The Supreme Court ruled the factory inspection provision of the 1938 FDC Act was too vague to be enforced

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On Dec. 8, 1952, in U.S. v. Cardiff, the Supreme Court ruled that the factory inspection provision of the 1938 Federal Food, Drug, and Cosmetic Act (FD&C Act) was too vague to be enforced as criminal law.  The U.S. Food and Drug Administration (FDA) consumer consultants were appointed in each field district to maintain communications with consumers and ensure that FDA considers their needs and problems.

A nationwide investigation by FDA reveals that chloramphenicol, a broad-spectrum antibiotic, has caused nearly 180 cases of often fatal blood diseases. Two years later FDA would engage the American Society of Hospital Pharmacists, the American Association of Medical Record Librarians, and later the American Medical Association in a voluntary program of drug reaction reporting.

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Source: JSTOR
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