## Facts

- The United States, acting through the FDA, filed an FDCA condemnation action against the “Hubbard Electrometer” (“E-meter”) and related literature, seeking nationwide condemnation.
- The E-meter was described as a simple galvanometer that measures electrical skin resistance; the court found it harmless and ineffective by itself.
- The device was used in Scientology “auditing,” where an auditor interpreted needle movements to address emotional or spiritual concerns.
- Promotional materials associated auditing and the E-meter with therapeutic and diagnostic benefits for physical and mental conditions.
- An earlier jury verdict for the government was reversed on appeal due to First Amendment concerns; on remand, the case was tried to the court on a largely stipulated record with additional evidence regarding religious use.

## Issues

1. Whether the E-meter and accompanying literature brought the device within the FDCA’s definition of a regulated “device.”
2. Whether the E-meter and its labeling/literature were misbranded under the FDCA due to false or misleading therapeutic claims and lack of adequate directions for use.
3. Whether, and to what extent, applying FDCA misbranding remedies to the Church’s use of the device would violate the Free Exercise and Establishment Clauses.

## Decision

- The court held the E-meter is a “device” within the meaning of the FDCA based on the intended uses conveyed by its labeling and associated literature.
- The court found the device and related literature misbranded when promoted or used as having diagnostic or therapeutic efficacy for physical or mental disease.
- The court declined to impose a total prohibition on use of the E-meter in bona fide religious practice.
- The court ordered condemnation subject to conditional release: the devices and literature could be returned and used only under strict limitations confining use to religious counseling and requiring prominent disclaimers rejecting medical or scientific therapeutic claims.

## Legal Principles

- Under the FDCA, a product’s status as a regulated “device” and its intended use may be established by promotional materials and labeling that represent diagnostic or therapeutic functions.
- A device is misbranded if its labeling is false or misleading, or if it lacks adequate directions for use in connection with claimed medical purposes.
- The First Amendment bars courts from adjudicating the truth of religious doctrine, but does not prevent regulation of false or misleading secular representations to the public that a product or practice treats or cures disease.
- Remedies must avoid unnecessary interference with religious practice; courts may permit restricted religious use while prohibiting health-related marketing claims and requiring disclaimers to prevent deception.

## Conclusion

The court concluded the Hubbard E-meter and related literature were misbranded under the FDCA when advanced as medical or psychological diagnosis or treatment, yet fashioned a limited remedy permitting religious use within the Church only if clear disclaimers and use restrictions prevented therapeutic representations and protected the public from misleading health claims.


United States v. An Article or Device . . . “Hubbard Electrometer”, 333 F. Supp. 357 (D.D.C. 1971)