Waterman, Moore and Friendly, Circuit Judges.
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).*fn1 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),*fn2 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, 122 U.S. App. D.C. 135, 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:*fn3 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 ...