360 F.2d 677 (2nd Cir. 1966), 325, Toilet Goods Ass'n v. Gardner

Docket Nº:325, 30261.
Citation:360 F.2d 677
Party Name:The TOILET GOODS ASSOCIATION, Inc., et al., Plaintiffs-Appellees, v. John W. GARDNER, Secretary of Health, Education and Welfare, and James L.Goddard, Commissioner of Food and Drugs, Defendants-Appellants.
Case Date:April 13, 1966
Court:United States Courts of Appeals, Court of Appeals for the Second Circuit

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360 F.2d 677 (2nd Cir. 1966)

The TOILET GOODS ASSOCIATION, Inc., et al., Plaintiffs-Appellees,


John W. GARDNER, Secretary of Health, Education and Welfare, and James L.Goddard, Commissioner of Food and Drugs, Defendants-Appellants.

No. 325, 30261.

United States Court of Appeals, Second Circuit.

April 13, 1966

Argued Feb. 25, 1966.

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Arthur S. Olick, New York City (Robert M. Morgenthau, U.S. Atty. for Southern Dist. of New York, James G. Greilsheimer, Asst. U.S. Atty., of counsel), for defendants-appellants.

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Edward J. Ross, New York City (Breed, Abbott & Morgan, New York City, Stephen R. Lang, New York City, of counsel), for plaintiffs-appellees.

Before WATERMAN, MOORE and FRIENDLY, Circuit Judges.

FRIENDLY, Circuit Judge:

In July 1960, Congress added to the Federal Food, Drug, and Cosmetic Act a number of new provisions known as the Color Additive Amendments, 74 Stat. 397, 21 U.S.C. §§ 321-376. These were intended

'to authorize the use of suitable color additives in or on foods, drugs, and cosmetics in accordance with regulations to be issued by the Secretary of Health, Education, and Welfare, prescribing the conditions, including maximum tolerances, under which such additives may be safely used.' H.R.Rep. No. 1761, 86th Cong., 2d Sess., 1960 U.S.Code Cong. & Ad.News, p. 2887.

The Commissioner of Food and Drugs, to whom the Secretary of Health, Education and Welfare has delegated the Department's functions under the Act, 22 F.R. 1951 (1957), 25 F.R. 8625 (1960), held rule-making proceedings conforming to § 4 of the Administrative Procedure Act, 5 U.S.C. § 1003, and issued Color Additive Regulations, 21 C.F.R. Part 8, effective, with certain exceptions, on June 22, 1963.

The following November the Toilet Goods Association, a trade organization of cosmetic manufacturers whose members allegedly represent 90% Of annual United States sales, and forty manufacturers and distributors of cosmetics brought this action against the Secretary and the Commissioner in the District Court for the Southern District of New York for a declaratory judgment that four provisions of the Regulations exceeded the authority conferred by the statute. Jurisdiction was properly predicated on 28 U.S.C. §§ 1331 and 1337. See Smith v. Kansas City Title & Trust Co., 255 U.S. 180, 41 S.Ct. 243, 65 L.Ed. 577 (1921). 1 The defendants moved to dismiss or to strike certain portions of the complaint on various grounds, among others that the case was inappropriate for declaratory relief and that the action was an unconsented suit against the sovereign; plaintiffs cross-moved for summary judgment. In November 1964 Judge Tyler denied both motions in an opinion, 235 F.Supp. 648, relying in part on Abbott Labs. v. Celebrezze, 228 F.Supp. 855 (D.Del.1964), where the court had granted a declaratory judgment invalidating labeling regulations under the same statute. A year later, when the case was nearly ready for trial, the Secretary and the Commissioner renewed their motion to dismiss on the two grounds stated, arguing that a different conclusion on 'the issue of justiciability' was called for by the Third Circuit's reversal of the Abbott Laboratories decision, 352 F.2d 286 (1965), 2 and the District of Columbia Circuit's recent holding that declaratory relief was not available to challenge certain regulations adopted under the Tobacco Inspection Act, 7 U.S.C. § 511m, Danville Tobacco Ass'n v. Freeman, 351 F.2d 832 (1965). Judge Tyler adhered to his determination but, at the defendants' request, made the necessary certification for an application to prosecute

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an interlocutory appeal under 28 U.S.C. § 1292(b); permission to appeal was granted by a panel of this court.


The first two counts of the complaint charge that the Regulations exceed the authority conferred by the statute in treating finished cosmetic products and all diluents-- unpigmented materials with which colors are mixed-- as 'color additives' subject to various requirements for testing and administrative certification. The basic section of the Color Additive Amendments is § 706 of the Act, 21 U.S.C. § 376, which provides that a 'color additive' shall be deemed unsafe unless it meets two conditions: 3 The additive must be covered by a 'regulation,' issued by the Secretary on a finding of suitability, which lists it for use either generally or under prescribed conditions; and it must either come from a batch certified for such use by the Secretary under appropriate regulations or have been exempted from the certification requirement.

The term 'color additive,' on which the controversy turns, is defined in § 201(t)(1), as a material which

'(A) is a dye, pigment, or other substance made by a process of synthesis * * * or otherwise derived * * * 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 other substance) of imparting color thereto.' 21 U.S.C. § 321(t)(1)

The Regulations of the Food and Drug Administration (FDA) interpret the statutory definition of color additive as including 'all diluents' and state further that

'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. Lipstick, rouge, eye makeup colors, and related cosmetics intended for coloring the human body are 'color additives. " Reg. § 8.1(f).

The term 'diluent' is defined as:

'any component of a color additive mixture that is not of itself a color additive and has been intentionally mixed therein to facilitate the use of the mixture in coloring foods, drugs, or cosmetics or in coloring the human body. The diluent may serve another functional purpose in the foods, drugs, or cosmetics, as for example sweetening, flavoring, emulsifying, or stabilizing, or may be a functional component of an article intended for coloring the human body.' Reg. § 8.1(m)

The manufacturers admit that the coloring ingredient in a cosmetic is a 'color additive' fully subject to both listing and certification requirements of 706, and that a 'diluent,' in what they insist is the accepted definition of an inert substance used to dilute dyes and pigments, is subject to the Secretary's power to certify additives 'with safe diluents or without diluents,' § 706(c). They complain, however, that the Regulations' comprehensive definition of 'color additive' goes beyond the reach of the statute in imposing both listing and certification requirements on finished products-- like lipstick, nail polish, etc.-- and non-color ingredients that were never intended to be subject to premarketing clearance, and on traditional diluents that were meant to be subject only to certification as components of dyes and pigments.

The third count of the complaint relates to provisions in the Regulations which attempt to subject hair dye products to premarketing clearance in what is alleged to be violation of the exemption recognized in the statute. The Act as passed in 1938, in defining those cosmetics that were deemed to be adulterated,

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contained in § 601(a) an explicit exemption for hair dyes:

This provision shall not apply to coal-tar hair dye, the label of which bears the following legend conspicuously displayed thereon: 'Caution-- This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.', and the labeling of which bears adequate directions for such preliminary testing.' 52 Stat. 1054

The exemption was carried forward in § 601(e) which declared that a cosmetic should be deemed adulterated 'If it is not a hair dye and it bears or contains a coal-tar color other than one' from a certified batch. When Congress revised the statute in the 1960 amendments, it left § 601(a) as it was but modified § 601(e) to read 'If it is not a hair dye and it is, or it bears or contains, a color additive which is unsafe' within the meaning of § 706.

The Regulations recognized the statutory exemption where proper labeling called for use of the patch test but, armed with an expansive definition of 'color additive' in § 8.1(f) which would on its face seem to include in a preparation for use on the hair any coloring ingredient as well as the finished product, proceeded to limit the exemption as follows:

'The 'hair dye' exemption in section § 601(a) of the act applies to those articles intended for use in altering the color of the hair and which are, or which bear or contain, color additives with the sensitization potential of causing skin irritation in certain individuals and possible blindness when used for dyeing the eyelashes or eyebrows. The exemption is permitted with the condition that the label of any such article bear conspicuously the statutory caution and adequate directions for preliminary patch-testing. If the poisonous or deleterious substance in the 'hair dye' is one to which the caution is inapplicable and for which patch-testing provides no safeguard, the exemption does not apply; nor does the exemption extend to poisonous or deleterious diluents that may be introduced as wetting agents, hair conditioners, emulsifiers, or other components in a color shampoo, rinse, tint, or similar dual-purpose cosmetics that alter the color of the hair.' Reg. § 8(u)

The manufacturers claim that the Regulations go beyond the statute in several ways: Whereas the...

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