21 U.S.C. § 393 — Food and Drug Administration

(a) The Food and Drug Administration ("FDA") is created inside the Department of Health and Human Services. (b) Mission. The FDA must: promote public health by promptly and efficiently reviewing clinical research and acting on product-marketing decisions in a timely way; for the products it regulates, make sure foods are safe, wholesome, sanitary, and correctly labeled, human and veterinary drugs are safe and effective, medical devices are reasonably assured to be safe and effective, cosmetics are safe and correctly labeled, and the public is protected from radiation given off by electronic products; work with other countries to reduce regulatory burden, align requirements, and set up fair reciprocal arrangements; and, as the Secretary decides is appropriate, do all this in consultation with scientific, medical, and public health experts, and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers. (c) Interagency collaboration. The Secretary must run programs and policies that get the FDA collaborating with the National Institutes of Health and other science-based federal agencies, to build up the scientific and technical expertise available for developing, testing, evaluating, and monitoring new medical treatments — including complementary therapies — and advances in nutrition and food science. (d) Commissioner. (1) There's a Commissioner of Food and Drugs, appointed by the President with Senate confirmation. (2) Through the Commissioner, the Secretary is responsible for running this law, including giving overall direction and setting management policy for the FDA, coordinating and overseeing all of FDA's internal units, conducting research on foods, drugs, cosmetics, devices, and tobacco products, running educational and public-information programs about FDA's role, and carrying out any other duties the Secretary assigns. (e) Technical and scientific review groups. Through the Commissioner, the Secretary can set up technical and scientific review groups needed for FDA's work — without following the usual federal hiring, classification, and pay rules — and can appoint and pay their members, except that federal employees don't get extra pay for serving on these groups. (f) Agency compliance plan. (1) Within 1 year of November 21, 1997, after consulting scientific and academic experts, health professionals, patient and consumer groups, and industry, the Secretary must publish a plan in the Federal Register for how FDA will meet all its legal obligations under this law. The plan must be reviewed every two years and revised as needed, with the same consultation. (2) The plan must set goals and ways to reach them, covering: making information about the application and submission review process clearer and easier to find; making information about new products clearer for consumers and patients; carrying out inspection and postmarket monitoring duties; making sure FDA has the scientific and technical staff it needs; setting up, by July 1, 1999, ways to meet the legal deadlines for reviewing applications submitted after November 21, 1997; and eliminating application-review backlogs by January 1, 2000. (g) Annual performance report. Each year the FDA must publish a report, and take public comment on it, that gives detailed statistics on how well FDA met the compliance plan's goals, compares that performance to the plan's goals and FDA's legal duties, and flags any regulatory policy that's hurting compliance along with proposed fixes. (h) Annual food report to Congress. By February 1 each year, the FDA must send Congress a report — including its efforts to coordinate with other federal agencies on food inspections — covering: information about food facilities, including money spent inspecting registered facilities the previous year, the average cost of inspecting a non-high-risk versus a high-risk facility if there's a difference, how many domestic and foreign registered facilities FDA inspected, how many scheduled inspections FDA missed, how many identified high-risk facilities FDA inspected, and how many scheduled high-risk inspections FDA missed; information about food imports, including how many import "lines" of food FDA physically inspected or sampled, how many it didn't, and the average cost of inspecting or sampling one import line; and information about FDA's foreign offices, including how many exist and how many staff are permanently stationed at each. (i) Public access. The FDA must make the reports required under subsection (h) available to the public on its website.

The record identifies the underlying enactment as the Act of June 25, 1938, ch. 675, which established the Federal Food, Drug, and Cosmetic Act. The particular provision now codified at 21 U.S.C. § 393, however, was not part of the original 1938 text; the source credit shows it was added later, as § 903, by Public Law 100-607, title V, § 503(a), on November 4, 1988. The credit further shows the section was amended by Public Law 100-690 (1988), Public Law 105-115 (1997), renumbered as § 1003 and further amended by Public Law 111-31 (2009), and again amended by Public Law 111-353 (2011). This sequence indicates recurring congressional attention to the section over more than two decades, with five distinct amendment actions noted in the credit. Historical context. The 1938 Act is generally understood as a response to public-health failures in food and drug regulation of the era, replacing an earlier 1906 statute with a broader framework covering safety and labeling. The 1988 addition creating a statutory basis for the Food and Drug Administration is commonly understood to reflect a later legislative effort to formally establish the agency's mission, leadership structure, and organizational authority within the Department of Health and Human Services, consolidating functions that had developed administratively over decades. The record does not establish the specific legislative motivations behind each subsequent amendment, including the 1997, 2009, and 2011 changes; without more, the particular purposes behind those revisions should not be assumed.