FDA Rulemaking Process

According to the Food and Drug Administration (FDA), the agency is responsible for establishing rules and regulations regulating issues concerning products such as food, drugs, cosmetics and radiation-emitting products.

Law

• The Code of Federal Regulations reports rules are introduced through a variety of processes including legislation, executive orders and political factors. The rule-making process usually begins with congressional action requiring a new rule to be introduced by the FDA.

Comment

• U.S. legislation sets a timescale for the introduction of FDA rules, with the proposed rule published in the Federal Register to allow time for public comment on the proposals. The FDA reports any member of the general public can submit a written comment concerning rules proposed in the Federal Register; contact details for comments are printed in the register.

Rules

• The Code of Federal Regulations reports the rule-making process for the FDA is completed when the public comment process is completed and any revisions to the proposed rules are made. According to the Code of Federal Regulations, the rule-making process for the FDA can often take more than one year to complete.