The opinion of the court was delivered by: TYLER
The merits of this controversy are now before this court upon the renewed motion of plaintiffs and cross-motion of defendants (hereinafter collectively referred to as "FDA") for summary judgment. For the history of this interesting litigation, see Toilet Goods Association, Inc. v. Celebrezze, 235 F. Supp. 648 (S.D.N.Y.1964); modified sub nom. Toilet Goods Association, Inc. v. Gardner, 360 F.2d 677 (2d Cir. 1966), aff'd, 387 U.S. 158, 87 S. Ct. 1520, 18 L. Ed. 2d 697 and 387 U.S. 167, 87 S. Ct. 1526, 18 L. Ed. 2d 704 (1967).
On June 9, 1967, after the aforementioned opinions of the Supreme Court were handed down, sustaining the view of this court and the Court of Appeals that three of the FDA Regulations challenged by plaintiffs are ripe for judicial review,
a pre-trial conference was held. At that conference, the parties, with the approval of this court, agreed that summary judgment based upon the pleadings, affidavits and depositions taken by plaintiffs of certain government witnesses was appropriate for resolution of the merits of plaintiffs' attack upon the Regulations in question. Final briefs were submitted and arguments were heard on the summary judgment motions on November 6, 1967. For reasons to be summarized hereinafter, this court sustains plaintiffs' challenge to the three pertinent administrative regulations.
On July 12, 1960, Congress engrafted upon the Food, Drug and Cosmetic Act, 52 Stat. 1040 (1938), as amended, 21 U.S.C. §§ 301-392 (1964), ("the Act"), certain new provisions known as the Color Additive Amendments, 74 Stat. 397 (1960) (codified in scattered sections of 21 U.S.C.), ("the 1960 Amendments"). After rule-making procedures in conformity with Section 4 of the Administrative Procedure Act, 5 U.S.C.A. § 553 (1967), the Commissioner of FDA issued Color Additive Regulations ("the Regulations"), 21 C.F.R. §§ 8.1 et seq. (1967), to take effect, with certain exceptions, in June, 1963. This suit was then commenced. After preliminary litigation of important questions of jurisdiction and scope of judicial review, there now remain issues as to the validity of three segments of the Regulations attacked in the first three stated claims in plaintiffs' complaint. These three claims may be briefly summarized as follows:
1. The 1960 Amendments require premarketing clearance by FDA of every color additive for commercial use and, as well, certification of each "batch" unless specifically exempted by regulation. The Amendments also define a color additive 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 * * *." 74 Stat. 397 (1960), 21 U.S.C. § 321(t)(1) (1964).
In its Regulations, FDA amplified the statutory definition of color additive to include any
"substance that, when applied to the human body results in coloring * * * 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'". 21 C.F.R. § 8.1(f) (1967).
Plaintiffs claim that in promulgating this Regulation definition so as to include many finished cosmetics, FDA expanded the 1960 Amendments' reach beyond limits intended by Congress.
2. In the same definitional section, FDA construed the statutory term "color additive" to include all diluents, elsewhere 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". 21 C.F.R. § 8.1(m) (1967). It is contended by plaintiffs that in so defining diluents and including them in Regulation § 8.1(f), FDA has expanded the number and category of items which must receive premarketing clearance beyond what Congress provided in the Act as amended.
3. Plaintiffs finally challenge a Regulation of FDA which concerns the socalled "exemption for hair dyes" appearing in Section 601(a) and (e) of the Act, 52 Stat. 1054 (1938), as amended, 21 U.S.C. § 361(a) and (e) (1964). Subsection (a) was first enacted in 1938 and was not changed by the 1960 Amendments. It provides that, notwithstanding the fact that they may be injurious if used as directed, hair dyes containing coal-tar colors cannot be deemed adulterated on account of any deleterious contents, so long as their labels display a certain cautionary notice prescribing a "patch test". This simple test is utilized by the purchaser to ascertain whether or not the particular dye in question will cause his or her skin to be irritated by application of the dye. Subsection (e) was also part of the 1938 Act. It originally provided that all cosmetics except hair dyes were deemed adulterated if they contained coal-tar colors and did not comply with the Act's certification, listing and pretesting provisions. See Section 601(e) of the Act, 52 Stat. 1054 (1938). This subsection was amended in 1960 to extend the concept of adulteration to the use of any color additive without the new certification procedures, but the general exemption for hair dyes was left unchanged. FDA's new Regulation acknowledges the continuing validity of a hair dye exemption, but, adds the following language:
"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". 21 C.F.R. § 8.1(u) (1967).
In plaintiffs' view, the quoted language of this Regulation cannot be reconciled with the statute. Specifically, they argue that: (1) whereas Section 601(a) plainly exempts all hair dyes complying with the patch-test requirement, FDA's language purports to limit the exemption to only those dyes for which the patchtest is an effective safeguard; (2) by virtue of the interaction of Regulation § 8.1(u) with Regulation § 8.1(f) and (m), FDA, without Congressional authority, is subjected to premarketing ...