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— updated 1998-01-19

Stop FDA attempts to restrict availability of herbs and natural products

American 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…

Copyright ©1997 by RMH-Publications Trust. Permission is given to reproduce and distribute this document without modification for non-commercial, not-for-profit purposes only; all other rights are reserved by RMH-Publications Trust.

Note: All footnotes and references within the body of text are denoted by a three or four-character alphanumeric code enclosed within brackets, i.e., [exa1]. This document has been designed for ease of use in either online or printed version.


Introduction

In 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 raids

Lest 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]

  • Dr Burzynski of Houston, Texas, has been harassed by the FDA for over a decade because of his pioneering and controversial use of a preparation he calls "antineoplastons" in the treatment of otherwise untreatable brain tumors. [fbu1]

    In 1991 five experts from the National Cancer Institute visited Burzynski's clinic, reviewed the records of seven of Burzynski's patients with "incurable" brain tumors. In their report, they verified anti-cancer activity in all seven cases, as well as five complete remissions. In spite of the NCI's recommendation for further study and clinical trials, harassment of Burzynski and his patients and seizure of his clinical records and files continued.

    "In 1983, FDA filed civil suit in federal court to stop Dr. Burzynski from manufacturing or treating patients with antineoplastons. In a motion dated May 2, 1983 and signed by Robert Spiller, the FDA's Associate Chief Counsel for Enforcement, the FDA warned Federal Judge Gabrielle McDonald that the FDA would not take "no" for an answer." In spite of this threat, Judge McDonald specifically declined to prevent Dr. Burzynski from treating patients in Texas, because she recognized that Burzynski's intrastate operations were not proper areas of jurisdiction for the FDA. From the details of the FDA's legal strategy, it is clear that the FDA had been frustrated in its attempts to prove that Burzynski engaged in unauthorized interstate shipment of his experimental medicine, as this is the only means by which it could obtain jurisdiction to prosecute him. Multiple grand jury hearings failed to yield any indictments of Burzynski.

    In an interview in January 1982, Dr. Richard J. Crout of the FDA, revealed the FDA's motive for targetting Dr. Burzynski for destruction: "I never have and never will approve a new drug to an individual, but only to a large pharmaceutical firm with unlimited finances," declared Dr. Crout. The next year, the FDA began its vendetta against Burzynski, an individual with limited finances. [fbu2]

  • 1950's, Maine: Wilhelm Reich, M.D., in one of the most infamous cases of FDA thuggery, was railroaded through the courts for his unorthodox views on medicine, politics, and society in general. His books and research journals were incinerated. Dr. Reich died in prison and his coworker, Dr. Michael Silvert, committed suicide after being released from prison. The FDA harassed many associated with Reich, and carried out invasions of these individuals' homes without warrant or court order. Such actions were typical of the raids generally conducted during the McCarthy period. [are] [fre1] Reich himself was well aware of the mechanisms behind such abuses of power, as evidenced by his book, The Mass Psychology of Fascism [rei].
  • 1950's, U.S.: Harry Hoxsey's herbal formulas for the treatment of cancer were targetted for obliteration by the FDA, after Hoxsey refused to sell his formula to Morris Fishbein, president of the AMA. The formulas were used in dozens of clinics across the USA during the 1950s. [aho]
  • Dr. Royal Rife's methods for microscopically viewing viral activity within living cells may have yielded a major breakthrough in cancer treatment, yet before it could be thoroughly investigated, the AMA threatened and harassed physicians who dared explore the new methods. Some of these physicians died mysteriously. Rife died an embittered man in 1971. [ari]

    Since Rife's death, many alternative health businesses have jumped on the bandwagon to promote Rife's suppressed techniques. However, many of them may be selling bogus imitations, discrediting Rife's work more effectively than any FDA harassment could possibly accomplish.

  • 1990: Max Gerson's dietary treatments for degenerative diseases were criminalized by the FDA just as he was publishing scientific evidence and clinical reports on their effectiveness in boosting immune system function. [age]
  • 1987, Florida: The Life Extension Foundation was raided by armed FDA agents, who seized nutritional supplement supplies, files, and personal belongings. Lawsuits against the FDA are still pending. [ajw]
  • 1990, Oregon: FDA agents raided Highland Laboratories and removed everything except office furniture. No employees were informed of the legal grounds for the raid and were threatened with violence if any of them attempted to enter their workplace. The FDA never charged anyone with a violation, but no property has ever been returned. [ajw]
  • 1990, California: The FDA raided and ransacked the pet food store of Sissy Harrington-McGill. FDA agents stated that her pet store literature claiming that vitamins would keep pets healthy was a violation of the Health Claims Law, which was never passed by Congress. Ms. Harrongton-McGill served 114 days in prison, after being tried and convicted by a judge without a jury trial, in spite of her request for a jury trial. Lawsuits have been filed against the FDA. [ajw]
  • 1990, Nevada: The Century Clinic, which administered chelation therapy, homeopathy, and nutritional supplements, was raided twice by FDA and Postal Service inspectors. First, the premises were ransacked and almost all supplies and equipment removed. After no charges were filed against the clinic by the FDA, Century Clinic sued the FDA for return of the seized property. The FDA retaliated with a second raid more extensive than the first, extending to the private homes of the businesses owners and employees. Again, no charges were filed by the FDA. [ajw]
  • 1991, Tijuana, Mexico: Jimmy Keller, who administered natural healing methods in cases of cancer after healing himself of metastasized cancer unresponsive to conventional therapy, was kidnapped from his office in a Mexican hospital by bounty hunters employed by the U.S. Justice Department. On arrival in the U.S., he was arrested for wire fraud: making interstate telephone calls to attract people to his clinic in Mexico. He was convicted to two years in prison. [ajw]
  • 1991, California: FDA agents raided NutriCology, a nutrition supplement company operated by Stephen Levine, Ph.D., a molecular geneticist from the UC Berkeley. Levine spent $500,000 to defend against three different FDA injunctions, all of which were thrown out of court. [ajw]
  • 1992, Washington state: FDA agents raided and terrorized the medical clinic of Jonathan Wright, M.D. The FDA initiated the raid after a recent batch of contaminated B-vitamins was discovered in another state, yet Wright's clinic had no connection to the company making the contaminated vitamins and dis not use their products. In spite of this, the FDA agents removed most of the clinic's contents, meanwhile terrorizing patients and treating them like criminals. As of 1993, no clinic property has been returned, yet no charges against the clinic or any of its employees have been filed by the FDA. [ajw] [awr]
  • 1992, California: David Halpern, several of his family members, and the presidents of three European vitamin companies are charged with 198 counts of conspiracy and smuggling for importing banned nutritional supplements that are freely available in Britain and Germany. The indictments carry a potential prison term of 990 years. [ajw]
  • 1992, Texas: The FDA induced the Texas Department of Health and Texas Department of Food and Drug to raid over a dozen major health food stores. Over 250 products were seized from the shelves, including vitamin C, zinc, herbs, aloe vera, and flaxseed oil. Following a massive public outcry, FDA threatened health food store owners, "Don't talk to the press, or we'll come down on you twice as hard.". No charges were ever filed by the FDA, and no products were ever returned. [ajw]
  • 1993, USA: Dozens of natural healing clinics, health food stores and natural product manufacturers throughout the U.S. were assaulted by combined forces from the FDA, DEA, IRS, Customs, and US Postal Service in commando-style SWAT raids. Stocks of vitamins and herbs were confiscated as well as bank accounts, automobiles, and computers. Especially of interest as a target of the raids were mailing lists of customers and clients. The Postal Service assisted in the actions by blocking all mail to some of the businesses, effectively preventing them from continuing any business and from conducting effective legal defense. [fre1]

The above list is by no means exhaustive, but is merely a sampling.

Some concerns about herbal quality

The 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 authority

In 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:

  • Must enacted for explicit purposes of protecting health, safety and welfare of the public.
  • Must not violate property rights or other personal rights recognized and guaranteed by the Constitution.
  • Must adhere to requirements of due process of law and equal protection of the laws as required by the 14th Amendment.
  • Must not be administered arbitrarily under the guise of protecting the public.
  • Cannot be used as a means for exercising control over harmless and innocent activities and businesses.
  • Cannot be used to prohibit or destroy otherwise lawful businesses.

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 products

One 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 harrass 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 members

Send 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:

Rep. Richard Burr (R-NC); <mail2nc5@hr.house.gov>
Member of Investigations and Oversight Subcommittee of the House Commerce Committee investigating FDA Abuses of Authority.
Rep. Thomas Bliley (VA); (no email address)
2241 Rayburn House Office Building; Washington, DC 20515; (202)225-2815
Rep. Joe Barton (TX); <barton06@hr.house.gov>
Rep. Michael Bilirakis (R-FL); <fl09@hr.house.gov>
Chairman, House Commerce Subcommittee on Health and the Environment
Senator Orrin Hatch (R-UT); <senator_hatch@Hatch.senate.gov>
Chairman, Senate Judiciary Committee
Senator Tom Harkin (D-IA); <tom_harkin@harkin.senate.gov>
Senator Tom Daschle (D-SD); <tom_daschle@daschle.senate.gov>
Senator Joe Biden (D-DE); <senator@biden.senate.gov>
He is ranking minority member of Senate Judiciary Committee
Rep. Peter DeFazio (D-OR); <pdefazio@hr.house.gov>
Rep. Jack Kingston (R-GA); (no email address)
1507 Longworth Building; Washington, DC 20515; (202) 225-5831. He sits on the Appropriations Subcommittee that funds the FDA.

Also, send comments to the U.S. Senators representing your state and the U.S. Congressional Representative for your district.

Summary

As 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

Footnotes

Footnotes are listed in order by their alphanumeric codes as they appear in the body of this report.

  • [age] Gerson, Max; A Cancer Therapy: Results of 50 Cases; Gerson Institute, Bonita, Calif., c1990.
  • [aho] Ausubel, Ken; Hoxsey: How Healing Becomes a Crime; Mystic Fire Video, Malibu, California, c1987.
  • [ajw] FDA Versus The People of the United States; Jonathan Wright Legal Defense Fund, Citizens For Health, PO Box 368, Tacoma, WA 98401; 206/922-2457, fax:206/922-7583.
  • [are] Greenfield, Jerome; "Wilhelm Reich Versus the USA", W.W. Norton, NY, c1979; Wyvell, Lois; "The Jailing of a Great Scientist in the USA", Pulse of the Planet, 1993 #4; DeMeo, James; "Author's Preface", The Orgone Accumulator Handbook; Natural Energy Works, El Cerrito, Calif., c1989.
  • [ari] Lynes, Barry L.; "The End of the Line: Royal Raymond Rife - Corrections and Perspective"; c1996(?). <http://www.endoftheline.com/health/rife_new.htm>. Lynes, Barry L.; "The Cancer Bureaucracy: How The Real Cures Are Suppressed"; Health Action Network Society, <http://www.hans.org/lynes.htm>.
  • [arm] Culbert, Michael L.; Medical Armageddon, vol. 1-2 and vol. 3-4; C and C Communications, San Diego, Calif., c1994. These volumes contain detailed descriptions of numerous FDA abuses, describing a systematic campaign of suppression of alternative health modalities from its beginnings in the early part of this century. The FDA began as an agency devoted to protecting the allopathic patent medicine manufacturers who sold their medicines without identifying the ingredients, unlike the herbalists and homeopathic manufacturers of that era.
  • [asu] A list of FDA raids; from Life Extension Magazine, republished by Sumeria. <http://www.livelinks.com/sumeria/health/raids.html>.
  • [awr] With Guns Drawn FDA Makes Vitamin Bust; Health Action Network Society. <http://www.hans.org/fdabust.htm>.
  • [dir] Walker, Martin J.; Dirty Medicine; Slingshot Publications, c1993. Chapters 1 and 2 describe the historical beginnings of the FDA in 1938 as part of a New Deal trend toward government regulatory agencies assuming responsibility for the scientific improvement of industry and society. Unfortunately, the largest corporations created a revolving door policy toward government regulatory officials: on leaving government, these officials frequently were offered lucrative jobs in the very same private industries they had regulated, in some cases receiving money and bribes while still in office.
  • [guy] Guyton, Arthur; "The Chemical Senses, Taste, and Smell"; in: Textbook of Medical Physiology; W.B. Saunders Co., Philadelphia, c1971; p.645. Human olfaction is capable of detecting 4x10-14 g/ml of the compound methyl mercaptan.
  • [mil] Milgram, S. (1963); Behavioral studies of obedience; Journal of Abnormal and Social Psychology, 67, 371-378.
  • [mir] Miranda v. Arizona, 384 U.S. (United States Reports) 436.
  • [kel] Kelman, H. (1973); Violence without moral restraint. Journal of Social Issues, 29, 25-61.
  • [or1] Pathogen Reduction; Hazard Analysis and Critical Control Point (HACCP) Systems; Proposed Rule. <http://www.dfst.csiro.au/fshbull/fr60_23.txt>. From the Federal Register, 1995.feb.03, p.6773, Department of Agriculture, Food Safety and Inspection Service, 9 CFR Part 308, et al. Describes how meat inspectors rely on organoleptic methods (smell and appearance) for effective detection of spoiled or contaminated meat and poultry.
  • [or2] Testimony of Dr. Michael Friedman before the Subcommittee on Livestock, Dairy, and Poultry; Committee on Agriculture, U.S. House of Representatives; 1996.may.22. <http://www.fda.gov/ola/cfood.html>. Mentions the effective use of organoleptic criteria in the detection of seafood spoilage by trained testers.
  • [poi] Egginton, Joyce; The Poisoning of Michigan; W.W. Norton and Co., c1980.
  • [rei] Reich, Wilhelm; The Mass Psychology of Fascism; St. Albion Press; c1970.
  • [tcm] Wicke, Roger; What is traditional Chinese herbology? (How to choose herbs using methods of Chinese herbology) <http://www.rmhiherbal.org/a/e.chooshrbs.html>.
  • [za1] U.S. Constitution, Article I, section 8. "The Congress shall have Power... to regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes;..."
  • [zbu] U.S. v. William M. Butler, 297 U.S. 1. "The question is not what power the federal government ought to have, but what powers, in fact, have been given by the people...The federal union is a government of delegated powers. It has only such as are expressly conferred upon it, and such as are reasonably to be implied from those granted. In this respect, we differ radically from nations where all legislative power, without restriction or limitation, is vested in a parliament or other legislative body subject to no restriction except the discretion of its members."
  • [zda] Davis v. Massachusetts, 167 U. S. 43; Packard v. Banton, 264 U.S. 140, 145. "Moreover, a distinction must be observed between the regulation of an activity which may be engaged in as a matter of right and one carried on by government sufferance or permission. In the latter case the power to exclude altogether generally includes the lesser power to condition and may justify a degree of regulation not admissible in the former."
  • [zha] Hale v. Henkel, 201 U.S. 43, 74-75. "...we are of the opinion that there is a clear distinction in this particular between an individual and a corporation, and that the latter has no right to refuse to submit its books and papers for an examination at the suit of the State. The individual may stand upon his constitutional rights as a citizen. He is entitled to carry on his private business in his own way. His power to contract is unlimited. He owes no duty to the State or to his neighbors to divulge his business, or to open his doors to an investigation, so far as it may tend to criminate him. He owes no such duty to the State, since he receives nothing therefrom, beyond the protection of his life and property. His rights are such as existed by the law of the land long antecedent to the organization of the State, and can only be taken from him by due process of law, and in accordance with the constitution. Among his rights are a refusal to incriminate himself, and the immunity of himself and his property from arrest or seizure except under a warrant of the law. He owes nothing to the public so long as he does not trespass upon their rights.

    "Upon the other hand, the corporation is a creature of the State. It is presumed to be incorporated for the benefit of the public. It receives certain special privileges and franchises, and holds them subject to the laws of the State and the limitations of its charter. Its rights to act as a corporation are only preserved to it so long as it obeys the laws of its creation. There is a reserved right in the legislature to investigate its contracts and find out whether it has exceeded its powers. It would be a strange anomaly to hold that a State, having chartered a corporation to make use of certain franchises, could not in the exercise of its sovereignty inquire how those franchises had been employed, and whether they had been abused, and demand the production of the corporate books and papers for that purpose. "

  • [zma] Marbury v. Madison, 5 U.S. (Cranch) 137, 174,176, (1803). "All laws which are repugnant to the Constitution are null and void."
  • [zmi] Miranda v. Arizona, 384 U.S. 436, 491. "Where rights secured by the Constitution are involved, there can be no rule making or legislation which would abrogate them." See also: Boyd v. U.S. 116 U.S. 616.
  • [zpe] Perry v. U.S., 294 U.S. 330, 353 (1935). "...the Congress cannot revoke the Sovereign power of the people to override their will as thus declared."
  • [zpo] Case citations regarding exercise of the police powers. Lochner v. New York, 198 U.S. 45; Yick Wo v. Hopkins, 118 U.S. 356; Butcher's Union Co. v. Crescent City Co., 111 U.S. 746; Lawton v. Steele, 152 U.S. 133; Mugler v. Kansas, 123 U.S 623.
  • [zte] Terry v. Ohio, 392 U.S. 39 (1967). "There have been powerful hydraulic pressures throughout our history that bear heavily on the court to water down constitutional guarantees and give the police the upper hand. That hydraulic pressure has probably never been greater than it is today. Yet if the individual is no longer to be sovereign, if the police can pick him up whenever they do not like the cut of his jib, if they can "seize" and "search" him in their discretion, we enter a new regime. The decision to enter it should be made only after a full debate by the people of this country."
  • [zv1] 42 U.S.C. 1963. "Every person who, under color of any statute, ordinance, regulation, custom, or usage, of any state or territory, subjects or causes to be subjected, any citizen of the United States or other person to the deprivation of any rights, privileges, or immunities secured by the constitution and laws, shall be liable to the party injured in an action at law, equity, or other proper proceeding for redress."
  • [zv2] Olmstead v. United States, 277 U.S. 438, 485 (1928). "Decency, security, and liberty alike demand that government officials shall be subjected to the same rules of conduct that are commands to the citizen. In a government of laws, existence of the government will be imperiled if it fails to observe the law scrupulously. Our government is the potent, the omnipresent teacher. For good or ill, it teaches the whole people by its example. Crime is contagious. If the government becomes a lawbreaker, it breeds contempt for the law; it invites every man to become a law unto himself; it invites anarchy. To declare that in the administration of the criminal law the end justifies the means.... would bring terrible retribution. Against that pernicious doctrine this court should resolutely set its face. "
  • [zv3] Mugler v. Kansas, 123 U.S. 623, 662. "It is a fundamental principle in our institutions, indispensable to the preservation of public liberty, that one of the separate departments of government shall not usurp powers committed by the Constitution to another department."
  • [zv4] From George Washington's Farewell Address. "It is important, likewise, that the habits of thinking in a free country should inspire caution in those intrusted with its administration, to confine themselves within their respective constitutional spheres; avoiding in the exercise of the powers on one department to encroach upon another. The spirit of encroachment tends to consolidate the powers of all the departments in one, and thus to create, whatever the form of government, a real despotism."
  • [zyi] Chisholm v. Georgia, 2 Dall 419, 471; McCullock v. Maryland, 4 Wheat 316, 404, 405; Yick Yo v. Hopkins, 118 U.S. 356, 370. In the United States, Sovereignty resides in the people, who act through the organs established by the Constitution."