Natural Appetite Control - One answer to the Obesity epidemic
We live in a world
filled with temptations – good tasting food and an appetite to match.
There are so many causes for obesity; it is like counting the many endless
causes of cancer. Once you list the first 100 causes of obesity (there are
1000’s by the way), do you really want to count further? Does the thought of
hopeless obesity make you depressed? Do you need a mood lift by serving
yourself a piece of chocolate cake with a scoop of vanilla ice cream?
A quick sugar surge
overcomes the depressing thought of being chronically overweight and no longer
being able to fit into your oversized jeans. Your skinny jeans, well, you gave
them away a long time ago because if you put them on, you risk getting arrested
for indecent exposure.
After smoking cigarettes
for decades, you are told it will shorten your life to continue this bad habit.
So one day you finally quit and then gain 30 or 40 lbs that won’t come off.
From the frying pan, you have leaped into the fire. It is a battle of the
bulge, and millions of us wage it every day.
As people age, it
becomes even harder to keep weight off. This is due not only to a reduction in
exercise, but an increase in toxins and the decreased function of both the
liver and kidneys. Metabolic rate declines along with an increase in adrenal
fatigue – exemplified by the need to take a nap several times a day. This
fatigue is the result of an increase in blood sugar levels and insulin
resistance. This result is increased cravings for sweets.
Toxins come from
multiple sources including consuming too much salt, food preservatives
(nitrates, nitrites, benzoates etc), trans-fatty acids, Bisphenol A in plastic
bottles, acrylamides in food cooked at high temperatures (precooked breakfast
cereals, precooked micro-waved foods etc), toxins in genetically modified
foods, especially corn and soybeans, coal tar derived food colorings, weed
killers, pesticides and insecticides, just to name a few.
Food sensitivities,
allergies and intolerance contribute to rapid weight gain. Some of the most
offending foods that contribute to weight gain are chocolate, eggs and wheat
gluten. It is usually the food you crave and eat daily that is the problem.
Food sensitivities lead to edema, water retention and intestinal dysbiosis. The
combined effects of toxins and food sensitivities are a sluggish liver and
impaired kidney function. This lowers the metabolic rate and with more calories
being eaten than expended, the waistline is first area to bulge.
Food as a source of enjoyment
Food as a source of enjoyment
To a great extent we are
the victims of the successful commercial marketing of processed foods, of
restaurants that bundle the purchase of every sandwich with a plateful of gut
busting french fries, of fructose corn syrup in just
about everything, and those secret flavor enhancers that are not even listed on
the product label.
In a comedy skit of the
“Golden Girls” in the early 90’s, Betty White wanted to order a healthy pizza
with a whole-wheat crust. Dorothy, (the tall one), objected, saying we want a
pizza, not a piece of cardboard. So they ordered a real pizza. Today at 90
years young, Betty White is a frequent guest on TV sitcoms and is admired for
her self-deprecating humor. [It is even rumored that President Obama wants to
see her birth certificate.]
Case reports of success and failure
Case reports of success and failure
About 10 years ago I
ordered a beer in a local tavern and a man sat down who was so overweight that
he need two bar stools. He was in his 30’s. I struck up a brief conversation
with him and he told me he weighed 400 lbs. He also said he ate only one meal
per day.
I didn’t offer him any
advice because I was overweight myself. I was sympathetic with his plight and I
wondered how eating just one meal a day could result in someone getting so
large. Several months later I learned that he died in that same bar from a
heart attack.
Since then I reflected
on this in considering the many successful diet plans where people eat 4 or 5
small meals each day and lose weight successfully on these programs.
There are several
reasons why one meal a day would not work in a person already overweight who
had developed high blood sugar, insulin resistance, and an oversized stomach.
First
of all, a large meal stretches the size of the stomach. With an oversized
stomach, you may need to eat 2, 3, 4, or 5 times as much food to feel full as
someone with a small or average sized stomach. Stomach stapling works to help
people weight by reducing the size of the stomach where the food can fit. Thus,
with a small amount of food, a person feels full.
Some
types of fiber like glucomannan (Konjac root) have the capacity to absorb water
and expand multiple times to fill the stomach. Fiber with meals slows down the
release of sugar into the blood stream and this lowers the glycemic index.
The
drawback with high fiber meals is that they may also reduce the flavor of the
food you are eating. Depending on how motivated a person is there are only so
many bran muffins or 100% whole grain slices of bread you will eat until
boredom drives you to back to a slice of freshly baked white bread - with real
melted butter on it instead of margarine.
Some fiber sources like raw apples are enjoyable and have a low glycemic index. Apples contain lots
of pectin, a natural weight loss aid
that also detoxifies the intestinal tract. On the other hand, apple juice with
each meal won’t help you lose weight as the pectin is missing and it has a
higher glycemic index. Applesauce has pectin it but also has a higher glycemic
index than a raw apple. Quince or a
slice of ripe raw pineapple are also
high in pectin and can be substituted for an apple at each meal.
To
help as a weight loss aid, you will need at least one such source of fiber with
each meal. The challenge and art of healthy eating is to strike the right
balance between the healthiest foods and the most flavorful foods without
sacrificing too much of either.
A second person who had
developed type II diabetes told me they lost 40 lbs by eating five meals a day
that consisted mostly of vegetables.
Another person who I
met who barely had an ounce of fat on his body told me he attributes his flat
stomach to drinking a quart of non-fat milk every day. The addition of non-fat
or low fat milk products has been associated with a loss of abdominal fat in a
number of published scientific studies. While some people are fortunate enough
to actually enjoy nonfat milk, more people find its flavor not much better than
dish-water (before the soap is added).
What is the secret of Nutri System’s success?
Nutri System diet plans
have been around for 40 years and they have figured out how to design a
successful weight loss program. Like many other plans it consists of 5 small
meals a day. The carbohydrates have a low glycemic index that means they digest
and are absorbed slowly to prevent wild fluctuations in blood sugar levels.
This keeps appetite depressed and reduces insulin resistance. Each meal is also
high in protein. A number of celebrities have lost weight on the Nutri System
program including Marie Osmond and Terry Bradshaw. More info can be found at
nutrisystem.com
Slimmer waistlines with Whey Protein
Slimmer waistlines with Whey Protein
Researchers in
Beltsville MD have found that whey protein was more effective than soy protein
in reducing waistline circumference and with fat loss in general (1). This is
not to say that soy protein was not effective but that gram for gram the whey
protein was more effective.
David
Baer et al state “A double-blind, randomized clinical trial was conducted to
determine the effect of consumption of supplemental whey protein (WP), soy protein
(SP), and an isoenergetic amount of carbohydrate (CHO) on body weight and
composition in free-living overweight and obese but otherwise healthy
participants.” (sic)
Ninety
overweight persons were assigned to “1 of 3 treatment groups for 23 wk: 1)
WP; 2) SP (each providing ~56 g/d of protein and 1670 kJ/d); or 3)
an isoenergetic amount of CHO.”
The
protein drinks were consumed as a beverage twice daily. The participants were
provided with no dietary advice and ate whatever they wanted. They weighed in
monthly. Body composition was also tested.
After
23 weeks, total body weight did not differ among the 3 groups except that in
the whey protein groups there was less body fat and the waist circumference was
smaller.
Ghrelin
was lower in those consuming whey protein than soy protein or CHO. The authors
stated; “Dietary recommendations, especially those that emphasize the role of
dietary protein in facilitating weight change, should also address the
demonstrated clinical potential of supplemental WP.”
1. Whey Protein but Not Soy Protein Supplementation Alters
Body Weight and Composition in Free-Living Overweight and Obese Adults by David
J. Baer et al.
Beltsville Human Nutrition Research Center, Agricultural
Research Service, USDA, Beltsville, MD 20705
Shirataki Noodles - a source of the fiber Glucomannan
Shirataki Noodles - a source of the fiber Glucomannan
These noodles are sold
in health food stores and are very filling and very low in calories. Even more
surprising, they taste good. This is because they contain yam powder made from
konjac root. Konjac root contains the fiber glucomannan. A package of these
noodles contains about 100 calories and is enough for two people. Add tomato
sauce and cooked ground beef or a veal cutlet and you have a filling low
calorie meal (200 to 300 calories)
Colon Comfort Formula
Colon Comfort Formula
Glucomannan is also
sold in capsule form. A problem with it is this form is that it does not
disperse evenly in the stomach and can form a glob that you can feel. A better
choice is a mixed fiber and probiotic formula called Colon Comfort Formula that
is also available in some health food stores. It contains fresh ground
flaxseed, inulin, pectin, glucomannan, along
with five strains of probiotics including L Plantarum. A rounded teaspoon mixed
with water taken before meals can reduce your overall appetite. L Plantarum reduces IGE, an
immunoglobulin linked to food sensitivities. Colon Comfort Formula can be also
found online at ojibwatea.com.
Natural Weight control with lipase inhibitors (green tea, apples, peanuts and ginseng)
Natural Weight control with lipase inhibitors (green tea, apples, peanuts and ginseng)
Researchers from the Department
of Nutrition and Food Sciences, Physiology and Toxicology, University of
Navarra, Pamplona, Spain in 2011 (1) find that natural inhibitors of pancreatic
lipase can have a role in weight management. The article published in Planta
Med is”Natural inhibitors of pancreatic lipase as new players in obesity
treatment.” By de la Garza AL et al
Lipase is a pancreatic
enzyme used in the digestion of fat. A lipase inhibitor would act as a fat
blocker. While this article focuses on the pharmaceutical industry’s efforts to
find an anti-obesity drug, and mentions one approved drug in Europe made from
actinobacterium, the article intriguingly mentions some common foods that also
contain lipase inhibitors. Mentioned are “tea, soybean, ginseng, yerba mate, peanut, apple, and grapevine.”
They state that some of
the ingredients in these common foods contain polyphenols and saponins that
have with “an inhibitory effect on pancreatic lipase activity, which could be
applied in the management of the obesity epidemic.”
Ref: 1. Planta Med. 2011 May;77(8):773-85.
The 3 apples a day weight loss plan-
Lose 17 lbs in 12 weeks
The 3 apple a Day Plan for weight loss was created by Tammi Flynn, a registered dietitian and Group Training instructor at Gold’s Gym in Washington
The foundation of the
3-Apple-a-Day Plan involves eating an apple before each main meal. The idea is
that the fiber in apples makes you feel full and the sweetness satisfies
cravings.
Eat 4 to 5 times a
day
Dieters are advised to
consume 4-5 small meals daily, which should be based on healthy foods that are
low in fat. Each meal or snack should also contain a source of lean protein
because this has been shown to reduce appetite and improve weight loss.
Eat
a lot of fruit and vegetables. In addition to eating three apples a day dieters
are advised to include six servings of other fruits and vegetables. This will
allow you to reduce your intake of calories without experiencing hunger.
Recommended Foods
Apples, low fat cottage
cheese, low fat yogurt, eggs, chicken breast, turkey, lean beef, salmon,
oatmeal, brown rice, broccoli, and lettuce.
A Yummy Whey Protein Drink
I made a delicious whey
apple shake by cutting up one medium sized raw apple and placing it in the
blender with one-half cup of water. Blend until all is liquefied. Then add one
scoop of plain whey protein powder containing about 20 grams of pure plain whey protein. You end up
with a very tasty drink. You can also eat it like a dish of ice cream. You can
flavor it by blending in some tart cherry juice concentrate or fresh or frozen
berries, peaches or other fruit. The whole raw fruit is most effective than the
fruit juice as it contains fiber that reduces the glycemic index.
Note: I chose a whey
protein that is plain with nothing added so I can flavor it the way I want.
Some protein powders used to make shakes have too many ingredients added that
add strong flavors that result in a medicine-like tasting drink instead of
something you can enjoy. If you don’t enjoy the taste of the finished product,
you will most likely find something else to eat that tastes better and is not
as beneficial to your health.
Secret Late night fat burning shake
Place 6 ounces of tart
cherry juice or cherry juice concentrate and water in a pint jar. Add 10 grams
of whey powder. Add nothing else to this mix. Shake and drink this about 30
minutes or less before bedtime. In the morning, you should see a substantial
amount of foam in your urine indicating fat was burned during the night. This
combination may be increasing the production of Human Growth Hormone (HGH)
while you sleep, although this requires further testing to validate this
theory.
Aloe vera and honey for Pets
Less than two months after using Black Salve diluted with alcohol to rid
my dog, named Cosca,” of an external tumor, a crisis occurred about one week
after I started feeding him a new whole grain dry dog cereal. The dog had been
doing well when I had cooked him brown rice with vegetables and canned salmon. I
thought I’d give this non-GMO dog cereal a try. After about one week, I got my
answer. In the morning of Dec 7th, Cosca began to bleed profusely
from his rectum. He had turned 14 years old two months earlier in Oct 2011.
For a few minutes, I
thought, he was going to bleed to death right there in front of me. I also
noticed a red lump growing below his tail. As I looked at the lump, I thought
the dog not only had grown tumors externally, but internally as well, and what
I was looking at was most likely rectal cancer.
What was I to do? If I
took him to the Veterinarian, he would most likely put him to sleep. After
about 5 minutes the bleeding slowed down then stopped. I reflected on what had
happened and why and asked myself why a whole grain dog food made without
genetically modified corn or soybeans would do this?
One theory that I
considered is that this dry breakfast dog food might have high amount of
acrylamides in it. Acrylamides are a cancer causing chemical produced when food
are cooked at high temperatures, the higher the temperature, the more
acrylamides are made.
The greatest danger is
in foods cooked over 400 degrees F. The World Health Organization (WHO) lists
acrylamides as a cancer-causing agent. Years ago, I read that rats fed All Bran
cereal got more cancer than a control group of rats fed white flour. Isn’t a
whole grain cereal suppose to be healthier than one made from white flour?
We don’t know the
manufacturing temperature of hundreds of “cold” breakfast cereals nor do we
know the manufacturing temperature of hundreds of ready to eat dry dog and cat
foods. Every purchase of any premade processed food for man or beast is a
gamble.
We do know that
millions of pets and people worldwide are developing cancer each year. Acrylamides
result when whole grain products are cooked at extremely high temperatures.
Many precooked ready to
eat breakfast cereals for humans are processed at high temperatures and the
amount of acrylamides in these cereals are unknown. The acrylamide content of precooked
cereals for humans or dry dog and cat food are an unknown health hazard.
Connecting the dots, I thought the new dog cereal I had used might have
contributed to Cosca’s deteriorating condition.
The thought occurred to
me that if this were happening with some precooked ready to eat breakfast
cereals for humans, and then it could just as likely be happening to dry dog
cereals as well. Connecting the dots, I thought the new dog cereal I had used
might have contributed to Cosca’s deteriorating condition. I immediately threw
out the remaining dry dog food.
First I went back to
making my own dog food by blending cooked vegetables (celery, peas carrots)
with brown rice and canned salmon. I added 2 teaspoons of cold pressed flax
seed oil once a day along with 2 finely chopped Brazil nuts for selenium. I
then made from an aloe vera plant in my living room my own version of Fr Romano
Zago’s formula. Since I could not easily locate the aloe arborescens species
used by Fr Zago, I used the North American variety known as aloe vera
barbadensis. I had a pot of this aloe vera variety growing in my living room
window.
I cut leaves
off the plant and removed the spines (the outer prickly edge). I left the green
skin on the aloe leaves. I added 4 ounces of these aloe vera leaves to a
blender. To this I added 4 ounces of raw honey and one ounce of Brandy. I
blended this mixture for one minute. I did not strain it and poured the mixture
into a small glass jar and kept it in the refrigerator.
Once a day, I gave
Cosca, my 25 lb Fox Terrier, one tablespoon of this mixture. I did this once a
day until the jar was empty – about 10 days total. The results were
encouraging. By the 5th day, the rectal bleeding had completely stopped
and the tumor and redness had substantially declined in both size and
intensity. By the 10th day, everything was back to normal. The inflamed redness of his outer rectum had completely vanished. You would
never know there had been a problem.
Other than the fact I
cook his food for him, I have given Cosca no further treatments. While the aloe
vera barbadensis strain worked for my dog, one case alone does not allow us to
draw broad conclusions.
GMO and our poisoned food supply
Today, thousands of
household pets are dying from kidney failure likely caused by genetically
modified corn and soybeans. The Bt toxin produced from soil bacteria Bacillus thuringiensis in corn is an
insecticidal poison. Most meat including pork, beef, and poultry (except for
those labeled organic) come from animals being fed corn containing the Bt
toxin.
Poisoned food creates
sick farm animals that are fed to the multitudes which create a wide range of ill health problems not fully understood. It should not
surprise anyone that millions of farm animals, household pets, and humans are
suffering the health consequences of eating meat produced with poisoned corn
that is also resistant to Monsanto’s weed killers.
Like humans, tens of
thousands of pets develop cancer and thousands die of kidney failure each year.
Recently I learned of a two year old puppy that died from kidney failure.
Genetically Modified Foods (GMO) corn, soybeans, and foods that are also
processed at high temperatures, that include most varieties of dry dog and cat
food, are contributing to the deteriorating health and death of household pets.
People are not escaping
the ill health effects of GMO corn and other crops either. In a local
television interview last week, a spokesman for St Luke’s Hospital in
Milwaukee, Wisconsin, stated that 300 people are on a waiting list for a new
kidney. Is there a similar waiting list for kidneys at other hospitals as well?
How about the waiting list for liver transplants? How many thousands, or should
I say hundred of thousands of pets and people, will die of kidney failure
before the US Food and Drug Administration will do something about it? The FDA
is still dilly-dallying around with the idea of requiring foods made with GMO
ingredients to be labeled as GMO. Let the buying public beware that any product
(corn chips, tacos etc) not labeled “Organic” most likely will contain GMO corn
or GMO soybeans.
WebMD on foods not to give your dog
WebMD on foods not to give your dog
Webmd.com reports that
the following foods should never be given to a dog. The possible adverse
effects include digestive problems, pancreatitis, liver, and kidney failure.
1. Avocado (causes allergy reactions)
2.
Chocolate – (may cause seizures)
3.
Onions and garlic (may damage red blood cells)
4.
Grapes and raisins (may make a dog ill)
5.
Macadamia nuts (cause weakness and rapid heart
rate)
6.
Sugar free sweeteners – (may elevate
insulin levels.)
7.
Bones that splinter (may cut or damage the
gastrointestinal tract and cause bleeding)
8.
Fruit (apricots, peaches etc) pits – (may
cause intestinal inflammation)
9.
Raw eggs – may contain salmonella.
Contains an enzyme that interferes with the absorption of a B vitamin.
10.
Salt – (too much may cause vomiting,
diarrhea and seizures, even death.)
11.
Alcohol – (may cause liver damage)
12.
Soda and sugar (causes elevated insulin levels
leading to obesity)
What to feed your Dog
What to feed your Dog
Grass fed beef and
poultry, canned salmon, cooked brown rice, barley, any vegetable except
avocado, onion and garlic. I cook celery, carrots, and peas along with the rice
or barley. I also add a little parsley. The dog seems happy on this diet.
Foods to not feed your Cat
Foods to not feed your Cat
1. Onion, garlic, chives –damages red blood
cells
2. Tuna – (too much may cause mercury poisoning)
3. Milk – may cause diarrhea
4. Liquor and alcohol – one tablespoon may lead
to a coma in a 5 lb cat.
5. Grapes and raisins – stresses the kidneys.
6. Caffeine – coffee, tea and chocolate –
may cause rapid breathing and tremors.
7. Sweets and sugar free treats – may spike
insulin.
Poison control Call ASPA 888-426-4435
FDA v Vital Health and Conrad LeBeau
FDA v Vital Health and Conrad LeBeau
A settlement is reached that allows me to appeal the case on several legal issues.
A settlement is reached that allows me to appeal the case on several legal issues.
Conrad LeBeau
Greetings,
This is an update because a lot has happened in the past 3 days. Two days of
discussions with US Attorney Gordon Giampietro indicated a plea agreement was
within reach between us. On Jan 10th, I wrote to Magistrate Callahan and asked
that the Federal Defender Joanna Perini, be appointed to represent the
corporation (Vital Health Products Ltd) and me. I did this so as to not leave
any loose ends. A plea agreement was finalized the following day. As a result
of these discussions, I entered a "Conditional Plea Agreement" of selling
one bottle Perfect Colon Formula in interstate commerce. The offense being that
I provided information in a handout flyer that one of the ingredients in the
formula, L Plantarum, helped to prevent and reduce food allergies.
The
FDA alleged that this information made Perfect Colon Formula a "new
drug" as they did had not approved of the information I used that came
from an abstract at the National Library of Medicine. The fine for me
personally was $100 plus a $25 special assessment. For Vital Health Products,
it was $400 plus a special assessment of $125.
The
most important concession made by the US attorney is that in the Conditional
Plea Agreement, I can raise all the legal issues I used in both of my Motions
to Dismiss and the Motion for Reconsideration (Docs 28 and 43). If I win on
appeal, the plea agreement will be vacated like it never happened and the
government will have to refund the money I paid.
Furthermore,
I was allowed a full page in the plea agreement to outline the 8 areas of legal
issues I reserved my right to appeal. Since the plea agreement is publicly
available, I thought it was a significant concession. A copy of the eight legal
issues is listed in this article. The final court hearing in this case will be
April 20th. From that point on, I will have 15 days to file a Notice of Appeal
and then write my brief in the following 30 days.
My
decision not to go ahead with the jury trial is for the following 3 reasons:
First,
the FDA in their jury instructions asked the court for so many restrictions on
what I could say that it would block all of my defenses based on legal
arguments including the 1st and 5th amendments’.
Second,
on the issue of the health claims themselves; the FDA was asking the court to
restrict NLM research presented to a jury to human, randomized, controlled,
double-blind studies that were published in a medical journal, and that the
product so studied had to be the same exact formula with the same ingredients
in the same proportions. The effect of these restrictions would be to block 99%
of all the expert opinion from the US National Library of Medicine for
presentation to a jury. The combined effect of these restrictions, if granted
by the judge, would be to have a jury trial in name only – by blocking
all my defenses both legal and factual as they apply to the science that
supports the claims’.
Third,
the stress on me personally would have taken a toll mentally, emotionally, and
physically. If I won, it would have benefited me only in a legal sense and
would have had no nationwide effect in curbing FDA's ongoing abuse of power.
The
other option I had was trial before the Judge. I decided against that because
in the past year, I gave the judge 3 opportunities to rule on my side of the
legal arguments I presented in my motions to dismiss. He passed over them on 3
sets of motions. It made no sense to me to present the same issues all over
again. The judge showed me his hand in his rulings. In my view, the judge was
too timid to rule against the FDA. The judge did not have the backbone to make
a ruling that would have caused the FDA to lose some of their regulatory
powers.
At
the Pretrial today, after answering some 30 questions under oath, a critical
juncture arrived when the judge asked me if I was "guilty" of this
one offense. I consulted with my attorney, Joanna Perini, who told the judge
"guilty was within the meaning of how the court applied the law as a
strict liability and not as a state of mind." The US Attorney consented to
this statement and the judge accepted the answer.
At the end the Pretrial Hearing, Judge Callahan showed self-doubt when he said: "maybe I was wrong in how I ruled in this case, if so, the 7th Circuit (Court of Appeals) will tell me." The judge then wished me well for the future and raised his right hand as to salute me. I responded in kind and the meeting ended.
Conrad LeBeau
(Note: The next email update will be
in May)
Excerpts from the Plea Agreement:
A brief description of some, but not all of
the legal issues raised in Docs 28 and 43 that the defendant reserves the
rights to appeal are-
1. Overbreadth -
Definition of the word “drug” from the Food and Drug Act of 1906 (21 USC
321 (g)(1). FDA’s expansion
of the definition of the word “drug” goes beyond “Patented Drugs” and
“Nostrums” and includes “foods” that were not intended by the Congress of 1906
to be defined as drugs. The FDA’s expanded definition of the word “drug” to
include “food” violates the Doctrine of Overbreadth, and is an over-reach of
regulatory powers. Defendant contends that Perfect Colon Formula was a food,
and therefore, is not a substance intended to be regulated as a drug within the
meaning of the original Food and Drug Act.
2. Arbitrary
definition of “New Drug.” per 21 U.S.C. Sec 321 (p)(1) The FDA has
arbitrary standards for defining drugs as “new.” Arbitrary standards violate
due process rights under the 5th amendment when the FDA applies the law
requiring a new material composition for a patented drug that is FDA approved
while classifying a non-patentable foods or herb as “new drug” solely by its
intended use only even though they do not have a new material composition.
3. Doctrine of Legal Impossibility per 21 USC Sec 355. Is it legally
impossible for a food or herb or other non-patentable products to ever be
approved by the FDA with a New Drug Application when the required patent number
is not possible to obtain for products that are not new in composition, and therefore,
patentable?
4. Doctrine of Economic Impossibility - if the financial hurdle of
filing and completing a New Drug Application for a non-patentable article could
be brought to completion, could the sponsor ever recover the investment when a
non-patentable article could never have exclusive marketing rights?
5. Public Policy and 3rd party labeling. Does Congressional approval
of making available to the public over 11 million scientific abstracts from the
National Library of Medicine through computer access online also become 3rd
party labeling of thousands of foods and dietary supplements for the
prevention, mitigation and treatment of disease?
6. Conflicts between FDA policy and the public policy of the NIH for
access to and use of the National Library of Medicine (NLM). As
distributors of food and nutritional supplements, did the defendant have a
first amendment right to use and share information derived from the NLM with
his customers? Was the defendant’s use of information derived from database
searches at the NLM a lawful exercise of a right of commercial speech under the
First Amendment?
7. 21 USC Sec 335 Hearing before report of criminal violation. “Before any violations of this Act [21 USCS SS 301 et seq] is reported by the
Secretary to any United States attorney for institution of a criminal
proceeding, the persons against whom such proceeding is contemplated shall be
given appropriate notice and an opportunity to present his views, either orally
or in writing, with regard to such contemplated proceeding.”
This hearing with the
defendant was not held by the FDA. The defendant will ask the Appellate Court
to overturn the 1943 case of United States v Dotterweich (1943) 320 US 277 that
held the hearing was not required and to restore the original intent of this
law as passed by Congress in 1906.
8. Restraint of Trade and violations of the US Constitution. The FDCA
as applied and enforced by the US FDA illegally restrains the trade of the
defendant by totally censoring the use of speech on the intended uses of his
health products, all in violation of the First Amendment, and further violates
due process rights under the 5th Amendment by the arbitrary and capricious
standards of defining a “new drug,” and further violates “freedom of choice in
medicine” under the 9th amendment by assuming powers not delegated to Congress
under Article 1 Sec 8 of the US Constitution that usurps the balance of powers
delegated to the States under the 10th amendment.
Note - In the past year, I resisted
three separate threats from the US attorney to either accept his plea offer or
he would ask for the maximum penalty - $100,000 in fines and one year in jail,
assuming I was convicted. It is little wonder that under these tactics, 98% of
all cases in Federal Court are settled in plea agreements. When it was over, the US Attorney looked
relieved. The feeling was mutual.
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