Natural Solutions Foundation

Environmental Health Center – Dallas
WIlliam J. Rea, M.D.
FA.C.S., F.AA.E.M.,
FA.C.N., FA.C.P.M.,
FA.CA., F.R.S.M.
Board Certified in
Thoracic and Cardiovascular Surgery
Abdominal and General Surgery
Environmental Medicine

8345 Walnut Hill Lane – Suite 220, Dallas,Texas75231 · Telephone:(214)368-4132- Facsimile: (214) 691-8432
Website: www.ehcd.com E-mail: inform@ehcd.com

September 18, 2007
Dear Patients:
This letter is being sent to you so that we may provide information about a
potential serious potential threat to your choice of medical care. To put it bluntly,
there is currently an organized nation-wide effort to destroy the specialty of
Environmental Medicine and to eliminate from practice physicians who diagnose
and treat patients suffering from chemical sensitivities.
Since October of 2005 the Texas Medical Board has been investigating me on
charges of providing substandard care and “endangering public health.” An
anonymous third party complaint was made to the board against me, citing five
specific patients as being mistreated. You may ask “What is an anonymous third
party complaint?” This type of complaint is made to the board without the
knowled2:e or consent of the patient. The complaint against me was almost
certainly made by United Health Care/Oxford. All five patients cited in the
complaint had no knowledge that they or their information was being used in this
way. Further, none of the patients are alleging mistreatment or malpractice against
me and all five are still under my care. Additionally, these patients have all
written to the Texas Medical Board and informed them that they are not part of
this complaint and they are not making any allegations against me of any kind.
Two of the patients have stated that I saved their lives.
The Texas Medical Board has dismissed the protests of these patients and
continues to pursue charges against me. Further, the board refuses to officially
reveal who made the complaint, what I am alleged to have done, or what evidence
was presented against me. They continually maintain that this information is
protected and does not have to be revealed.
However, we are almost certain that United Health Care/Oxford is behind the
complaint. All five patients were from Manhattan (New York City), New York
and all had the same insurance company – United Health Care/Oxford. As you
know, our clinic does not take insurance, so all patients file claims directly with
their respective insurance companies. We therefore do not have any direct
connection with this insurance company. Evidence showing these facts was
supplied to the Texas Medical Board, but was apparently disregarded as they have
decided to pursue the charges despite the evidence.
The board has conducted an anonymous so-called peer review of the five patient’s
medical records and the treatment they received, again without the permission of
these patients. A peer review of a physician’s action can be undertaken for a
variety of reasons but there is always one common factor in the process.
September 18, 2007
Page Two
That common factor is that the reviewer is required to be both knowledgeable about and a
practitioner of the specialty that is being reviewed. Thus, the reviewer is a “peer” of the
physician being reviewed.
In my case the Texas Medical Board chose a reviewer who does not specialize in Environmental
Medicine, and who is in fact an allergist. This reviewer, who was anonymous, gave a negative
review of the treatment of the five patients, despite the fact that all have improved, several of
them substantially so, while under my care. I had 17 actual peers, physicians who practice
Environmental Medicine, review all five of these cases as well. To a person these 17 reviewers
found that my treatment of these patients was not only adequate, but that it met or exceeded the
standard of care for treatment in our specialty. Further, the reviewers also noted that the state
board reviewer was UNINFORMED about the specialty of Environmental Medicine, clearly did
not understand the complex nature of the diagnosis and treatment of patients who suffer from
chemical sensitivities, grossly misunderstood many of the facts in the medical records, was
antagonistic towards and biased against the specialty of Environmental Medicine, and was
clearly unqualified to conduct such a review due to lack of experience, knowledge, and
expressed biases. The board has chosen to dismiss the review done by 17 actual peers and has
chosen to support the conclusion of their one unqualified reviewer.
Based on secret evidence provided by an anonymous accuser and supported by and anonymous
reviewer the board has recommended that my license to practice medicine be placed in jeopardy.
Currently, the Texas Medical Board is one of the most difficult for physicians to deal with in the
entire country. It is particularly noted for not treating physicians fairly and denying their basic
constitutional rights. Pleased be assured that I still have my license, that I am fighting the
charges, that the Environmental Health Center is still open, and we are still seeing patients and
plan to continue doing so.
Unfortunately, my case is not unique. Recently across the United States there has been an
organized attempt to deprive citizens of their choice in individual health care by attempting to
have the licenses of doctors who are deemed to practice “alternative” medicine revoked. This
campaign has been going on for at least 10 years now and is being led primarily by health
insurance companies. These efforts are also being supported by a small group of individuals (and
other groups) working for or associated with the National Council Against Health Fraud in
Allentown, Pennsylvania.
The typical pattern in these attacks is to single out physicians they do not like and file
anonymous complaints against them with different state medical boards. For example, over the
past 10 years the number of physicians who are willing to diagnose and treat Lyme Disease has
dropped sharply, while cases of Lyme disease have skyrocketed. This is because several health
insurance companies have systematically targeted the doctors who specialized in treating that
illness. Many of these physicians have had complaints made against them in exactly the same
manner that they have been made against me. These same types of complaints have been made
— —-
September 18, 2007
Page Three
against doctors who treat patients for chemical sensitivities, mold exposure, for Gulf War
Syndrome, and now possibly against physicians who are treating patients who were injured in
the 9/11 tragedy.
You may ask why this campaign is taking place. It appears that quite simply the health insurance
companies want to be the sole arbiter of what types of treatments are available to patients, and
thus what they will be required to pay. They clearly do not want new diagnoses and treatments
established because they will then have to pay for these. Finally, many of us who have been
turned in to state medical boards do not take insurance assignment. We do this so that we can
provide treatment to our patients without insurance company interference. In recent years the
health insurance carriers have tried to automate their claims processing procedures. When claims
are denied, they then have to be handled by a human and this costs money. When physicians do
not accept insurance assignment, the claims submitted by their patients often have a higher
denial rate. This results in higher processing costs for the insurance companies. If these carriers
can eliminate the independent physicians with higher denial rates they can potentially save a lot
of money. Certain state medical boards appear to agree with this strategy and cooperate in the
process.
Of course, these attempts are also being made in order to try and standardize treatments and
make all patients fit into one “box.” Americans need more choices in health care, not fewer. We
hope you, as an informed citizen, want to be part of an effort to help preserve freedom of choice
in health care. Insurance carriers and a small group of “Quack busters” should not be allowed to
decide what type of health care is available in this country.
It is unconscionable that the Texas Medical Board would want to limit freedom of choice in
health care, and allow insurance carriers to interfere with the doctor-patient relationship. Please
join our effort for freedom of choice in health care and write your protest to members of the
Texas Legislature. You can also copy your protest to members of the Texas Medical Board. If
you do not know who your representatives are, go to the following website to find out:
http://www.fyi.legis.state.tx.us/
If you are out of state, you can contact Texas State Senator Jane Nelson and Representative Fred
Brown, both of whom have taken an interest in recent activities of the Texas Medical Board. You
can also send letters of protest to the Executive Director of the Texas Medical Board, Donald
Patrick, M.D., J.D., bye-mail, phone, or fax. Please petition the elected officials to:
1. Support the dismissal of the anonymous complaint made against Dr. Rea, or at
the very least the revelation of who made the complaint and what evidence was
presented against him.
— —-
September 18, 2007
Page Four
2. Prohibit the Texas Medical Board from conducting anonymous peer reviews by
unqualified reviewers, or using reviewers with a bias or conflict of interest.
3. Prohibit the Texas Medical Board from accepting and pursuing complaints in
such a way that they deprive physicians of their constitutional rights and their
ability to defend themselves.
4. Strongly oppose the anonymity given to billion dollar insurance compames
when making state board complaints against physicians.
5. Urge the Texas Legislature to hold hearings on the Texas Medical Board and
their seeming cooperation with health insurance companies’ attempts to delicense
physicians in specialties that they do not like and the board’s denial of
due process to accused physicians in direct contradiction to the due process that
the board claims that it provides.
Thank you very much for your help. Together, we can stop the Texas Medical Board and other
state medical boards from unfairly targeting physicians that outside interests do not like. We can
also expose the despicable tactics of the insurance companies in their efforts to control all
aspects of healthcare.
r!!::J~ President
Environmental Health Center-Dallas
Texas Leeislators:
Texas Senator Jane Nelson
Chair of the Senate Health and Human Services Committee
P. O. Box 12068
Austin, TX 78711
512/463-0112
j ane.nelson@senate.state.tx.us
— – — –
September 18,2007
Page Five
Representative Fred Brown
Room CAP GWA
P.O. Box 2910
Austin, Texas 78768
(512)463-0698
(512) 463-5109 Fax
Members of the Texas Medical Board:
Correspondence to the Board Members can be sent to:
Texas Medical Board
P. O. Box 2018
Austin, Texas 78768
TEL: (512) 305-7030
FAX: (512) 305-7051
Donald W. Patrick, M.D., J.D. (Executive Director)
Lawrence LaZelle Anderson, M.D. (Dermatology)
Tyler
Michael Arambula, M.D. (Psychiatry)
San Antonio
Julie Attebury (Public Member)
Amarillo
Jose M. Benavides, M.D. (Internal Medicine)
San Antonio
Patricia S. Blackwell (Public Member)
Midland
Melina S. Fredricks (Public Member)
Conroe
Manual G. Guajardo, M.D. (Obstetrics/Gynecology)
Brownsville
— – — – – – – — – – — —
September 18, 2007
Page Six
Roberta M. Kalafut, D.O. (Physical Medicine and Rehabilitation)
Current board President
Abilene
Amanullah Khan, M.D. (Oncology)
Dallas
Melina McMichael, M.D. (Internal Medicine)
Austin
Margaret C. McNeese, M.D. (Pediatrics)
Houston
Charles E. Oswalt, III,M.D. (Trauma Surgeon)
Waco
Larry Price, D.O. (Cardiovascular Diseases)
Current Board Vice President
Temple
Annette P. Raggette (Public Member)
Austin
Paulette B. Southard (Public Member)
Alice
Timothy J. Turner (Public Member)
Current Secretary-Treasurer
Houston
Timothy Webb (Public Member)
Houston
Irvin E. Zeitler, Jr., D.O. (Family Practice)
San Angelo
—–

Natural Solutions Foundation Media Release
www.GlobalHealthFreedom.org

GeneralStubblebine@GlobalHealthFreedom.org

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.