## Facts

- The United States filed an in rem action under the Federal Food, Drug, and Cosmetic Act (FDCA) seeking seizure and condemnation of 16 “Sinuothermic” machines as misbranded medical devices.
- The government alleged the machines were misbranded because a promotional leaflet, “The Road to Health,” made false or misleading therapeutic claims about the devices’ ability to diagnose, cure, mitigate, treat, or prevent disease.
- The machines were shipped in interstate commerce from Florida to an Ohio recipient, Kelsch, a former pupil of the claimant; Kelsch used the machines in treating patients and sold some to patients.
- The allegedly misleading leaflet was not shipped in the same package as the machines; it was mailed separately from Florida to Ohio at a different time and appeared to arrive after the machines.
- Urbuteit had agreed to furnish Kelsch a supply of leaflets as part of the overall business arrangement, and Kelsch used the leaflets to explain and promote the machines to patients.
- The machines themselves bore no substantive claims beyond a name and serial number; the disputed representations were contained in the leaflets.

## Issues

1. Whether devices may be condemned as “misbranded when introduced into interstate commerce” under FDCA § 304(a) when the allegedly false or misleading “labeling” is shipped separately from the devices but as part of the same transaction and used to promote and explain them.

## Decision

- The Supreme Court reversed the court of appeals and reinstated the district court’s condemnation order.
- The Court held that separate shipment of the machines and the leaflets did not prevent condemnation under FDCA § 304(a) as devices “misbranded when introduced into” interstate commerce.
- The Court treated the contemporaneous decision in *Kordel* as controlling on the “accompaniment” question.

## Legal Principles

- Written materials used to promote and explain a device in commerce may constitute “labeling” under the FDCA even if not physically attached to, or shipped simultaneously with, the device.
- For FDCA misbranding, “accompanying” is satisfied when the device and the promotional materials are part of an integrated commercial transaction and function together in distribution or sale.
- Misbranding liability and seizure authority under FDCA § 304(a) cannot be avoided by splitting a product shipment and its promotional labeling into separate interstate shipments.

## Conclusion

The Court held that FDCA misbranding and condemnation may rest on false or misleading promotional leaflets that are shipped separately from the devices, so long as the leaflets are part of the same interstate commercial transaction and are used to market and explain the devices.


United States v. Urbuteit, 335 U.S. 355 (1948)