|
— updated 1998-01-19
|
|
— updated 1998-01-19
|
Stop FDA attempts to restrict availability of herbs and natural productsAmerican herbalists' realpolitik, essay #6. The Food and Drug Administration (FDA) persists in attempting to restrict the availability of herbal products by regulations, in spite of public outrage. Suggestions for political strategy in defeating these trends are outlined. Note: this article is of an educational nature and should not be construed as providing legal advice. by Roger W. Wicke, Ph.D. |
|
Subtopics on this page…
IntroductionIn spite of recent passage of the Dietary Supplement and Health Education Act (DSHEA) by Congress, which was intended to protect the access of consumers to nutritional supplements and herbal products, the FDA is currently proposing GMP ("Good Manufacturing Practice") regulations that could potentially jeopardize the viability of small herbal product manufacturers. If proposed regulations requiring expensive lab testing are adopted, small herbal businesses may be forced to close due to the burdensome expenses these regulations may impose. Similar legislation is being promoted worldwide by the pharmaceutical cartels, both on an individual national level and through an international treaty proposal referred to as Codex. (See "Other resources" section, below, for information on the Codex and FDA proposals.) The FDA has claimed that it wants input from the community of professional herbalists and manufacturers before drafting final versions of its proposals. The unstated purpose of the FDA, and similar organizations in many other countries, is and always has been the protection of major pharmaceutical company profits. [arm] [dir] Expensive testing protocols act as a way to keep drugs and herbs within the control of the international cartels. While such tests may make sense for newly synthesized drugs with no track record in cultural tradition or popular usage, they are inappropriate for herb and food products, especially those with a long history of usage. The FDA must be held within its lawful authority as defined by Congress, and any unlawful exercise of power beyond this must be stopped. While recent legislative actions to restrict herbal products in Australia, New Zealand, Canada, or Great Britain may have relevance for U.S. herbalists, through no merit of our own generation we have more legal and constitutional protections against government abuse that citizens of these other countries of the former British empire. Due to an accident of history, American citizens are not subjects of a monarchy or parliamentary government that rules largely at its own discretion, but are, in principle, sovereign citizens whose rights, recognized by the Constitution, cannot be abrogated by any government action. [zbu] [zyi] [zpe] [zma] [zmi] This fact has had considerable impact on the protection of individual rights and liberties in U.S. legal practice and is not merely a theoretical or quaint distinction. It would be sad indeed if through ignorance we failed to utilize these protections, and by so failing, lost them entirely. [zte] Since the early 1990's, Gestapo-like actions by the FDA against health practitioners around the country have escalated, and public outrage over this behavior pressured Congress to pass legislation (DSHEA) protecting the availability of nutritional supplements and herbs. To understand why the FDA might have chosen to engage in such behavior, let's examine what undercover agents, intelligence operatives trained in torture techniques, and law enforcement officials know as the "Mutt and Jeff" routine as described in the U.S. Supreme Court case of Miranda vs. Arizona. [mir] In the first step of this routine, "Mutt", the burly henchman, tortures, threatens, and abuses the victim without mercy. When the victim appears near breaking, a kindly "Jeff" appears to relieve the victim's suffering, offering a path to salvation by giving in to "reasonable" demands. If the kindly Jeff's suggestions are rejected, the threat of Mutt is ever in the background. (The author extends apologies to anyone whose real name is Jeff.) Terrorism, whether sponsored by rogue organizations or governments, often takes this form: the stick or the ever-so-reasonable carrot. Is it merely a coincidence that the current worldwide push for Codex-type legislation restricting the availability of herbal products worldwide has been preceded by acts of FDA-sponsored terrorism? Were these acts of terrorism intended to soften up citizen-victims to make them more malleable in the hands of the suave and debonair "Jeff's", officials at the FDA, who are merely trying to do their jobs and would like our cooperation? Such Macchiavellian strategies cannot be defeated by well-meaning but naive herbalists who think that rational discussions alone will achieve success. Moreover, herbalists who aspire to political power may succumb to the temptation of hobnobbing with these Jeff's, convincing themselves of the rightness of their course of action by the seeming reasonableness of the FDA's demands. When asked by fellow herbalists to justify their actions, these dissembling Chamberlains of health care appeal to our sense of immediate convenience rather than our principles. For on principles alone, one cannot justify compromise with an agency that has shown the most callous disregard for the health and well-being of the citizens it claims to represent. It is ironic that while many members of the lay public are outraged over this callousness, some professional herbalists are debating the inevitability of a creeping police state and the relative merits of groveling and compromise, when instead, they should be demanding thorough investigation of FDA abuses by Congress, followed by prosecution of criminal misconduct by invidual officials who have exceeded their authority, who have abused the public trust, and who have engaged in felony racketeering on behalf of the pharmaceutical cartels. A brief compendium of recent FDA raidsLest one forget the long list of abuses, here follows a brief review of recent FDA actions and policies. Many of these cases are documented in greater detail elsewhere. [fre1] [asu] [arm]
The above list is by no means exhaustive, but is merely a sampling. Some concerns about herbal qualityThe American herbal community encompasses individuals and businesses with a wide variety of experience and skill. While there remains potential for improvement, FDA regulation is not necessarily the proper or the best means for achieving this. Such improvement depends on a relationship of mutual respect and an understanding of the professional needs of the herbalist community, and is highly unlikely to result from an abusive relationship. In any case, following are several areas in which improved quality may be desirable. Some herbalists and health professionals have expressed the desirability of becoming more aware of proper herb species identification and of inspecting for contamination of herbal products by mold, E. coli, and other microorganisms and impurities. Organoleptic methods (odor, taste, appearance and tactile quality) are potentially sensitive means for assuring accurate identification and quality. They are commonly employed by FDA meat, fish, and poultry inspectors as quick and efficient methods of detecting spoilage and contamination. [or1] [or2] Experienced wine tasters are still in demand because the human sense organs of smell and taste are far more sensitive than than all but the most expensive and sophisticated chemical assays. Sensory cells of olfaction are capable of detecting as little as 4x10-14 g/ml of certain fragrances. [guy] While chemical testing requires the completion of specific tests for suspected chemicals, the taste buds and olfactory sensors of an experienced taster can quickly scan for variations from the expected. Similarly, the author has consulted numerous physicians on their professional estimate of the typical accuracy of stool cultures for parasites; estimates of up to 70% rate of false negative are commonly reported. This is easily understood by the fact that commercial services for stool culture inspection employ lab technicians who may be instructed to scan the slide under only one microscopic magnification rather than a broad range of magnifications, thus missing organisms that are much smaller or much larger than the range selected. According to these physicians, symptoms and clinical signs may be a better indicator of gastrointestinal parasite infestation. Likewise, olfactory quality control (smelling) may be the most effective means of detecting spoilage or rancidity. Microbiological tests are more susceptible to overlooking relevant tests in a given case. In the author's experience, more side effects from herbal usage are due to improper and excessive use of correctly identified herbs, rather than from incorrectly identified or substituted herb species. Such inappropriate and excessive herbal use extends to such commonly available foods and spices as cayenne pepper, goldenseal, garlic, prune juice, and even drinking water (when ingested obsessively or to excess). Many of the perceived hazards of herbal usage are sensationalized exaggerations, blown out of proportion by supporters of the pharmaceutical cartels, who conveniently forget to mention the countless side effects and numerous deaths from synthetic pharmaceutical products. [gahg] There is a need for developing more accurate and appropriate means for assessing client's health so that contraindicated herbs may be more easily recognized and avoided. Chinese herbal and Ayurvedic methods are examples of how this may be achieved by one's skills in observation and with minimal technology. [tcm] Such improvements in herbal methodology are not likely to be solved by FDA action, but by public education and promotion of common sense in diet and herbal usage. Sub-optimal techniques and training within the herbal professions are not necessarily solved best by government regulatory intervention. While medical licensing and other forms of professional regulation, in the hands of officials acting from integrity and understanding, can serve to benefit the public, even the most well-designed regulations can be sabotaged by bureaucrats whose underlying motives are to enrich themselves by conspiring with pharmaceutical companies to enhance drug sales and destroy competition. Even beneficent bureaucracy risks instilling complacency and ignorance among people as they trade common sense and experience for an unhealthy dependence on experts. Herbalists, of all people, should be painfully aware of the disintegration of common sense in diet and family health matters as a result of excessive reliance on licensed medical experts. As increasing numbers of people are recognizing the failure of the medical system to promote health, they are taking responsibility to reacquire much of the wisdom of their great-grandparents in the use of herbs and local plants. This sense of responsibility cannot be achieved by government decree. I know of no safe depository of the ultimate powers of the society but the people themselves: and if we think them not enlightened enough to exercise their control with a wholesome discretion, the remedy is not to take it from them, but to inform them. - Thomas Jefferson Rather, government's best role in these matters would be to encourage such responsibility, acting as a clearing house of information. An agency with integrity will come to be trusted by the public and its advice followed. An agency whose advice is based upon corporate profit motives rather than public health should be ignored. Principles of law, limitations of FDA authorityIn the interest of understanding the current attempts of the FDA to restrict herbal manufacture and dispensing, it is useful to review the legal principles of administrative law so that we can recognize potential violations by FDA officials. Those who remain ignorant of these principles, and especially those who fail to learn about their rights and to exercise them, will not only place themselves at risk, but will endanger the livelihoods of their fellow herbalists by promoting foolhardy courses of political action. A relevant issue in the regulation of herbal manufactures involves the distinction between corporations and non-incorporated professionals and businesses. The failure to recognize this distinction has affected almost every aspect of American life for the worse. Ralph Nader was the only recent presidential candidate who intelligently discussed this problem. [kpm] [krn] Many people are under the mistaken impression that corporations have the same rights as individuals, since corporations are considered to be legal "persons" who can enter into contracts with other legal persons and individuals. Due to gradual evolution of legal case law, corporate privileges have increased steadily at the expense of individual rights. In theory, and still in law, however, corporations are creatures of the state, and they can and should be regulated for the protection of the public. [zda] [zha] Corporations are granted the privileges of limited liability for debt and the ability to enter into contracts as legal persons to facilitate industry. The primary task of Congress for many decades after the establishment of the U.S. was to regulate these corporations. It is well known that a board of directors of a company, or a mob, or any group of people is more capable of violence in the name of a symbol of authority or a fictitious legal entity than most individuals acting alone. [mil] [kel] [rei] This is sometimes known as the Nazi effect: "I was only following orders." "I don't approve of this personally, but the board voted on it." For these reasons, citizens have a reasonable expectation that corporations shall be closely regulated, for which state and federal government were given many of their powers. That these powers were purchased by the very corporations to be regulated and were turned against us is an unfortunate fact of life in the 20th century. That many individuals are not even aware of the legal theory behind corporate governance compounds the problem. In summary, private citizens, non-incorporated businesses, and sole proprietor businesses cannot be regulated under the powers granted to state and federal government for the regulation of corporations, at least not if the individual citizen or private business has the good sense not to volunteer into the jurisdiction applicable to corporations. By entering into such jurisdiction, they exchange some of their rights for privileges, which can be taken away. And in the corporate world, the biggest sharks tend to win more privileges and the less powerful may lose everything. While anyone can make a mistake, an individual's mistakes can often be more easily corrected as they affect relatively fewer people; on the other hand, a corporation's mistakes are magnified a thousand or million-fold. For a particularly nasty example of this, The Poisoning of Michigan [poi] describes the PCB contamination disaster in Michigan several decades ago. In this incident one careless worker in a chemical factory mistook bags of PBB powder (white) for magnesium chloride (also white). The former is deadly and highly toxic even in parts per billion. The container of PBB was accidentally mixed into cattle feed, which poisoned many of the dairy cows in the state. This is another example of why lots of individual small manufacturers may be safer than large chemical companies. Small herbal product manufacturers are seldom engaged in the production of PBB's, anthrax toxins, or sarin in their spare time, whereas large chemical and pharmaceutical manufacturers may attempt to juggle the transport, storage, and manufacture of a wide variety of chemicals under one roof. The meat industry provides another example of corporate irresponsibility which FDA regulations have helped to control. [or1] [or2] Here again, the large corporations, whose board of directors may never face eye-to-eye their customers, or even their blue-collar employees, may endorse unsanitary and dangerous business practices that would be unthinkable for an individual who grows and sells meat for consumption by his family, neighbors, and fellow townfolk. Unless one is involved in interstate commerce or comes under federal jurisdiction on being granted a privilege (federal alcohol license, etc.), regulations applicable to corporations may not apply to private individuals and dispensing herbalists, regardless of how certain officials will try to mislead these individuals into assuming that they are corporate entities. [zda] The only way Congress can justify regulating unincorporated businesses that are not federally licensed or chartered is to exercise their authority over "interstate commerce", [za1] which has steadily expanded until about 1980, based on the tenuous theory that everything ultimately affects interstate commerce. (A person sneezing in Kansas may affect the purchase of tissues in Nebraska if the sneezing is severe enough, thus requiring the regulation and licensing of sneezing, and taxes on particularly violent sneezes, etc.) Recently this pernicious doctrine is slowly being reversed by the courts, and one by one, federal jurisdiction is being denied in matters that formerly were proper subjects of state regulation. Even if the subject of regulation falls within the domain of interstate commerce, exercise of the police powers of any federal agency is constrained by well-established legal principles. [zpo] Federal regulations:
The numerous examples of FDA harassment mentioned previously provide abundant evidence that the FDA has violated all of the above requirements numerous times and with premeditated malice. Strategies for countering increased FDA restrictions of herbal productsOne can expect that the FDA will engage in the same cynical trickery that Health Canada (the Canadian equivalent of the FDA) has used to restrict herbal product availability. By engaging in a dialog with herbalists, Health Canada proclaimed it solicited input from the herbal community, then proceeded to adopt the most restrictive proposals which were discussed. The official responses of herbal organizations to the FDA should be formulated very carefully, planning the overall strategy before presenting any written position statements. All correspondence with the FDA should be backed up with solicitations of support from sympathetic Senators and Congressmen, since it is Congress that has the power to restrain and control the FDA. Pleas to the FDA without such backing and political pressure are more likely to be ineffective, and may even be detrimental to herbalists' interests. Suggested strategies: Support Congressional hearings to investigate FDA abuses of power, and demand that FDA officials responsible for such abuse of power be prosecuted for criminal misconduct. Such letters are appropriately addressed to legislative representatives rather than to the FDA, since it is Congress that has proper authority to rein in rogue agencies of its own creation. This should take precedence over all other courses of action, since one cannot justify even the most reasonable regulations if they will be enforced by an agency that has no respect for due process of law, for public health, or for minimal standards of human decency. Congressman Richard Burr called the FDA's actions in the Burzynski case "the worst abuse of the criminal justice system I've ever witnessed." "The FDA is an agency out of control. Its lawyers have such a weak case it's not prosecution, it's persecution." He called for the guilty FDA employees to be fired and criminally prosecuted. [fbu2] [fbu3] Herbal product associations submitting an official position statements to the FDA should back these up with support from their U.S. Congressman and Senator, if possible. Supporting herbalists' rights has proven to be a winner for many representatives during the last election, since the large volume of crazed and angry letters from constituents over FDA actions are still fresh in their memory. Do not rely solely on expectations of rational and equitable behavior by the FDA. Remember the tricks played by Health Canada with the rights of Canadian citizens and herbalists. Do make it clear to them that you are knowledgeable about the range of their authority and jurisdiction, that you have already notified members of Congress and Senate about your concerns that they may again exceed such authority, and that you are concerned lest they break the laws again and diminish public trust in their agency (what little remains). Be aware of the divide and conquer ploy. For example, one group of alternative health practitioners or manufacturers may be offered easy treatment or special regulatory loopholes in exchange for agreeing to help them harass another group. Lest any group be tempted to take this bait, consider that federal legislation is like shifting sand: the wind blows every two years, and a legislative advantage can be taken away as quickly as it is given. However, organizational goodwill can be destroyed overnight by such venality and may take decades to restore. Any rational organization would not engage in such tricks, if interested in pursuing long-term objectives. Due to the increasing popularity of herbs and alternative health care, the public no longer responds as well to the tired old medical establishment propaganda about "lack of scientific proof" and "quackery". Instead people are more likely to quack back at the FDA and AMA. So expect the divide and conquer ploy to be used more frequently; it is a sign of desperation. Here's how advanced divide and conquer works: Since most members of alternative health organizations would not be so foolish as to sabotage their own organization's goodwill by favoring underhanded deals with the AMA or FDA, these deals are usually consummated in other, more subtle ways. For example, say that group A is relatively powerful, but sees group B coming up in the ranks. Group A may decide to plant a sleeper agent in group B who pretends to be in favor of group B's agenda, or group A may be more bold and simply state that it wants to "help" group B. Often such an agent will be in the guise of a political consultant or lawyer advising the group's top officials. After agent of A becomes well trusted by B, he suggests a course of action to the group's leaders that involves lobbying for legislation advantageous to group B, but that will be at the expense of group B's competition (groups C, D, etc.). The agent advises secrecy to ensure the other groups will have little time for an effective countermeasure. At the last minute, group A arranges for the scheme to be leaked to the press, so that the whole world knows about group B's duplicity. Of course, groups C, D, E, etc. will all be outraged at their betrayal. Group A walks away laughing while groups B through E sling mud at each other. Replace A with AMA or FDA, and groups B, C, D, and E with alternative health professions, and you get the idea. Please don't let this happen. Turn the tables on the FDA. The FDA is effectively challenging herbalists to justify why they should not be regulated. Yet a cardinal principle of use of the police powers is that it is up to the governing agency to demonstrate that to protect public health and welfare, other means are inadequate and regulation is necessary. What specific abuses of herbal dispensing or manufacture have been documented? How could these best be remedied (voluntary compliance, independent watchdog organizations, etc.)? In the author's opinion, Ralph Nader has done a better job of embarrassing corporations into changing their wayward habits than many government agencies. That's because public education and political pressure can be effective in promoting change. Do not be fooled by the FDA's expressed concern for charlatans and quacks in the alternative health fields. The FDA benefits by a steady parade of charlatans before the public's eyes in order to justify its continuing assault on honest scientists and innovators who threaten the status quo. No doubt there are frauds and quacks in any field, especially allopathic medicine, but how effectively have FDA regulatory restraints curbed these abuses? Coordinate your efforts worldwide with anti-Codex groups internationally. Codex is an international trade proposal which is being pushed by the major pharmaceutical companies. It is the international equivalent of what the FDA is attempting within the U.S. This type of legislation is being promoted in many countries simultaneously, together with Codex, as they are mutually complementary. Involve the Chinese whole herb importers in this issue. They may have a lot to lose, both with Codex and with national legislation of this type. They are also influential and powerful. Become personally knowledgeable in the law. Don't rely on attorneys to do it all for you, since their favorite game is to unnecessarily complicate matters to increase their billing time. Often the legal issues are surprisingly simple once you get to the heart of the matter. Keywords: corporation, privilege, right, due process, citizen, person, police power, interstate commerce. Make a clear distinction between the FDA's beneficial role in controlling unsanitary food manufacturing from its role as protector of pharmaceutical cartel profits. Herbs should be regulated in the same manner as foods; there is no compelling public interest in doing otherwise. To endorse their regulation as drugs or medicines will only prolong the criminal mischief and harassment the FDA has inflicted on physicians and health care professionals who have challenged the status quo by their attempts to improve their fellow citizens' health. Remember that the FDA officially ridicules herbs as being "quackery". See their website for details. [fqu] Contact U.S. House and Senate membersSend email messages to members of U.S. Congress and Senate regarding FDA abuse of power. Following is a sample letter: The Honorable [firstname] [lastname], Please support: 1) Congressional hearings into the intolerable criminal actions that the FDA has committed against numerous physicians, alternative health providers, and health product manufacturers; 2) legislation which would severely restrict the ability of the FDA to abuse citizens' rights to health care freedom of choice; 3) criminal prosecution of FDA officials who have violated citizens' rights and conducted campaigns of persistent and malicious harassment. FDA officials must not be above the law and must be prosecuted for criminal violations of citizens' rights, including gross violations of due process, harassment, confiscation of property without due process, and outright terrorism against American citizens. After studying the voluminous documentation concerning these abuses, I've concluded that words on paper, regulations, and public statements of good intention are useless until FDA officials are forced to obey the laws of this country as the rest of us are expected to do. Thank you for your attention to this matter. Sincerely, ... There are many FDA critics in Congress who seem determined to institute real reform. Following is a list of key legislators to contact regarding FDA abuses of power:
Also, send comments to the U.S. Senators representing your state and the U.S. Congressional Representative for your district.
SummaryAs in all walks of life, in government there coexist scoundrels as well as saints. Many FDA officials may privately feel remorse over the shady history of their agency. (In the Burzynski case, "while the scientific divisions of the FDA have been cooperative, helpful and anxious to conduct clinical trials of antineoplastons, the Enforcement Division has long been obsessed with shutting Dr. Burzynski down." [fco]) However well meaning some of them may be, good intentions alone do not remedy the pattern of abuse of government authority, although it may help. The actions of conscientious FDA officials may be easily overwhelmed by the politically motivated policies of its director and by the irresponsible and often criminal actions of its enforcement branch. The issues should remain the legal causes of action, the political and legal authority to remedy them, and the need to reform the FDA as an agency so that its stated intentions become aligned with its actions. The rights of herbalists and of consumers are in jeopardy until this realignment occurs. The stated purpose of the FDA to protect consumers against fraud and unsafe products is a valid one, and could be beneficial if FDA officials are constrained to obey the laws of this country as the rest of us are required to do. However, this valid purpose has frequently been used as a subterfuge for committing terrorism against honest individuals whose ideas and products are an economic threat to the status quo. Where institutional wrong-doing has become a way of life, no progress can be made until the FDA takes internal measures to reform rogue agents and bureaucrats; such individuals should be fired and prosecuted to the full extent of the law for any criminal violations of public trust. [zv1] [zv2] [zv3] [zv4] To pretend that the FDA has American citizens' health uppermost in its concerns without major internal reform would be foolhardy. Until this happens, no mere words on paper, no reasonable-sounding regulations, or public statement of good intentions will have any weight. While the herbal professions, both in the clinic and in manufacturing, may have room for improvement, it may be a serious mistake to endorse the FDA as the agency most able to foster this improvement, when its legal authority and jurisdiction do not extend this far. Many of the professional deficiencies of herbalists, especially of herbalists dispensing preparations for individual clients, are not proper subjects for regulation by the FDA, since they far exceed their jurisdiction based on Article I, Section 8 of the U.S. Constitution giving Congress authority to regulate interstate commerce. While the company that ships herbs to the dispensing herbalist may fall under such jurisdiction, the dispensing of herbs within each state is not a federal question, but a state one, and herbalists who accede to the FDA's intentions to regulate such areas are helping to spawn a serious breach of power. Other resources
FootnotesFootnotes are listed in order by their alphanumeric codes as they appear in the body of this report.
|
