The FDA regulates imported shipments of food, drugs and supplies.
Under the U.S. Federal Food, Drug and Cosmetic Act, the Federal Drug Administration (FDA) regulates international importers who import food, drugs, cosmetics, electronic devices and medical equipment into the U.S. to ensure safety and proper labeling according to U.S. standards. The FDA is authorized to detain shipments that do not meet U.S. standards.
FDA Regulations for Importing Drugs
Drugs that have not been previously approved by the FDA are illegal to import. Unapproved drugs include new drugs or foreign versions of existing U.S. drugs. The FDA has authority to enforce actions against companies that fraudulently import drugs into the U.S. or drug companies that manufacture products which contain significant health risks. In situations where the drug was being used to treat individuals internationally, but there is no existing FDA-approved drug treatment in the U.S., the FDA should not pursue any enforcement actions against the manufacturer. The FDA may work with the U.S. Drug Enforcement Administration to ensure drugs are not being fraudulently introduced into U.S. commerce. Congress, recognizing it could be cost-effective to use foreign-made drug equivalents of already approved U.S. pharmaceutical products, does not allow drugs to be imported without prior approval in these situations. The drugs may consist of unknown quantities of unknown chemicals without any proof of efficacy, and the drugs may be improperly labeled.
FDA Regulations for Importing Medical and Electronic Devices
The FDA does not honor foreign countries' approvals for devices imported into the U.S., and the imported medical devices must meet U.S. standards. The FDA requires premarket notification if the foreign importer is importing a medical device that has never been shipped before or the device has previously been imported but is intended for a different use. Additionally, the notification is required for devices that already exist in the U.S. market, but there are changes to the marketing which may affect its use or safety. Electronic devices that emit radiation must be registered using Form FDA 2877 (Radiation Standard Declaration) prior to being shipped into the U.S.
FDA Regulations for Importing Food: The Bioterrorism Act of 2002
The FDA must take affirmative steps to safeguard the public from imminent or actual bio-terrorist attacks on our country's food supplies. Foreign importers must provide advance notice of food shipments and register their business facilities with the FDA. The FDA and the Bureau of Customs and Border Protection will work together to target inspections from potential bio-terrorist attacks on our supplies. The FDA does not regulate poultry or meat products (USDA's responsibility).
FDA Regulations for Importing Milk: The Federal Import Milk Act
The Federal Import Milk Act requires importers to obtain permits for importing milk and cream into the U.S., according to Title 21 of the United States Code, Sections 141 through 149.
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