United States v. Sullivan
92 L. Ed. 2d 297, 332 U.S. 689, 1948 U.S. LEXIS 2617 (1947)
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Rule of Law:
The Federal Food, Drug, and Cosmetic Act's prohibition on misbranding articles 'held for sale after shipment in interstate commerce' applies to the act of removing a drug from its properly labeled bulk container and selling it to a consumer in a new, unlabeled package, even if the repackaging and sale occur purely intrastate.
Facts:
- A laboratory shipped a large bottle containing 1,000 sulfathiazole tablets from Chicago, Illinois, to a wholesale consignee in Atlanta, Georgia.
- This bulk bottle was properly labeled with adequate directions for use and warnings against dangerous misuse, as required by federal law.
- A retail druggist, the respondent, purchased one of these properly labeled bottles from the Atlanta wholesaler.
- The druggist transferred the bottle to his drugstore in Columbus, Georgia, where he held the tablets for retail sale.
- On two separate occasions, the druggist removed twelve tablets from the large, properly labeled bottle.
- He placed these tablets into smaller, individual pill boxes and sold them to customers.
- These smaller boxes were labeled only with the word 'sulfathiazole' and lacked the federally required directions for use and safety warnings.
Procedural Posture:
- The United States charged the respondent, a retail druggist, in the United States District Court with violating the Federal Food, Drug, and Cosmetic Act.
- The respondent's motion to dismiss was overruled.
- Following a trial where a jury was waived, the district court found the respondent guilty.
- The respondent appealed the conviction to the United States Circuit Court of Appeals.
- The Circuit Court of Appeals reversed the district court's conviction.
- The United States government petitioned the Supreme Court for a writ of certiorari, which was granted.
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Issue:
Does Section 301(k) of the Federal Food, Drug, and Cosmetic Act, which prohibits misbranding an article 'held for sale after shipment in interstate commerce,' apply to a local retail druggist who repackages and sells drugs without the required labels after the drugs have completed their interstate journey?
Opinions:
Majority - Mr. Justice Black
Yes. The Federal Food, Drug, and Cosmetic Act applies to a local retail druggist's actions because the statute's plain language covers any misbranding of a drug that occurs while it is held for sale after having been part of an interstate shipment, regardless of how many intrastate sales have occurred. The court reasoned that the purpose of the Act is to protect the ultimate consumer, and this protection must extend from the moment a drug enters interstate commerce until the moment it is delivered to the consumer. To limit the Act's reach to only the first sale after an interstate shipment would create a loophole that frustrates this protective purpose. The act of transferring the tablets to an unlabeled box constitutes misbranding because it denies the consumer the vital safety information from the original label. This application of the Act is a constitutional exercise of Congress's power under the Commerce Clause, consistent with precedents like McDermott v. Wisconsin, as it regulates articles that have been part of the stream of interstate commerce.
Dissenting - Mr. Justice Frankfurter
No. The Federal Food, Drug, and Cosmetic Act should not be interpreted so broadly as to cover the respondent's actions. The dissent argues that the key phrase, 'the doing of any other act,' should be read in the context of the preceding words: 'alteration, mutilation, destruction, obliteration, or removal' of a label. Simply transferring tablets from a labeled container to an unlabeled one is not the same kind of act. The majority's 'clear meaning' is not so clear, and its interpretation would absurdly apply the same logic to a grocer selling a piece of candy from a labeled jar, placing every small retailer under federal scrutiny for routine local sales. The statute's prohibitions apply equally to foods, drugs, and cosmetics, and the court cannot simply apply a broad interpretation to drugs while ignoring the impractical consequences for other goods.
Concurring - Mr. Justice Rutledge
Yes. The Federal Food, Drug, and Cosmetic Act applies here, but the 'slippery slope' argument that this will criminalize every grocer selling candy is a false dilemma. The concurring opinion agrees with the majority that the Act's plain language covers the druggist's actions. However, it emphasizes that the Act treats drugs, foods, and cosmetics differently, with separate and distinct definitions of what constitutes 'misbranding' for each category. The labeling requirements for dangerous drugs under § 502(f) are far more stringent and vital for public health than those for foods, which have broader exemptions based on practicality under § 403(k). Therefore, a court can find that repackaging a dangerous drug without a warning label is a prohibited 'act' that results in misbranding, without being forced to conclude the same for repackaging a piece of candy.
Analysis:
This case significantly broadened the reach of the Federal Food, Drug, and Cosmetic Act by clarifying that federal oversight does not end when an item completes its interstate journey. The Court established that the Commerce Clause power extends to regulate local, intrastate activities involving goods that have previously moved in interstate commerce, provided the regulation is aimed at fulfilling the goals of the federal statute. This 'stream of commerce' doctrine allows for federal regulation to follow a product all the way to the ultimate consumer, ensuring public safety. The decision confirmed that repackaging and relabeling at the retail level is a critical point of federal interest, setting a precedent for robust federal enforcement against local misbranding of drugs, foods, and other regulated products.
