The Fukushima Nuclear Core Meltdowns
The 9.0 earthquake of March 11, 2011, that struck off the northeast corner of Japan has had repercussions that are affecting the health of the planet we live on from the air we breathe to the water we drink and the food we eat. Besides moving the entire country of Japan 13 ft to the east and causing nearly 30,000 to be dead or missing, a growing pollution threat now faces everyone in the northern hemisphere and eventually the entire planet. This includes radioactive iodine, cesium and other isotopes that continue to be emitted into the air and water. The ongoing pollution is caused by over-heated nuclear reactors whose cooling system that relied primarily on water have been irreparably damaged by the tsunami that followed the earthquake.
An ill wind blowing from the west to the east carries these radioactive isotopes over the pacific ocean to the United States and then over the Atlantic ocean to Europe and beyond. News reports from various internet web sites including Naturalnews.com have reported radiation levels in milk in Hawaii at 3 times the level considered safe by the EPA. In France, the government has advised against infants drinking milk.
While radioactive iodine has a short shelf life, until the radioactive emissions from the 3 nuclear power plants at Fukushima stop emitting particles into the air, the problem will not go away. While Chernobyl was eventually sealed with concrete, this took a long period of time and allowed radiation to ruin hundreds of square miles of Russia territory. The following are some recent statistics from datablog followed on the next page by a plan I devised to safely seal the nuclear reactors and stop the further polluting of the planet. Up to date radiation levels in the air can be found for most states at www.epa.gov or at http://www.epa.gov/radiation/rert/radnet-data-map.html
Data summary from The Guardian
Fukushima nuclear power plant update - 19th April 2011
A PROPOSAL TO SEAL FUKUSHIMA NUCLEAR REACTORS
A PROPOSAL TO SEAL FUKUSHIMA NUCLEAR REACTORS
Water is one way to cool an object that is over-heated but when the temperatures are extremely high, it can also cause sudden contractions in the overheated object making it crack or even shatter. When the reactor vessels outer wall is overheated, spraying room temperature water on the vessel's outer wall may cause a contraction that could crack the reactor's containment vessel and this would allow radioactive material to be released into the atmosphere. Mostly likely this has already happened to Reactor No 1 and 3, and possibly No 2 as well.
At extreme temperatures, water can create an explosive atmosphere if it breaks down into hydrogen and oxygen and then ignites causing further damage to the uranium rods, the containment vessel or the building structure. It would be the wrong cooling material to use directly on uranium rods melting down as the exploding water may also act like a sandblaster and cause more radioactive material to be released into the atmosphere. The resulting steam (like a steam cleaner) picks up radioactive materials and washes it into the ocean causing even more damage to the environment.
What I am proposing here a fast way to both cool and seal the reactor core and vessel. In my estimate, it would take from 75 to 150 tons of copper or pellets per reactor to be placed around the reactor core and vessel to significantly lower the core temperature. Both copper and aluminum are excellent conductors of heat and will immediately draw heat from the reactor core and/or outer vessel and move it into the molten metal pellets. This could drop the internal temperature of the reactor core by as much as 50% in a matter of hours.
Covering a 12-ton reactor with 150 tons of copper pellets will result in a layer of copper metal about 5 ft thick. Copper is probably the best choice as its melting temp is about 500 degrees F less that the melting temp of the stainless steel vessel that surrounds the reactor core.
Enough metal pellets needs to be poured on the reactor vessel until an outer crust forms and solidifies. Water is then sprayed on this outer crust to cool it off. At this point, you need to spray water on it until the temperature dissipates and the entire mass becomes one sealed blob of solid metal. This could take several weeks. As the surface area increases, it will dissipate the heat more efficiently. To top off this crude radiator, large beams of steel or iron could be placed on top or against the reactor to further dissipate the heat.
At this point the reactor core is sealed and the heat is being siphoned off via the copper metal and no more radiation is escaping into the atmosphere or going into the ocean.
Materials needed - 150 tons of aluminum or copper pellets 1/8 to 1/4 inch in diameter will be needed per Nuclear Reactor and dropped on and around the reactor vessel.
The cement pump that US Navy is now using to spray water could be used with the extender to reach the top of the nuclear reactor core vessel or the reactor core itself. Copper pellets and water could be mixed and delivered together to the top of the nuclear reactor vessel or core. Water and copper pellets are then blasted onto the vessel or into the core until it is filled up.
The reactor core may be in the 4000 to 5000 F degree range and copper melts at 1981 degrees F. When the total mass of the reactor core and the copper pellets are equal in weight, the temperature of the reactor core should drop 40 to 50% or around the mid to lower 2000 degree F range.
Like a Volcano that is cooling, a skin covers the outer layer of the molten copper. This will create a larger surface area to dissipate heat from the reactor core. Water sprayed on the mass of metal will cool it and eventually create a thick skin of solid metal. With the radioactive isotopes sealed inside, they no longer enter the atmosphere. The water absorbs heat from the metal blob and it safely flows into the ocean without further contamination.
Cost - about One Million Dollars worth of copper pellets per nuclear reactor to shut it down. Japan has copper pellets on the mainland in sufficient amounts to accomplish this task.
Please pass this idea on to the appropriate government officials and your elected leaders.
This plan was written by Conrad LeBeau of West Allis WI on 4/17/11. Posted at keephopealive.org. 414-231-9817.
Nutritional supplements: Potassium iodide if you can find it - use as directed. Kelp and Dulse and other seaweed harvested before March 11, 2011 or if after March 15th - obtained from down under (New Zealand, Australia, South Atlantic and South Pacific.) Antioxidants will counter the free radicals caused by small amounts of radioactive isotopes absorbed into the body.
However, before you panic, consider that the world survived over 50 surface explosions of dirty nuclear bombs detonated in the 1950s during the height of the cold war. I even remember when a 50 megaton nuclear bomb was detonated by the Soviet Union on Halloween in the late 1950's. Krushchev was the President of the Soviet Union at the time. Pretty spooky. Yes, I lived through that period and this is not yet that bad. However, we cannot stop what the wind carries our way.
THE ASSAULT ON HEALTH FREEDOM
Based on what I have been reading, herbs are hard to obtain in Europe right now. Apparently, big corporations have infiltrated government regulatory agencies in Europe like they have done here in the United States with the US Food and Drug Administration to create rules to eliminate low cost alternatives to patented drugs. The following report on "thunder God vine" is one example of a Chinese herb that fights cancer and might also be beneficial as an immune modulator to increase CD4 counts in persons with HIV.
Cancer herb to be taken off shelves in Europe
Cancer herb to be taken off shelves in Europe
A herb used in Traditional Chinese Medicine (TCM) can block cancer growth, researchers have discovered this week - and it's about to disappear from stores throughout Europe.
The herb, thunder God vine (lei gong teng), has been used for centuries by TCM as a remedy for rheumatoid arthritis. But researchers from Johns Hopkins School of Medicine say it can also stop tumour growth. Its active ingredient, triptolide, is an anti-inflammatory, an immunosuppressant, contraceptive - and anti-tumour agent, says Jun Liu, professor of pharmacology and molecular sciences.
Yet, on May 1, it will disappear from the shelves around Europe under an EU directive that will dramatically reduce the range of herbal remedies we can buy. Every single remedy from TCM, Ayurvedic and Amazonian medical traditions will disappear under the EU's Traditional Herbal Medicinal Products Directive. Of the hundreds of remedies currently available, just 79 will survive - and a pharmaceutical company manufactures a third of these.
In laboratory tests, low doses of thunder God vine blocked cell growth in 60 different types of cancer, and even killed off some cancers.
(Source: Nature Chemical Biology, 2011; 7: 182).
Inhibition of tumor cellular proteasome activity from the medicinal plant 'thunder God vine'.
Lu L, Kanwar J, Schmitt S, Cui QC, Zhang C, Zhao C, Dou QP. Anticancer Res. 2011 Jan;31(1):1-10.
AIMS: The molecular mechanisms of triptolide responsible for its antitumor properties are not yet fully understood. The ubiquitin/proteasome system is an important pathway of protein degradation in cells. This study investigated whether triptolide may inhibit proteasomal activity and induce apoptosis in human cancer cells.
RESULTS: Triptolide did not inhibit the chymotrypsin-like activity of purified 20S proteasome. However, treatment of triptolide was able to cause decreased levels of cellular proteasomal chymotrypsin-like activity and accumulation of ubiquitinated proteins and three well-known proteasome target proteins in human breast and prostate cancer cells, associated with apoptosis induction.
CONCLUSION: It is possible that at least one of metabolites of triptolide has proteasome-inhibitory activity.
Molecular targets of celastrol derived from Thunder of God Vine have a potential role in the treatment of inflammatory disorders and cancer
Kannaiyan R, Shanmugam MK, Sethi G. Cancer Lett. 2011 Apr 1;303(1):9-20
Celastrol is one such compound that was originally identified from traditional Chinese medicine (Thunder of God Vine) almost three decades ago and generally used for the treatment of inflammatory and auto-immune diseases.
Celastrol has attracted great interest recently, especially for its potential anti-inflammatory and anti-cancer activities. The anti-inflammatory effects of this triterpene have been demonstrated in animal models of different inflammatory diseases, including arthritis, Alzheimer's disease, asthma, and systemic lupus erythematosus.
This triterpene has also been found to inhibit the proliferation of a variety of tumor cells and suppress tumor initiation, promotion and metastasis in various cancer models in vivo.
Celastrol's ability to modulate the expression of pro-inflammatory cytokines, MHC II, HO-1, iNOS, NF-_B, Notch-1, AKT/mTOR, CXCR4, TRAIL receptors DR4 and DR5, CHOP, JNK, VEGF, adhesion molecules, proteasome activity, topoisomerase II, potassium channels, and heat shock response has been reported. This review describes the various molecular targets of celastrol, cellular responses to celastrol, and animal studies with celastrol in cancer and other inflammatory disorders.
How "thunder of God vine" is used
According to WebMD.com, an extract of the herb has been used
Orally - For rheumatoid arthritis (RA): 180-570 mg of thunder god vine extract per day for up to 20 weeks.
For kidney problems (nephrotic syndrome) in children: 1 mg per kg of body weight daily for up to 20 weeks.
Topically: For rheumatoid arthritis (RA): a tincture of thunder god vine applied over affected joints five to six times daily.
Other uses reported but not studied extensively are for cancer, hiv, lupus and multiple sclerosis where the immune system is over-active and has shifted to TH2 from TH1. The effects of this herb are anti-inflammatory like hydrocortisone.
Using it for 5 years has been associated with osteoporosis in one study. High doses have been associated in some persons with stomach upset, diarrhea and male infertility. It would be best to consult with a health care professional (licensed accupuncturist) who specializes in traditional Chinese medicine about how to use this herb and where to obtain it. Most regular doctors will ask "thunder of God what"?
New Birch Ash Water Recipe (Swedish)
Holistic Birch ash from northern Finland have traditionally been used as a panacea for almost all diseases (cancer, arthritis etc). The reason is that birch ash is very mineral-rich and highly alkaline (basic). The includes minerals such as potassium, sodium, calcium, magnesium, phosphorus, chromium, zinc, manganese, molybdenum and selenium. The ashes are boiled in water per the recipe below.
Recipe for birch ash extract: 4 tablespoons birch ash mixed with 2 liters of water in a glass pot. Boil for 15 minutes with the lid. Let Birch Ash mixture cool. (Do not boil in aluminum or metal pot as metals may dissolve in the solution.) Strain through an unbleached coffee filter. Store in a cool place or refrigerator. 2 or 3 tablespoons of the extract are mixed with a glass of water and consumed 1 to 3 times daily. Birch ash water may also be applied topically. (sore joints, wounds etc).
Note: Birch logs and branches can be burned on a cement slab to produce your own ashes.
FDA vs Vital Health and LeBeau
FDA vs Vital Health and LeBeau
On Dec 28 2010, I was indicted by the US Food and Drug Administration (FDA) on 4 misdemeanor counts of selling unapproved drugs. The maximum fine, if I am convicted, would be $100.000 per count and one year in jail. In 2009, the FDA purchased products from Vital Health Products. The alleged violations "unapproved new drugs" are printed in bold. They include
1. Spirokete made by Kroger Herb co - (may help with Lyme disease).
2. Sacchromyces Boulardii - (for diarrhea related to C Difficile).
3. Perfect Colon Formula - (Research shows that L Plantarum may help reduce food allergies)
4. LeBeau's Cold and Flu Formula - FDA alleges the name makes it an illegal new drug.
In February, 2011, I requested under the Freedom of Information Act (FOIA) 19 sets of documents from the FDA. So far they have only supplied two. A status hearing on this case occurred on April 15th 2011. My attorney, Federal Defender Brian Mullins asked for 3 weeks to file the Motion to Dismiss and Judge William Callahan granted until May 6th to file the motion. The 4-page motion has a 60 page brief in support. There are multiple legal defenses in this motion and the brief. It will be available online at some future date.
This legal fight has stopped my writing career on health books at this time. I am doing a lot of research and it is consuming most of my time. If the FDA loses at the trial level, they will most certainly appeal and this case will be fought all the way to the U.S. Supreme Court. If I lose in whole or in part, the case may be appealed or go to a jury trial or both.
The following is a partial excerpt from a 60 page Brief that will be filed before May 6, 2011, and gives some of the background and legal issues of this case.
UNITED STATES v. Case No 10-CR-253
VITAL HEALTH PRODUCTS LTD., and CONRAD E. LEBEAU Defendants.
Excerpts from my "Brief"
Excerpts from my "Brief"
A brief overview of some preliminary facts about the 4 allegations in plaintiff's complaint
1. SPK Spirokete is an herbal formula made by Kroger Herb Co in Boulder, CO. The name "Spirokete" is a spelling variation of "spirochete" the infectious agent that causes Lyme disease. With the name Spirokete, the letter "k" is substituted for the letters "ch" in spirochete. Both words are pronounced the same way. As shown in the exhibits, the original manufacturers literature as retrieved in a Google search on the internet shows that the manufacturer, Kroger Herb Co, talks about Lyme disease and spirochetes in the first paragraph under "Product description." From 8 to 10 year ago when the defendants were first informed about Spirokete to today there has been a change in name and the disappearance of references to "Lyme disease" under product description. The name change in the past year or so has been from Spirokete to "SPK Spirokete" to "SPK" the current name. A recent search of Kroger Herb Co website finds no product description at all for SPK. A Google search, however, even today clearly shows the intended use is for Lyme disease.
2. Saccharmyces Boulardii is a dietary supplement manufactured by Jarrow Formulas of Los Angeles, CA. S. Boulardii is a probiotic or friendly flora that lives in the intestines of some people and has a variety of health benefits. I recall receiving an article about S Boulardii and C. Difficile from Jarrow Formulas several years ago. However, a recent search at the Jarrow website finds no references to using S Boulardii for preventing relapses of C difficile related diarrhea. Published research shown in the exhibits retrieved from the US National Library of Medicine and other prominent sites including WebMD and the Mayo Clinic indicate that S Boulardii has been helpful in preventing recurrences of a type of diarrhea caused by Clostridium Difficile.
3. Perfect Colon Formula was manufactured for a number of years by Vital Health Products and was our number one selling product. It is a food product that is a mixture of fiber and a blend of friendly flora. Published research from the National Library of Medicine was used in the design of this product and excerpts from some of the published research was used in a handout flyer that accompanied the product. While it was never the intention of the defendants to make a "disease claim" for this product, research was cited (from the U.S. National Library of Medicine) in a handout flyer that one of the key ingredients L. Plantarum, a probiotic was found to help prevent and reduce food allergies.
4. LeBeau's Cold and Flu Formula is an herbal formula manufactured by Vital Health Products. The ingredients used in this product were chosen based on research done at the U.S. National Library of Medicine. The product was never labeled as a treatment for the Swine Flu.
Of the 4 products in question, the first one's intended use came from the manufacturer, Kroger Herb Co and of products 2, 3 and 4, any information provided on their health effects listed would have been based on expert opinion derived from the U.S. National Library of Medicine. SPK Spirokete and LeBeau's Cold and Flu Formula were strictly herbal products while Saccharmyces Boulardii was a dietary supplement and was so labeled by Jarrow Formulas. Perfect Colon Formula was a food product. Since it was a food item, it was not considered or labeled as a dietary supplement nor was it ever considered by the defendants to be a drug.
An overview and historical background of this case
An overview and historical background of this case
The issues in the current case are directly linked to an FDA inspection that started on Nov 24, 2008 and continued on Dec 4, 5 and 8 of the following month. Everything considered, the two inspectors spent more time in their investigation than most police spend at a crime scene.
Local FDA inspectors Joel Hustedt and Christina Castineyea conducted what they said was routine inspection that lasted for 4 days but was anything but routine. During the inspection, I bared my soul to them about the FDA, the FDC Act, the 9th amendment and freedom of choice in medicine and the court case going back to 1991. I told Christina about the difficulty of knowing when a health claim for preventing or mitigating a disease had the approval of a consensus of scientific experts that did not require the prior approval of the FDA to use the claims. I asked them how would you determine when a consensus of expert opinion that supported a health claim could be used. Joel replied that he was at the bottom of the food chain and could not give me the answer.
I told Joel how I had observed over the years that magazines had published articles about a natural dietary supplement and the articles were heavily footnoted with scientific citations that supported the health claims. I also observed that the same articles were sometimes written by the same people who manufactured the products discussed in the articles, and that the FDA did not react negatively to the articles.
I told him that when a health claim is made and backed with significant scientific research that I observed that the FDA looked the other way. Joel did not react - he was silent. I also told him that except for a few products manufactured by other companies, the products I made were carefully researched with multiple database searches at the U.S. National Library of Medicine (NLM) and that I did not make any claims for any products I assembled without first doing a search at the NLM.
During the span of these several days, I discussed with them my understanding of the FDC Act in regards to the definition of what was a "new drug" and stated that if a majority supported a health claim it should legal under the FDC Act.
I discussed with him and Christina the meaning of the words "consensus of scientific opinion." I asked Joel and Christine if this meant a simple majority or more? Neither one had an answer. He told me that he was here to gather information and get me to sign an affidavit and that it was not up to him to determine if there were any violations of the FDC Act.
As the inspection went on into the 2nd day, I noticed the inspectors were paying special attention to 10 or so products that had a few words after them on my Order Form indicating a health effect or benefit. Knowing that I had done database searches at the U.S. National Library of Medicine (NLM) before placing information on those health effects on the Order Form, I went back and redone those searches. When I presented a set of those abstracts from the NLM to Joel Hustedt that showed the scientific basis for the health claims I had used on the Order Form, I asked Joel to sign a receipt that he had received them. Joel told me he was under instructions not to sign any paper or receipt.
I used the following search terms at the NLM -
1. Myrrh - parasites
2. Eucalyptus- antiseptic
3. Selenium- candida
4. Cilantro - mercury
5. Beets - liver
6. Cinnamon - blood pressure
7. Cinnamon - blood sugar
8. Grapefruit seed
9. Neem - antibiotic
10. Garlic - antibiotic
11. Saw palmetto
The results of the searches at the NLM provided scientific studies that supported the intended uses of the supplements under examination. On the last day of the inspection, I was told I would be contacted by Tyra Wisecup, a compliance officer for the Food And Drug Administration in Minneapolis, MN. I told Joel and Christina several times that I would comply with any labeling changes she wanted. I was given Tyra Wisecup's phone number. As the inspection entered its third day, I brought up the subject of using a tape recorder during an inspection. Joel told me that he was not allowed to conduct an inspection if a tape recorder was present.
On Dec 8th, the last day of the inspection, Joel Hustedt put great pressure on me to sign an Affidavit. I refused because the affidavit was clearly a document slanted for the benefit of a prosecuters point of view. It had some inaccurate statements in it and did not reflect my intent or understanding of the law or acknowledge the scientific data I had given him. I refused to sign the affidavit Joel had written and offered to write one of my own. Joel declined my offer. He said: "Do you want this (inspection) to end?"
Then he insisted on reading the affidavit to me sentence by sentence and would ask me after each sentence if I agreed with it. About half way through his reading I stopped him and asked him why he was giving me an impromptu deposition. He did not reply. I then added: "Do you think I wake up every day and plan to make some outrageous health claims for my products? I asked him why he was treating me like a criminal when the only information I had used came from the United States National Library of Medicine. At that point, the stress of their investigation got to me. In an emotional moment I suddenly found myself unable to speak. Joel and Christina then hurriedly left the office.
The Interval before the letter from FDA Attorney Nathan Sabel
On the evening of December 8th, I called Joel and left a message on his answering machine that I would call Tyra Wisecup to discuss with her any of her labeling concerns. I also told him that if the inspection was to resume that I would have a tape recorder present. I did not receive a return phone call from Joel or Christina. On Dec 10th I called Tyra Wisecup and left her my phone number. I asked her for her email address in case I had any questions before our phone discussion. I assured her that I would make any changes in labeling she wanted.
As the days went by they turned into weeks and I never did receive a return phone call from Tyra Wissecup. At first I did not know how to interpret her silence. I thought that maybe she was impressed that I did my research at the National Library of Medicine before making any health claims. However another voice inside my head had reservations and I asked myself whether or not there were some secret regulations that I was not aware of that would make those abstracts unusable. As a precaution, I went over my Order Form and website and deleted the health claims for those 10 products.
Both before and after the inspection of Nov/Dec 2008 I always believed that my website for Vital Health Products was visited by the FTC and the FDA. One question that was always on my mind when I made changes to the website was: what will the FDA think of this? After making the deletions, I left a few other claims as they had been there through previous FDA inspections and there had been no objections raised and no Warning Letters received. Meanwhile I waited for the phone call from Tyra Wisecup that I had been promised by FDA inspectors Joel Hustedt and Christina Castineyea, but the phone call and Warning Letter never came.
At the Nov/Dec FDA inspection, Joel Hustedt told me to go to the FDA website as good manufacturing practices (GMP) for businesses under 20 employees would take effect on June 1, 2010 and I would need to comply with them. I certainly was the bottom of the totem pole as far as small businesses were concerned as I was the owner and only employee and part time at that.
I was told by Joel Hustedt that the GMP regulations for dietary supplements for large companies had already taken effect in 2008 and would take effect for mid-sized companies in 2009. I visited the FDA website but, not being familiar with how to get around it, could not find the link to the GMP regulations. Being uncertain about what the future would bring after the Dec 2008 inspection, I thought about getting out of the health products business altogether and going into writing full time.
The letter from FDA Attorney Sabel
Nov 3, 2009. I received a letter from an FDA Attorney Nathan Sabel written on Nov 2, 2009 in which he said he was writing to the local US attorney and recommending that criminal charges be brought against me. This had the effect of having my brain tazered with an electrical stun gun. The letter shocked me as I thought I was in compliance with what the FDA wanted. After reading the letter, I felt ill as I realized I was being dragged into a legal fight I had done my best to avoid. Mr Sabel left his phone number in the letter in case I wanted to discuss it with him.
I called him the same day I got his letter. I asked him why I had not received a return phone call from Tyra Wisecup that I had been promised a year before or why I had not received a Warning Letter if they thought there were ongoing violations. He replied that he was the only person I needed to talk to now. I told him that I first carefully searched the database at the National Library of Medicine before using any of that information on my Order Form. He said: "an abstract does not mean anything." He also said that my claim on Perfect Colon Formula about "reducing food allergies" was a disease claim. I told him that the statements on the handout flyer was based on one or more abstracts I had retrieved from the NLM. However, I also told him that I did not realize that "preventing and reducing food allergies" was a disease claim.
As for a few other products manufactured by other companies that had health claims for them I told him that I was not responsible for their health claims. Attorney Sabel told me that I was responsible for all health claims including those made by the manufacturers of other products. I replied: "that is news to me." I said: "Are you saying that I am just as responsible for health claims on a product that I did not manufacture or label as the manufacturer of the product?" He said "yes" and then advised me to get an attorney.
I had a second phone call from Mr. Sabel and he wanted to discuss a settlement. I told him I had been considering going out of the health products business for some time and doing writing and publishing instead. He said that would not be enough and that I would need to also sign a "consent decree." I told him I would first need to reply to his letter.
I replied to Mr. Sabel's 4 page letter with a 10 page response and exhibits in support on Nov 15, 2009. In my reply, I asked him a number of questions to which he did not respond. (A copy of Mr. Sabel's letter me and my reply and exhibits is attached to this brief.) After receiving Mr. Sabel's letter, I decided that if I received one more letter accusing me of selling unapproved new drugs that I would, to maintain my sanity, get out of this business.
The next 'shock and awe" moment came when I received a letter for local US Attorney Gordon Giampietro around June 26, 2010 in which he said he was considering "indicting me" on alleged criminal violations and offered to meet with me to allow me to have an input in the case. On the same day I received the letter from Gordon Giampietro I decided to close down the business and posted a notice on my website. On July 1st 2010, I mailed a notice to my customers that I was going out of business at the end of the month.
Because none of the alleged violations of the FDC Act in this case no 10-CR-253 resulted from the inspection of Nov/Dec 2008 or Mr. Sabel's letter and my reply of Nov 15, 2009, I will move on. My purpose in providing all this information here is to give the Court an understanding of the facts, intent and issues from my perspective and to further show that I acted in good faith at every step in my communications with the FDA, but the FDA did not respond in kind.
I was promised by FDA inspector Joel Hustedt that Tyra Wisecup would contact me and I could speak with her at the time to discuss and resolve any labeling issues. That promise was broken. My phone call to Tyra Wisecup was never returned. The letter and my very brief phone conversation with Mr. Nathan Sabel did not resolve much but it led me to remove the few remaining health claims from my Order Form of the health products from other manufacturers and I changed the wording on the handout flyer for Perfect Colon Formula from "reduces food allergies" to reduces "food sensitivities" which has a more nuanced meaning.
I met with Attorney Giampietro on July 12, 2010 and he offered me a plea deal of a small fine and no jail time. I told him I would consider it. I then handed Attorney Giampietro a copy of a case on the labeling of selenium supplements for preventing cancer that the FDA lost the previous month in Federal Court in the Washington DC District.. It was Alliance for Natural Health v. Sebelius, - F. Supp. 2d -, 2010 WL 2110071 (D.D.C. May 27, 2010). I said there were factors in this case that applied to my case but he thought it had to do with selenium. I had something else in mind (rights of commercial speech) having read the case but did discuss it further.
On July 31, having gone out of business, I thought that the FDA would simply go away and stop bothering me. However, the FDA attorneys persisted in convincing Mr. Giampietro to indict me before the end of 2010. (Note: I learned on July12th in my meeting with U.S. Attorney Gordon Giampietro that 4 FDA attorneys had been in his office a month earlier pressuring him to indict me. It is amazing to me that the FDA would spend money to fly 4 of its top attorneys to Milwaukee, WI, to twist the arm of the local U.S. attorney to indict me. I left there wondering what the real reason was since I had already had enough of the harrassment and decided to quit the supplement business. I concluded it was the booklet I wrote on Hydrogen Peroxide and Ozone that had sold over 150,000 copies over a period of 20 years that the FDA disliked it so much they felt they had to make an investment in the courts to discredit me.
A few weeks went by after the arraignment on Jan 4, 2011 while I studied the case carefully. I found defects and concluded the government's case was weak and would not be winnable before a jury. However a jury trial is a lot of work for everyone involved including me. If I won and I thought I could, it would only benefit me and not the millions of people who are lost and confused when they walk into a health food store and find little or no information on the hundreds of products and foods there and how they might help prevent disease.
The Purpose of the Motion to Dismiss
The purpose of this motion is a legal and constitutional challenge to parts of the FDC Act as amended to date that define what a "drug" is and what a "new drug" is as well as unconstitutional restrictions on freedom of the press (commercial speech) under both the Food Drug and Cosmetic Act and the Dietary Supplement Health and Education Act of 1994 (DSHEA).
1. Defendants allege that Congressional intent in the original Pure Food and Drug Act of 1906 that defines what a "drug" is in reference to the word "substance" (later changed to "article" in 1938) did not include foods and edible herbs used as foods; that the Congressional Record of 1906 shows the intended meaning of the word "drug" in the Pure Food Act of 1906 was "Nostrums" and "Patented Drugs" and not foods. Defendants allege that the FDA has misused the use of regulatory powers granted by Congress and expanded the definition of the word "drug" to include foods and edible herbs and spices in direct violation of Congressional intent. This process of regulatory over-reach to expand the power, control and authority of the FDA is illegal because the Congress of 1906 did not intend to include "foods" as drugs in the definition of the word "drug" nor did Congress authorize the FDA to change the meaning of the word "drug" by writing regulations with an expanded definition.
2. Defendants allege that the definition of what a "new drug" is in amendments to the FDC Act in 1938 as amended in 1962 to date was an over-reach of powers granted to the Federal Government under the interstate commerce clause and is unconstitutional. While Congress has the power to regulate speech on the intended use of new substances (items of therapeutic value) that are patented or patentable because such substances are truly "new" in that they do not exist in foods, plants or soil. Articles (substances) of foods and herbs are "old" in that they have existed for many thousands of years and exist in nature by the hand of Divine Providence. Hence, food and herbs are "natural" in contrast to patented drugs that are invented by man that are truly new substances or new molecular compounds.
New discoveries about the use of "old" foods and herbs for preventing and treating disease is a right of free speech and cannot be restricted by the Federal Government under the First Amendment unless such speech is untruthful, misleading or fraudulent. What is defective about the definition of "new drug" in 21 U.S.C. Sec 321 (p)(1) is that the "new intended uses" of a natural health product define it as a "new drug" and not because there is anything "new" about the food or herb itself.
With patented drugs, both definitions apply (the chemical compound itself is new and its intended use is new) but with natural foods and herbs, only the intended use applies to the definition as the substance of the food or herb does not change. Because foods of plant or animal origin are not patentable, they are not "new foods" or "new herbs" created by a person. Man has not figured out how to create a living cell let alone an aloe vera plant or garlic bulb or broccoli or blueberries.
3. Defendants allege the constitutionality of parts of the Dietary Supplements and Education Act of 1994 (DSHEA) violate commercial rights of free speech to provide consumers with truthful information on the health benefits of foods, herbs, vitamins, minerals and other dietary supplements that can help prevent or treat disease.
4. Congressional financing and approval of the release of scientific studies from the U.S. National Library of Medicine and NIH policy noted in the Federal Register in 2004 has resulted in 3rd party labeling by the Federal Government of thousands of foods, herbs and dietary supplements for the prevention, mitigation and treatment of disease. That although this 3rd party labeling may not have explicitly been intended as labeling, the effect of how foods, herbs and other non-patented and non-patentable items prevent or mitigate disease through a search on a personal computer at the NLM is no different than if the same information were placed on the product label by the manufacturer of a food, herb or nutritional supplement.
The record of FDA approval of new drugs has never included one non-patented food or herb in the entire history of the agency. Removing the yoke of language restrictions from the intended uses of foods, herbs and dietary supplements would restore freedom of speech and freedom of choice in medicine.
If defendants prevail on the merits of their arguments, foods and herbs will not longer be classifisd as "new drugs" based solely on their intended use for preventing and treating disease. FDA censorhip of scientific research for how certain foods and herbs and natural medicines can prevent disease could no longer be blocked by the FDA even when the information is printed on the product label. But first, we must win at the trial level, then defend the case all the way through to the U.S. Supreme Court. Today, we made the second step on what will be a long journey.
Update - On monday May 23rd at a special court hearing, I requested that the appointed federal attorney be dismissed. I was then given permission by Judge Callahan to represent myself in this case. May 26th - I filed a Motion to Dismiss with a 68 page Brief, 200 pages of Exhibits and a copy of Jonathan Emords book on "The Rise of Tyranny" earlier today. The government has until June 24th to respond to my motion and the arguments in my brief and then I have until July 8th to respond to their reply. After that the judge will have to decide the merits of my motion and the arguments on both sides. More details will be posted later. Conrad LeBeau
Updated reports on this case can also be found at lebeaubooks.com
Conrad LeBeau 414-231-9817