Monday, April 4, 2011
By Paul Martin

By Attorney Jonathan Emord
April 4, 2011

Since the 1960’s the Food and Drug Administration has repeatedly endeavored to regulate dietary supplements out of the market. With the adoption of costly new process controls (current good manufacturing practice regulations) regulating every aspect of supplement production and the recent passage of the Food Safety Modernization Act, FDA is poised to cull from the industry 20 to 30% of existing companies, force a rise in supplement prices, and eliminate from the market most, if not all, herbal supplements. The regulators’ decades old dream of ridding the market of supplements and leaving the field to FDA approved drugs is closer now to realization than ever before. The combination of aggressive regulation, an anemic industry in an economic downturn, Congressional encouragement, and less public angst against regulatory excesses by the agency has permitted the agency to place its enforcement knife next to the supplement industry’s jugular. Will the public awaken to the threat and compel FDA to back down, or will the agency succeed in driving from the market all manner of safe supplement products to the detriment of the consuming public?

Before 1962, FDA regulated drug safety but not drug efficacy. Then in 1961 thousands of deformed newborns began appearing across Europe—victims of the sedative thalidomide. Although existing law included safety reviews that would presumably prevent the sale of thalidomide in the United States, FDA, the pharmaceutical industry, and a sympathetic Congress argued for expanded FDA powers based on the thalidomide catastrophe. The Kefauver-Harris Drug Amendments became law in 1962. Under the 1938 Act, new drug applications were automatically approved unless FDA acted to deny them. Under the 1962 Act, new drug applications were denied unless FDA acted to approve them. For a new drug application to be granted, FDA had to conclude that the new drug was safe and effective. The new law was a bi-product of drug industry/government collusion, causing its safety and efficacy reviews to lack real teeth. The FDA would defer to the drug industry’s own testing on the questions of safety and efficacy, never testing drug agents on its own. If a drug company did not identify a safety problem, the agency presumed it not to exist. From the start of the Kefauver-Harris Drug regulatory regime, the drug industry carried great clout within the agency. That clout grew over the years, to the point where within the agency political managers overseeing FDA career scientists referred to drug applicants as FDA “clients” and drug approval rates and speed of approvals became ever greater. Before 1995, FDA approved sixty percent of all new drug applications. By the end of that decade and to the present, the agency has approved over eighty percent of all new drug applications.

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