Food And Drug Administration

The mission of the Food and Drug Administration is to enforce laws enacted by the U.S. Congress and regulations promulgated by the Agency to protect the consumer’s health, safety and pocketbook.

1. The Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-392), and the Fair Packaging and Labeling Act (15 U.S.C. 1451-1461), which apply to food and drugs for man or animals, cosmetics and medical devices.

2. Sections of the Public Health Service Act relating to biological products for human use (42 U.S.C. 262-263) and control of communicable diseases (42 U.S.C. 264).

3. The Radiation Control for Health and Safety Act, relating to electronic products which emit radiation, such as X-rays, lasers, microwave ovens and TV sets (42 U.S.C. 263b-263n).

The Federal Food, Drug and Cosmetic Act is the basic food and drug law of the United States. With numerous amendments, it is the most extensive law of its kind in the world. Many of the states in the United States have laws similar to the Federal Law, and some have provisions to automatically add any new Federal requirements.

The law is intended to assure the consumer that foods are pure and wholesome, safe to eat and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative and not deceptive. Another law, the Fair Packaging and Labeling Act, affects the contents and placement of information required on the package.

On Nov. 28, 1990, President George Bush signed the Safe Medical Devices Act of 1990 (P.L. 101-629). This law was intended by Congress to strengthen the Federal Food, Drug and Cosmetic Act (FFDCA). One of the consequences of the Safe Medical Devices Act is that the provisions of the Radiation Control for Health and Safety Act of 1968 (RCHSA) have now been transferred to Chapter V of the FFDCA.

The requirements for electronic product radiation control will remain unchanged. The responsibilities of the Food and Drug Administration’s Center for Devices and Radiological Health also will remain the same. The RCHSA, however, has been renamed and recodified as follows:

RCHSA (old) Chapter V, FDDCA (new)
Sec. 354, Purpose Sec. 530
Sec. 355, Definitions Sec. 531
Sec. 356, Control Program Sec. 532
Sec. 357, Studies Sec. 533
Sec. 358, Standards Sec. 534
Sec. 359, Defects Correction Sec. 535
Sec. 360, Imports Sec. 536
Sec. 360A, Inspections, Records, Reports
Sec. 537
Sec. 360B, Prohibited Acts Sec. 538
Sec. 360C, Enforcement Sec. 539
Sec. 360D, Report to Congress Sec. 540
Sec. 360E, Federal/State Relations Sec. 541
Sec. 360F, State Standards Sec. 542

The regulations pertaining to radiation control have not been changed or renumbered. They are still contained in Title 21, Code of Federal Regulations (CFR), Parts 1000 through 1050.