Toilet Goods Association v. Finch

Decision Date25 August 1969
Docket NumberNo. 617,Docket 32531.,617
Citation419 F.2d 21
PartiesThe TOILET GOODS ASSOCIATION, Inc., et al., Plaintiffs-Appellees, v. Robert H. FINCH, Secretary of Health, Education and Welfare, and Herbert L. Ley, Jr., Commissioner of Food and Drugs, Defendants-Appellants.
CourtU.S. Court of Appeals — Second Circuit

Alan B. Morrison, Asst. U. S. Atty. (Robert M. Morgenthau, U. S. Atty. for the Southern District of New York, Michael D. Hess, Asst. U. S. Atty., of counsel), for defendants-appellants.

Edward J. Ross (Breed, Abbott & Morgan, Stephen R. Lang, New York

City, of counsel), for plaintiffs-appellees.

Before WATERMAN, FRIENDLY and KAUFMAN, Circuit Judges.

FRIENDLY, Circuit Judge:

Nine years ago Congress amended the Food, Drug, and Cosmetic Act, 52 Stat. 1040 (1938), by enacting the Color Additive Amendments of 1960, 74 Stat. 397. Nearly three years later, after appropriate rule-making proceedings, the Food and Drug Administration (FDA) published its Regulations thereunder, 28 F.R. 6439. This litigation about the validity of their provisions concerning diluents, finished cosmetics and hair-dyes has continued ever since. An initial effort by the Government to prevent the judicial review of the Regulations sought by the cosmetics industry, on the ground of lack of "ripeness," was rebuffed by Judge Tyler in the District Court for the Southern District of New York, 235 F.Supp. 648 (1964). A year later, when the case was nearly ready for trial, the Government renewed its effort to obtain dismissal for lack of ripeness on the basis of an allegedly conflicting decision by another circuit, with no success beyond obtaining a certificate from the district judge for an interlocutory appeal under 28 U.S.C. § 1292(b) which we allowed. We sustained the district court save in one respect no longer material, 360 F.2d 677 (1966). Both sides successfully sought certiorari but the Supreme Court affirmed, 387 U.S. 167, 87 S.Ct. 1526, 18 L.Ed.2d 704 (1967). The case then returned to the district court where Judge Tyler rendered a decision favorable to the plaintiffs, 278 F.Supp. 786 (1968). This time the defendants were some seventeen months in bringing their appeal to us.

I. Finished Cosmetic Products as Color Additives

The key provision of the Color Additive Amendments is 21 U.S.C. § 376, providing for what the parties term "premarketing clearance." This begins by saying in subsection (a):

A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or cosmetics, be deemed unsafe for the purposes of the application of sections 342(c), 351(a) (4), or 361(e) of this title, as the case may be, unless —
(1) (A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c) of this section, for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or
(2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section.

Subsection (b) (1) directs the Secretary to provide by regulation

for separately listing color additives for use in or on food, color additives for use in or on drugs, and color additives for use in or on cosmetics, if and to the extent that such additives are suitable and safe for any such use when employed in accordance with such regulations.

Section 8.4(c) of the Regulations sets forth the requirements for a listing application in elaborate detail. These include a complete description of the chemical and physical properties of the color additive, the chemical and physical tests relied on to identify it, and the methods and ingredients used for its production; a description of practical methods to determine the amount of the color additive, and of any substance formed by its use, contained in the final product; full reports of investigation made with respect to its safety; complete data to allow the Commissioner to consider the probable consumption of or other exposure to the additive and any substance formed therefrom; and proposed tolerances. If an exemption from batch certification is requested, supporting data are to be furnished. Each listing application must be accompanied by a fee of $2600 to cover the FDA's costs in processing the application and performing tests. Other provisions of the Regulations, § 8.22-§ 8.30, contain equally detailed requirements with respect to certification, including a provision, § 8.26, that "the person to whom a certificate is issued shall keep complete records showing the disposal of all the color additive from the batch covered by such certificate."

The parties are in basic disagreement concerning what constitutes a color additive requiring the premarketing clearance just described. On this the statute informs us, § 321(t) (1):

(1) The term "color additive" means a material which —
(A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and
(B) when added or applied to a food drug or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with any other substance) of imparting color thereto; except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.

The disputed Regulation, 21 C.F.R. § 8.1 (f), after repeating this definition, adds two provisions of which the industry complained. One is "This includes all diluents"; the other is:

A substance that, when applied to the human body results in coloring, is a "color additive," unless the function of coloring is purely incidental to its intended use, such as in the case of deodorants. Lipsticks, rouge, eye makeup colors and related cosmetics intended for coloring the human body are "color additives."

The industry contended, and the district court held, that the Regulation exceeded the statutory authority in requiring premarketing clearance of diluents1 and of finished cosmetic products. The Government does not claim error in the conclusion that § 8.1(f) is invalid in defining diluents as color additives and thereby making them subject to premarketing clearance. But it vigorously attacks the holding that the section is similarly invalid in so defining finished cosmetic products.

In a valiant effort to overcome the instinctive reaction that when Congress spoke of a "color additive" it scarcely meant the entire product, the Government has developed an ingenious parsing of the definition in § 321(t). A finished cosmetic product, it says, while not a dye or pigment within subdivision (A), is an "other substance." And while such a product is not "added or applied to a food, drug or cosmetic" within subdivision (B), it is applied "to the human body or any part thereof" and "is capable (alone or through reaction with any other substance) of imparting color thereto." Hence the finished cosmetic product is itself a color additive. Indeed, says the Government, any other construction would fail to comply with the canon that every word in a statute must be given effect, since, as it claims, the industry has been unable to point to any "other substance" which, when added or applied to the human body, is capable of imparting color thereto.2

The district judge rejected the Government's construction on several grounds, 278 F.Supp. at 790-791. He pointed to the numerous instances where Congress used the word "cosmetics" when that was what it intended. See 21 U.S.C. §§ 331, 374, 381. He countered the defendants' canon with that of ejusdem generis; the natural interpretation of "other substance" is a coloring ingredient having properties similar to a dye or pigment, see fn. 2. Defendants' reading "other substance" to include a cosmetic would cause the definition to refer to "a dye, pigment, or other substance (including a cosmetic)" which, when added to "a food, drug or cosmetic" is capable of imparting color, a result he deemed absurd. When Congress wished to employ a comprehensive term for finished products, it used the word "articles," 21 U.S.C. § 321, whereas "substance" was used to connote a component or ingredient, 21 U.S.C. §§ 321(s), 346.

The Government answers the last argument rather effectively by pointing to other instances where the word "articles" was used to refer to components, §§ 321(f) and (i) and 355(b). It also contends that if the industry's construction is right, the exemption for pesticides in § 321(t) (3) was unnecessary, to which the industry responds that this was inserted on the request of pesticide manufacturers out of abundant caution, and that in any case it would have been more logical to call pesticides and fertilizers which might alter the color of plants "color additives" than to apply the term to finished cosmetics. The Government argues from the rejection of many similar requests to limit the definition that it was intended to have broad scope, while the industry asserts that many of these requests stemmed from such absurd fears — for example, that the peas in a can of peas and carrots might be "color additives" because they are not the same color as the carrots — that they reinforce Judge Tyler's restricted reading of the phrase "dye, pigment, or other substance."

Coming closer to the critical issue, the Government points to § 361(e),...

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