Opinion ID: 287533
Heading Depth: 1
Heading Rank: 2

Heading: The Hair-Dye Exemption

Text: 28 The teeth of the control over cosmetics are in 21 U.S.C. § 361, prescribing that A cosmetic shall be deemed to be adulterated under any one of five conditions there prescribed. The introduction of an adulterated cosmetic into interstate commerce is a prohibited act, § 331, which is subject to injunction, § 332, and constitutes a crime, § 333, and the adulterated goods are subject to seizure, § 334. 29 The two provisions of § 361 relevant to the FDA's hair-dye regulation are subdivisions (a) and (e). They say that a cosmetic shall be deemed adulterated 30 (a) If it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual: Provided, That 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. For the purposes of this subsection and subsection (e) of this section the term hair dye shall not include eyelash dyes or eyebrow dyes. 31 (c) 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 section 376(a) of this title. 32 Subdivision (a) was part of the original legislation concerning cosmetics, 52 Stat. 1054 (1938), and was not altered in any manner in 1960. Subdivision (e) had previously read 33 (e) If it is not a hair dye and it bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 604. 34 The Regulation held invalid by the district court, 21 C.F.R. § 8.1(u), provides: 35 (u) 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. 36 Although the Regulation appears to be limited to § 361(a), the court's decree was broader. The decree not only invalidated the Regulation in its entirety but also 37 any other provisions of the Regulations which have or may have the purpose or effect of defining or treating hair dyes or hair coloring products as color additives, or of requiring the listing or certification of such products, or of limiting or changing in any way the statutory exemption for hair dye products, or which may cause or result in having the provisions of Sections 601(a), 601(e), 602(e), 706, 301, 303, 304 of the Act, or of regulations issued or purported to be issued thereunder, applied to hair dyes or to hair coloring products, or to the ingredients thereof, which are exempt from the provisions of said Sections of the Act. 38 Taking first things first, we agree with the invalidation of so much of the Regulation as sought to deprive coal-tar hair dyes of the exemption conferred by § 361(a) in cases where, in the view of FDA, the coal-tar color ingredient carries a danger for which patch-testing provides no safeguard. The Government's argument should indeed be appealing to a legislator — what good is the warning to make a patch test if the test will not disclose the danger? But a court must take the statute as it is, and Congress wrote with great specificity. Whether it relied solely on the patch test warning because it was unaware in 1938 that coal-tar dyes might have damaging effects not detectable by such a test, as the Government asserts but the industry denies, or because it thought such instances so rare as not to warrant indentation of the exemption, the language is too clear for us to read it as meaning something different from what it so plainly says, at least in the absence of persuasive legislative history. The case fits perfectly Mr. Justice Brandeis' famous stricture, What the Government asks is not a construction of the statute, but, in effect, an enlargement of it by the court, so that what was omitted, presumably by inadvertence, may be included within its scope. Iselin v. United States, 270 U.S. 245, 251, 46 S.Ct. 248, 250, 70 L.Ed. 566 (1926). Cf. Commissioner of Internal Revenue v. Acker, 361 U.S. 87, 80 S.Ct. 144, 4 L.Ed.2d 127 (1959). 39 It is equally plain that the exemption of § 361(a) does not apply to coloring ingredients in hair dyes not derived from coal-tar; indeed we do not read the decree as prohibiting a regulation which would make that clear. We likewise see no basis for invalidating the portion of the Regulation which says that the exemption does not apply to poisonous or deleterious diluents. It is inconceivable that Congress meant to deprive the FDA of its ordinary powers with respect to other ingredients simply because they were combined with a coal-tar dye. 40 We think the court also erred in excluding from § 361(e) color additives in hair dyes other than those made from coal tar. The 1938 Act applied only to coal-tar colors, and the exemption of hair dyes in subdivision (e) was logical since coal-tar colors were dealt with by subdivision (a) in a supposedly adequate fashion. The modification of subdivision (e) in 1960 was part of a program to regulate all colors, and not merely coal-tar colors. But, if the statute be read with entire literalness, the unaltered introductory provision in subsection (e) now would have the effect of excluding any sanction for the use in a hair dye of an unlisted or uncertified coloring ingredient although not within the proviso to § 361 (a). In the absence of any legislative history indicating an intention to broaden the exemption in § 361(e), the most sensible construction is that, despite the retention of the introductory words if it is not a hair dye, Congress did not mean to exempt non-coal-tar color additives used in hair dyes from the requirement of listing and certification. There is no inconsistency between this ruling and that with respect to coal-tar color additives in hair dyes. As to the latter we hold that, in the absence of any indication of a changed Congressional intent, § 361(a) continued to mean what it said and had always been thought to mean. As to non-coal-tar hair dyes we refuse to rule that the retention of an introductory phrase, appropriate when enacted in 1938, should produce a result wholly inconsistent with the basic purpose of the 1960 amendments. 41 We therefore affirm the holding of the district court with respect to § 8.1(f) of the Regulations, affirm in part and reverse in part with respect to § 8(u), and remand for proper modification of the decree. No costs.