Regulatory Freeze Memorandum: What it Means for Key Food Regulatory Initiatives

On January 20, 2025, President Trump issued a memorandum directing all federal agencies to place a freeze on new or pending federal rules until the new administration has had an opportunity to review them. Similar freezes were issued by President Biden in 2021, President Trump in 2017, and President Obama in 2009. This alert explains the scope of this action and analyzes its potential impact on key food regulatory initiatives.

Scope

The regulatory freeze applies to new or pending “rules” which, with some exceptions described further below, include regulations ready to be sent to the Office of the Federal Register (OFR) for publication, regulations already sent to OFR but not yet published, and regulations that have been published in the Federal Register but are not yet effective. The term “rule” includes the federal actions defined as such under the Administrative Procedure Act and Executive Order 12866. The regulatory freeze therefore encompasses: (1) “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency;”[1] and (2) “any substantive action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking.”[2] It also includes guidance documents and any other agency statement “that sets forth a policy on a statutory, regulatory, or technical issue or an interpretation of a statutory or regulatory issue.”

The regulatory freeze requires executive departments and agencies to perform three primary actions with regard to new or pending rules:

• New Rules: Not to propose or issue any rule, including by sending to OFR, until a department or agency head President Trump appointed or designated reviews and approves the rule.
• Rules sent to OFR but not yet published: Immediately withdraw any unpublished rule (including a proposed or final rule) already sent to OFR so that such President Trump-appointed official can review and approve the rule.
• Published rules not yet effective: Postpone for 60 days from January 20, 2025 the effective date of any not yet effective rule already published in the Federal Register or issued in any other manner to allow for a review of and, where the agency deems appropriate, public comment on questions of fact, law, and policy the rule raises, and for certain rules, consider proposing further notice-and-comment or delaying the effective date for a longer period.

The regulatory freeze does not apply to exceptions the Office of Management and Budget grants for emergency situations or other urgent circumstances, including rules subject to statutory or judicial deadlines that require prompt action. Additionally, it does not direct federal agencies to stop working on new regulations or impact comment periods for currently open dockets, nor does it prevent agencies from considering comments already submitted. It also does not impact regulations that have already taken effect.

Analysis

We have identified the following examples of recent food-related federal regulatory actions that could potentially be impacted by the regulatory freeze:

• FDA’s order to revoke the use of Red No. 3 in food and ingested drugs (Issued Jan. 15, 2025; Revocation of 21 C.F.R. § 74.303 (foods) effective Jan. 15, 2027; Revocation of 21 C.F.R. § 74.1303 (drugs) effective Jan. 18, 2028)
• FDA’s proposed rule regarding Front-of-Package Nutrition Labeling (Issued Jan. 14, 2025)
• FDA’s final rule on the nutrient content claim “Healthy” (Issued Dec. 19, 2024; Effective Feb. 25, 2025)
• FDA’s draft guidance on the labeling of plant-based foods (issued Jan. 6, 2025)
• USDA Food Safety and Inspection Service’s proposed rule and proposed determination regarding Salmonella as an adulterant at certain levels in raw poultry (Issued Aug. 7, 2024)

The regulatory freeze could also potentially delay the publication of any additional rules that FDA or USDA complete in the near future.

In addition to the regulatory freeze, there may be other avenues through which the Trump Administration could prevent, restrict, or delay the implementation of food regulations or guidance that are already in effect. Food companies that would like to explore these avenues further should consider how best to engage the Trump Administration regarding such issues.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.