Archive for The Law & CODEX – Page 61
Natural Solutions Foundation Media Release
www.GlobalHealthFreedom.org
GeneralStubblebine@GlobalHealthFreedom.org
Protecting Health Freedom for Consumers and Entrepreneurs
1. While health care reformers want a more educated health care consumer, FDA seeks to further stifle health information. FDA has issued a Guidance prohibiting the making of any Health Claims that lack “Significant Scientific Agreement,” an impossible standard since “significant” and “agreement” cannot be defined. Under a policy of “Harmonization,” as well as a published preference for international over domestic rulemaking (Federal Register, October 11, 1995), FDA’s own Head of Dietary Supplements Office convinced an international body, the UN-sponsored Codex Alimentarius, to prohibit as “advertising” any food related health benefit information that can change consumer behavior. Congress should pass HR 2117, the “Health Freedom Protection Act,” to allow “common law”claims and follow Supreme Court decisions, empowering consumers with helpful information on food and supplements.2. While these same health reformers want to expand access, FDA is threatening supply with another FDA Guidance, on “Complementary and Alternative Medicine” (CAM), which creates new categories of “medicine”, services and products not authorized by Congress. By using the word “Medicine” instead of “Modalities,” FDA is setting up natural therapies for a takeover by the world of licensed physicians. FDA’s intent here was made clear in March, 2007, when, after the Michigan Cherry Growers Association published scientific evidence of the healing benefits of cherries for arthritis, FDA forced the removal of that information under threat forbidding cherries as an “untested drug.” Since state medical boards often forbid natural therapies as outside the scope of medical practice, licensees who engage in such modalities could lose their licenses; lack of insurance coverage for natural modalities further will further restrict their availability. Congress should hold hearings on FDA’s attack on the natural therapies industry.
3. With a pending recession threatening jobs, FDA is poised to put manufacturers of natural therapies out of business. FDA’s own Economic Impact analysis of its dietary supplement “Good Manufacturing Practices” (GMPs) showed “establishments with not only high costs, but also average costs, could be hard pressed to continue to operate…Very small businesses with less than 20 employees will be at risk of going out of business.” Supplement manufactures already are facing cruel surprise invasions by FDA inspectors dedicated to a “strong enforcement policy” (www.fda.gov/oc/whitepapers/enforce.html). Congress should divest the FDA of “food regulation”, adding an independent Inspector General and a consumer ombudsman to protect the US food supply.4. In an FDA Revitalization bill pending Conference, the Senate version seeks to reform food regulation in response to complaints about Chinese import dangers. Section 608 would exempt from this food proposal supplements which as “food” are generally considered safe under the 1994 Dietary Supplement Health Education Act (DSHEA). Any final FDA Reform bill should retain Section 608.
Today, Saturday, April 28, 2007, the Working Group on the Proposed Draft Amendment for the Labeling of Prepackaged Food will meet in the Ottawa Congress Center, Ottawa, Canada. On Sunday, April 29, the Working Group for the Production, Processing, Labeling and Marketing of Organically Produced Foods will meet. Both meetings are a single day long each year. Both sort out thorny issues n dry as dust terms. But that dust, like the rest of Codex, contains the seeds of the future health of the planet within it. Each Working Group meets for a one day meeting held each year before the start of the Codex Committee on Food Labeling which is hosted by Canada in Ottawa annually.
After the meeting tomorrow I will fill you in on what takes place. What is going on at Codex is vitally important to your health and your planet. BUt what is going on at Codex is also going on at home, too.
Ralph Fucetola, a regulatory lawyer, has written a beautiful guest blog which follows. Please read it and pass it along to everyone in your circle of influence. It is a really important piece. By the way, Big Pharma’s agenda knows neither national borders nor compassion for the vulnerable. Senator Kennedy’s new bill shows neither sense nor respect for your rights. The FDA Guidance shows neither respect for your health nor your health freedom.
We, the people, are neither amused nor hoodwinked and are once again standing and roaring that we control our freedoms, we, not merchants and not politicians, and certainly not bureaucrats or doctors.
Here is Ralph’s Guest Blog:
A Natural Solutions Foundation Guest Editorial
www.vitaminlawyernews.com
FDA CAM DRAFT GUIDANCE INFORMATION
Docket No. 2006D-0480 – http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm
1. Guest Blog for NSF – 04/28/07
2. FDA CAM Threat Assessment – 04/26/07
3. Comments to FDA regarding CAM draft Guidance – 04/06/07
A Natural Solutions Foundation Guest Blog Entry
See: https://staging.drrimatruthreports.com/index.php/?p=367
Don’t be Duped: Multiple Assaults Need Multiple Responses
Our Health Freedom is threatened again. It’s been going on for centuries,
this struggle between healers and bureaucrats. Even back in the age of Henry
the 8th the surgeons of London got a law passed effectively outlawing their
herbalist competitors by granting themselves a monopoly, and, a couple years
later, after many herbalists were brought before the courts, the King had to
intervene, obtaining Parliamentary approval for what is now known in the
Common Law as The Herbalists Charter, to protect traditional methods of
healing and allow their practice “without suit, vexation, trouble, penalty
or loss…”1 As recently as the start of the Twentieth Century, one state
Supreme Court noted, “”The state has not restricted the cure of the body to
the practice of medicine and surgery — allopathy, as it is termed… that
would be to limit progress by establishing allopathy as the state system of
healing, and forbidding all others. This would be as foreign to ours system as
a state church for the cure of souls… To restrict all healing to that one
kind — to allopathy, excluding homeopathy, osteopathy, and all other
treatments — might be a protection to doctors in surgery and medicine; but
that is not the object of the act, and might make it unconstitutional, because
creating a monopoly.” 2
Just such a monopoly was created. For convenience, we can call it the Big
Pharma Cartel. It has money and powerful friends in government – who often
play bureaucratic “musical chairs” among agencies, big companies and
universities. They use that power to harass, jail and even kill their
competitors. We honor the memory of doctors Wilhelm Reich and Dinshah Darius,
among other victims of this witch hunt (as we honor the memories of those
earlier victims of witch hunts who were often Wise Women and Healers.).
In America, after decades of sporadic and arbitrary attacks on health food
stores, holistic doctors and alternative practitioners, a powerful groundswell
of public opinion surged in the early 1990s. People demonstrated at FDA
offices around the country, converged on Washington, flooded Congress with
letters and faxes. Those were heady days, when the political establishment
first took note of what has come to be called the Health Freedom Movement. The
result was congressional passage, without any negative votes, of the Dietary
Supplement Health and Education Act of 1994 (DSHEA). That law was supposed to
protect the right of nutrient purveyors to make truthful and not misleading
claims about the nutritional benefits of their products for the normal
structure and function of the body.
This did not, however, stop the attempts of cartel and its friends in power.
Numerous times since then efforts have been mounted in the media, through
cartel-financed schools and journals, and in the government, to discredit all
dietary supplements and all Complementary and Alternative Modalities (CAM).
The usual process includes fake science, smear and innuendo. In recent years,
add to that, very sophisticated attacks on web sites offering products or
information about nutrition and CAM.
The battle is being fought in each state, where now discredited
“quackbusters” attacked doctors wanting to practice advanced CAM
techniques; in the federal government where important therapies that can
benefit many people, such as the responsible use of silver in health 3, are
under attack; and on the international level where “harmonization” means
reducing our Freedom to some bland bureaucratic “minimum daily
requirement.” On the international level Codex Alimentarius, the World Food
Code, is the chief bureaucratic mechanism to undermine organic standards,
prevent people from knowing what foods are genetically modified – and which
are not – and otherwise make the Big Pharma Cartel agenda international
policy. Regional bureaucracies, such as the EU, NAFTA and the ominous North
American Union play an important role in imposing the harm of harmonization.
4
Recently, even the Journal of the AMA, JAMA, included a highly suspect
“meta-analysis” of carefully chosen “studies” to claim that taking
vitamins could be bad for your health! This article was strongly criticized
by Life Extension Foundation5 and others in the field, but the mass media
covered only the fake science, not the response. Literally tens of thousands
of good scientific studies prove the value of supplementation. It has been
suggested that those who trust the AMA and FDA should certainly not take any
vitamins, especially the mega doses many of us have used for decades. Then in
a few years, we’ll see who is still around to continue the argument!
Yes, at each turn, the attacks of the cartelists and bureaucrats have been met
with stiff public resistance. The attempt to water down organic standards gave
rise to a tidal wave of protest. The original FDA “structure and function”
regulation in 1999 was successfully opposed and the final rule was rather more
friendly to nutritional products. The public outcry in each of these cases was
similar to what is happening now with the FDA’s surreptitiously promulgated
CAM draft Guidance (“issued” on December 26th; no public notice until
February 26th; initially only a short comment period). The grassroots of the
Health Freedom Movement caught fire when the people learned that FDA’s
bureaucrats, under the guise of “just restating the law” were actually
setting the basis for handing over our supplements and alternatives to the Big
Pharma Cartel. 6
But the song continues, and big government representative Ted Kennedy, has
just introduced S-1082, a bill that may gut our Health Freedom. Curiously, we
had heard this bill was dead before submission and would not be submitted. As
soon as the current public outcry reached a very high level, along comes the
senator, with a bill intended to divert attention from the other
anti-supplement bills, Codex, the NAU and the anti-CAM guidance.
It is time to Kill the Kennedy Bill in Committee! While we won’t be diverted
from our vigilance of the FDA anti-CAM maneuver, it is important to react to
these other assaults on Health Freedom. We would like to see this bill killed
in committee. Better to knock it out in congressional committee than allow it
to waste our time. While comments directed at the FDA over its anti-CAM draft
guidance was the proper response, as required by the Federal Register notice,
this back-door effort by the senior senator from Massachusetts should be met
with a flood of messages to the chairman and the members of the oversight
committee that must approve the bill before it goes before the entire Senate.
That will be our strategy in the coming weeks. Of course, if we cannot stop it
in committee, it may be necessary to attempt constructive engagement with the
committee and senators, to amend the bill to protect supplements. Just this
step, according to postings on April 28th on the blog at Mercola.com, has been
suggested by leading nutrition attorney Jonathan Emord JD.
All of these multiple assaults are, of course, connected. They are connected
in philosophy, proponents and beneficiaries. Their proponents refuse to allow
us the freedom to make our own choices, deeming that their political power
gives them the authority to decide for us. We have had enough of such
deciders. They have given us a medical system that kills hundreds of
thousands each year. We reject the philosophy that “the leader is always
right;” that we should just shut up and take all the prescriptions Big
Pharma sells. We know that the cartel that benefits from all these rules and
regulations has plenty of money and jobs to bribe politicians and bureaucrats.
None of that matters when the people are alerted and vigilant! We assert our
“Right to heal and be healed.” 7 We will not be duped by false leaders,
naysayers and nitpickers. We are “mad as hell and won’t take it anymore!” The
time has come to assert thatfundamental right. We need, in both law and
fact, for this basic human right to be respected. We need an end to the power
of the cartel and its bureaucratic allies. And all this will come to pass
using the tools of modern communication, which will prove, I believe, in the
end, more powerful than cartels and politicians.
It does, however, depend on you. You need to support organizations like the
Natural Solutions Foundation, www.HealthFreedomUSA.org, which shows continuing
leadership and, in fact, broke the FDA anti-CAM guidance story. Like everyone
else who unmasks the face of the Big Pharma Objective, they are currently
being smeared and defamed through disinformation and innuendo. Don’t be duped
by disinformation any more than you are by bad science. It’s up to you to see
through to the core of truth and to make your voice heard. It is time to
dream of a world where each person has the right to heal and be healed. That
is the dream we need to have, for our dream to come true.
Ralph Fucetola JD
www.vitaminlawyer.com
Notes
1. See the Charter at http://home.earthlink.net/~lifespirit23/herbcharter.htm
2. North Carolina’s Supreme Court in State v MacKnight, 42 S.E. 580, 1902 at p
582.
3. See: www.silverfacts.com
4. See Dr. Laibow’s Nutricide at www.globalhealthfreedom.org
5. See: http://www.lef.org/featured-articles/consumer_alert_020307.htm
6. See “Take Action” at www.healthfreedomusa.org
7. See: http://www.lifespirit.org/wiltondec.html
04/06/07
Let CAM Continue to Develop Freely
To: Food and Drug Administration
From: Natural Solutions Foundation
Re: FDA Docket No. 2006D-0480
These comments are submitted by Major General Albert N. Stubblebine, Rima Laibow, MD and Ralph Fucetola, JD on behalf of Natural Solutions Foundation with regard to the Food and Drug Administration’s draft “Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration.” They are submitted with reference to the request of FDA for comments on the proposed Guidance stated at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-3259.htm .
The Natural Solutions Foundation is a tax exempt, recognized nongovernmental organization active in the United States and internationally, communicating Natural Solutions to the many health problems caused by government intervention, with emphasis on FDA and Codex Alimentarius over-regulation of natural foods and supplements.
Complementary and Alternative Modalities (CAM), including traditional remedies and nutrition to achieve and maintain a healthy status, are preferred by many Americans to so-called “standard” allopathic medical treatment, primarily due to the well-documented iatrogenic death and disabilities, the dangerous side effects and persistent failures of the so-called “standard” model. The Dietary Supplement and Natural Remedies market has grown to over $28 billion dollars annually as Americans consistently vote with their dollars choosing CAM products out of un-reimbursed funds.
The Foundation urges the FDA to take into account an important legal distinction that FDA appears to ignore totally in the draft Guidance. That distinction is between “treatment of disease” and “therapies that may benefit.” In keeping with that distinction, explained below, it is suggested that the Guidance be titled, “Guidance for Industry on Complementary and Alternative Modality Products and Their Regulation by the Food and Drug Administration.” CAM is not “medicine”, does not rest in medical models and allopathic methods and does not seek to be considered “medicine.” In fact, CAM seeks to shed the appearance of “medicine” which is not in keeping with CAM traditions and activities.
We request the FDA take the following steps: (1) hold public hearings on the proposed Guidance; (2) formally revise the Guidance title to replace the word “Medicine” with “Modality” and (3) use of the terms “therapy” and “therapeutic” with reference to Complementary and Alternative Modality health practices, instead of the words “treat” and “treatment of disease” which are used exclusively in the draft Guidance. The terms “treat” and “treatment of disease” are, in fact, antithetical to CAM therapies.
CAM health practices can be generally defined as traditional or other practices that are used by individuals, often for self-help, to achieve and maintain a healthy status, either on their own or complementary to standard medical care. These practices do not include the potentially dangerous use of invasive techniques and toxic drugs that are the sole province of licensed medicine. They do, however, include developing therapies and nonstandard approaches that are outside the scope of licensed medicine. Such approaches as Nutrition, Homeopathy, Hands-on-Healing, Magnetics, Sound Health, Energy Therapies, Biofeedback, Meditation, Breath Work, Reiki, Chi Gong, Tai Chi and Herbology are examples of complementary and alternative therapeutic practices. Traditional Chinese, Ayurvedic medicine or folk remedies and “Dr. Mom” home remedies are also examples of CAM practices. These practices aim, in the words of the late Philip J. Hodes, PhD., at “more efficient physiological integration and function of the human organism, leading to optimal wellness.” This definition is the polar opposite of non CAM practices which seek to suppress or ameliorate symptoms without an approach to optimal wellness.
The terms “therapy” and “therapeutic” do not occur, for example, in the context of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Rather, that statute, passed by unanimous Congressional Consent, tells us that Dietary Supplements may not “diagnose, treat, cure or prevent” any disease. It does not specifically forbid the use of the word “therapy” (or “therapeutic”). Under the Supreme Court’s rule in the Thompson v Western Medical case, we should expect that these words would not be forbidden by the Courts and should not therefore be overtaken by the regulators.
Further, the Code of Medical Ethics of the American Medical Association also acknowledges an independent use of the term “therapy.” The original Hippocratic Oath, with its injunction to “Do no harm.” has been replaced by a complex Code detailing the relationship between physician and patient and alternative practitioner. Changes made during the early 1990’s were inspired by anti-trust lawsuits brought (and won) during the 1980’s by chiropractors and other non medical practitioners. These changes are just now becoming recognized by regulators and courts.
While “treatment which has no scientific basis” remains condemned (Opinion 3.01), under Opinion 3.04, physicians are free to “refer” a patient “for therapeutic or diagnostic services to another physician, limited practitioner or any other provider of health care services permitted by law to furnish such services, whenever he or she believes that this may benefit the patient.” Thus, unscientific “treatment” is distinguished from “health care services permitted by law.” “Treatment” — which means the use of standard medicine and surgery to “cure” disease — is distinguished from other health care services (therapies) which need only meet the lesser “may benefit” standard. While physicians “prescribe” treatments for disease, therapies that may benefit may be subject to “referral” thereby further indicating the distinction. Thus, for example, Dietary Supplements that support normal structure and function to support therapeutic outcomes can be seen to complement licensed medicine, but not to be held to its strictures, nor limited in its practice to licensed physicians. Since such therapies are not prescription services, members of the public may choose such services without the permission of their physician. Purveyors may restrict sale of therapeutic products to physicians, complementary practitioners, exercise and health care professionals, although they should not be required to do so.
We have analyzed the word “therapy” and the similar word “therapeutic” because these words are not forbidden by DSHEA and are referenced by the AMA Ethics Code. We recommend “Therapeutic Nutritionals” for alternative practices centered on Nutrition. We recommend the use of the qualifying word, “Nutritional” in this context to make it completely clear that the practitioner is not offering “treatment of disease.”
The claims made for Therapeutic Nutritionals must, of course, be allowed Structure and Function Claims. Thus, for example, under current law as interpreted by the FDA, one cannot claim that a nutrient lowers cholesterol levels – since there is now a “disease” of hypercholesterolemia – but can claim that a nutrient maintains normal cholesterol levels for persons with normal cholesterol. A purveyor may say that a certain combination of multivitamins was designed to maintain normal structure and function for a person with diabetes, but not that the combination “treats” diabetes or affects the blood sugar level. Similarly, any Health Claim made for any alternative practice must meet the FTC standard of “truthful and not misleading” and must be based on standard commercial substantiation criteria.
CAM products are intended to benefit normal structure and function and are not prescribed as treatment for medical or psychological conditions, nor for diagnosis, care, treatment or rehabilitation of individuals, nor to apply medical, mental health or human development principles.”
As the High Court said in Thompson, “We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. * * * Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring … a warning…”
What is the proper level of substantiation for CAM nutrient or health claims? It is not the “significant scientific agreement” required of drug claims, but rather, the general “competent scientific evidence” standard that applies to all commercial claims. That does not imply that purveyors need to have multiple double-blind experiments (as may be required for drug approval). Substantiation merely needs to be competent and scientific. We urge this to include research studies (which is when scientists review the work of others and apply it to specific questions) and clinical trials (which may be as formal as double-blind, placebo controlled investigations but need not be, since multiple variables, like those involved in CAM practices designed to promote optimal health, are not well studied by double-blind, placebo controlled investigations) as well as traditional knowledge, clinical case studies, observational reports and clinical experience. All of these sources of information and experience have a role to play, but ultimately, such substantiation must rest on the informed professional opinion of some credentialed or appropriately experienced person who can (in the case of Dietary Supplements, for example) sign onto the Structure and Function Claims Notice to the FDA, attesting that “the notifying firm has substantiation that the Statement to which this Notice applies is truthful and not misleading.” (Regulations under 21 U.S.C. 403(r) (6)).
The Natural Solutions Foundation favors a market approach to these issues and urges the FDA to reduce regulation to those minimum levels that will encourage the continued rapid development of CAM approaches. Especially when dealing with Dietary Supplements and Traditional Remedies, we are dealing with foods which, as foods, are presumed to be safe. There is no need for the high level of regulation that is required for the dangerous and invasive drugs and techniques of so-called “standard” medicine. Even with this stringent level of oversight, drugs are a major cause of death in every developed country while CAM remedies are an insignificant-to-absent cause of death world-wide. Rather, this is a situation where the public is best served by a policy of Laissez-Faire: allow CAM to develop freely in the public interest.
Throughout the world today people are looking to traditional methodologies and leading-edge CAM techniques because they offer alternatives to toxic, expensive drugs with their dangerous side effects, un-manageable and unreasonable costs and other invasive technologies of modern medicine. This search for alternatives is protected by the fundamental right of individuals to communicate and learn; to heal and be healed. This has been settled law for over a hundred years.
“The state has not restricted the cure of the body to the practice of medicine and surgery — allopathy, as it is termed, — nor required that, before anyone can be treated for any bodily ill, the physician must have acquired a competent knowledge of allopathy and be licensed by those skilled therein. To do that would be to limit progress by establishing allopathy as the state system of healing, and forbidding all others. This would be as foreign to our system as a state church for the cure of souls. All the state has done has been to enact that, when one wished to practice medicine or surgery, he must, as a protection to the public [not to the doctor], be examined and licensed by those skilled in surgery and medicine. To restrict all healing to that one kind — to allopathy, excluding homeopathy, osteopathy, and all other treatments — might be a protection to doctors in surgery and medicine; but that is not the object of the act, and might make it unconstitutional, because creating a monopoly.” North Carolina’s Supreme Court in State v MacKinght, 42 S.E. 580, 1902 at p 582.
Costs, safety and, most of all, liberty, require that the distinction be made and maintained by the FDA between “treatment” and “therapy” if the US Constitution and public are to be served.
Dated: April 6, 2007
Respectfully submitted,
Maj. Gen. Albert N. Stubblebine III,
(US Army, Ret.)
Rima Laibow MD
Ralph Fucetola JD
For: Natural Solutions Foundation
www.HealthFreedomUSA.org
Ref: Federal Register: February 27, 2007 (Volume 72, Number 38
[Notices – [Page 8756-8757]
[wais.access.gpo.gov – DOCID:fr27fe07-95]
This was sent by a supporter. If the events were not so close to reality, the piece would be absurd. As it is, they could just as well be real: in fact, under different names they happen every day.
Silicon Crunch
API – Washington, D.C., June 1, 1999 …………….. by Mark D. Gold
The U.S. Food and Drug Administration (FDA) announced today that it will
approve the controversial new food additive, “Silicon Crunch.” Silicon
Crunch is a flavored filler made by combining artificial flavors with
finely ground, recycled glass bottles. The product was developed by the
Association of Chemical Food Manufacturers (ACFM) — a collaboration of 12
chemical chemical and food ingredient companies.
Dr. Arthur A. Morales, Vice President of Development for the inventor,
ACFM, hailed the decision as “proof that chemical company scientists can
literally make anything info food!” Dr. A. Morales went on to say that
“Silicon Crunch will change the way food is made. The versatility of this
product is amazing! It can be mixed with a variety of artificial
flavorings, colors, and sweeteners. The consistency of Silicon Crunch can
very easily be changed from crunchy to creamy by controlling the
pre-treatment of the glass food materials. We believe that this will be the
best-selling food additive in history!”
Dr. A. Morales responded to questions of concern about the safety of
Silicon Crunch by stating that “There will always be a hysterical few who
question the safety of an innovative new product. Today’s decision proves
that Silicon Crunch meets the FDA’s stringent safety requirements for food
additives.”
Officials at the U.S. Environmental Protection Agency (EPA) were elated
over the decision which they called “a victory for recycling.” Incoming
EPA Administrator, Dr. Morissa Green-Washington stated, “Recycling will
only work if there is a market for recycled products. The FDA’s decision
opens up the market for recycled glass. Our goal is to work with industry
to help create similar markets for other recycled products. We encourage
the development of new markets for other waste products by food and
chemical companies.” Several senior EPA scientists who spoke on the
condition of anonymity said that they do not share Dr. Green-Washington’s
views on this issue. One scientist summed up his viewpoint by stating,
“The approval of Silicon Crunch sets a significant precedent in that
Americans will now be eating recycled garbage. Even though it is
sterilized, I do not think it is appropriate.”
Considerable controversy could be seen at the FDA both before and after
the decision was announced by FDA Commissioner, Dr. Herbert D. Banner. Two
FDA scientists resigned in March claiming that the scientific review
process has been sidetracked by political and economic goals. FDA
Toxicologists Martin Fitzpatrick, Ph.D. and Elizabeth Shuller, Ph.D. held
a press conference yesterday in protest of what they allege was an
“inevitable decision without any scientific basis.” In a harsh criticism
of the FDA Commissioner, Dr. Shuller stated that there was never any
interest by FDA officials to look at the issue in a scientific way. She
went on to say that “Dr. Banner refused to even consider the extensive
documentation provided about the dangers of ingested glass! We were forced
to consider only the scientific documents on Silicon Crunch provided by
ACFM. The documentation provided by ACFM was ridiculous on the face of it,
yet there was no possibility of considering evidence challenging this
documentation given the rules we were forced to follow.” Dr. Fitzpatrick
added, “I believe that the whole process was motivated by money and that
the revolving door between drug and chemical companies and the FDA has
done irreparable harm to the credibility of the FDA.”
Commissioner Banner responded that “These two scientists were given every
opportunity to produce reputable scientific research that has shown that
ingesting heat-treated, finely-ground glass food material causes adverse
health effects. They were unable to produce any studies showing that
Silicon Crunch causes disease. The research they submitted showing serious
adverse effects from ingesting glass particles is simply not relevant
because those studies considered only normal ground bits of glass and not
specially heat-treatment Silicon Crunch. The important point is that the
majority of the FDA officials reviewing the product agreed that the
manufacturer has met its burden of proof that it is safe.”
“Silicon is already present in the body,” Commissioner Banner pointed out.
“It is in the tendons, cartilage, and blood vessels. And silicon is
already being ingested from plant fiber and hard water. The glass food
material in Silicon Crunch is simply another good source of silicon. There
is some evidence that as atherosclerosis develops, silicon levels decline
in the arteries. Adding Silicon Crunch to the diet may help prevent heart
disease!”
In response to the allegations of a “revolving door” at the FDA between
FDA officials and ACFM members, the Commissioner responded by saying,
“This whole issue of ‘revolving door’ has been grossly overblown. Firstly,
fewer FDA officials have left to work at ACFM member companies in this
calendar year than in previous years. Secondly, not all FDA officials
offered jobs by ACFM member companies have accepted those jobs. In fact, I
was offered such a job, but turned it down because I still have important
work to do as Commissioner of the FDA — namely, developing strategies to
keep herbs and supplements from stifling the development of legitimate
pharmaceuticals. Finally, former ACFM member company employees, who are
now FDA officials, have not been part of all of the critical aspects of
the decision-making process in the Silicon Crunch decision. These
‘conspiracy theories’ should not be taken seriously by the general
public.”
Commissioner Banner stated that the FDA took the cautious approach by
creating five strict requirements which must be met by the manufacturer
and other food companies using Silicon Crunch. The Commissioner provided
this official FDA summary of those requirements:
Three-layered filtration process must be installed to guarantee that no
large pieces of glass food particulates would ever be found in Silicon
Crunch. This size of these particulates are to be no more than 1/3 the
size that caused bleeding gums in animal research.
The Association of Chemical Food Manufacturers (ACFM) would be required to
monitor any unexpected adverse reactions.
ACFM would be required to design and fund research to provide continued
assurance of the safety of Silicon Crunch.
No dangerous products such as herbs or vitamins and minerals (above the
Recommended Daily Allowance) would be allowed in products which contain
Silicon Crunch.
Initially, no claims of medical benefit would be allowed on the label of
any food product which contains Silicon Crunch. However, claims such as
“Fat Free,” “Low Cholesterol,” and “Low Calorie” could be allowed for such
products. A petition to the FDA filed by ACFM for allowing a medical
claim, “Prevents Heart Disease” is currently being examined by FDA
scientists.
The food company members of ACFM are preparing to add Silicon Crunch to
many of their snack products. According to Dr. A. Morales of ACFM, “Our
goal is to get Silicon Crunch products on the shelves by late October to
coincide with the start of Halloween candy purchasing. American children
will be the first ones treated to this new wonder- product!” Dr. A.
Morales went on to say that ACFM plans to quickly obtain approval of
Silicon Crunch in other countries around the world that generally look to
the FDA to make a sound, scientific safety evaluation.
A written statement from the American Dietetic Association (ADA) pointed
out that they are still evaluating the situation. It went on to state that
the ADA will work closely with ACFM officials under a grant from that
organization to develop a workable Fact Sheet on the issue. In contrast, a
statement from the Association of Consumers for Nontoxic Food Choices
(ACNFC) claimed that the food industry has “spearheaded the destruction of
the scientific method and risk assessment for the last 25 years. This
included abuse of science and the politicizing of the approval and
evaluation process in the cases of aspartame, MSG, Olestra, acesulfame-k,
rBGH and many others. The approval of Silicon Crunch merely puts the
finishing touches on the destruction of the scientific method and approval
process.” An official of the ACNFC told this reporter that “Only a total
idiot would ingest Silicon Crunch…but given what the food industry has
been able to get Americans to ingest, I don’t hold out much hope of
preventing its widespread use.”
It appears that the controversy may rage for a considerable length of
time. The only agreed upon fact is that very soon many people will
experience first-hand the benefits or risks of Silicon Crunch.
Nutricide (noo trih side):
1. Intentionally bringing about our causing the death of a body of knowledge and information concerning the health promoting and curative attributes of herbs, food and food components
.
2. Intentionally bringing about our causing the death of large numbers of people through nutritional manipulation
.
Codex Alimentarius (the international food standard organization) and multinational corporation collusion together impair and gravely threaten world health. If Codex has its way, its deadly standards and guidelines will be implemented in the United States by 2010 significantly impairing the health and health prospects of all Americans, killing those with chronic illnesses who depend on therapeutic dose nutritional supplements for survival.
.
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