Public comment dockets often draw significant focus when FDA contemplates agency action, and filing a public comment is an important way to convey stakeholder interests for the agency's consideration. For significant regulatory actions, however, public comments are not the only way for stakeholders to make their voices heard when agency action is imminent.
The Office of Information and Regulatory Affairs, or OIRA, housed within the Office of Management and Budget, reviews significant regulatory actions before they are issued. These actions can include proposed rules, final rules, notices, and guidance documents. Under Executive Order 12866 and related executive orders, when a significant regulatory action is pending review at OIRA, interested parties may request what is commonly called an "EO 12866 meeting" or "OIRA meeting."
For FDA-regulated stakeholders, these meetings offer a useful way to participate in the regulatory process before an agency action is issued and provide a unique opportunity to voice important viewpoints in front of a relevant audience of FDA and OIRA regulatory officials.
What Is an EO 12866 Meeting?
An EO 12866 meeting is a listening session requested by a member of the public while OIRA is reviewing significant regulatory action. Attendees include the requesting party, OIRA officials, and representatives from the agency taking that action.
The meetings occur only while the significant regulatory action is under OIRA review, and to qualify for OIRA review, an action must be a "significant regulatory action." That term includes actions with major economic effects, including effects on a sector of the economy, jobs, public health or safety, or state, local, or tribal governments or communities. It also reaches actions that may create serious interagency inconsistencies, materially alter the budgetary impact of federal programs, or raise novel legal or policy issues.
Importantly, an FDA action does not need to be classified as "economically significant" to warrant OIRA review or to present an EO 12866 meeting opportunity. Any "significant regulatory action" can qualify. This may include guidance documents, notices, enforcement policies, proposed rules, or final rules that raise important legal or policy issues, interagency considerations, public health or safety questions, or other significant implications, even where the action is not among the federal government's most important rules.
Why These Meetings Matter
An EO 12866 meeting is not a guarantee that FDA or OIRA will change course. But it can provide a meaningful opportunity to bring operational, scientific, technical, economic, legal, and practical considerations to the government's attention before the action is issued. For FDA-regulated stakeholders, that opportunity can be especially important where the details of implementation may affect product development, labeling, manufacturing, testing, distribution, or market access.
Public comment periods remain critically important, but they are not always the only opportunity to engage. Companies and trade associations concerned about regulatory actions that are pending OIRA review may consider whether an EO 12866 meeting could help ensure that relevant stakeholder perspectives are heard before the action takes place.
How Do Stakeholders Request an EO 12866 Meeting?
Any member of the public may request an EO 12866 meeting through Reginfo.gov by entering the action's Regulatory Identification Number (RIN) on OIRA's meeting request form or, if unknown, by locating the action on Reginfo's pending-review list or Regulatory Review search page and selecting the "Request EO Meeting" link.
OIRA generally makes every effort to accommodate EO 12866 meeting requests, but a meeting is not guaranteed. OIRA review may conclude before a meeting can be scheduled, and OIRA may need to cancel a meeting if review concludes first. For stakeholders with common concerns, coordination through a trade association, coalition, or other group presentation may be worth considering, particularly where a consolidated presentation would avoid duplication and make efficient use of the limited meeting time.
What Happens During the Meeting?
EO 12866 meetings are generally scheduled for 30 minutes. OIRA staff attend, and FDA or other agency staff may also participate. The government generally does not provide a copy of the action under review or answer substantive questions about what the draft says. Instead, the meeting requester presents its views, and government participants may ask clarifying questions.
Useful topics may include anything that the stakeholder believes OIRA and FDA should consider during review. In the food, dietary supplement, and cosmetic space, these topics might include reformulation timelines, supply chain impacts, label inventory, laboratory capacity, supplier documentation, ingredient sourcing, contract manufacturing realities, small-business effects, international harmonization, testing methodology, and implementation deadlines. In the drug and medical device space, stakeholders may also wish to address issues such as clinical development timelines, manufacturing changes, quality system requirements, post-market surveillance obligations, pharmacovigilance or adverse event reporting, device design and validation, software or cybersecurity requirements, supply chain resilience, and implementation deadlines.
Stakeholders should also remember that certain details regarding EO 12866 meetings are public-facing. OIRA publicly discloses the meeting date, attendees, organizational affiliations, and any written materials submitted by outside parties. These meetings are also not a substitute for submitting comments to FDA when a public comment docket is open. Information shared only through an EO 12866 meeting is not the same as a formal comment submitted to the agency's administrative record. However, an EO 12866 meeting gives stakeholders an opportunity, while an action remains under executive branch review, to present practical, technical, scientific, legal, and economic information directly to OIRA and FDA. Ideas, data, concerns, and proposed alternatives shared at this stage can help identify implementation challenges, unintended consequences, or less burdensome approaches before the agency action is issued or a certain policy choice gains even greater momentum.
FDA Actions Currently Under OIRA Review
As of July 1, 2026, FDA had a significant number of actions pending at OIRA, including proposed rules, final rules, notices, and guidance documents. They include:
- Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry — Notice; RIN 0910-ZC37
- Substances Generally Recognized as Safe — Proposed Rule; RIN 0910-AJ02
- Cannabidiol (CBD) Products Compliance and Enforcement Policy — Notice; RIN 0910-ZC82
- Serotonin-2A Agonists and Related Products: Considerations for Clinical Investigations; Guidance for Industry; Availability — Notice; RIN 0910-ZC89
- Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods — Final Rule; RIN 0910-AI72
- Food Standards of Identity Modernization; Pasteurized Orange Juice — Final Rule; RIN 0910-AI98
- Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry — Notice; RIN 0910-ZD09
- Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry; Availability — Notice; RIN 0910-ZD12
- Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants — Notice; RIN 0910-ZD15
- New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry — Notice; RIN 0910-ZD23
- Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension — Final Rule; RIN 0910-AJ03
- Rulemaking to Provide by Regulation That an Ingredient Is Not Excluded from the Dietary Supplement Definition — Proposed Rule; RIN 0910-AI91
Several of these actions are highly relevant to food and dietary supplement companies, including GRAS reform, CBD enforcement policy, salt substitutes in standardized foods, orange juice standards of identity, cadmium action levels for baby foods, food traceability enforcement, NDI guidance, and dietary supplement ingredient status. Cosmetic companies should separately monitor OIRA closely, particularly as FDA continues implementing the Modernization of Cosmetics Regulation Act and related requirements.
Venable's FDA team can help companies and trade associations evaluate whether to request an EO 12866 meeting, prepare written materials and talking points, and present stakeholder perspectives in meetings with OIRA and FDA.