United States v. Sullivan

1947-10-27

Headline: Retail druggist’s relabeling of prescription tablets is covered by federal law; Court upheld broad federal power to criminalize mislabeling of drugs even after interstate shipment, protecting consumers at point of sale.

Holding: The Court ruled that the Government may criminally punish a retail druggist who removes labeled drug tablets from interstate-shipped containers and sells unlabeled packages, because the law covers misbranding while held for sale after interstate shipment.

Real World Impact:

Allows federal prosecution for repackaging drugs sold after interstate shipment.
Requires retailers to keep required drug directions and warnings on packages sold.
Administrator may exempt minor violations, reducing prosecutions for trivial infractions.

Topics: drug labeling, consumer protection, retail drug sales, interstate shipment, federal enforcement

Summary

Background

A retail druggist in Columbus, Georgia bought a properly labeled bottle of sulfathiazole that had been shipped from Chicago to Atlanta. He removed small numbers of tablets, put them into unlabeled pill boxes marked only 'sulfathiazole,' and sold them on two occasions. The original bottle labels contained required directions and warnings; the pill boxes did not. The druggist was convicted under the Federal Food, Drug, and Cosmetic Act, the appeals court reversed, and the Supreme Court agreed to review the question.

Reasoning

The Court addressed whether the federal law reaches misbranding that occurs when an article is “held for sale after shipment in interstate commerce,” even long after interstate shipping and after intermediate intrastate sales. The majority read the statute literally and found no ambiguity. It held that removing tablets from a properly labeled container and selling them without required directions and warnings results in misbranding within the statute. The Court relied on the Act’s consumer-protection purpose and legislative history, and noted that the agency has power to exempt or ignore minor violations.

Real world impact

The ruling permits federal enforcement against retailers who repackage and sell drugs without required directions and warnings, extending protection to consumers at the point of sale. It increases the reach of federal labeling rules into local sales of drugs, while administrative exemption powers may limit prosecutions for technical or minor cases.

Dissents or concurrances

Justice Rutledge agreed with reversal but emphasized differences between drugs and foods and the agency’s exemption powers. Justice Frankfurter (joined by Reed and Jackson) dissented, arguing the statute is ambiguous and warning against criminalizing ordinary retail practices.