging. Luccioli stated that “health claims, first of all, you have to understand that they are voluntary,” and warned that “a health claim is just on a package, and people can’t get a full view of what that means.” He also clarified that “when you use words such as prevention, that is a drug claim,” underscoring that foods cannot legally claim to prevent disease.
  • Under the 2021 notification, the FDA permitted narrow peanut risk-reduction language tied to certain categories of high-risk infants and required inclusion of healthcare provider consultation language. Broader or simplified claims, including egg-related language, were not authorized. Expanding early introduction messaging would likely require revisiting that 2021 interpretation, entertaining a new qualified health claim petition, or relying on updated language in the 2025–2030 Dietary Guidelines for Americans to support a revised claim. Absent congressional change, the agency remains constrained to “may reduce risk” phrasing rather than “prevention.”
  • The panel also exposed a capacity bottleneck. While oral immunotherapy shows promise, Edwin Kim noted that “only about 15 to 20 percent of U.S. allergists are highly active with OIT.” Even if early introduction reduces incidence and early therapy improves outcomes, scaling treatment depends on reimbursement, staffing and specialty capacity. Payment policy and insurance barriers fall partly outside the FDA’s direct authority, but regulatory flexibility in trial design, product approval and labeling could influence how quickly new modalities reach broader clinical settings.
  • The format of the session shaped its scope. The panel began with formal scientific presentations, followed by moderated discussion based on pre-submitted questions. Those questions focused on whether more randomized trials are needed beyond peanut and egg, how immunotherapies should be positioned, whether eczema treatment can reduce risk and what role the FDA can play in expanding risk reduction claims. The structured exchange kept discussion within defined clinical and regulatory parameters.
  • Makary broadened the conversation at the end of the session, raising questions about microbiome research, antibiotic exposure, C-sections and ultra processed foods. Because he introduced many of these themes during closing remarks, there was limited opportunity for panelists to respond. Other experts mentioned the microbiome and hygiene hypotheses in scientific terms, but they largely remained centered on trial evidence, eczema prevention, immunotherapy development and regulatory pathways. That contrast suggests Makary is positioning food allergies within a broader food policy narrative while the scientific panel stayed focused on clinical evidence and regulatory feasibility.
  • Finally, the panel signaled that the discussion will continue beyond the meeting itself. Iorio, principal medical advisor with the FDA, said that a public docket would be (and now is) open for comment and said the organizers “will also try and draft a white paper to submit to our colleagues in the regulatory realm and see if we can all get on the same page and make some progress for our patients.” That step suggests the panel is intended not as a standalone event but as part of a coordinated effort to align scientific consensus, regulatory authority and policy direction.
  • Taken together, the discussion revealed strong alignment among researchers on early introduction and early intervention. The friction lies less in scientific disagreement and more in statutory language limits, regulatory implementation, clinical delivery capacity, and how threshold science may be operationalized. For FDA leadership, the central policy questions are not whether the science supports earlier exposure or therapeutic innovation, but how far existing authorities can stretch to reflect that evidence in labeling, treatment, and enforcement without triggering unintended regulatory consequences.

To contact the author of this item, please email Scarlett Salem ( ssalem@agencyiq.com)
To contact the editor of this item, please email Karen Early ( kearly@agencyiq.com).

Key documents and dates·