United States v. 45/194 Kg. Drums of Pure Vegetable Oil, Efamol, Ltd., Claimant-Appellant
Opinion
Opinion
McNAMEE, J.
FACTS
Appellant, Efamol Ltd., Surrey, England, researches, exports and markets evening primrose oil (EPO). EPO is made from the crushed seeds of the evening primrose plant. Efamol sells EPO as a dietary supplement of fatty acids.
In February 1979, the Food and Drug Administration (FDA) informed Efamol representatives that EPO was not generally recognized as safe for use as a dietary supplement. If Efamol wanted to export EPO to the United States, it would have to file a Food Additive Petition with the FDA, pursuant to 21 C.F.R. section 171, or an affirmation petition in accordance with 21 C.F.R. section 170.35. Efamol informed the FDA it would no longer export EPO to the United States.
Despite Efamol’s assertion that it would not export EPO to the United States, Efam-ol has been shipping bulk EPO from the United Kingdom to Banner Gelatin Products (Banner) in Chatsworth, California since 1985. Banner mixes EPO with vitamin E and puts the combined mixture into soft gelatin capsules. The capsules are then shipped to distributors, who market them as a dietary supplement'.
On January 6, 1989, the FDA filed a Complaint for Forfeiture under 21 U.S.C. section 334 (a)(1), seeking the…