## Facts

- Kenneth Baker manufactured a “synthetic heroin” product in California.
- Baker sold the drug without proper labeling, including information identifying the drug, its effects, or directions for use and dosage.
- The ingredients used to make the drug had traveled in interstate commerce before Baker used them to manufacture the finished product.
- Federal prosecutors charged Baker under the Food, Drug, and Cosmetic Act (FDCA) for misbranding based on conduct occurring while the drug was held for sale after shipment of its components in interstate commerce.
- Baker was convicted in federal court.
- Baker appealed, arguing that the FDCA did not apply because the finished drug itself was manufactured and sold entirely within California and never traveled across state lines.

## Issues

1. Does the FDCA’s interstate-commerce element for misbranding permit federal prosecution when only the drug’s ingredients (not the finished misbranded drug) traveled in interstate commerce, and the manufacture and sales were purely intrastate?

## Decision

- The court rejected Baker’s argument that the FDCA requires the finished drug to have moved in interstate commerce.
- The court held that the interstate-commerce requirement is satisfied when the misbranding occurs while the drug is held for sale after its components have been shipped in interstate commerce.
- The conviction was affirmed.

## Legal Principles

- Under the FDCA’s misbranding provisions, the interstate-commerce nexus can be established by prior interstate shipment of a drug’s components or ingredients, even if the final product is manufactured and sold within a single state.
- The FDCA reaches misbranding that occurs after interstate shipment of components, so long as the misbranded drug is “held for sale” at the time of the violative act.
- A defendant cannot defeat the FDCA’s interstate-commerce element merely by converting interstate ingredients into a finished drug that is later sold only intrastate.

## Conclusion

Baker v. United States holds that the FDCA may be applied to the sale of an unlabeled drug made and sold entirely within one state when the drug’s ingredients previously moved through interstate commerce, because the misbranding occurred while the drug was held for sale after interstate shipment of its components.


Baker v. United States, 932 F.2d 813 (1991)