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IPFS News Link • Food And Drug Administration / F.D.A

"Who Will Build the Roads?" Part 2

• https://www.fff.org, by Wendy McElroy

It is interesting to note, however, that it took the government 86 years longer than the USP to address the same issues of drug quality through passage of the Pure Food and Drug Act (PFDA) in 1906. The FDA itself was established in 1930 by renaming a related federal agency. When the government finally took notice, it adopted the USP wholesale.

The FDA
At this point, a question should arise. Can the private USP simply replace the governmental FDA? The answer hinges on the purpose of standardizing food and drug information. Two separable purposes are education and enforcement. If the purpose is to provide information so people can make better choices on how to self-medicate, then the USP filled this role long ago. A Cato Institute white paper entitled "Drug Reformation: End Government's Power to Require Prescriptions" by Jeffrey A. Singer and Michael F. Cannon offers a fascinating insight. The PFDA "codified the privately created USP and defined a drug as 'adulterated' if it failed to meet the USP's standards. Those provisions had little apparent effect, as the USP was already the widely recognized standard of practice." In short, the free market had already solved a social problem for which the government passed laws many years later. Of course, government assumes the credit for this solution as evidenced by the fact that very few people have heard of the USP while everyone knows about the FDA.

On the other hand, if the purpose of standards is to enforce them by law, whatever the wishes of consumers, then the USP cannot replace the PFDA. It might have been possible in 1906, when both shared a respect for self-medication. Singer and Cannon explain, "Rather than infringe on the right to self-medicate or limit medical autonomy, the PFDA attempted to provide more information to consumers and physicians…. The PFDA also defined the crime of 'misbranding', stating that a drug was misbranded if it contained alcohol, opium, cocaine, or any other dangerous or potentially addictive substance and failed to list those ingredients (and their proportional inclusion) on the product label." Arguably, the laws against "misbranding" were simply laws against fraud.

The authority wielded by the current FDA has expanded vastly, however, and its main mission is no longer information; its mission is law enforcement and regulation. Moreover, additional "purity" legislation, such as the Food, Drug, and Cosmetics Act (FDCA) of 1938, have been passed and embedded into society. The FDCA is largely responsible for federally mandated prescription practices that persist to this day.


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