## Facts

- Federal agents, acting through the Food and Drug Administration (FDA), seized Hubbard Electrometers (“E‑Meters”) used in Scientology “auditing,” along with a large quantity of Scientology literature.
- The government filed an in rem condemnation action under the Federal Food, Drug, and Cosmetic Act (FDCA), alleging the E‑Meters were “devices” that were “misbranded.”
- Misbranding was asserted on two theories: (1) “false or misleading” labeling based on therapeutic and diagnostic claims attributed to Scientology writings; and (2) lack of “adequate directions for use.”
- At trial, the government relied heavily on books, pamphlets, and other writings to show the E‑Meter was promoted as beneficial for diseases or physical or mental conditions.
- The Church contended the E‑Meter’s significance was religious and spiritual rather than medical, and argued the proceedings violated the First and Fourth Amendments.
- A jury returned a general verdict for the government, and the district court entered a decree condemning and ordering destruction of the devices and literature.
- The Church appealed, challenging the breadth of “labeling,” the sufficiency of the evidence and instructions, and the seizure’s constitutionality.

## Issues

1. Whether Scientology books and writings relied on by the government qualified as “labeling” of the E‑Meter under 21 U.S.C. § 321(m), as applied consistent with the First Amendment.
2. Whether condemning and destroying religious literature based on its content violated the Free Exercise Clause.
3. Whether the seizure of the devices and literature violated the Fourth Amendment.
4. Whether the evidence and jury instructions were sufficient to support a general verdict of misbranding where the jury may have relied on protected religious writings.

## Decision

- The D.C. Circuit reversed the condemnation and destruction decree and remanded for further proceedings.
- The court held that the case went to the jury on an overbroad conception of “labeling” that could sweep in general religious and doctrinal texts.
- Because the verdict was general, the court could not determine whether the jury’s misbranding finding rested on materials that should not have been treated as “labeling.”
- The court concluded that the erroneous statutory construction required reversal.
- A dissent would have affirmed, viewing the government’s evidence and use of materials as labeling as sufficient under prior FDCA authority.

## Legal Principles

- The FDCA definition of “labeling” (“accompanying” written matter) must be construed and applied to avoid unconstitutional burdens on protected religious expression.
- Materials closely tied to the device’s commercial promotion and distribution may constitute “labeling,” but general religious doctrine and sermons not used as part of a sales or promotional presentation cannot be treated as labeling merely because they discuss spiritual healing.
- The government may regulate false or misleading commercial representations about devices, but enforcement cannot rest on adjudicating the truth or falsity of religious doctrine.
- When a statute admits of a narrowing interpretation that avoids serious constitutional problems, courts should apply the statute in that narrowed manner.

## Conclusion

The court set aside the FDCA condemnation because the jury was permitted to treat broad categories of Scientology religious writings as device labeling, creating a substantial risk that protected religious expression formed the basis for misbranding; the case was remanded for a constitutionally limited identification of any materials that could properly be treated as labeling.


Founding Church of Scientology of Wash., D.C. v. United States, 409 F.2d 1146 (D.C. Cir. 1969)