FDA's Rulemaking process

The food and drug agency (FDA) issues regulations to the public notifying them of the various actions taken by the agency. Such regulations are either required or authorized by statute. As Ruder & Woods (2020) highlighted, the FDA’s egg safety regulations for example, are aimed at addressing identified problems or hazards while on the other hand, citizen petition regulations are either procedural or administrative. The current rule making procedure come from a memoranda issued by the president, US law and the FDA’s own regulation.

The process that is often used to issue the rules in normally called “notice and comment rule making”. Issuance of the proposed rule is the first step in the notice and comment rule making process. The proposed rule issued by the agency gives a detailed information of the agency’s intentions and basis, they then ask for public comments (Davis & Miller, 2017). After the agency receive and review the public comments they decide on whether there is need for further action. Based on the received comments the agency might to decide to; end the rule making process, issue a new proposed rule or issue a final rule.

Some agencies develop their rules through negotiation. They invite interested member of the public to meetings where they try to reach a consensus on the terms of the proposed rules. If the participant reaches a common ground on the rules, the agency may use their ideas as the basis of the proposed rule. Additionally, the agency gathers through informal conversation with the interest member of the public (Gavoor & Miktus, 2016). Finally, all the proposed rules are published in the federal register. The notice of the proposed rule has a physical address where the comment can be mailed.


Davis, A. L., & Miller, J. D. (2017). The European medicines agency and publication of clinical study reports a challenge for the US FDA. In JAMA - Journal of the American Medical Association (Vol. 317, Issue 9, pp. 905–906). American Medical Association. https://doi.org/10.1001/jama.2017.0918

Gavoor, A. A., & Miktus, D. (2016). Public Participation in Nonlegislative Rulemaking. Villanova Law Review, 61. https://heinonline.org/HOL/Page?handle=hein.journals/vllalr61&id=799&div=&collection=

Ruder, A. I., & Woods, N. D. (2020). Procedural Fairness and the Legitimacy of Agency Rulemaking. Journal of Public Administration Research and Theory, 30(3), 400–414. https://doi.org/10.1093/jopart/muz017