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Since Ernst T. Krebs Sr. and Jr. claimed to have discovered it as a cure for cancer, laetrile has had an unsettled status. Under the Federal Food, Drug, and Cosmetic Act, drugs which are “new drugs” are regulated by the Food and Drug Administration (FDA). Difficulties concerning laetrile stem from the fact that it has been classified as a “new drug” by the FDA. To understand the problem in context, it is important to look at the history of the governing statutes. In 1906, Congress passed the Food and Drug Act. The Act required primarily that drugs be properly labelled and not be contaminated. It was repealed in 1938 and replaced by the Federal Food, Drug, and Cosmetic Act. The major change made by the new Act was a requirement that a “new drug” be safe for its intended purpose. Burdens of investigation were placed upon the proponent of the new drug, and evidence of testing was to be submitted with a new drug application (NDA) for approval. In 1962, the latest amendment to the Act added a requirement of efficacy to the safety provision. Now the proponent of a drug must show evidence that the new drug is both safe and effective for its intended use.

Without approval of the FDA, a new drug may not be transported across state lines or otherwise be involved in interstate commerce. Governmental authority to enforce the Act and to approve new drugs is delegated to the Secretary of HEW.

Not only has laetrile been classified as a “new drug” by the FDA, but an NDA has been refused because the FDA decided that there is insufficient evidence and testing concerning safety.

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