Kenneth M. Baker v. United States
91 Cal. Daily Op. Serv. 3377, 91 Daily Journal DAR 5374, 932 F.2d 813 (1991)
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Rule of Law:
Federal jurisdiction under the Federal Food, Drug, and Cosmetic Act (FDCA) for drug misbranding exists even if the final drug product is manufactured and sold entirely within one state, as long as its component ingredients were shipped in interstate commerce.
Facts:
- Baker manufactured a substance that was sold as synthetic heroin.
- The synthetic heroin was sold without any labels identifying the drug, its effects, or the proper dosage.
- The components and ingredients used to produce Baker's synthetic heroin were shipped across state lines (interstate commerce).
- The manufacturing and distribution of the finished synthetic heroin product by Baker occurred entirely within California.
- Baker and others entered a nolo contendere plea to charges of violating 21 U.S.C. § 331(k) for misbranding the drug after its components had been shipped in interstate commerce.
Procedural Posture:
- Baker was convicted of misbranding drugs under the Federal Food, Drug, and Cosmetic Act (FDCA) following a plea of nolo contendere in a federal district court.
- Baker filed a "Petition for a Writ of Error Coram Nobis" in the district court, which was construed as a motion to vacate his sentence pursuant to 28 U.S.C. § 2255, arguing that the federal court lacked jurisdiction because the drug transactions were wholly intrastate.
- The district court found a sufficient nexus to interstate commerce and denied Baker's motion to vacate his sentence.
- Baker appealed the district court's denial of his motion to vacate to the United States Court of Appeals for the Ninth Circuit.
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Issue:
Does 21 U.S.C. § 331(k) establish federal jurisdiction over the misbranding of a drug manufactured and sold wholly within one state, when only the drug's components, not the finished product, have traveled in interstate commerce?
Opinions:
Majority - Booochever, Circuit Judge
Yes, 21 U.S.C. § 331(k) applies to the misbranding of a drug even when the final product is manufactured and sold intrastate, as long as its components traveled in interstate commerce. The court found that a plain reading of § 331(k) supports this interpretation, particularly because the FDCA defines "drug" to include "articles intended for use as a component of" a recognized drug, pursuant to 21 U.S.C. § 321(g)(1)(A) & (D). Citing Supreme Court precedent in United States v. Bacto-Unidisk and Kordel v. United States, the court emphasized that Congress intended the FDCA's coverage to be as broad as its literal language indicates, warning against creating statutory loopholes. Other circuit courts have consistently held that the interstate shipment of ingredients satisfies the jurisdictional requirement of § 331(k), even for intrastate sales of the final product. The court rejected Baker's reliance on United States v. Gonsertron, stating it was incorrectly decided and did not represent the current state of the law, noting a subsequent case (United States v. Korleen Tablets) from the same district judge contradicted its reasoning. Furthermore, Baker's nolo contendere plea estopped him from making a "loss of identity" argument (that the components lost their interstate character upon being combined), and Supreme Court precedent in United States v. Generix Drug Corp. clarifies that all ingredients, whether major or minor, active or inactive, fall under the definition of a "drug" component, making such distinctions inconsequential.
Analysis:
This case significantly broadens the reach of federal regulatory power under the FDCA, affirming that federal jurisdiction over drug misbranding can be established by the interstate movement of any component of the final product, regardless of whether the final product itself ever crosses state lines. The ruling reinforces the Supreme Court's mandate for a broad interpretation of the FDCA to prevent perceived loopholes. It also highlights the preclusive effect of a nolo contendere plea on a defendant's ability to challenge the factual basis of their conviction, limiting subsequent jurisdictional arguments.
