Tyranny and hypocrisy are inextricably intertwined. The emperor expects his subjects to abide by a code of law that he himself transgresses. That is the legacy of our tyrannical Food and Drug Administration. A few choice examples illustrate the point. The examples reveal FDA to be invested with far too much power and provide empirical support for passage of the Congressional Responsibility and Accountability Act and the Health Freedom Act, both introduced by Congressman Ron Paul.
In the Dietary Supplement Health and Education Act, Congress included a provision that exempted from the definition of “labeling” independent publications that contained discussions of the effects of nutrients on disease. Congress intended to permit companies that sold dietary supplements to distribute such publications to consumers along with supplements so the public could be edified concerning the effect of nutrition on disease. Once the DSHEA was enacted, however, FDA rendered this provision unenforceable by holding that even if independent publications were exempt from the definition of labeling, FDA would still prosecute dietary supplement companies that distributed them. It would do so on the theory that the publications were evidence of an intent to sell a dietary supplement for the treatment of disease (i.e., to sell a supplement as a drug without FDA approval). Consequently, while Congress envisioned this provision as one that would fill the market with science capable of educating consumers about the potential of nutrients to affect disease, independent science remains locked out of the market by an FDA that views itself as above the law.
Former FDA Chief Counsel and Harvard Law professor Peter Barton Hutt explained that FDA refused to enforce provisions of the DSHEA because FDA Commissioner David Kessler decided to violate the law instead. Hutt wrote the following in the September 21, 2009 Natural Products Insider magazine: “Kessler was so infuriated by the enactment of DSHEA . . . that he ordered FDA not to enforce the new law . . . . Kessler was convinced if the law was not enforced and the worst elements of the dietary supplement industry were allowed to run wild, Congress would repeal the law.” In other words, David Kessler viewed his power as superior to that of Congress. He had such an inflated view of his own importance that he thought it appropriate, despite his oath of office, to violate the DSHEA by not enforcing it. He was never made to account for that hubris and illegality. Among the provisions he detested was the exemption from labeling. Instead of enforcing that limit on FDA power, he circumvented it and maintained precisely the same censorship as existed before Congress enacted the labeling exemption.
In the Nutrition Labeling and Education Act, Congress required the FDA to adopt a standard for evaluation of dietary supplement health claims (nutrient-disease claims) that was not based on “significant scientific agreement,” the standard prescribed by the NLEA for evaluating health claims for foods. FDA first construed the term “significant scientific agreement” to compel whatever proof it deemed sufficient (ordinarily conclusive proof which almost never exists in science). It then applied that “significant scientific agreement” standard to dietary supplements as well as foods directly contrary to the NLEA statute which forbad FDA from applying that standard to supplements. In addition, although Congress plainly intended all nutrient-disease claims to be allowable as health claims, FDA announced that no claim associating a nutrient with treatment of disease would ever be allowed for a dietary supplement.
It thereby constricted allowable health claims to those associating a nutrient with a reduction in the risk of disease and to those it proclaimed proven to a near conclusive degree. Without any statutory authority, it also decided that science concerning the treatment effect of nutrients on disease and animal and in vitro studies would be categorically excluded from any review of nutrient-disease claims. In this way, FDA has reconstructed the NLEA health claims provision to cripple it and to render it ineffectual in the overwhelming majority of cases.
In the FDA Modernization Act, Congress included a provision requiring FDA to permit dietary supplement companies to use on product labels and in product promotional materials (without prior FDA “significant scientific agreement” review) all “authoritative statements” of federal health agencies concerning the association of nutrients with disease. In its regulations concerning this provision, FDA directly contradicted the statute, announcing that it would not recognize any statement of a federal health agency as “authoritative” unless the party intending to use it proved to FDA’s satisfaction that the statement was backed by “significant scientific agreement.”
These three examples prove the hubris of the FDA and its willful violation of the rule of law. The agency is a rogue whose leaders view themselves as above the law and unaccountable to the courts and Congress. Operating according to the whim or caprice of the FDA Commissioner, FDA is a government unto itself, refusing to respect limits on its power contained in its enabling statute and in the Constitution. Two bills introduced by Congressman Ron Paul would end this tyranny. The Congressional Responsibility and Accountability Act would prevent any regulation from being enforced unless first passed into law by the Congress of the United States in the way in which the Constitution designates.
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The Health Freedom Act would remove from FDA its prior restraint on claims and on scientific literature, permitting them in the market without advance review. The federal government would have the power to proceed against any party that made false claims in the market if it proved by clear and convincing evidence that the claim was indeed false. In this way, the First and Fifth Amendment burden of proof would be restored and government prior restraint on speech (which was to be forbidden by our First Amendment) would be forbidden.
� 2010 Jonathan W. Emord - All Rights Reserved