Nutrition 2000 - - Vitamins, Dietary Supplements, Minerals, Herbal Products
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(205) 533 9045
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COMPANY UPDATE
It has been our pleasure to
serve our customers for over a decade. Unfortunately, due to FDA
harassment we are being forced to close our operations. We have sold
our inventory to various vendors. If you wish to order any our
products, please call 205 533
9023
while supplies last.
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 Wicke, Ph.D.
Page contents.....
Introduction
A brief compendium of recent FDA raids
Some concerns about herbal quality
Principles of law, limitations of FDA
authority
Strategies for countering increased FDA
restrictions of herbal products
Contact U.S. House and Senate members
Summary
Other resources
Footnotes
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.
U.S. House of
Representatives. <http://www.house.gov/Welcome.html>
U.S. Senate. <http://www.senate.gov/>
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
FDA - DSHEA and related regulations
[dgm]
Current Good Manufacturing Practice in Manufacturing, Packing,
or Holding Dietary Supplements; Proposed Rule. Department of
Health and Human Services, Food and Drug Administration, 21 CFR
Ch.1. From Federal Register, 1997.feb.07 (Vol.62, No.25),
p.5699-5709. Online access to
Federal Register: <http://www.access.gpo.gov/su_docs/aces/aces140.html>
[dsh]
Dietary
Supplement Health and Education Act of 1994. <http://vm.cfsan.fda.gov/~dms/dietsupp.html>.
U.S. Food and Drug Administration, Center for Food Safety and
Applied Nutrition, 1995.dec.01. Summary of its main effects on
health product manufacturers.
[dle]
The Dietary
Supplement and Health Education Act: Key Provisions.
<http://venable.com/govern/dietact.htm>. By Geoffrey M. Levitt.
A summary of key provisions of the regulations enacted
1994.oct.25.
[dfl]
Proposed Rules for Food Labeling: Nutrient Content Claims,
General Principles; Health Claims, General Requirements and
Other Specific Requirements for Individual Health Claims.
<http://204.31.98.5/~feddemo/19951221/docs/95-31008/95-31008.txt>.
From the Federal Register, 1995.dec.21 (Vol.60, No.245),
Department of Health and Human Services, Food and Drug
Administration, 21 CFR Part 101.
FDA - recent abuses
[fbu1]
Antineoplastons: FDA
Declares War. <http://cancermed.com/antineo3.htm>. 1996
January. The case of Dr. Burzynski.
[fbu2]
Antineoplastons: How
the FDA Stops Medical Progress. <http://cancermed.com/fdamore.htm>.
[fbu3]
FDA and Courts
Block Dr. Burzynski's Patient's Treatments. <http://www.lef.org/fda/burzynsk.htm>.
By the Life Extension Foundation. 1996 February. Includes list
of legislators to contact with demands for Congressional action
against FDA abuses.
[fco]
Congress Holds Hearings
on FDA Abuses of Authority. <http://cancermed.com/fda.htm>.
Summary of hearing on 1995.jul.25. Opening comments by
Congressman Richard Burr.
[fqu]
FDA Backgrounder - Top Health Frauds. <http://www.fda.gov/opacom/backgrounders/tophealt.html>.
1996 November. The FDA considers herbs "quackery". Read their
official website for this and other humourous but disturbing
commentary.
[fre1] DeMeo, James;
Anti-Constitutional Activities and Abuse of Police Power by
the U.S. Food and Drug Administration and other Federal
Agencies. <http://id.mind.net/community/orgonelab/fda.htm>.
Reprinted from On Wilhelm Reich and Orgonomy, Pulse
of the Planet #4, 1993.
[frh1]
Power-Hungry
FDA Is Hazardous to Our Health. <http://www.independent.org/ahiggsp.html>.
By Robert Higgs, Ph.D. 1995.aug.10.
[frh2] Public Health vs.
Bureaucratic Self-Interest:
Don't Trust
the FDA to Reform Itself. <http://www.independent.org/ahiggsfs.html>.
1995.may.18.
[fsb]
Strong-arming
American Business. <http://www.sbsc.org/sbsc/rw-fda2.html>.
SBSC Reg Watch: Second in a Three-Part Series on the FDA. 1995
July.
Professional and industry groups that promote herbalists' rights
[gahg]
American
Herbalists' Guild. <http://www.healthworld.com/herbalists/>.
For their position paper on the proposed regulations related to
the Dietary Supplement and Health Education Act:
<http://www.healthworld.com/herbalists/LaborCom.htm>.
[gapm]
American
Preventative Medical Association. <http://www.arxc.com/apma/index.html>.
[gahp]
American Herbal
Products Association. <http://206.135.37.254/pan/trade/ahpa/>.
[gcfh]
Citizens for Health.
<http://www.citizens.org/index3.htm>. Also: up-to-date synopses
on current legislation affecting health care and availability of
natural and alternative health products.
[ghan]
Health Action Network
Society (Canada). <http://www.hans.org/lynes.htm>.
Codex: international trade agreement proposal that would
restrict herbal product and nutritional supplement availability in
all countries who become signatories to this treaty.
[ica]Lesso, John;
Codex
Update and the Significance of the German Proposal to Australia.
<http://www.pnc.com.au/~cafmr/newsl/codx-aus.html>.
[ich]
Letters to Senator
Orrin Hatch by Milton Bass regarding UN/WHO Codex
Alimentarius. <http://www.lef.org/fda/codex.htm>.
[icl]
Life Extension
Foundation: Fighting for Health Freedom. <http://www.lef.org/fda/fda.htm>.
Articles by Saul Kent and William Faloon on the FDA and Codex.
[icn] Hammell, John;
American
health freedom threatened by international commission.
<http://www.serv.net/~net_usa/news/codex.html>. Published by the
Tribune.
[icr]
Codex committee on
Nutrition and Foods for Special Dietary Uses. <http://www.tasinc.com/codexrpt.htm>.
Bonn, Germany. Report prepared by James T. Heimbach, Ph.D.,
1996.oct.15
Excessive corporate influence in government
[kpm]
Ralph Nader and
the Real Presidential Race: Corporate Oligarchy vs.
Resurgent Democracy. <http://www.tnews.com/text/Nader3.html>. By
Patrick Mazza, posted to Cascadia Planet, 1996.sep.19.
[kra]
Ending
Corporate Governance; We The People: Revoking Our
Plutocracy. <http://www.ratical.com/corporations/index.html>.
Articles and resources for people wishing to restrain the
influence of large corporations in government.
[krn]
Ralph Nader on
Corporatism and Plutocracy.
<http://connix.com/~harry/nader.htm>. Excerpts from a speech
given at Harvard University.
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."
.
Stop FDA attempts to restrict
availability of herbs and natural products
Introduction
A brief
compendium of recent FDA raids
Some concerns
about herbal quality
Principles
of law, limitations of FDA authority
Strategies
for countering increased FDA restrictions
of herbal products
Contact U.S. House
and Senate members
Summary
Other
resources
Footnotes
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.
U.S. House of Representatives.
<http://www.house.gov/Welcome.html>
U.S. Senate.
<http://www.senate.gov/>
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
FDA - DSHEA and related regulations
[dgm]
Current Good Manufacturing Practice in Manufacturing, Packing,
or Holding Dietary Supplements; Proposed Rule. Department of
Health and Human Services, Food and Drug Administration, 21 CFR
Ch.1. From Federal Register, 1997.feb.07 (Vol.62, No.25),
p.5699-5709. Online access to
Federal Register:
<http://www.access.gpo.gov/su_docs/aces/aces140.html>
[dsh]
Dietary
Supplement Health and Education Act of 1994.
<http://vm.cfsan.fda.gov/~dms/dietsupp.html>. U.S. Food and Drug
Administration, Center for Food Safety and Applied Nutrition,
1995.dec.01. Summary of its main effects on health product
manufacturers.
[dle]
The Dietary
Supplement and Health Education Act: Key Provisions.
<http://venable.com/govern/dietact.htm>. By Geoffrey M. Levitt.
A summary of key provisions of the regulations enacted
1994.oct.25.
[dfl]
Proposed Rules for Food Labeling: Nutrient Content Claims,
General Principles; Health Claims, General Requirements and
Other Specific Requirements for Individual Health Claims.
<http://204.31.98.5/~feddemo/19951221/docs/95-31008/95-31008.txt>.
From the Federal Register, 1995.dec.21 (Vol.60, No.245),
Department of Health and Human Services, Food and Drug
Administration, 21 CFR Part 101.
FDA - recent abuses
[fbu1]
Antineoplastons: FDA
Declares War. <http://cancermed.com/antineo3.htm>. 1996
January. The case of Dr. Burzynski.
[fbu2]
Antineoplastons: How
the FDA Stops Medical Progress.
<http://cancermed.com/fdamore.htm>.
[fbu3]
FDA and Courts
Block Dr. Burzynski's Patient's Treatments.
<http://www.lef.org/fda/burzynsk.htm>. By the Life Extension
Foundation. 1996 February. Includes list of legislators to
contact with demands for Congressional action agai | |
