Cover Image


View/Hide Left Panel

Sections. After careful consideration of the NLEA language and the entire Congressional Record discussion of NLEA Section 6(b)(1), the Committee rejected this recommendation. It concluded that the existence of Section 6(b)(1) is evidence of the conclusion of Congress that it cannot be presumed that the six FDCA Sections to be studied are being adequately implemented. The Committee also concluded, however, that the absence of an implementing regulation should not lead to an automatic conclusion that implementation is inadequate, although it could raise suspicions. There are two reasons for this conclusion. First, from a legal standpoint, regulations ordinarily are not necessary to implement Federal law. Second, FDA implements policy in ways other than by regulation, and such policy statements deserved consideration by the Committee. However, lack of any formal policy could be troublesome.

A second view, supported especially by States, was that a determination of adequate implementation could not be made without considering whether the statute, regulations, or other implementing policies were being actively and aggressively compiled with and enforced. Enforcement was defined as the application of dollar and personnel resources and the use of civil, criminal, or administrative sanctions against violators. States argued that they often established and enforced their own requirements because FDA failed to "enforce" its own statutes, regulations, or other policies. A number of States suggested that Federal implementation would be adequate if only it was well enforced (i.e., Crawford, 1991; Harden, 1991; McClellan, 1991; Niles, 1991).

This second view was particularly troublesome to the Committee. The concerns expressed about the lack of FDA enforcement of policies that were otherwise viewed as adequate in implementing FDCA Section 403 were not without merit. The Committee considered this matter with cognizance of the NLEA provision for State enforcement of Federal law that, in effect, expands the total means available to enforce otherwise adequate provisions. From a pragmatic standpoint, however, the Committee could not ignore the realities of fiscal constraint at all levels of government. If any government agency, Federal, State, or local, has insufficient funding to carry out all of the activities that the agency, or its critics, believe are important to achieve, agency leadership must establish priorities. Historically, such priority setting for resource allocation has been the case, and the Committee is aware of the fact that for many years, FDA's broad enforcement priorities have included health hazards, and filth and related adulteration ahead of economic violations (DHHS, 1991).

From the research it conducted, the Committee could not determine in any conclusive fashion whether or how the States' enforcement of their misbranding statutes differs from that of FDA. Many misbranding charges

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement