Kordel v. United States

Background

A man who wrote and marketed health-food products supplied both the products and printed pamphlets about them to vendors. He was charged on twenty counts with introducing misbranded drugs into interstate commerce, tried without a jury, convicted, and fined. Some pamphlets were shipped with the products; others were mailed separately or sold on their own.

Reasoning

The central question was whether written material that explains or promotes a product can be treated as the product’s label even when mailed separately. The Court held that such material “accompanies” the product if it supplements or explains the product and is used in its sale. The Court relied on the text of the statute, the statute’s purpose to protect consumers, and the agency’s understanding, and therefore affirmed the convictions.

Real world impact

The decision means manufacturers and vendors cannot avoid federal labeling rules simply by shipping explanatory booklets at different times or separately. Federal enforcement agencies’ definition of “labeling” that covers accompanying written matter is given support. Consumers receive stronger protection from false or misleading claims tied to a product’s sale.

Dissents or concurrances

A dissenting opinion agreed that such pamphlets can be “labeling” but argued that charging the defendant under the specific offense of introducing misbranded drugs was not proved for many counts where the booklets were shipped long after the product; that dissent would have reversed those counts and cautioned against expanding criminal reach without clear congressional action.