Fmali Herb, Inc. v. Heckler
United States Court of Appeals for the Ninth Circuit
715 F.2d 1385 (1983)
- Written by Alex Ruskell, JD
Facts
Fmali Herb, Inc. (plaintiff) wanted to import food from China containing an herb commonly used in China but never widely used in the United States. In 1974, the Food and Drug Administration had promulgated a regulation stating that common use in food meant common use in the United States only. Thus, no substance could be introduced into the United States without scientific evidence of its safety no matter how widespread or prolonged its use was outside of the United States. Fmali sued, seeking a declaratory judgment that evidence of use outside the United States could meet the definition of common use in food. The court ruled in the government’s favor, and Fmali appealed.
Rule of Law
Issue
Holding and Reasoning (Fletcher, J.)
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