## Facts

- Lelord Kordel marketed “health food” products consisting of vitamins, minerals, and herbs, and authored literature describing the products’ claimed effects.
- Vendors distributed circulars and pamphlets to consumers containing statements about the products’ efficacy.
- Kordel supplied vendors with both the products and the pamphlets; some literature was displayed in stores, some given with purchases, some sold independently, and some mailed to customers.
- It was undisputed that Kordel shipped, or caused to be shipped, both the products and the literature in interstate commerce.
- In some counts, drugs and literature shipped in the same cartons; in other counts, the literature shipped separately and at different times, both before and after the associated drug shipments.
- Kordel was charged in multiple criminal informations with introducing misbranded drugs into interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), convicted in a bench trial, and fined; the court of appeals affirmed.

## Issues

1. Whether pamphlets and circulars describing a drug’s uses and efficacy qualify as FDCA “labeling” that “accompany[ies]” the drug when shipped separately and at different times.
2. Whether the fact that some pamphlets were sold for a price prevents them from being treated as “labeling” for misbranding purposes.
3. Whether FDCA enforcement over such materials is barred because general false advertising regulation was assigned to the Federal Trade Commission.
4. Whether prosecution by information (rather than indictment) was authorized when the charging documents did not allege intent to defraud or mislead.

## Decision

- The Supreme Court affirmed the conviction.
- The Court held that shipping a drug in interstate commerce together with false or misleading pamphlets designed for use in the drug’s advertisement, sale, and use violates FDCA § 301(a), even if the pamphlets are shipped separately and at a different time.
- The Court held that “accompanying such article” in the FDCA’s definition of labeling is not limited to matter physically on or in the package or transported simultaneously with the drug.
- The Court held that selling the pamphlets is immaterial when they perform the function of labeling and cannot be used to avoid the Act.
- The Court held that transferring general false advertising control to the FTC did not remove from the FDCA written matter that functions as labeling.
- Because the informations did not allege intent to defraud or mislead, the offenses were misdemeanors, and prosecution by information was permitted.

## Legal Principles

- Under the FDCA, “labeling” includes written matter that “accompanies” a drug in a functional sense, not merely by physical attachment or simultaneous shipment.
- Promotional literature that explains a product’s uses, value, or advantages and serves as an essential supplement to the label may be treated as labeling for misbranding analysis.
- Separate shipment, timing differences, and charging a sales price for the literature do not prevent such materials from constituting labeling when they are part of an integrated distribution plan for the product.
- FDCA misbranding provisions may reach advertising-like materials when they function as labeling, notwithstanding overlapping FTC authority over false advertising.
- When intent to defraud or mislead is not charged, FDCA violations are punishable as misdemeanors and may be prosecuted by information.

## Conclusion

The Court upheld misdemeanor misbranding convictions, holding that pamphlets functionally tied to a drug’s sale and use are “labeling” that “accompanies” the drug under the FDCA even when shipped separately, at different times, or sold, and that such offenses may be prosecuted by information absent an allegation of intent to defraud.


Kordel v. United States, 335 U.S. 345 (1948)