FDA (Food and Drug Administration)

Definition

The Food and Drug Administration (FDA) is a Partner Government Agency (PGA) essential for regulating various products—including biological products, medical devices, food, and cosmetics—to ensure their safety, security, and efficacy for the US public. The FDA holds imported products to the exact same rigorous standards as domestically produced goods under the Federal Food, Drug and Cosmetic Act.

Compliance and Enforcement

All imported FDA-regulated goods undergo review for compliance. If a shipment fails to meet standards or requires further examination, the FDA may issue an FDA hold. This is a type of customs hold placed after initial review.

Once a hold is placed, the agency may:

• Review and release the shipment.

• Request additional documentation or information.

• Inspect the cargo physically.

• Detain the goods if they fail to meet appropriate standards, potentially refusing entry.

Regulated Product Categories

Importers must be aware that the FDA regulates a wide range of products, including:

• Human foods

• Human drugs

• Vaccines, blood, and biologics

• Medical devices

• Radiation-emitting electronic products (e.g. LED lights)

• Cosmetics

• Animal and veterinary products

• Tobacco products

Expert Compliance Advice

Due to the complexity and strict requirements associated with FDA import clearance, most importers hire experienced customs brokers. A skilled broker assists with pre-filing requirements, documentation management, and expediting the release process, significantly minimizing the risk of costly FDA holds and detentions.