Laetrile and the Fda: A Case of Reverse Regulation

After presenting a historical background, this paper examines several legal facets of the Laetrile controversy: the “new drug” designation and grandfather clause exemption; the notion of harm and its relationship to freedom of choice; the “informed consent” concept; the reliance on “expertise”; and issues involved in the burden of proof and the determination of jurisdiction over litigation. The authors conclude generally that Congress should act on the Laetrile question and they propose specific guidelines for such legislation, as well as for the appropriate role of the Food and Drug Administration.