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"For more than 100 years, the Food & Drug Administration has been one of the leading groups in this country working on analytical methodology," Peter Barton Hutt, former FDA general counsel and now an attorney in the law firm of Covington & Burling, tells C&EN.
Some people are surprised to hear that FDA, in some form, has been in existence for more than a century. Even more surprising is that FDA can trace its origins to the chemistry laboratory in what was once the agricultural division of the old Patent Office.
The agency's history is a tangled skein, with a strand of chemistry woven through it.
When Congress created the Department of Agriculture in 1862, the Patent Office's chemistry lab was transferred to the new agency and renamed the chemical division. President Abraham Lincoln appointed Charles M. Wetherill, a chemist, to direct the division, which in 1890 underwent another name change: It became the division of chemistry.
In 1901, the Division of Chemistry became the Bureau of Chemistry. And the bureau, in turn, became the Food, Drug & Insecticide Administration in 1927 and - finally - the Food & Drug Administration in 1930.
A decade later, FDA was transferred from the Agriculture Department to the Federal Security Agency, and Walter G. Campbell was appointed the first commissioner of food and drugs. In 1953, the security agency became the Department of Health, Education & Welfare (HEW), which was renamed the Department of Health & Human Services (HHS) in 1979. FDA is now part of the Public Health Service within HHS.
In the early years, FDA's predecessor organizations focused on food adulteration. This emphasis originated with Peter Collier, who became the Agriculture Department's chief chemist in 1879, and intensified under Harvey W. Wiley, who became chief chemist in 1883.
Soon after becoming chief chemist, Collier began lobbying for a national food and drug law. But it took Congress until 1906 to enact the Food & Drugs Act, which prohibited interstate commerce in mislabeled or adulterated foods, drinks, and drugs.
It took Congress more than 30 years to beef up the 1906 law. In 1938, it passed the Federal Food, Drug & Cosmetic Act, which extended FDA's reach to cosmetics and therapeutic devices. The law also set in motion a new system of drug regulation. It required that new drugs be proven safe before marketing.
Since its adoption, the 1938 law has been amended repeatedly, eventually extending FDA's regulatory powers to pesticides and food additives. In 1958, the Delaney clause was incorporated into the law. This now controversial provision prohibits the approval of any food additive found to induce cancer in humans or animals.
Over the years, FDA lost some areas of jurisdiction, but gained others. For instance, in 1970, when the Environmental Protection Agency was formed, Congress transferred FDA's program for setting pesticide tolerances in food to the new agency. But the next year, FDA picked up the Bureau of Radiological Health and the National Center for Toxicological Research, which traces its origins to U.S. biological warfare programs.
In 1988, Congress passed the Food & Drug Administration Act, which officially established FDA in HHS, and made FDA's commissioner a presidential appointee. Two years later, Congress passed the Nutrition Labeling & Education Act, which requires nutritional labeling on all packaged foods.
FDA's responsibilities have expanded through the years, but its budget hasn't grown commensurately. As a result, the backlog of product approvals, especially for drugs, has mounted. To decrease the backlog and speed up approvals, FDA asked Congress for legislation requiring industry to pay fees for product approvals.
In 1992, Congress passed the Prescription Drug User Fee Act, which FDA has drawn upon to hire hundreds of additional reviewers to assess industry's new product applications. FDA claims these fees have helped it substantially reduce both the backlog and the time it takes to approve new products for the marketplace. Agency critics disagree, and FDA today finds itself under siege from industry and some in Congress seeking regulatory reforms.