Without much public notice, governments in Europe and the United States are redefining the meaning of dietary supplement adulteration. Through that redefinition, those governments are laying legal foundations for the removal of a large number of dietary supplements from the market. The actions, reminiscent of government political control of science in national socialist countries of the 1930s, deprive people of a most basic freedom of choice, the right to choose which nutrients to ingest.
In the Sixteenth Century, Swiss philosopher, alchemist, physician, and scientist Paracelsus made an observation that became the essential principle of toxicology: “All things are poison, and nothing is without poison, only the dose permits something not to be poisonous.” In other words, dose determines toxicity. The Paracelsian principle applies to everything, even water. If consumed at a certain dose level, water will cause injury, including death. Conversely, virtually everything has a dose level at which it will not cause injury. From the truth written by Paracelsus came laws European and American that included a presumption that nutrients consumed safely were lawful and that the government bore the burden of proof to show a dose level at which significant and unreasonable harm would occur before it could restrict consumer choice.
Nutrients, like most substances in our environment, are the subject of imperfect scientific knowledge. Conclusive proof of safety is the rare exception. It is thus the case that when we eat common fruits, vegetables, or meats, we do so with some degree of risk that is unavoidable. For all we know we may be in a known or emerging subset of the population that suffers an “allergic” reaction to the nutrient or some other adverse effect and, in certain instances, the reaction may be fatal. Consequently, freedom to choose among nutrients carries with it a degree of risk that is unavoidable. Historically mankind has gladly accepted that risk, limiting government intervention to instances where significant and unreasonable harm was generally occurred.
An alternative view has swept the health governors of Europe and federal and state health regulators in the United States. That view holds inconclusive science concerning the relative risk of commonly consumed nutrients as inherently vulnerable territory warranting government controls and restrictions. The absence of sure knowledge of safety, which creates uncertainty, leads those who favor this alternative view, called the Precautionary Principle, to advocate banning or restricting public access to nutrients until such time, if ever, as sure knowledge of safety is acquired. While that principle has logical importance when a substance is inherently volatile in even tiny amounts (like fissile or some explosive materials), it becomes a bane on freedom of choice when it is imposed on nutrients for which there is a long history of safe human consumption within a wide range of doses.
Advocates of government management of science have long embraced the Precautionary Principle as a means to insinuate government into private decisionmaking. They have rejected the Paracelsian Principle not because they view it as false but because they view all that which is not presently provable in science to be potentially dangerous and to invite government control. At least since the 1930s, national socialists have embraced the Precautionary Principle as a justification for government sovereignty at the expense of individual freedom. The Germans used the term Vorsorgeprinzip (which means precautionary principle), as their term for the need to establish prohibitions to bar public choice in the midst of perceived vagaries in science.
In the Twentieth Century, the Precautionary Principle again became a means of government control when it was adopted as Principle 15 at the 1992 Earth Summit in Rio. On February 2, 2000, the European Commission Communication on the Precautionary Principle revealed the principle presumptively the law of risk for all 27 member states of the European Union. In Europe today no unauthorized nutrient may lawfully be sold; each must be approved by the European Food Safety Authority (EFSA) following a safety and bioavailability review.
All member states of the European Union are obliged to enforce EFSA’s nutrient bans. This gross assumption of power over the most basic human decisions concerning what to ingest represents a massive deconstruction of European food markets. Before the EFSA requirement, European countries largely followed the Paracelsian Principle, permitting their people the freedom to choose nutrients in any dose level except that which was demonstrably unsafe (with the burden resting on government to establish a lack of safety). EFSA has used the Precautionary Principle to flip the Paracelsian Principle on its head. Now substances that have been consumed safely are presumed unsafe until such time as a party pays a half million dollars or more to prove the product safe to EFSA’s satisfaction. Rather than constituting a scientific determination, food safety has become, as never before, a political determination. Moreover, proof of safety essentially requires proof that the product at the dose level sold produces no demonstrable physiological effect, whether good or ill. That is because any demonstrable effect helpful to some or most is almost invariably harmful to a minority (e.g., those allergic to the substance). If harmful to any, EFSA may well ban the product, leaving in the market only those doses that are so low as to be of no benefit.
In the United States, the movement toward greater government restriction of the nutrients we may freely ingest has taken many forms. Through the current Good Manufacturing Practice regulations for dietary supplements, the FDA is succeeding in driving from the market manufacturers of products that have been safely consumed. Through the Food Safety Modernization Act, Congress has compelled FDA to increase its enforcement activity, multiplying the harm. FDA deems all manner of technical violations, including record-keeping violations, to be adulteration even in the absence of any proof that a finished product poses any actual risk to health.
On April 12, 2004, the FDA banned from the market all dietary supplements containing ephedrine alkaloids, regardless of the dose level sold. It did so despite the absence of any scientific proof that ephedrine alkaloids in daily dose levels lower than 20 mg per day posed any risk of injury. The agency’s basis for the ban was its assumption that all ephedrine alkaloids increased blood pressure and heart rate, creating a risk of injury to the heart or even death in some with pre-existing conditions. The agency lacked evidence of heart toxicity of any kind for doses levels of 20 mg or less.
In February 2003, the tragic sudden death of twenty-three year old prospective Baltimore Oriole pitcher Steve Bechler raised political demands for FDA to ban ephedra. Bechler had consumed three ephedra pills on an empty stomach before commencing a grueling day of training. Although no proof of causality existed to establish ephedra as the reason for Bechler’s death, those interested in achieving greater FDA control over supplements seized on the event and publicized it as if causality had been proven. In fact, Bechler was overweight and had vigorously practiced in extreme heat without sufficient hydration.
In an adulteration case my firm brought on behalf of Nutraceutical Corporation against the FDA, we prevailed at the district court level. We argued that FDA acted arbitrarily and contrary to statutory authority when it banned all ephedrine alkaloids without scientific proof that every dose level posed a significant and unreasonable risk of injury. The United States District Court for the District of Utah agreed, holding the ban unlawful. The decision sent shock waves through Congress as members either ignorant of science or in love with the FDA clamored loudly for legislative action to compel the ban. Against that backdrop, the United States Court of Appeals for the Tenth Circuit reversed. It held FDA possessed the discretion to remove from the market a nutrient it deemed potentially harmful without the necessity of proving that the dose sold actually caused harm. That decision effectively invited FDA to implement across the board the Precautionary Principle.
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With its ephedrine ban restored, FDA no longer is restricted by the distinguishing principle of Paracelsus. Rather than have to prove a dose harmful to ban its sale, FDA may now declare any nutrient potentially harmful at some dose level and then ban it at every dose level (as it did with ephedra). That sweeping authoritarian power denies American consumers essential freedom of choice and invites an endless series of agency actions that will, bit by bit, remove from the market all manner of nutrients disliked by regulators for one reason or another. In the United States, as in Europe, politics has triumphed over science, and government control has replaced freedom of choice.
© 2011 Jonathan W. Emord - All Rights Reserved