42 Food Drug Cosm. L.J. 101 (1987)
The Infant Formula Act of 1980: A Case Study of Congressional Delegation to the Food and Drug Administration

handle is hein.journals/foodlj42 and id is 107 raw text is: FOOD DRUG COSMETIC LAW JOURNAL 42, 101- 154 (1987)

The Infant Formula Act of 1980: A Case Study of Congressional
Delegation to the Food and Drug Administration
TOBY MILGROM LEVIN, ESQ.*
More than any other food product, we expect infant formula to be manufactured to exacting
standards. No margin of error can be tolerated. Every reasonable effort to insure safety and
quality must be undertaken. Parents rightfully demand a high degree of care and performance
from those involved in this important industry.
Representative Henry A. Waxman
Chairman, House Subcommittee on
Health and the Environment'
AN OVERVIEW
In November 1979, the Food and Drug Administration (FDA) was faced with a
major health crisis. An infant formula had been found to be deficient in an essen-
tial nutrient, and this deficiency had led to severe health reactions in what was yet
an unknown number of infants. This incident, followed by an incomplete recall
that FDA critics contended was poorly supervised, led to a clamor on Capitol Hill
for new legislation to assure that all infant formula is nutritionally adequate, a
necessity since formula serves as the sole source of nutrition for thousands of
infants. In September 1980, the Infant Formula Act (IFA)2 was passed virtually
unanimously; and FDA was given the authority to implement it.
This paper uses the IFA as a case study of congressional delegation of authority
to FDA. The IFA is particularly appropriate for such an analysis because the
legislative history and the agency implementation both have transpired during a
relatively short time period. In addition, many of the policy makers and their staff
who were involved in drafting or implementing the IFA were still in their respec-
tive positions or otherwise accessible for interviews in preparing this paper.
Third, several public interest groups critical of FDA's implementation of the IFA
sued FDA seeking an injunction to order the agency to revise its implementing
* Toby Milgrom Levin is an attorney with the Federal Trade Comm'n, Div. of Advertising Practices.
She prepared thi, paper as a Food and Drug Law Institute research scholar for 1983-84, under the
supervision of Prof. Sandra N. Hammer, at the Columbus School of Law, Catholic U. of America.
The views expressed are those of the author and do not reflect FTC policy.
I Nutritional Quality of Infant Formula: Hearings on H.R. 6590, H.R. 6608, H.R. 5836, H.R. 5839
Before the Subcomm. on Health and the Environment of the House Comm. on Interstate and Foreign
Commerce, 96th Cong., 2d Sess. 1 (1980) [hereinafter cited as Waxman Hearings].
2 Infant Formula Act of 1980, Pub. L. No. 96-359, 94 Stat. 1190 (codified at 21 U.S.C.  350a, 301,
321(aa), 331, 374(a) (1980).
101
0015-6361/87 $3.00
Copyright  1987 by Academic Press. Inc.
All rights of reproduction in any form reserved.

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