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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

     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

     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

     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

     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

     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)

     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

  Flynn discovered that when one of her clients ate an apple before each meal without changing anything else, she was able to break a weight loss plateau. Flynn experimented with this approach with her other clients and witnessed incredible results, with typical weight losses of seventeen pounds in twelve weeks.

     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. Then follow a low carb-eating plan. In addition to eating apples dieters follow a food plan that is very similar to the South Beach Dietwith a relatively low intake of carbohydrates and reduction of saturated fats. Refined sugars are to be eliminated while low glycemic index carbohydrates are emphasized.

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.  

Cosca

     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. I certainly would be interested in hearing the results from anyone who has a pet and who tries this combination.

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.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

     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

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

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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