Federal Court Sets January 2028 Deadline For Changes To Key Elements Of Bioengineered Food Disclosure Regulations

The U.S. District Court for the Northern District of California recently issued a final remedy decision in a lawsuit challenging the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service’s (AMS’s) final rule implementing the National Bioengineered Food Disclosure Standard (BE Rule).¹ In its August 3, 2026 decision, the court prospectively vacated the rule’s exclusion from the disclosure requirements for “highly refined” foods containing no detectable modified genetic material, as well as the rule’s “quick response” (QR) code digital disclosure and text message disclosure provisions.² The prospective vacatur takes effect January 1, 2028. The court declined USDA’s request to delay the vacatur of the disclosure provisions until January 1, 2029. As a result, absent further judicial action, AMS will need to issue revised regulations and companies will need to make any corresponding changes by January 1, 2028.

The agency indicated in its 2026 regulatory agenda that it plans to issue a proposed rule to comply with the court’s decision in August 2026. Importantly, companies will need to wait to see the proposed and final rule to know whether any labeling changes are needed. There is a strong possibility that AMS will maintain the current detectability standard in the revised rule, but will rely on different legal authority than in the current regulations. The agency has also stated that it will complete a new study on consumer access to QR code disclosures, which could conclude that consumers have adequate access to the digital disclosure, in which case no additional elements would be required for the QR code disclosure and the agency could simply revoke the text message disclosure option, which is rarely if ever used.

Background

In a 2020 lawsuit filed against USDA, the USDA Secretary, and the AMS Administrator, plaintiffs –including retail stores that sell natural and organic food products, and food safety advocacy organizations – challenged the disclosure statute and implementing regulations issued by USDA. Plaintiffs primarily argued the regulations violate the Administrative Procedure Act (APA) because they (1) permit a text message disclosure option as an alternative to a digital disclosure; (2) require disclosures that use the word “bioengineered”; and (3) exclude highly refined foods that do not contain detectable amounts of bioengineered materials. In 2022, the lower court invalidated the text message disclosure regulation and denied plaintiffs' motion in all other respects. The lower court declined to vacate the text message disclosure regulation until AMS revised the final rule consistent with the court's decision. That is, USDA was given time to amend the regulations without a need for companies to immediately change their disclosure practices.

As brief background, the statute directed USDA to conduct a study to “identify potential technological challenges that may impact whether consumers would have access to the bioengineering disclosure through electronic or digital disclosure methods.” In the event USDA determined “that consumers, while shopping, would not have sufficient access to the bioengineering disclosure through electronic or digital disclosure methods,” the agency was directed to “provide additional and comparable methods” to access the disclosure. AMS hired Deloitte Consulting to conduct the study, and based on the results of the study, which was completed in July 2017, concluded that “consumers would not have sufficient access to the bioengineering disclosure through electronic or digital means under ordinary shopping conditions at this time.” To improve consumer access to the bioengineering information, AMS created a fourth disclosure option involving text messages, separate from the digital disclosure method. Under the final rule, companies could choose among the text disclosure statement on the label, symbol, text message, or the digital disclosure option. The digital option also requires a phone number on-pack that provides access to the disclosure.

Ninth Circuit Decision (2025)

In October 2025, the Ninth Circuit Court of Appeals held that the lower court abused its discretion in declining to vacate the digital disclosure and text message disclosure provisions that it held were invalid, and directed the district court to prospectively vacate those rules after receiving the parties’ input as to the proper form of such a prospective vacatur. Additionally, the Ninth Circuit reversed the lower court's decision to uphold AMS’s exclusion of highly refined foods that do not contain detectable modified genetic material from the definition of “bioengineered food.” The Ninth Circuit otherwise affirmed the lower court's decision, including upholding USDA's mandated use of the term “bioengineered” as opposed to “GMO.” The Ninth Circuit remanded the case to the lower court with instructions to (1) find unlawful the current detectability standard (while also leaving open the ability for AMS to craft a detectability standard based on its discretionary authority, which the court suggested could survive review); (2) remand the final BE Rule to AMS for revisions; and (3) determine whether any portions of the BE Rule should be vacated.³

District Court Proceedings on Remand (2026)

In March 2026, on remand, the district court granted summary judgment to the plaintiffs on the detectability issue, holding that, pursuant to the Ninth Circuit opinion, it was arbitrary and capricious for AMS to exempt from the “bioengineered food” definition, and therefore from the disclosure standard, foods where the modified genetic material is not detectable. The court then directed the parties to submit briefs addressing vacatur of the BE Rule’s (1) detectability provision, (2) QR code disclosure provision, and (3) text message disclosure provision.

In their remedy brief, plaintiffs urged the court to prospectively vacate all three provisions with an effective date of January 1, 2028. With respect to the two disclosure method provisions, plaintiffs wrote that the Ninth Circuit had already directed the district court to impose a prospective vacatur, leaving only the timing of the vacatur at issue. Plaintiffs contended that a January 1, 2028 effective date would, among other things, align with FDA’s and USDA’s uniform compliance date for food-labeling regulations published between January 1, 2025 and December 31, 2026, which applies to products introduced into commerce on or after January 1, 2028.⁴ According to plaintiffs, prospective vacatur that takes effect January 1, 2028, would therefore “allow manufacturers to incorporate the required changes into routine label updates and exhaust existing stock on the already established timeline contemplated and set by USDA and FDA.” Plaintiffs also contended that the 2028 effective date would be reasonable because manufacturers “increasingly rely on digital printing technologies and shorter production cycles” and stakeholders “have been on notice for nearly six years that these provisions were under a serious legal cloud[.]” 

In defendants’ response to plaintiffs’ brief, defendants did not oppose prospective vacatur of the detectability provision effective January 1, 2028. Defendants stated that “AMS’s error in relying on the incorrect statutory authority for defining the term bioengineered food to include a detectability standard is slight as evidenced by the Ninth Circuit panel’s conclusion that AMS could adopt a similar standard by invoking a different statutory provision.” They also stated that AMS intends to issue a proposed rule regarding the definition of “bioengineered food” and the scope of the standard in summer 2026, and publish a final rule by the end of 2026. Defendants, however, urged the court to delay the effective date of prospective vacatur of the disclosure method provisions until January 1, 2029, explaining that AMS intends to “stagger” its rulemaking efforts by addressing the disclosure method provisions and the detectability provision in separate rulemakings, and that the delay would provide AMS sufficient time to complete the former rulemaking without delaying the latter. Defendants also explained that the delay would afford regulated entities time to make any necessary label changes. According to the government, AMS had undertaken preparations necessary to conduct a new research study of consumer accessibility to electronic and digital disclosures, given technological developments since the agency's initial study in 2017. Specifically, in May 2026, the agency issued a solicitation notice for Request for Quotations to conduct a second study. The brief states that AMS expects to complete the study by winter 2026, publish a notice of proposed rulemaking regarding disclosure methods in spring 2027, and issue a final rule in fall 2027.

In their reply brief, plaintiffs then argued that the court should adopt plaintiffs’ proposed 2028 vacatur date for the disclosure method provisions rather than defendants’ proposed 2029 date. According to plaintiffs, defendants misapplied the relevant inquiry in contravention of the Ninth Circuit’s decision by effectively seeking remand without vacatur and allowing the rule to stand until it is potentially replaced. Plaintiffs contended that the key question is not if or when USDA will complete a replacement rulemaking, but rather how much time industry needs to transition to existing lawful disclosure methods (such as on-pack text or symbols) and to relabel or deplete existing inventory. Plaintiffs further argued, among other things, that “the structure of the inquiry and default of vacatur places the burden of persuasion on Defendants, … which they have not met here”; and that defendants failed to provide a compelling rationale why USDA has to “stagger” its rulemaking when the original rulemaking was done all at once.

On August 3, 2026, the district court issued its final remedy decision, ordering the prospective vacatur of the detectability provision, and the QR code and text message disclosure provisions, effective January 1, 2028. The court declined USDA’s request to delay the vacatur of the disclosure provisions until January 1, 2029 while the agency completes the rulemaking process for the replacement regulations.Citing the Ninth Circuit’s 2025 decision, the court reasoned that “[a]llowing an inadequate disclosure option to continue throughout the entirety of the administrative process for amending the regulations would itself perpetuate a disruption in consumer access to bioengineering disclosures.”

Next Steps

No immediate changes are needed by food manufacturers because the vacatur will not take effect until January 1, 2028. That said, food manufacturers should closely follow developments on this issue so that they will maximize their time to implement any label changes before January 1, 2028. In the meantime, AMS will need to issue revised regulations and companies will need to make any corresponding changes before that date. The government initially stated that AMS intended to issue a proposed rule on the detectability provision in summer 2026 and a final rule by the end of 2026; and issue a proposed rule on the methods of disclosure in spring 2027 and a final rule in fall 2027. However, we now anticipate that a single rule will be issued on both topics given that AMS listed on its 2026 regulatory agenda its plan to issue a proposed rule to amend the National Bioengineered Food Disclosure Standard to comply with the court’s decision, with a date of August 2026 for the proposed rule. To date, a proposed rule has not been published nor sent to the Office of Management and Budget (OMB) for review:

• National Bioengineered Food Disclosure Standard—Court Remand: In December 2018, AMS published a final rule to establish a national mandatory bioengineered food disclosure standard for food manufacturers, importers, and other entities that label foods for retail sale. After the Ninth Circuit Court of Appeals (Natural Grocers et al. v. Rollins) October 31, 2025, decision, AMS proposes to address deficiencies from its previous final rule. (Proposed Rule: August 2026).⁵

The government also stated that AMS expects to complete a new research study of consumer accessibility to electronic and digital disclosures by winter 2026. Given the Ninth Circuit’s discussion about how the detectability standard could potentially survive review if based on the agency’s discretionary standard, our expectation is that AMS will propose to maintain this standard. Further, if the new consumer study on access to the digital disclosures concludes such access is adequate, then no further changes to the digital disclosure would be needed; rather, AMS could simply revoke the text message disclosure option.

We will continue to monitor AMS’s forthcoming rulemakings and related developments. Please do not hesitate to contact us about this or any other matter.

Footnotes

1 Natural Grocers et al. v. Perdue et al., No. 3:20-cv-05151, Dkt. No. 82 (N.D. Cal. Aug. 3, 2026).

2 7 C.F.R. §§ 66.1(1)(ii), 66.106 and 66.108.

3 See HLC Update, Appellate court invalidates key elements of Bioengineered Food Disclosure Standard regulations (Nov. 12, 2025), available at https://www.hlc.com/en/publications/appellate-court-invalidates-key-elements-of-bioengineered-food-disclosure-standard-regulations. 

4 Uniform Compliance Date for Food Labeling Regulations, 89 Fed. Reg. 106996 (2024) (codified at 21 C.F.R. Part 101), https://www.federalregister.gov/documents/2024/12/31/2024-31419/uniform-compliancedate-for-food-labeling-regulations; Uniform Compliance Date for Food Labeling Regulation, 89 Fed. Reg. 93470 (2024) (codified at 9 C.F.R. Parts 317 and 381), https://www.federalregister.gov/documents/2024/11/27/2024-27864/uniform-compliance-date-for-foodlabeling-regulations.

5 Office of Mgmt. & Budget, 2026 Unified Agenda of Regulatory and Deregulatory Actions, available at https://www.reginfo.gov/public/do/eAgendaMain; see also HLC Update, ­OMB Releases 2026 Unified Agenda of Regulatory Actions (July 30, 2026), available at https://www.hlc.com/en/publications/omb-releases-2026-unified-agenda-of-regulatory-actions.

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