United States v. Sullivan , 68 S. Ct. 331 ( 1947 )

Mr. Justice Rutledge,

concurring.

This case has been presented as if the Federal Food, Drug, and Cosmetic Act of 1938 had posed an inescapable dilemma. It is said that we must either (1) ignore Congress’ obvious intention to protect ultimate consumers of drugs through labeling requirements literally and plainly made applicable to the sales in this case or (2) make criminal every corner grocer who takes a stick of candy from a properly labeled container and sells it to a child without wrapping it in a similar label.

The trouble-making factor is not found in the statute’s provisions relating specifically to drugs. Those provisions taken by themselves are clear and unequivocal in the expressed purpose to protect the ultimate consumer by the labeling requirements. So is the legislative history. Standing alone, therefore, the drug provisions would cover this case without room for serious question.

However, those provisions do not stand entirely separate and independent in the Act’s structure. In some respects, particularly in § 301 (k), they are interlaced with provisions affecting food and cosmetics. And from this fact is drawn the conclusion that this decision necessarily will control future decisions concerning those very different commodities.

If the statute as written required this, furnishing no substantial basis for differentiating such cases,, the decision here would be more difficult than I conceive it to be. But I do not think the statute has laid the trap with which we are said to be faced. Only an oversimplified view of its terms and effects could produce that result.

The Act is long and complicated. Its numerous provisions treat the very different subjects of drugs, food and cosmetics alike in some respects, differently in others. The differences are as important as the similarities, and cannot be ignored. More is necessary for construction of the statute than looking merely to the terms of § § 301 (k) and 502 (f).

It is true that § 301 (k) deals indiscriminately with food, drugs, devices and cosmetics, on the surface of its terms alone. Hence it is said that the transfer of sulfathiazole, a highly dangerous drug, from a bulk container to a small box for retail sale, could not be “any other act” unless a similar transfer of candies, usually harmless, also would be “any other act.” From this hypothesis it is then concluded that the phrase must be interpreted with reference to the particularities which precede it, namely, “alteration, mutilation, destruction, obliteration or removal” of any part of the label, and must be limited by those particularities.

That construction almost, if not quite, removes “any other act” from the section. And by doing so it goes far to emasculate the section’s effective enforcement, especially in relation to drugs. Any dealer holding drugs for sale after shipment in interstate commerce could avoid the statute’s effect simply by leaving the label intact, removing the contents from the bulk container, and selling them, however deadly, in broken parcels without label or warning.

I do not think Congress meant the phrase to be so disastrously limited. For the “doing of any other act with respect to, a food, drug, device, or cosmetic” is prohibited by § 301 (k) only “if such act . . . results in such article being misbranded.” And the statute provides, not a single common definition of misbranding for foods, drugs and cosmetics, but separate and differing sections on misbranded foods, misbranded drugs and devices, and misbranded cosmetics. § § 403, 502, 602.

The term “misbranded” as used in § 301 (k) therefore is not one of uniform connotation. On the contrary, its meaning is variable in relation to the different commodities and the sections defining their misbranding. So also necessarily is the meaning of “any other act,” which produces those misbranding consequences. Each of the three sections therefore must be taken into account in determining the meaning and intended scope of application for § 301 (k) in relation to the specific type of commodity involved in the particular sale, if Congress’ will is not to be overridden by broadside generalization glossed upon the statute. As might have been expected, Congress did not lump food, drugs and cosmetics in one indiscriminate hopper for the purpose of applying § 301 (k), either in respect to misbranding or as to “any other act” which produces that consequence. Brief reference to the several misbranding sections incorporated by reference in § 301 (k) substantiates this conclusion.

The three sections contain some common provisions.¹ But the fact that each section is also different from the other two in important respects indicates that each broad subdivision of the Act presents different problems of interpretation. Neither the misbranded foods section nor the misbranded cosmetics section contains any provision directly comparable to § 502 (f), which the respondent here has violated. That section, however, is to be contrasted with § 403 (k), one of the subsections dealing with misbranded foods. Comparison of the two provisions indicates that the doing of a particular act with respect to a drug may result in misbranding, whereas the same method of selling food would be proper.

Section 502 (f) provides that a drug shall be deemed to be misbranded:

“Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users: Provided, That where any requirement of clause (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Administrator shall promulgate regulations exempting such drug or device from such requirement.”

This provision, dealing with directions for use and warnings against improper use, in terms is designed “for the protection of users.” To be effective, this protection requires regulation of the label which the container bears when the drug reaches the ultimate consumer.² The legislative history leaves no doubt that the draftsmen and sponsors realized the importance of having dangerous drugs properly labeled at the time of use, not just at the time of sale.³ The intent to protect the public health is further emphasized by the limited scope of the proviso, which directs the Administrator to make exemptions only when compliance with clause (1) “is not necessary for the protection of the public health.”

Section 403 (k), which contains the principal basis for “making every retail grocer a criminal,” is very different. By its terms food is deemed to be misbranded:

“If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact: Provided, That to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Administrator. The provisions of this paragraph and paragraphs (g) and (i) with respect to artificial coloring shall not apply in the case of butter, cheese, or ice cream.”

The section, in contrast to § 502 (f)’s comprehensive coverage of drugs, applies not to all foods shipped interstate, but only to the restricted classes containing artificial flavoring, or coloring, or chemical preservatives. The labeling requirement is much simpler. And the proviso confers a much broader power of exemption upon the Administrator than does the proviso of § 502 (f). Under the latter he is given no power to exempt on the ground that compliance is impracticable. He cannot weigh business convenience against protection of the public health. Only where he finds that labeling is not necessary to that protection is he authorized to create an exemption for drugs and devices. Health security is not only the first, it is the exclusive criterion.

Under §403 (k), however, in dealing with foods the Administrator can dispense with labels much more broadly. In terms the criterion for his action becomes “the extent that compliance ... is impracticable” rather than, as under § 502 (f), “where any requirement of clause (1) [adequate directions for use] ... is not necessary for the protection of the public health.” Practical considerations affecting the burden of compliance by manufacturers and retailers, irrelevant under § 502 (f), become controlling under § 403 (k). Thus under the statute’s intent a much more rigid and invariable compliance with the labeling requirements for drugs is contemplated than for those with foods, apart from its greatly narrower coverage of the latter. And the difficulty of compliance with those requirements for such articles as candies explains the difference in the two provisos.⁴

These differences, and particularly the differences in the provisos, have a direct and an intended relation to the problem of enforcement. The labeling requirements for foods are given much narrower and more selective scope for application than those for drugs, a difference magnified by the conversely differing room allowed for exemptions. What is perhaps equally important, the provisos are relevant to enforcement beyond specific action taken by the Administrator to create exemptions.

His duty under both sections is cast in mandatory terms. Whether or not he can be forced by mandamus to act in certain situations, his failure to act in some would seem to be clearly in violation of his duty. Obviously there must be many more instances where compliance with the labeling requirements for foods will be “impracticable” than where compliance with the very different requirements for drugs will not be “necessary for the protection of the public health.” That difference is obviously important for enforcement, particularly by criminal prosecution. I think it is one which courts are entitled to take into account when called upon to punish violations. The authors of the legislation recognized expressly that “technical, innocent violations . . . will frequently arise.” S. Rep. Ño. 152, 75th Cong., 1st Sess. 4. In other words, there will be conduct which may be prohibited by the Act’s literal wording, but which nevertheless should be immune to prosecution.

When that situation arises, as it often may with reference to foods, by virtue of the Administrator’s failure to discharge his duty to create exemptions before the dealer’s questioned action takes place, that failure in my judgment is a matter for the court’s consideration in determining whether prosecution should proceed. Whenever it is made to appear that the violation is a “technical, innocent” one, an act for which the Administrator should have made exemption as required by § 403 (k), the prosecution should be stopped. This Court has not hesitated to direct retroactive administrative determination of private rights when that unusual course seemed to it the appropriate solution for their determination. Addison v. Holly Hill Fruit Products, 322 U. S. 607. If that is permissible in civil litigation, there is much greater reason for the analogous step of taking into account in a criminal prosecution an administrative officer’s failure to act when the commanded action, if taken, would have made prosecution impossible.

It is clear therefore that the comer grocer occupies no such position of jeopardy under this legislation as the druggist, and that the meaning of § 301 (k) is not identical for the two, either as to what amounts to misbranding or as to what is “the doing of any . . . act” creating that result. The supposed dilemma is false. Congress had power to impose the drug restrictions, they are clearly applicable to this case, the decision does, not rule the corner grocer selling candy, and the judgment should be reversed. I therefore join in the Court’s judgment and opinion to that effect.

1 E. g., §§ 403 (a), 502 (a) and 602 (a) are in identical .language.

2 See S. Rep. No. 361, 74th Cong., 1st Sess. 19.

3 See H. R. Rep. No. 2139, 75th Cong., 3d Sess. 8.

4 “The proviso of this paragraph likewise requires the establishment of regulations exempting packages of assorted foods from the naming of ingredients or from their appearance in the order of predominance by weight where, under good manufacturing practice, label declaration of such information is impracticable. This provision will be particularly applicable, for example, to assorted confections, which under normal manufacturing practices may vary from package to package not only with respect to identity of ingredients but also in regard to the relative proportions of such ingredients as are common to all packages.” S. Rep. No. 493, 73d Cong., 2d Sess. 12. The proviso discussed is in § 403 (i), not in § 403 (k); but the discussion brings out the sort of considerations which require exemption when compliance is impracticable.