## Facts

- The United States brought an in rem condemnation action under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 334, against seized “Acu-Dot” devices.
- Acu-Dot was marketed over the counter as a “magnetic analgesic patch” consisting of a small magnet affixed to an adhesive patch.
- Packaging and labeling claimed the product provided “temporary relief of occasional minor aches and pains of muscles and joints” and instructed consumers to place patches on points of sharpest pain for two to five days.
- A pamphlet accompanying the product stated it combined “magnetic therapy and acupressure principles,” characterized the treatment as “safe, simple, and effective,” and suggested use for various conditions by placement on specific points.
- The government presented expert testimony that the device’s magnet configuration had no scientifically recognized analgesic mechanism and that the claimed acupressure-based theory lacked scientific support.
- The claimant relied in part on reports of subjective pain relief; the court found such reports consistent with a placebo response rather than a device-specific therapeutic effect.
- By stipulation and narrowing of claims, the bench trial focused on whether the device was “misbranded” under 21 U.S.C. § 352.

## Issues

1. Whether the device’s labeling was “false or misleading in any particular” under 21 U.S.C. § 352(a) based on the claimed magnetic/acupressure analgesic efficacy.
2. Whether the device “fail[ed] to bear adequate directions for use” under 21 U.S.C. § 352(f)(1) given the directions and the promoted therapeutic uses.

## Decision

- The court found the Acu-Dot devices misbranded under 21 U.S.C. § 352(a) because the labeling conveyed therapeutic efficacy grounded in magnetism and acupressure without adequate scientific foundation.
- The court also found misbranding under 21 U.S.C. § 352(f)(1), reasoning that directions for using a device to achieve therapeutic results it cannot reliably produce are not “adequate directions for use.”
- The court ordered condemnation of the seized articles under 21 U.S.C. § 334.

## Legal Principles

- Under the FDCA, a device is misbranded if its labeling is “false or misleading in any particular,” including by implication or omission, not only by explicit falsehood.
- Therapeutic representations must be evaluated against recognized scientific evidence; anecdotal reports of benefit do not, by themselves, establish that labeling claims are not misleading.
- A placebo effect does not make mechanism-based therapeutic claims (e.g., magnetism or acupressure efficacy) truthful when the asserted mechanism and claimed effectiveness lack adequate scientific support.
- “Adequate directions for use” requires more than step-by-step instructions; directions are inadequate when they instruct lay consumers to use a product for therapeutic purposes the product cannot perform as represented.
- The FDCA’s misbranding provisions are preventive and protect consumers from being misled by unsubstantiated therapeutic claims, without requiring proof of actual injury.

## Conclusion

The court condemned Acu-Dot magnetic patches as misbranded because their labeling and promotional materials asserted scientifically unsupported therapeutic pain-relief claims and, given that lack of substantiated efficacy, did not provide “adequate directions for use” as required by the FDCA.


United States v. An Article . . . Acu-Dot . . ., 483 F. Supp. 1311 (N.D. Ohio 1980)