Attorney Jonathan Emord
March 30, 2010
Dose determines toxicity. That basic toxicological principle was first articulated by Theophrastus Phillippus Aureolus Bombastus Von Hohenheim (also known as Paracelsus) (1493-1541), a Renaissance physician, botanist, alchemist, and astrologer. Paracelsus put it this way: “All things are poison and nothing is without poison, only the dose permits something not to be poison.”
Although the Dietary Supplement Health and Education Act (DSHEA) places the burden of proof on FDA to establish that a dietary ingredient presents a significant or unreasonable risk of illness or injury before it may ban the ingredient, the agency has circumvented that law through adoption of the view that if a dietary ingredient presents harm at some dose level, it may be banned at all dose levels. It clings to that position even though it conflicts with the plain and intended meaning of the DSHEA, with basic principles of toxicology, and with the decisions of the federal courts. Here, as in many other circumstances, FDA operates as a law unto itself unanswerable to the Congress, the Courts, and the American people.
FDA removed ephedra from the market on a foundation of politics, rather than one of toxicology. A number of years ago it banned the sale of products containing ephedrine alkaloids at every dose level. It did so despite the fact that it had no competent evidence that ephedrine alkaloids at daily dose levels below 25 mg presented any genuine risk of illness or injury. In a case I brought on behalf of Nutraceutical Corporation, the United States District Court for the District of Utah held FDA violated the DSHEA by banning ephedrine alkaloids at every dose level instead of at dose levels scientifically proven to present a risk of injury. On the same logic FDA applied to ephedrine alkaloids, the agency could ban water because at some level of ingestion water becomes toxic. The District Court agreed with us and held Nutraceutical Corporation’s 10 mg ephedra supplement unlawfully banned because no evidence existed to prove it unsafe.
The FDA predicted the case against it unwinnable. It therefore shocked the agency when the Court condemned its action as a violation of the DSHEA adulteration provision. The agency reacted badly by refusing to honor the decision. Instead, it marshaled its congressional support and began an extensive media offensive labeling ephedra an inherent poison. Members of Congress were quick to condemn ephedra as an inherent poison, as were trade groups interested in currying favor with the FDA for their large corporate members. The truth then as now is that this herb at ephedrine alkaloid dose levels under 25 mg per day is safe. The truth is that Paracelsus, the father of modern toxicology, was correct that dose determines toxicity for everything from ephedra to water. Moreover, ephedra is one of the few agents in nature that actually contributes to weight loss, making its complete ban irresponsible and a disservice to a nation suffering from an epidemic of obesity that carries with it significant risks of death from diabetes, heart disease, and cancer not to mention enormous public costs.
Truth be told, FDA’s real interest in banning ephedrine alkaloids at all dose levels was not to protect public health (it could achieve that by banning ephedrine alkaloids at dose levels scientifically documented to produce harm). No, its real interest was in acquiring new regulatory power to ban nutrients from the market at will. If it could get the courts to defer to its determination that a dietary ingredient was unsafe without proof to support the charge, then it could punish market players selectively for one political reason or another when it disapproved of what they sold or what they claimed in the market.
FDA won its appeal of the ephedra decision (the U.S. Court of Appeals for the Tenth Circuit reversed the district court decision in Nutraceutical Corporation’s favor), but did not prevail in convincing the court to recognize a broadly applicable deference enabling FDA to gut the DSHEA burden of proof whenever it choses.
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Nevertheless, FDA rarely pays attention to the limits of law when it is intent on taking action. While it presently asks Congress to recraft adulteration law to give it unbridled discretion to take any product off the market, it proceeds presently without legal support to wield that very power, interpreting unsubstantiated complaints of harm as sufficient to justify coercing and cajoling manufacturers and distributors to stop selling products it dislikes for one reason or another. FDA has replaced the science of toxicity with poison politics.
© 2010 Jonathan W. Emord - All Rights Reserved