On February 19, 2025, President Trump issued an Executive Order titled “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” (the EO). The stated purpose of the EO is to advance the Administration’s policies of focusing executive enforcement actions on regulations “squarely authorized by federal statute” and deconstructing the administrative state in order to achieve the stated goal of “[e]nding Federal overreach and restoring the constitutional separation of powers.” The EO appears to present opportunities for FDA-regulated stakeholders to identify certain regulations, guidance, and enforcement actions for recission or termination. Likewise, certain stakeholders may face changes in the competitive balance with competitors if the EO causes FDA to stop enforcing regulations that currently prohibit the marketing of certain products. 

Key Provisions of the EO

In order to effectuate the stated policy, the EO provides for 1) the rescission of existing regulations across federal agencies, 2) the de-prioritization and termination of certain ongoing enforcement actions, and 3) the review of new regulations by members of the Department of Government Efficiency (DOGE) and the Administrator of the Office of Information and Regulatory Affairs (OIRA):

1. “Rescinding Unlawful Regulations and Regulations That Undermine the National Interest”: The EO directs agency heads, in coordination with their DOGE team lead and the Office of Management and Budget (OMB) Director, to, within the next 60 days, review all agency regulations and identify regulations deemed to be 1) unconstitutional, 2) unlawful, 3) based on “anything other than the best reading of the underlying statutory authority or prohibition,” 4) implicating “matters of social, political, or economic significance that are not authorized by clear statutory authority,” 5) excessively costly, 6) “harmful to the national interest,” or 7) overly burdensome for small businesses or entrepreneurs. Notably, and consistent with the Administration’s other recent deregulatory actions, the EO defines “regulations” to include guidance documents. The EO states that the Administrator of OIRA, in consultation with agency heads, will then develop a Unified Regulatory Agenda to rescind or modify the identified regulations. Pursuant to this mandate, FDA will likely be expected to conduct a broad review of its regulations and guidance documents over the next 60 days and identify items that may merit rescission.
2. “Enforcement Discretion to Ensure Lawful Governance”: The EO grants agency heads discretion to “preserve their limited enforcement resources” by 1) de-prioritizing enforcement of regulations that are “based on anything other than the best reading of a statute” or “that go beyond the powers vested in the Federal Government by the Constitution”; and 2) to terminate ongoing regulatory enforcement proceedings which “do not comply with the Constitution, laws, or Administration policy.” This, in turn, could pose significant implications for both future and ongoing FDA enforcement actions. Under the EO, even long-standing precedents that provide the foundation for FDA’s enforcement activities could be scrutinized if the Administration considers them to be not based on the current “best” reading of a statute. In practical terms, this could lead to the truncation or effective deletion of certain long-standing regulatory requirements across all product areas regulated by FDA. 
3. “Promulgation of New Regulations”: The EO requires that agency heads consult with their DOGE Team Leads and the Administrator of OIRA on potential new regulations as soon as practicable and instructs DOGE Team Leads and OIRA to evaluate potential new regulations against certain criteria outlined in the EO.

The EO is one of a series of Executive Orders by President Trump aimed at deregulation, including a Regulatory Freeze, 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, and a 10-to-1 Deregulation Initiative, requiring that whenever an agency promulgates a new rule, regulation, or guidance, it must identify at least 10 existing rules, regulations, or guidance documents to be repealed. 

Opportunities and Challenges for Stakeholders

The EO and those referenced above may present a ripe opportunity for stakeholders to assist FDA in identifying regulations, guidance, or enforcement actions about which they may have concerns and which may fit into the classes described above. For example, in the food space, this could include recently issued regulations such as FDA’s Food Traceability Rule and Rule Defining the Nutrient Content Claim “Healthy,” along with certain food standards of identity. In the drug space, a portion of the recently promulgated rule on nonprescription drug products with Additional Conditions for Non-Prescription Use that purports to allow simultaneous marketing of the same product as both a prescription-only and nonprescription product may be subject to reexamination. Likewise, there may be many regulations and guidance in the medical device and digital health spaces that could be revisited under this EO.  For example, given that many stakeholders (including a former FDA Commissioner) have raised concerns with FDA’s current guidance on Clinical Decision Support Software issued in 2022, that guidance could be subject to reexamination.

The EO may also present challenges to companies that comply with current regulatory expectations and rely on FDA to police the market to limit unapproved and substandard competitors. For example, as announced during the prior Trump Administration in its termination of the FDA’s Unapproved Drug Initiative in 2020, FDA could alter its enforcement discretion policies to effectively narrow the definition of a “new drug” to allow more currently unapproved drugs onto the market.

In addition to this EO and other FDA-related EOs, we have seen a few critical hires at FDA this week worth flagging. Robert Foster was named FDA’s Chief Counsel and Kyle Diamantas was named Deputy Commissioner for Human Foods, following Jim Jones’s resignation over the weekend.

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