The FDA was established in 1992 as the Food and Drugs Board (FDB) on the basis of the 1992 Food and Drug Law (PNDCL 305B), later amended by the Food and Drugs ACT of 1996. The Food and Drugs legislation was revised in 2012 and integrated into a new Public Health ACT 851, 2012 that gave birth to the Food and Drugs Authority.

The FDA’s legal mandate is found in Part 6 (Tobacco Control Measures), Part 7 (organisation and responsibilities of the FDA), and Part 8 (Clinical trials) of the Public Health Act, 2012 Act 851.

The FDA is the National Regulatory Body responsible for the regulation of food, drugs, food supplements, herbal and homeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products, blood and blood products as well as the conduct of clinical trials protocols. The Public Health Act, 2012, Act 851 provides for the establishment of a Governing Board with the responsibility of ensuring the effective implementation of the functions of the Authority. The Authority currently has eleven-member Governing Board.