LOCATION: Smith County Jail
DOCKET NO.: 336
DECIDED BY: Warren Court (1965-1967)
LOWER COURT: United States Court of Appeals for the Second Circuit
CITATION: 387 US 158 (1967)
ARGUED: Jan 16, 1967
DECIDED: May 22, 1967
Facts of the case
Media for Toilet Goods Association, Inc. v. Gardner
Audio Transcription for Oral Argument - January 16, 1967 in Toilet Goods Association, Inc. v. Gardner
Number 336, the Toilet Goods Association Incorporated et al. Petitioners versus John W. Gardner, Secretary of Health, Education and Welfare, and number 438, John W. Gardner, Secretary of Health, Education and Welfare versus the Toilet Goods Association.
Mr. Chief Justice, may it please the court.
This case which is here on cross-writs of certiorari to the Court of Appeals for the Second Circuit, demonstrate even more clearly than does the Abbott Laboratories case the harms which flow from premature judicial intervention and of the administration of the Food and Drug and Cosmetic Act.
Under the terms of that statutes enacted in 1938, the Food and Drug Administrations was to protect the nations’ consumers against certain harmful coloring ingredients in foods, drugs and cosmetics by a premarketing clearance procedure under which it was to require manufacturers to test coal-tar colors for safety.
After the Food and Drug Administration had reviewed the results of these tests, it was authorized to list such colors as it found harmless or suitable for use.
Late in 1958, this court sustained the Food and Drug Administrations’ position that the statutory scheme under that 1938 Act contemplated that only totally harmless coal-tar colors could be listed.
In other words, that the Food and Drug Administration was not required to concern itself with the precise concentration or the mixtures in which such colors would have been used in foods, drugs or cosmetics or with any of the products with which they were combined.
Only if the coloring ingredient was absolutely and totally harmless could it be listed under the existing standard that was Flemming versus Florida Citrus Exchange in 358 U.S.
Recognizing the merit of an industry complaint that such an absolute standard prohibited the use of coloring ingredients which might be totally innocuous in small quantities that actually used, the Food and Drug Administration supported the mandatory legislation which was enacted to the Color Additive Amendments in 1960.
That statute which is reprinted in relevant portions of pages 24 and 29, and 37 of our brief in this case extended the premarketing clearance procedure to all color items both natural and synthetic coal-tar and any other coloring ingredients which were derived from any other source.
It empowered the Food and Drug Administration, which had been delegated the powers of the Secretary of Health, Education and Welfare under the act to list color additives after review of testing information submitted by the manufacturer with “conditions under which the additives might be safely used.”
Section 706(a)(2)(b), and (a)(3) which appear at page 30 of our brief are quite clear on that subject.
They authorized the secretary to list a color additive for a “more limited use or uses than have been applied for” and “prescribed the conditions under which such additive maybe safely employed for such use or uses.”
The act was passed in July of 1960 with appropriate provisions, for provisional listings of color additives which had been used until the administrative machinery had gone through the process and completed verifying the information on the color additive applications, which would be submitted.
In June 1963, the commissioner of Food and Drugs after reporting notice and an opportunity to submit return comments in the Section 4 of the Administrative Procedure Act issued substantially the regulations which appear 22 CFR 8.1 to 8.52, it covers about 20 pages in the code of federal regulations.
Among those regulations were four clauses which are specifically the challenge in this case.
Section 8.1, all those four all appear at pages 37 and 38 of our brief.
Section 8.1F defined color additives as used in the statute and have been subjected to these procedures by the Congress to include “a substance that when applied to the human body results in coloring,” and it specifically enumerated lipstick, rouge, eye makeup colors and related cosmetics intended for coloring the human body.
In other words, the Food and Drug Administration construed the act as subjecting to this premarketing clearance procedure, finished cosmetic products used for coloring the human body.
The very same section of the code of federal regulation also defined color additive to include old diluents and diluents were defined in the definitionary provisions of that regulation as any component of a color additive mixture that is not of itself a color additive and has been intentionally mixed there in to facilitate the use of the mixture in color.
In other words, anything added for purposes of -- essentially anything added to a product which contains coloring ingredient.
In addition Section 8.01(u) defines the Hair Dye Exemption Statute, the statute specifically Congress exempted from its provisions, hair dyes provisions of the Food, Drug and Cosmetic Act in the preclearance procedures, hair dyes which contain color ingredients whose harmful nature could be determined by what’s commonly known as a patch test.
A test, which the consumer could apply to his own skin and determine whether there was anything in that hair dye which would, which would harm him or her.
And the Food and Drug Administration in these regulations construed the Hair Dye Exemption of the statute as not applying to any hair dyes containing products whose harmful products, whose harmful effects could not be testified in a patch test.
It was going behind the words of the statute to the purpose of Congress.
And finally the fourth provision involved in this suit and the one on which the Food and Drug Administration was sustained by the Court of Appeals warned that if employees of the Food and Drug Administration were denied access to manufacturing facilities, processes or formulae of drugs -- of cosmetics which they were required to certificate it in effect by batch certifications to check -- though the very product itself, then the commissioner might immediately suspend the certification service there by making those products nonmarket, that was in July of 1963.
In November of that year, before the regulations were put in effect, and for compliance with any of these regulations or before an effect these procedures have been gone through, this action to declare clear those regulations invalid was instituted.
The District Judge first denied a motion to dismiss in November 1964 and then after the Abbott Laboratories case was decided by the Third Circuit in December of 1965, he certified interlocutory appeal under 28 U.S.C. 1292(b) on that issues to whether this suit was premature or it was right at this juncture or not.
The Court of Appeals affirmed the district judge's refusal to dismiss the first three counts of the complaint but concluded that the fourth count attacking the factory inspection provision was premature and should be dismissed.