The United States Food and Drug Administration regulates approximately $1 trillion worth of products each year. This includes foods (excluding aspects of meat, poultry and egg products that fall under USDA oversight); human and animal drugs; biological products like blood vaccines and cell and gene therapy products; medical devices; cosmetics as well as food and consumer product ingredients that emit radiation. The Office of Regulatory Affairs (ORA) conducts the majority of field work within the Agency – its employees being known as its “eyes and ears”. ORA has five regions, each divided further into 20 districts within themselves – while there are multiple field offices throughout both America as well as overseas that cover its regulatory needs.

The FDA derives its regulatory authority from the Food, Drug, and Cosmetic Act and related statutes. Under these authorities, the Agency issues legally-binding regulations to implement and interpret these statutes; additionally it issues non-binding guidance documents as needed. All this regulatory information can be found in one place – The Code of Federal Regulations or CFR which is published daily containing final regulations as well as proposed rules or meeting notices issued by the Agency.

FDA is accountable for ensuring the safety of food, drugs and devices while simultaneously monitoring their environmental impacts. As part of their duties under NEPA, this requires them to assess decisions made and provide any relevant data related to such analyses.

As part of its public accountability obligation, the FDA must abide by the requirements outlined by the Administrative Procedure Act (APA), or compliance law when taking actions related to developing or taking certain other actions. These transparency laws help ensure that it makes decisions with the best interests of Americans in mind.