Toilet Goods Association v. Gardner
Citation | 360 F.2d 677 |
Decision Date | 13 April 1966 |
Docket Number | Docket 30261.,No. 325,325 |
Parties | 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. |
Court | United States Courts of Appeals. United States Court of Appeals (2nd Circuit) |
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.
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.
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, 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 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 "diluent" is defined as:
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, contained in § 601(a) an explicit exemption for hair dyes:
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:
Reg. § 8(u)
The manufacturers claim that the Regulations go beyond the statute in several ways: Whereas the 1938 Act literally exempted from premarketing clearance any coal-tar hair dye complying with the statutory condition of notice and the amendments did not purport to effect any change, the Regulations grant exemption only if the color additive in the hair dye substance is one whose irritating qualities would be...
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