Is the Food and Drug Administration only for the US?

Answer 1

The United States has a Food and Drug Administration (USFDA), but so does China (CFDA). Other countries might also have an FDA or an equivalent agency.

People tend to forget that the USFDA does not just regulate drugs. It also regulates food (human and animal) not covered by USDA, medical devices, radiation emitting products, tobacco, animal drugs, vaccines, blood & biologics. Initially, FDA's jurisdiction was restricted to only those products involved in interstate commerce. The definition of that has expanded in recent years so that more items and businesses who thought they did not fall under FDA now appear to do so. Even if one ingredient from China is used in bread made and sold by a local bakery, that item could fall under FDA jurisdiction.

All the previously mentioned products that are imported come under FDA when it reaches our shores. There are a huge number of products that are listed under the FDA Import Alert system that are subject to refusal, detention or special examination.

Although FDA does not have jurisdiction in foreign countries, FDA does perform a large number of inspections at foreign companies that make product destined for the United States. The goal of the foreign inspection program is to assure the products comply with US laws and regulations before arriving in the U.S.

Answer 2

The Food and Drug Administration is a USA agency. The FDA can only oversee and regulate the manufacture of drugs that are made or sold within the borders of the USA and its territories. The FDA has no input or control over drugs manufactured or sold outside the USA.