[Source: Peter Baron Hutt, The Transformation of United States Food and Drug Law, J. Ass'n Food & Drug Officials, Sept. 1996, at 1 (reprinted in Law, Medicine, and Medical Technology, Noah et al., at 70 (2002)]
Neither the 1906 Act nor the 1938 Act is self-executing. Both have required FDA to implement very broad and general statutory provisions with more specific operating rules. Thus, FDA has spent the past century determining, and then making public, procedural and substantive policy statements designed to facilitate its administration of the organic statute.
Prior to the 1970s, it was common practice simply to propose a regulation, obtain public comment and then publish a final regulation, without an explanation of the reasons for the proposal or why the changes recommended by the public comment were or were not accepted in the final regulations. FDA pioneered the use of explanatory preambles to both the proposed and the final regulations. These preambles served and continue to serve to this day the purpose of educating FDA employees, the regulated industry and the general public about the importan work of the agency. Today Congress requires all federal agencies to justify their rulemaking.
Under the 1906 Act, any violation constituteed a misdemeanor punishable by a fine, imprisonment or both. Violative products were also subject to seizure. The 1938 Act expanded FDA's enforcement power. In addition to criminal liability and seizure, FDA was authorized to obtain a judicial injunction against any violation of the statute. FDA was also authorized to issue a written administrative notice or warning for minor violations in lieu of formal court proceedings, to conduct factory inspection and to issue publicity and other public information. As the 1938 Act was amended to require premarket approval for regulated products, FDA was able to enforce the statute informally through administrative decisions as part of the approval process rather than by formal court action.
From a policing role under the 1906 Act, FDA gradually undertook the role of sole gatekeeper to the marketplace. For a product subject to premarket approval, no manufacturer may lawfully distribute the product and no member of the public has a right to obtain it unless and until FDA authorizes marketing.
Premarket approval under the 1938 Act includes no mechanism for public accountability. Citizens who wish to obtain a product have no right to participate in the process and no access to judicial review of whatever action is taken by FDA. Even the applicant is precluded from access to the courts until final action is taken on a product application.
