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Main Differences Between FDA & EU Regulations

The main difference between the United States Food and Drug Administration and the European Union regulations is that FDA regulations apply to products within the United States, and EU regulations apply to products within Europe. Although the FDA and EU regulatory systems have similar objectives, their systems of operation vary, and approval of one does not equal approval by the other.

  1. History

    • In 1906, the passage of the Pure Food and Drugs Act prohibited misbranded and adulterated food and drugs, and launched the FDA to monitor the much-abused consumer product marketplace. The EU regulatory system followed the 1957 European Community treaty, put in place to monitor the basic principles and requirements concerning public health and safety within Europe, and to inform its procedures. The economics drove the development of the EU regulatory system, focusing on the free movement of goods, in contrast to the development of FDA regulations, according to the nonprofit Farm Foundation.

    Key Functions

    • Within the FDA, the Office of Regulatory Affairs regulates U.S. public health and safety by inspecting production facilities and warehouses; analyzing and reviewing over-the-counter and prescription drugs, medical devices, and other key health concerns; ensuring that imports meet U.S. standards; and investigating illnesses, complaints, or outbreaks resulting from consumer goods. Similarly, the main objective of the European Union regulatory system is to ensure the protection of public health in Europe. The functions of its Office of Consumer Affairs basically matches that of the U.S. Office of Regulatory Affairs, but other regulatory agencies within the EU follow varying levels of protocol, depending on the type of product under review or inspection, versus the strict set of procedures followed by the FDA.

    Risk Assessment Methods

    • A main difference between FDA and EU regulations comes in the perception of risk and how to manage it. The FDA reviews specific data about consumer product complaints and uses a quantitative method of risk assessment. The risk assessment process involves five steps: stating the problem, identifying the cause of the problem, determining how much exposure has taken place, assessing the response to the hazard, and determining the affected population's level of exposure. The EU regulatory system's risk assessment process employs a more qualitative method, based on the entire set of available data. The EU's process identifies hazards and population at risk, examines and prioritizes identified risks, creates a plan of prevention, takes action based on three previous steps, and finally assesses what part of the plan works and what doesn't. Additionally, licensed officers carry out the FDA's risk assessment, while the EU holds companies responsible for it.

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