FDA is responsible for the safety of most of the food Americans eat, everything except for meat, poultry, and processed egg products, which are regulated by the United States Department of Agriculture (USDA). Each year, FDA regulates about 49 billion dollars of imported food that comes from over 150 countries or territories and enters through more than 300 American ports. There are approximately 214,000 registered foreign facilities that manufacture, process, pack, or hold food that is consumed in the United States.

Approximately 15 percent of the United States’ food supply by volume is imported. For some products, a much higher percentage is imported. For example, approximately 60 percent of fresh fruits and vegetables consumed in the United States are imported. Americans are eating fresh fruits and vegetables year-round, thanks to the imports that fill in the times when the United States is not producing certain fruits and vegetables.

How are consumers affected by imported food?

Some foods, whether domestic or imported, may contain bacteria that can be harmful. Among those at highest risk for foodborne illness are those who are very young, older adults, as well as others:

• with immune-compromised diseases such as those who are HIV positive
• who receive chemotherapy
• who receive other immunosuppressive treatments

Symptoms of foodborne illness range from mild stomach discomfort to life-threatening problems that can affect the nervous system, liver, and kidneys.

Foodborne illnesses are caused by 200 different agents such as viruses, bacteria, parasites, and toxins plus a vast number of chemical contaminants and metals. The agents associated with foodborne illness have steadily grown over the last few decades, and this trend is expected to continue.

How are food imports changing?

In the past, a large percentage of FDA-regulated imports consisted of unprocessed food ingredients that would be subsequently processed domestically with FDA oversight. Today, the volume and complexity of imported food has increased. Because of this, FDA’s approach to handling imports has changed.

How does FDA regulate imported food products?

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), all food, whether imported or domestic, must be safe, clean, and produced under sanitary conditions.

Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BT Act), prior notice is required for all imported human food and animal feed shipments to be submitted to the FDA before the food is allowed to enter the United States. This means that FDA must be notified in advance of when and where food shipments will enter the United States and what those shipments will contain as well as the facility and country where the food was manufactured and/or grown. This requirement helps increase the security and safety of the United States food supply.

Data on imported food products, with a few exceptions, are submitted and processed through United States Customs and Border Protection and/or FDA import systems. The data are electronically screened to assist in determining whether the food appears to present a significant risk to the public health. When necessary, FDA physically examines targeted import food shipments on the basis of apparent risk.

Food products that pose higher risks or companies with a history of problems are physically inspected more frequently than those that pose little or no apparent risk. FDA inspectors can refuse entry of imported food if there is the appearance that the food does not comply with applicable food safety laws. When products are detained, the burden to comply with FDA law falls on the importer. If the food cannot be brought into compliance with the law, it can be denied entry into the country.

FDA has a team of more than 2,000 staff (675 in food import safety) who are dedicated, scientifically trained specialists who:

• conduct inspections
• collect and analyze product samples
• perform investigations
• oversee recall of products
• take enforcement actions, when necessary, and
• monitor the entry of all FDA-regulated products at our country’s borders.

What more can FDA do to increase its oversight of imported foods?

In November 2007, FDA initiated its Food Protection Plan (FPP). The FPP is designed to further protect the nation’s food supply. It identifies FDA’s most critical needs and addresses the changing nature of global food sources, production systems, and consumption patterns.

The FPP provides a framework for FDA’s efforts to prevent problems before they occur; to use risk-based measures to identify potential hazards and intervene before they cause harm; and to provide a rapid coordinated response if contaminated food is detected that could harm humans or animals.

The major components of this new initiative are based on prevention, intervention, and response. The FPP complements the United States Government’s Import Safety Action Plan (ISAP), which makes short-term and long-term recommendations to improve imported product safety.

The FPP strengthens FDA’s role and supports the Agency’s continued partnership with other federal agencies that play a vital role in the safety of our nation’s food supply. They include the Centers for Disease Control and Prevention (CDC), the USDA, and the Department of Homeland Security. The goal is to ensure a thorough, far-reaching, food safety and food defense program that meets the emerging risk posed by the types of foods that FDA regulates.

As a key part of the Import Safety Action Plan, FDA has established permanent offices in China ( Beijing, Shanghai, and Guangzhou), Europe ( Brussels), Latin America ( Costa Rica), India ( New Delhi and Mumbai) and plans to establish an office in the Middle East. Having staff stationed overseas will allow FDA personnel to work closely with local authorities as well as with industries that ship food and medical products to the United States to help ensure their safety, quality, and security.

What can consumers do to help protect themselves from potentially unsafe imported products?

FDA urges consumers to pay attention to the information reported in the media about imported food or any food products. FDA also encourages consumers to report problems they have with any FDA products by using, “Your Guide to Reporting Problems to FDA.”