Impact of 10-for-1 deregulatory executive order will extend beyond ‘regulations’

While a 2017 executive order (EO) from the first Trump administration moved two regulations out for each new regulation adopted, a new EO now imposes a one-in-ten-out policy. In addition, the new order has a significantly expanded definition of what counts as a “regulation,” with substantial impacts likely for FDA’s policymaking through guidance, memos, and other avenues.

The ten-for-one Executive Order: EO 14192

• On Jan. 31, 2025, President DONALD J. TRUMP <announced a new EO on a “massive 10-to-1 deregulation initiative.” The fact sheet for the EO, published in advance of the actual text of the EO, previewed that agencies would need to identify 10 regulations to repeal for every “new rule, regulation, or guidance.”
• The new EO was formally published Feb. 6, 2025. As <AgencyIQ previously discussed, the new EO, <EO 14192: “Unleashing Prosperity Through Deregulation,” builds on efforts undertaken during the first Trump administration <under a 2017 EO, EO 13771, that was later rescinded by President Biden. While the new EO has the same general focus as the 2017 version – namely, a reduction in the regulatory policy documents that agencies keep on the books – it also builds and adds on that original 2017 EO (EO 13771).
• Both versions of the Trump deregulatory EOs call for agencies to identify and rescind/repeal/eliminate existing regulations for each new regulation published. While the 2017 version of the EO, EO 13771, had a one-in-two-out ratio, the 2025 version of the EO, EO 14192, directs a one-in-ten-out process. For every new regulation published, agencies now need to eliminate 10, not two. The 2025 version of the EO also directs the Director of the Office of Management and Budget (OMB) to set a “regulatory budget” for agencies and prohibits agencies from publishing regulations that are not in the <Unified Agenda. Both of these latter provisions start in 2026, and mirror similar policies from the original 2017 EO 13771.
• <Read AgencyIQ’s full analysis of the 2025 EO 14192, here.

There’s another major difference in the new version of the EO: The definition of “regulation”

• <EO 13771 from 2017 applied to “regulations” and “rules” – as defined in the order. The 2017 EO included its own definition of the policymaking documents to which the EO, and therefore the two-for-one policy, applied. The 2017 EO defined “’regulation’ or ‘rule’” as “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency,” excluding regulations related to national security/agency personnel and management, or other categories that were exempted by the OMB Director.
• The new version of the deregulatory EO significantly expands on this definition, concomitantly expanding the scope of policymaking avenues that fall under the new order. While it opens with the same definition as the 2017 version, it then goes on to describe specific document types that count as a “regulation” for the purposes of this EO: “including, without limitation, regulations, rules, memoranda, administrative orders, guidance documents, policy statements, and interagency agreements, regardless of whether the same were enacted through the processes in the Administrative Procedure Act … [emphasis added].”
• What’s new here? Unlike the original two-for-one policy in 2017, the 2025 ten-for-one EO policy now explicitly and “without limitation” includes guidance documents, memos, and policy statements from the agencies.
• This could significantly hamstring FDA’s ability to issue policy documents. The FDA had a limited response to the original 2017 EO, pulling or rescinding relatively few documents. The <agency did call for comments “to help FDA identify existing regulations and related paperwork requirements” that could be modified, repealed, or replaced under the directive of the EO, but only a few regulatory actions were flagged as being in response to the EO. In general, these were actions that either revoked niche standards or removed outdated requirements. For example, the FDA proposed to add a <less-burdensome method for analysis of sulfites in foods, <revoke the standard of identity for French [salad] dressing, <remove references to outdated requirements about inspection timing for biologics, and <adjust testing requirements for human dura mater tissue intended for transplantation – and, potentially most famously, <to revoke the FDA’s standard for frozen cherry pie in 2020.
• Previously, the agency could make the case as to why different documents didn’t fall under the 2017 EO. For example, the <2020 proposed rule on intended use states that “This proposed rule is not expected to be subject to the requirements of Executive Order 13771 because this proposed rule is expected to result in no more than de minimis costs,” while the 2019 final rule <on electronic device submissions states that the rule is not a “significant regulatory action” and therefore not subject to EO 13771.
• EO 14192, the 2025 order “Unleashing Prosperity Through Deregulation,” includes less flexibility. Compared to the 2017 EO, the new version now includes an entirely new <section on “implementation” (section 6) that charges the OMB director to issue specific guidance on implementing the provisions of the EO. While it also grants the OMB director flexibility to exempt policies from the EO, including the exemption of “regulations or categories of regulations that impose minimal costs or burdens on the private sector,” the wording of EO 14192 seems intended to limit carve-outs from the policy. Guidance publication continued largely uninterrupted during the first Trump administration, despite the directions in EO 13771, and memos and similar policy statements were wholly unaffected, although they were not specifically excluded from the “rules and regulations” definition in the 2017 EO. The enumeration of the document types specifically included in the scope of the new EO leaves agencies less flexibility in interpreting its scope.
• Some potential for flexibility does exist: The OMB director, RUSSEL VOUGHT, is tasked with “providing agencies with updated guidance on implementing the ten-for-one rule… including processes for identifying regulations for elimination, determining what constitutes, generally and specifically, a “rule” or “regulation” for purposes of this order… [emphasis added].”
• The provisions of the EO extend beyond the ten-for-one policy. <The order also prohibits agencies, starting in 2026, from publishing regulations that are not in the Unified Agenda. If the definition of “regulation” in the EO is extended to mean guidance documents, policy statements and memos, this would effectively prohibit the agency from accomplishing its guidance agenda publication tasks.
• AgencyIQ previously analyzed both <the current Unified Agenda and the <FDA’s guidance agendas. The Unified Agenda lists the formal rulemaking each agency is working on, while the guidance agendas from the FDA’s different divisions are significantly more comprehensive, describing a larger number of smaller documents. While FDA’s current Unified Agenda includes a little over 50 documents, taken together, the guidance agendas from the FDA’s medical products divisions include nearly 200 documents. If the EO is interpreted to mean that the Unified Agenda is the de facto agenda for any policy document the FDA issues, the result would be to significantly hamstring the agency’s ability to publish policy documents. According to the EO, the OMB director <will also be tasked with “approving” each agency’s Unified Agenda based on aggregated costs, which would potentially limit the FDA’s ability to add its guidance agendas to the Unified Agenda.

What does all this mean?

• As written, EO 14192 would effectively cut off FDA’s ability to issue guidance documents and policy memos, communications that make up most of the FDA’s formal policy communication to industry. Implementing the EO with this interpretation of its language would profoundly change the U.S. regulatory landscape.
• Of course, that doesn’t mean that the FDA would simply stop making policy – instead, it would face significant limitations in how it communicates policies to industry. Documents in approval packages would continue to transmit agency perspective, but the life sciences industry would need to work harder to connect those individual decisions to understand and cite regulatory precedent, or to get a sense of what the FDA thinks is acceptable in different situations.
• While the communications freeze is still in place, there’s limited information about next steps, but it may be that the cadence and source of information about life sciences regulatory policy in the U.S. will see significant change in the coming years.

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

Key Documents and Dates

• <EO 14192: Unleashing Prosperity Through Deregulation
• <AgencyIQ Analysis: Trump reintroduces revamped deregulatory executive order: One in, 10 out, and a bigger role for the Unified Agenda