DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Office of Public Affairs

5600 Fishers Lane

Rockville, MD 20857

Publication No. FS 01-12

FDA Web site: www.fda.gov

Revised: December 2003

FDA’s Global Shield for American Consumers

The Agency Acts Worldwide to Ensure High Quality Imports

To protect the health of American

consumers, the FDA can no longer

focus its activities only on products

made in the United States. More

than 20 percent of all fresh produce,

80 percent of all seafood, and

millions of other FDA-regulated

products—medications, medical

devices, and veterinary products—

consumed or used in the United

States are produced abroad.These

imports, whose safety and high

standards are also the FDA’s responsibility, reached nearly 8 million

entries in 2002, and they continue to

rise. Over 9 million entries are

expected in 2003.

Because the enormous volume

and variety of imports make their

inspection in the United States

difficult, the FDA has developed

numerous strategies to ensure that

imported products meet the high

U.S. public health standards before

they leave the exporting country.

These are the FDA’s main

international programs:

• Memoranda of Understanding

(MOUs).The FDA has more than

50 MOUs with foreign governments

to help ensure that products exported

from their countries to the United

States meet U.S. public health

standards.

• Inspections. Each year, the FDA’s

specialists inspect approximately

1,000 foreign plants that export food,

medications and other critical

regulated products to the United

States to make certain that they

follow quality-enhancing good

manufacturing practices (GMPs).

• Training.The FDA trains its

regulatory counterparts in countries

that export food and other regulated

products to the United States to

ensure that the exported products

meet U.S. public health

requirements.

• Higher international standards.

The FDA is making significant

contributions to the efforts of United

Nations-sponsored organizations,

such as the Codex Alimentarius

Commission and the International

Organization for Standardization, to

raise the standards for food, medical

devices and other regulated products

worldwide.

• Harmonization of guidelines.

The FDA has taken the lead in

founding four international

organizations that combine the

efforts of regulatory authorities and

industrial associations to harmonize

regulatory guidelines for new drugs,

medical devices, veterinary

medications, and cosmetics.

• Mutual Recognition Agreements.The FDA is implementing an

agreement under which the FDA and

its counterparts in the European

Union share inspection reports and

other information relating to firms

that export pharmaceuticals and

medical devices.

For more information, contact the

FDA’s Office of International

Programs at 301-827-4480 or visit

the FDA Web site at www.fda.gov/

oia/homepage.htm.

Keeping Out Hazardous Products

The terrorist attacks on Sept. 11, 2001,

heightened the importance of the FDA’s

role in ensuring that regulated imports

do not endanger the health of the U.S.

public. As part of its counterterrorism

program, the FDA is substantially

strengthening its inspection staff in the

U.S. ports of entry. The agency is also

requesting an authority to take rapid

measures in an emergency to protect the

public against potentially hazardous

imported food. The agency does not

hesitate to take action against suspect

imports. For example, in recent years the

FDA has detained shipments of certain

products of animal origin from more

than 30 countries whose cattle herds

have, or are at a high risk for, bovine

spongiform encephalopathy (BSE), the

so-called “mad cow disease.”