## Facts

- Jamieson-McKames Pharmaceuticals, Inc., and related companies operated a drug-manufacturing and distribution business in Missouri, with principal activity at facilities in St. Louis and Wentzville.
- Federal and state investigators, including FDA personnel, suspected that the operation was producing and distributing drugs in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), including drugs that were counterfeit, misbranded, or adulterated.
- Investigators conducted multiple entries, inspections, and searches of the defendants’ facilities; some activity proceeded under the FDCA inspection scheme without a traditional criminal search warrant, and some searches were conducted under administrative inspection warrants.
- The searches resulted in the collection of records and physical evidence concerning manufacturing practices, labeling, and equipment used to make and package drugs.
- Defendants argued that certain entries were unconstitutional because they were warrantless, because the FDCA did not allow entry when access was refused, and because consent (especially at the Wentzville site) was not validly obtained.
- During the on-site inspections, investigators questioned individuals associated with the businesses; defendants later sought suppression of statements, claiming Miranda warnings were required.
- The government brought (1) a criminal prosecution charging conspiracy to violate the FDCA and multiple substantive FDCA violations involving counterfeiting, misbranding, and adulteration, and (2) a civil in rem action seeking condemnation and forfeiture of specified drug-manufacturing equipment under 21 U.S.C. § 334(b).
- With the parties’ consent, the criminal and civil cases were consolidated and tried to the district court in a lengthy bench trial; the district court found the corporate and individual defendants guilty on the conspiracy count and ten substantive counts, and it ordered condemnation and forfeiture of listed manufacturing equipment.

## Issues

1. Whether warrantless FDA inspections and related searches of a drug-manufacturing operation under the FDCA violated the Fourth Amendment, given the regulatory nature of the industry.
2. Whether the FDCA authorizes warrantless forcible entry when a facility refuses entry, and whether disputed entries (including at Wentzville) were justified by valid consent.
3. Whether administrative inspection warrants used in the investigation were supported by the regulatory (administrative) probable-cause standard and were reasonable in scope.
4. Whether statements made to investigators during on-site inspections were inadmissible under the Fifth Amendment because the questioning was custodial and required Miranda warnings.
5. Whether the evidence supported the conspiracy and substantive FDCA convictions and supported condemnation/forfeiture of the manufacturing equipment under 21 U.S.C. § 334(b).

## Decision

- The Eighth Circuit affirmed the district court in large part, upholding the conspiracy conviction, most substantive FDCA convictions, and the condemnation and forfeiture order.
- The court treated drug manufacturing as a pervasively regulated industry and held that FDA regulatory inspections may be reasonable under the Fourth Amendment without meeting ordinary criminal search requirements.
- The court held that, because the FDCA penalizes refusal to permit inspection (21 U.S.C. §§ 331(f), 333(a)), the statute does not permit warrantless forcible entry; the government must proceed by penalty or obtain a warrant rather than force entry.
- The court upheld the administrative inspection warrants that were used, applying the relaxed probable-cause standard appropriate to regulatory inspections.
- The court rejected the Miranda claim, concluding the interviews during the inspections were not custodial interrogation.
- The court vacated and remanded two counts tied to the Wentzville facility for further proceedings focused on whether consent to search was validly obtained for the searches supporting those counts.

## Legal Principles

- Drug manufacturing is subject to extensive regulation, and regulated-business inspections can fall within the “closely regulated industry” line of Fourth Amendment cases (including *Colonnade* and *Biswell*), allowing regulatory inspections under standards different from ordinary criminal searches.
- When a regulatory statute provides criminal penalties for refusing an inspection, courts generally read the scheme as not authorizing warrantless forced entry; refusal is handled through prosecution for refusal or by obtaining a warrant.
- Administrative inspection warrants may issue on regulatory probable cause tied to enforcement needs and indicators of noncompliance; they are not held to the same showing as criminal probable cause.
- Miranda warnings are required only for custodial interrogation; questioning during on-site regulatory inspections is not custodial when the circumstances do not amount to arrest-like restraint.
- Under 21 U.S.C. § 334(b), equipment used to manufacture drugs in violation of the FDCA may be condemned and forfeited when the government shows a sufficient connection between the equipment and the unlawful activity.

## Conclusion

The Eighth Circuit largely sustained the government’s FDCA case against Jamieson-McKames and related defendants, holding that regulatory inspections and administrative warrants in this pervasively regulated industry were generally reasonable and that Miranda did not apply to the on-site questioning, while also ruling that the FDCA does not allow warrantless forcible entry and remanding two Wentzville-related counts for additional findings on consent.


United States v. Jamieson-McKames Pharmaceuticals, Inc., 651 F.2d 532 (1981)