## Facts

- The United States filed an in rem action under the Federal Food, Drug, and Cosmetic Act (FDCA) seeking seizure and condemnation of a quantity of a drug described as “Ethionamide-INH.”
- Federal authorities seized a large amount of Ethionamide-INH from Amfre-Grant, Inc., which appeared as the claimant to the seized article.
- The government alleged the product was a “new drug” that lacked required FDA approval under the FDCA’s new-drug provisions.
- Amfre-Grant asserted the drug was supplied for shipment to Vietnam and was not intended for sale or use in the United States.
- The product’s directions were in French and Vietnamese, which Amfre-Grant offered as evidence that the drug was prepared and labeled for foreign use.
- Amfre-Grant argued that, because the drug was intended only for export, it fell within the FDCA exemption for drugs intended for export and therefore was not subject to domestic new-drug approval requirements.

## Issues

1. Whether a drug that is a “new drug” under the FDCA is exempt from the Act’s new-drug approval requirements solely because it is intended for export and labeled for a foreign market.
2. Whether the FDCA’s export exemption bars the United States from seizing and condemning an unapproved “new drug” that is being held in the United States for foreign shipment.

## Decision

- The court treated Ethionamide-INH as a “new drug” within the meaning of the FDCA.
- The court rejected the claimant’s contention that export-only intent and foreign-language labeling, by themselves, removed the drug from the FDCA’s new-drug approval scheme.
- The court concluded that a “new drug for export only” remained subject to the FDCA’s new-drug approval requirements and could be proceeded against through seizure/condemnation.

## Legal Principles

- A drug that meets the FDCA definition of “new drug” is subject to the Act’s premarket approval requirements unless a statutory exemption applies on its terms.
- The FDCA’s export exemption is not a blanket shield for unapproved new drugs; export intent alone does not eliminate the need for compliance with new-drug approval requirements.
- Foreign destination and foreign-language directions may show intended export, but they do not, standing alone, prevent application of the FDCA’s new-drug provisions to an article located in the United States.
- The United States may use in rem seizure and condemnation to enforce the FDCA against an unapproved “new drug,” even when the claimant asserts the product was being held for export.

## Conclusion

In *United States v. An Article of Drug . . . Ethionamide-INH*, the court held that Ethionamide-INH was an unapproved “new drug” and that the claimed export-only status—supported by shipment plans to Vietnam and labeling in French and Vietnamese—did not automatically exempt the product from the FDCA’s new-drug approval requirements, leaving the drug subject to federal seizure and condemnation.


United States v. An Article of Drug . . . Ethionamide-INH, 196501968 FDLI Jud. and Ad. Rec. 16 (1967)