ABSTRACT

The tugging and pulling at the warp and woof of the legal system exerted by the Laetrile phenomenon's entry into the individual/federal rights thicket is nothing new in the health/cancer arena. The Food and Drug Administration (FDA) maintains that Laetrile is subject to the Act, while the Laetrile proponents have argued that Laetrile is not a drug, or that even if it is a drug, it is exempt. In 1960 the FDA began the first in a continuing series of enforcement actions with the seizure of Laetrile in Dallas. The "evidence" which the FDA is supposed to provide lies within in the control of those physicians and manufacturers who are said to be using and making Laetrile. The decision of the court of appeals broke new ground when it flatly declared that the safety and efficacy provisions of the Act were inapplicable to Laetrile administered intravenously by a physician to terminally ill cancer patients.