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FOOD
Food sold in the United States is required by law to comply with the Food and Drug Administration (FDA). The FDA is responsible to ensure food sold in the United States is safe, wholesome and properly labelled. This applies to foods produced domestically, as well as food from foreign countries.
DRUGS
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires firms that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S. to register with the FDA. Additionally, foreign establishments must identify a U.S. agent and importers at the time of their registration.
MEDICAL DEVICES
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must engage a U.S FDA agent for that establishment.
COSMETIC
FDA’s legal authority over cosmetics is different from our authority over other products we regulate, such as drugs, biologics, and medical devices. Under the law, cosmetic products and ingredients do not need FDA premarket approval, with the exception of colour additives. However, FDA can pursue enforcement action against products on the markets that are not in compliance with the law or against firms or individuals who violate the law.