Internet Articles (2015)
odex AlimentariusLatin for "food rules"was created out of the "overpopulation fears" of the early 1960s. Shortly after the publication of Paul Ehrlich's 1962 ecoalarmist best seller, "The Population Bomb," which predicted that by the year 2000 half the people in the world would be starving, the Rockefeller Foundationwhich fanned the fears by promoting Ehrlich's bookfunded the startup of Planned Parenthood to curb population growth globally, pushed to legalize abortion, and through the Club of Rome, urged the United Nations to establish the rules necessary to safeguard the world's food supplies.
The United Nations Codex Alimentarius Commission [UN CAC] was formed in 1962 as a trade commission whose job it would be to regulate how multinational agricultural and pharmaceutical companies produced food and nutritional supplementsand how those products would be marketed globally. While David Rockefeller, head of the world's wealthiest oil family and the unofficial overseer of the global central banks, was primarily concerned about overpopulation and starvation, the world's pharmaceutical giants saw an opportunity to use the ecoalarmists' food supply fears to seize control of the health supplements industry.
Pressured by Big Pharma, the UN added pharmaceuticals and natural supplements to the Codex, ostensibly to establish "universal standards" in the vitamin industry so that consumers would be assured that supplements imported from Asia or Africa would contain exactly the same ingredients as those manufactured in the United States or Europe, thereby protecting the consumers who used them.
For close to four decades lobbyists for the world's pharmaceutical giants have been urging global lawmakers to classify vitamins and all other natural supplements as toxinsas the UN CAC doesso that herbs and vitamins could be regulated. Under Codex, UN CAC regulators would establish ultra-low, nonprescription levels for all vitamins and herbal supplements, and mandate that non-regulated supplements be sold in such small dosages that a consumer would have to take several supplements to get what is, today, considered the normal minimum daily requirement of that nutrient.
In July, 2005, UN CAC (pressured by Big Pharma to do so) introduced the Codex Alimentarius Vitamin and Mineral Guideline [VMS]. VMS greatly reduced the daily amount of common vitamins that can theoretically be safely consumed (although consumers have been safely consuming much, much higher doses of the same vitamins for the past 50 to 60 years. When Nobel Prize winning researcher Dr. Linus Pauling developed his nonprescription cardiac regime, it included approximately 4,000 mg of L-Lysine, 4,000 mg of vitamin C and 1,000 mg of vitamin Edaily. The Linus Pauling heart therapy has been heralded by doctors around the world one of the safest natural regimes to help prevent heart attacks.
Yet in July, 2005, the FDA arbitrarily decided that the maximum safe dosage of vitamin E is 400 mg and that doses larger than that could be toxic. And because it is found in so many food products today, the FDA advised that those taking nutrient supplements should limit their daily intake of vitamin C to 500 mg. Consumers who were using the Pauling heart regime that reduced their consumption of these supplements, would no longer be taking a "preventive dose" of the Pauling regime to safeguard against heart attacks. They would simply be "taking vitamins." Under Codex, L-Lysinewhich is an amino acidwould be even more stringently regulated since many in the medical community believe the unregulated availability of any amino acid poses a significant health risk to the public.
In 1989 there were 1,500 cases of eosinophilia-myalgia syndrome [EMS] in the United States that were linked to the amino acid supplement L-tryptophan and hydroxy-L-tryptophan. Thirty-seven known deaths were linked to the supplement. The Center for Disease Control [CDC] still insists that the number of those affected was much higher. As a result, the FDA banned the over-the-counter sale of L-tryptophan.
An investigation by the FDA produced evidence that the contaminated L-tryptophan all came from one source in JapanShowa Denko KK even though not everyone who took the Showa Denko supplement got sick. Since 1989 several instances of a related disease, eosinophilic fascitis, which the CDC believed was linked to L-tryptophan but just took several years to materialize, surfaced. The CDC and the FDA insist that universal standards are needed and must be mandated to prevent contaminated supplements from getting into the country. At the time, the FDA ran tests on various brands of L-tryptophan consumed by those who developed EMS, and determined that consuming high doses of L-tryptophaneven that which was not contaminatedposed a significant health risk. The FDA claims that those ingesting "label" amounts of the amino acid risk developing myofascial thickening and pancreatic fibrosis. At least, the animal studies sited by the FDA produced those pathological results.
Big Pharma's Prize
If Big Pharma gets its way and vitamins, herbal supplements and amino acids become regulated under Codex, L-tryptophan will become the "drug of choice" for medical doctors and psychiatrists to fight bipolarism. Today, chemical drugs like Prozac, Ritalin, Zoloft and Paxil are the most commonly-used antidepressants. The problem with that family of neurotransmitters is that they sometimes have a reverse affect on some patients. Instead of enhancing the serotonin levels in the brain and suppressing the manic mood swings that bipolar people experience, those drugs may actually suppress the serotonin levels instead of increasing it, causing violent reactions that include suicide or increased violent behavior towards others.
On the other hand, ingested L-tryptophan increases serotonin productioneven in individuals who generate little or no serotonin on their own. Logic suggests that doctors would be better served to place manic depressive peopleparticularly teenagers who generally had adverse reactions to Prozac and Paxilon L'tryptophan instead of the chemical drugs which are currently prescribed. However, Big Pharma has a problem. A month's supply of Prozac, Ritalin, Zoloft or Paxil retails between $350 and $450. A 30-day supply of L-tryptophan (before it was banned) was ten to fifteen bucks. Compounding the dilemma for Big PharmaL'tryptophan is a more effective treatment for bipolarism with less negative side affects. If Big Pharma wins, and the health supplement industry falls under FDA regulation, you will immediately see a new generation of antidepressants with Prozac-sounding names at Prozac-selling pricesbut whose primary ingredient is L-tryptophan will replace the chemical drugs now being used. Only, because it will be classified by the FDA as a toxin, only a pharmaceutical company will be allowed to wholesale it, and only a pharmacist will be allowed to dispense it.
Consumers Battle Codex
Fighting the threat of Codex regulation through the WHO and the FDA, a massive grassroots movement was launched by health rights activists. The groundswell it created pressured Congress to enact the Dietary Supplement Health and Education Act of 1994. DSHEA was designed to prevent the pharmaceutical industry from stealing the vitamin industry.
Under DSHEA, the law scientifically classifies natural nutritional supplements as food items. As such they cannot be regulated by the FDA which only has jurisdiction over manufactured or "manipulated" products. For example the pit of apricots, peaches and plums contain amygdalinvitamin B17a nitritoside. Amygdalin is a proven cancer cell killer. While the FDA cannot regulate vitamin B17, it can and does regulate the serum form of vitamin B17Laetrilebecause in its serum form amygdalin has scientifically been manipulated from a solid to a liquid. Laetrile, which is used to cure cancer in Mexico, is banned in the United States. Why?
Because within amygdalin is beta-cyanophoricglycoside. The intact molecule is completely nontoxic. However within the molecule is the element, hydrocyanide (hydrolyzed free hydrogen cyanide). Cyanide is a poison. Ingested at sufficient levels, its lethal. Because chemically, amygdalin contains cyanide, the FDA has been trying to ban Vitamin B17 for decades. However, for reasons scientists have never been able to figure out, when amygdalin is ingested by humans and reaches the intestines, hydrocyanide is detoxified by the enzyme rhodanese and is converted into relatively nontoxic thiocyanate molecules. Amygadalin, whether consumed as the nut within apricot, peach or plum pits, or as apple seeds, grape pits, lima beans, millet or wheat grass, is completely safe and nontoxictaken in safe doses. Remember, anythingeven chocolate cakecan be toxic if consumed in large enough "doses."
The FDA, pressured to do so by the AMA, banned Laetrile and is feverishly working to "protect" the American people by classifying Vitamin B17 as a toxin. If this practice is implemented in the United States through the backdoor of UN's Codex Alimentarius Commission, Laetrileunder a brand new patentwill become one of the leading, and most effective, cancer drugs in America.
Then Big Pharma would infuse the stock market with new life and those without prescription drug coverage would be forced to wonder how to pay for the new miracle drug to sustain their own lives when then apricot or peach pits in the fruit they buy in their local supermarket has been declared a Class II substance.
Does that mean that peaches, apricots and plums will have to be pitted before they reach the produce department of your local supermarket? Or that fresh fruit, because the seeds are construed to be toxic, will become a taste of the past that will shortly become available, pitted, and only in a can?
Codex has already classifies apricot, peach and plum pits as toxins. In fact, Codex has unscientifically classified all herbal supplements and vitamins as toxins. The VMG has established ultra-low doses as the "safe limits," arguing that massive doses of any vitamin is unsafe unless prescribed by a licensed medical practitioner. Clearly, VMG violates both the spirit and the letter of DSHEA. However, Big Pharma is pumping millions of dollars into the campaign coffers of scores of irresponsible politicians who will trade their souls for reelection. Add to that advocacy groups like the National Nutritional Foods Association [NNFA] and the Council for Responsible Nutrition [CRN] who have fallen prey to Big Pharma out of fearor greedand have become the messengers of disinformation by assuring their members that Codex is good for the American people because it will protect them from unscrupulous profiteers in the natural health good and supplements industry.
Just who are the profiteers? When the European Union adopted Codex in July, 2005 and allowed the World Health Organization to curtailed the nonprescription access to natural health supplements in Europe, 75% of the inexpensive over-the-counter natural herb remedies vanished from apothecary shelves by midsummer. The cheap nonprescription vitamins were replaced with very expensive prescription versions of the same vitamins.
In Norway, for example, the Food Supplements Directive saw the price of a 30-day supply of the immune-enhancing herb Echinacea jump from $14 to $153. Zinc tablets, classified by VMG as a toxin, leaped from $4 to $52 per bottle. And some "toxins," like Omega-3 and Omega-6 which are essential for good health, are simply no longer available in the European Union. Health rights advocate John Hammell noted that you can buy cigarettes in any apothecary in France, Germany, or Scandinavia, but vitamin Cwhich is classified as a toxinis now legally banned. Hammell is convinced Big Pharma wants to keep people borderline healthyand borderline sick.
Clearly, the profiteers are not the naturopaths, herbalists and health supplement industryit's the pharmaceutical industry which realizes that many of the cures for the sicknesses that are increasingly plaguing America todaylike cancer, heart disease, and diabeteswill come from the salves, elixirs and medicine capsules of the 18th and 19th century apothacarists who treated their patients with natural supplements, and not from the chemical laboratories of Big Pharma who spend billions to synthesize the natural remedies of their ancestors because the natural supplements, which were "invented" by Dr. God, can't be patented.
The AMA, which now sides with Big Pharma and the CAC, formerly supported a myriad of clinical studies in which they observed that most people do not consume the optimal amount of vitamins. In order to avoid cardiovascular disease, colon and breast cancer, osteopenia, fractures and several chronic diseases it said, "...it appears prudent for all adults to take vitamin supplements." Today, the AMA supports the "scientific" views of the UN CAC chairman Dr. Rolf Grossklaus whowith the help of the pharmaceutical giant, Pfizerestablished the "safe upper limits" for the nonprescription intake of vitamins based on the Nordic Ministries Council recommendations that has already swept clean Europe's apothecary shelves of high potency vitamins and herbal remedies.
German scientist Gerd Stueckler summed it up when he told the Codex committee that the real health risk to people "...lies mostly in the lack of sufficient nutrients." He concluded that "...the whole Codex Alimentarius endeavor is not about protecting the world's health...It's about protecting the profits of pharmaceutical companies and the profits of the health industry."
The FDA's Stealth Attack
Thus far Big Pharma has been unable to get around DSHEA. Congresswomen Susan A. Davis [D-CA] who receives no financial support from the pharmaceutical or medical industry, sponsored HR 3256 to amend the Federal Food, Drug and Cosmetic Act of 1994 with the Dietary Supplement Access and Awareness Act. Co-sponsoring the legislation is John Dingell [D-MI] and Henry Waxman [D-CA]both of whom have friends in, and take contributions from, the healthcare industry. Davis' legislation, posing as a bill that's concerned only about guaranteeing the safety of vitamins and herbal supplements, is actually designed to provide Codex allies in Congress with the ammunition they need to outlaw all nonprescription health supplements based on the theoretical toxicity that Congress believes occurs from unregulated overuse. (The human body is a miraculous devise that can calculate how much of the vitamins in the body it will require, and dumps the unneeded vitaminswith the exception of Vitamin Afrom the body through the bladder.) (Warning: taking extremely heavy doses of any nutrient that exceeds what the digestive system can healthily assimilate is dangerous. If the body can't rid itself of the excess, it will have a toxic affect and, in some rare instances, "overdoses" of vitamins can, and will, kill a person.) In this instance, however, we are speaking of "normal" daily maximums established over the past fifty years or so.
Starting in the late 1950s the FDA, whose thinking was dominated by the American Medical Association [AMA], began a covert investigation of healthcare companies which utilized unorthodox approaches and paid for medications not deemed to be acceptable by the AMA. Throughout second half of the 20th century, the AMA dominated the thinking not only of the medical community but the "medical" thinking of the federal bureaucracy. The views of the FDA were the views of the AMA. If the AMA didn't like certain medical procedures, practices or medications they lobbied whomever they needed to curtail or outlaw the procedure, practice or medication.
Chelation therapy has been used by both medical and osteopathic physicians since the 1980s to reduce or clear blockages in human arteries to prevent heart attacks. The AMA lobbied against chelation and pressured the health insurance industry not to cover the procedure. At a cost of $85 to $125 per procedureand the need for three or more treatments each weekfew people can afford the $255 to $375 per week for up to 10 weeks and, for that reason, few "at risk" people do chelation. However, when the health insurance industry began to compare the cost of providing chelatin therapyat about $3,750 for a complete treatmentagainst the cost of a triple bypass at $85 to $125 thousand, most HMOs and PPOs will now pay for the proceduresbut only if the treatments are ordered by the insured's primary care physician. The AMA, using State and federal medical licensing boards, threaten doctors who use procedures, like chelation therapy, that the AMA opposes. When the licensing boards refuse to kowtow to the AMA, the organization lobbies Congressas they are once again to legalize Codex.
In what has been an undeclared war for much of the past century, most of the medical associations in the country spend exorbitant sums to fund slanderous media attacks against what the AMA and the FDA construe to be "quacks"herbalists and naturopaths pretending, they claim, to be doctors. Depending on the effectiveness of the naturopathic treatment or the cure rate of the herbal remedy, allegationsand sometimes criminal chargeswill be brought by the FDA against the practitioner or herbalist.
On Oct. 28, 1998 the FDA went after www.apricotseeds.org and the website's owner, Jason Vale for promoting apricot seeds as a cancer cure. Vale was a walking billboard for amygdalin. Twelve years earlier he had a deadly form of Ewing's Sarcomaa nasty, fast spreading cancer that kills 50% of those infected. After chest wall surgery, chemotherapy and radiation treatment, Jason's parents tried apricot seeds. The cancer went into remission. Vale became one of the primary advocates of apricot seed therapy. Only on his website, Vale forgot about the surgery and chemo, declaring that his chest tumors were healed by the apricot seeds. Thousands of people flocked to Vale's website and bought amygadalin. But thousands more went to other sites. To whittle down his competition, Vale crossed the line from selling a natural supplement (apricot seeds) to selling a manufactured supplement (serum Laetrile) whose distribution is controlled by the FDA. Vale had ventured into the realm of Big Pharma which was already testing synthetic Laetrile under the brand names Sarcarinase, Nitriloside and Anitoxin which were formulations of malonide, glyoxylide and parabenzoquinone that reportedly promised the curative affects of amygadalinwithout the cyanide toxic side-effects.
In their warning letter to Vale, the FDA said: "This letter is in reference to your promotion and distribution of the unapproved drug Laetrile in the form of your products: 'Apricot seeds,' 'Vitamin B17,' and 'Amygadalin ampules.' Labeling for these products makes therapeutic claims which cause the products to be drugs as defined in Section 201(g) of the Federal Food, Drug and Cosmetic Act. Labeling is now limited to the immediate product containers but includes all promotional material including video tapes which you distribute with your products." The letter, charging civil violations, started a five year legal odyssey that ended in 2003 when Vale was convicted of criminal violations of Section 201(g). In the civil trial that ended in June, 1999 with a summary judgment against Vale and his company for $631,585most of which went to AOL for Vale's spamming AOL email users. Instead of taking his lumps and giving up, Vale changed his company name and continued selling apricot seeds even though the FDA awarded an injunction in federal court that prevented Vale from engaging in the sale or distribution of amygadalinunder any company name.
This time, the FDA filed criminal charges. A jury found him guilty on July 21, 2003. He was sentenced on June 18, 2004. Vale is currently serving a 63 month sentence. He will serve an additional 3 years of supervised release when he completes his prison time. Because all of his assets were seized to satisfy the $631 thousand judgment, Vale was defended in his criminal trial by a public defender. After his conviction, the court learned that Vale had earned over a half million dollars from the sale of Laetrile that the government could not account for. As a result, the court ordered Valewho is pennilessto repay the government $31,000 for his defense.
What happened to Vale is nothing new. The FDA has been the strong-arm of the AMA since its creation by Franklin D. Roosevelt during the New Deal Era when the federal bureaucracy was being created. One of its first victims was a former coal miner and oilman turned herbalist, Harry Hoxsey. His great-grandfather, John Hoxsey, a horse breeder, watched a cancerous lesion on the leg of his favorite horse heal after it ate on a particular clump of shrubs and flowering plants in the Hoxsey pasture. John Hoxsey formulated a herbal liquid, a salve, and a powdered form of the cancer-curing herbs. Hoxsey's fatheralso Johna veterinary surgeon, used his grandfather's remedy on horses. Then quietly, he began treating human patients. When the formula was passed on to Harry he took his show on the road, becoming an itinerant healer for a couple of years before opening the first Hoxsey's Cancer Clinic in Dallas in 1924.
That decision began the protracted battle between Harry Hoxsey and the AMA. Hoxsey was arrested more times (for practicing medicine without a license) than any other "medical quack" in the history of the United States. But none of his patients ever testified against him. Why? Because Hoxsey's treatment worked. In 1946 Mildred Nelson, a registered nurse, was introduced to his name when her mother, Della Mae, went to Hoxsey's Clinic to have her cancer treated. Believing he was a quack, Mildred left her home in Jacksboro, Tennessee and went to Dallas to stop her mother from wasting her money. Instead of dying, her mother's cancer disappeared. Mildred became a believerand Hoxsey's nurse. Mildred's father, who was battling cancer in the eye socket, and had already lost one eye to cancer, was also treated by Hoxsey. He became cancer-free and lived until 1957 when he died from meningitis.
The medical orthodoxy labeled Hoxsey as the "worst cancer quack of the century." The AMA and the FDA branded his elixirs and salves as "useless backyard weeds" and the American Cancer Society added Hoxsey to its blacklist. In 1968eight years after the FDA banned the sale of all Hoxsey medications. FDA investigators would go to the homes of Hoxsey's patients and seize their medications, telling them that the elixir was worse than the disease, and would kill them before the cancer did.
Eminent botanist, James Duke, Ph.D, of the US Department of Agriculture, testified that all of the Hoxsey herbs contain known anti-cancer properties. All of the herbs in the Hoxsey formulasbloodroot, licorice, red clover, burdock root, stillingia root, berberis root, poke root, cascara, prickly ash bark and buckthorn barkare cited in the book, Plants Used Against Cancer, a compendium of medicinal plants by National Cancer Institute scientist Jonathan Hartwell. After the FDA banned the Hoxsey formula, Dr. J.W. Fell of the Middlesex Hospital in London developed a paste made from bloodroot and applied to a malignant growth on a patient in the hospital. Within two weeks Dr. Fell's paste destroyed the cancer completely. Fell's team expanded the study, healing cancers of the nose, external ear, and other external cancersusing the quack's bloodroot salve.
A group of 10 medical doctors visited Hoxsey's clinic for a 2-day inspection tour in 1954, and examined hundreds of case histories and interviewed scores of current patients. At the conclusion of their investigation, the doctors released a report stating the clinic "...is successfully treating pathologically-proven cases of cancer, both internal and external, without the use of surgery, radium or X-ray...Some of those presented before us have been free of symptoms as long as 24-years, and the physical evidence indicates that they are all enjoying exceptional health at this time. We, as a committee, feel that the Hoxsey treatment is superior to such conventional methods of treatment as X-ray, radium or surgery. We are willing to assist this Clinic in any way possible in bringing this treatment to the American public." That was not to be. The AMA buried the report. Hoxsey remained a quack, and the FDApushed to do so by the AMAsucceeded in banning the Hoxsey formulas from reaching the public six years later. America would likely be cancer free today if we did not have the heavily politicized FDA running the gauntlet for the bureaucrats in the AMA who really don't want to see cures for any of the most profitable disease since it will adversely affect the livelihood of their members who earn above average incomes treating those who are suffering and dying from those diseases.
In addition to going after those whom the medical community has labeled as quacks, the AMA supports quack-watch groups like the National Council Against Heath Fraud. NCAHF ratchets up public opinion against health care professionals who step across the great orthodoxy divide as the group of doctors did by visiting the Hoxsey Clinic. Doctors who recommending vitamins and natural supplements to their patients instead of the usual regulated drugs, or those who recommend chelation therapy or other unorthodox treatmentsregardless how effective the the alternative treatments may be are also branded as quacks. About one-third of all adults in America currently use, or have used, some form of unconventional medical treatment. Many go to chiropractors. Some go to massage therapists. Many pregnant women go to midwives instead of medical obstetricians. The percentage of Americans who use natural healing methodsand herbal medicationsis increasing dramatically much to the dismay of the AMA and its strong-arm enforcer, the FDAthus, the reason and the appeal by the AMA and the FDA for Codex. And, of course, the very reason that the FDA is now resorting to a new strong-arm tactic.
Over the past two years the FDA has embarked on a new ploy to intimidate natural health advocatesattacking and threatening them with legal action or criminal prosecution for minor infractions in labeling or advertising. In many cases, the FDA holds administrative hearings that are equivalent to biased trials can virtually shut down the operations of the offending natural health company. If the consumer fights back, more times than not, the FDA will then pursue criminal action.
The letter (below) listed in its entirety, was sent to Jeffrey Grimmer of Grimmer Enterprises in North Mankato, Minnesota by the FDA last June. It begins:
Dear Mr. Grimmer:
On July 22, 2004, an investigator with the United States Food and Drug Administration (FDA) collected a sample of American Ginseng capsules from you. You informed the investigator that you had purchased the Ginseng from Shang Gardens, Inc., and that you then market it on the Internet.
The 50 count bottles of American Ginseng capsules that were collected from you were labeled, in part, MFG. SHANG GARDENS and the lot number was identified as 110154. The label identifies this product as a dietary supplement and, as such, it is a food within the meaning of Sections 201 (f) and 201(ff) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 321(ff)].
You can find the Act on the Internet through links on FDA's web page at www.fda.gov. Our review of your labeling for your American Ginseng product found on your website at http:// www.shanggardens.com revealed that you made claims that cause your product to be a drug under the Act. Labeling is not limited to the immediate product container but, as defined in Section 201(m) of the Act [21 U.S.C. 321(m)], includes all promotional material you distribute in connection with your products.
Specifically, we have determined that your American Ginseng product is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. The therapeutic claims on your website establish this product as a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of some of the claims observed on your website include: Home Search 12/8/05 11:42 AM Warning Letter to Page 1 of 3 http://www.casewatch.org/FDA warning/prod/2004/grimmer.shtml 1. Under the icon for "what is American ginseng?"
Your website states, "(g]inseng has been shown to.. .lower cholesterol, prevent infections,. . . aid in cancer treatment, arthritis and impotency to name a few cases." 2. Under the icon for "key benefits of ginseng use" A. Your website states, "cardiovascular health. . . restore blood pressure after shock and heart attacks." "[r]eport that ginseng helps to reduce high blood pressure." "[S]everal studies suggesting that ginseng reduces cholesterol in the circulation." "American ginseng is the most successful at lowering cholesterol levels. . ." B. Your website also states, "Prevent infections..." "Cancer Treatment." "[S]tudies have shown that patients given a regular dose of ginseng were able to better cope with increased anticancer drugs." C. It further states, "Diabetes...it has an effect on diabetes..." "It has also lowered blood sugar levels..." D. In addition, it states, "[D]octors noticed striking improvements when using ginseng in the treatment of patients suffering form impotence." E. Finally,, your website states, "[H]elps to treat cardiovascular diseases..." "[G]enseng reduces their arthritis substantially. One gentlemen was so crippled up with arthritis he was unable to climb to his deer hunting stand. After taking ginseng for some period of time, he described his arthritis as being 80% gone."
Furthermore, FDA has no information that your American Ginseng product is generally recognized as safe and effective for the above-referenced conditions and therefore, the product may also be a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law.
Many of these products may be legally marketed as dietary supplements or as cosmetics if therapeutic claims are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations.
Under the Act, as amended by the Dietary Supplement Health and Education Act (DSHEA), dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (structure/function claims), if certain conditions are met. However, claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims), excepting health claims authorized for use by FDA, cause the products to be drugs.
The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at http://vm.cfsan.fda.gov/~lrd/fr000106.html [codified at 21 C.F.R. 101.93(g)].
In addition, the Ginseng capsules were analyzed by FDA to determine compliance with the Act. Analysis of the capsules found pesticide chemicals for which no tolerance levels have been established. As a result, the product constitutes an article of food that was adulterated when introduced into and while in interstate commerce, and was adulterated while held for sale after shipment in interstate commerce, within the meaning of Section 402(a)(2)(B) of the Act [21 U.S.C. 342(a)(2)(B)]. The article bears and contains pesticide chemical residues, namely Pentachlorobenzene, Quintozene, Pentachloroaniline and Lindane, that are unsafe within the 12/8/05 11:42 AM Warning Letter to Page 2 of 3 http://www.casewatch.org/fdawarning/prod/2004/grimmer.shtml meaning of Section 408(a) of the Act [21 U.S.C. 346a(a)], because no tolerance or exemption from the requirements of a tolerance is in effect for the pesticide chemical residue on the article of food.
This letter is not intended to be an all-inclusive review of your website and products your firm may market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. Failure to do so may result in regulatory action, without further notice, such as seizure and/or injunction. You should notify this office, within 15 working days of the receipt of this letter, of the specific steps you have taken to correct the noted violations.
You should direct your reply to Compliance Officer Jane Nelson at the address on the letterhead. She may be reached at (612) 758-7119 if you have any questions.
Charles Becoat, Director
Since January, 2004 the FDA has mailed hundreds of these warning letters to Internet entrepreneurs all over the United States. Most of those targeted are not large companies with internal legal departments and lawyers on the payroll, or those with the funds to hire a major law firm to assist them. Most are family businesses. Not all of them are selling vitamins and herbal supplements although it appears the bulk of those singled out for scrutiny and harassment have been targeted for trivial violations of the Federal Food, Drug and Cosmetic Act. Some are family farms selling basic food itemslike apples...or cherries.items that no reasonable mind would construe as a regulated "drug."
The King Family are fruit farmers in northern Michiganin the heart of the tart cherry growing district. They farm 300 acres and employ about three dozen people from the community. They are, in every sense of the word, a family-owned and operated business. Like thousands of Internet entrepreneurs around the country last year and this, the King Family received a polite warning from the FDA earlier this year advising them that by discussing potential health benefits of Montmorency tart cherries on their website and in their promotional literature, they violated the law, and because they did, the FDA believes it can legally classify the cherries as a drug under Section 201(g)(l)(B) or the act USC 321(g)(I)(B), and place the cherriesand the King Familyunder the jurisdiction of the FDA.
The King Family farm, like hundreds of family farms in the country, is economically threatened by unfair and many times illegal competition from overseas. and from the agri-giants in the United States pushing down wholesale prices in order to bankrupt their independent competition, is struggling for its existence. To survive, many of these family farms have been forced to adopt direct marketing strategies utilizing the Internet to bypass the wholesalers (who are usually owned by the agri-giants) and sell direct to the public. But to do so, the farmer must be able to sell the benefits of his product over those found in the local supermarket.
Fighting back as best they can over the Internet, the King Family sent out a broadcast email in which they said: "...This is a serious and unconstitutional abrogation of our right to freedom of speech. We are being threatened with action if we do not cease publishing scientific research abstracts on the Internet. It is very disturbing that we are being asked to register cherries as a new drug when cherries have been safely consumed for centuries, while at the same time the same agency approved drugs such an Vioxx, Celebrex, and many others for which there are now substantial reports that these drugs have marked deleterious effects on people's health. We did not seek out, nor wish to engage in a legal or mass media battle with any governmental agency, but this is our legitimate, ethical and honest business livelihood that is being threatened. As small, independent family farmers, we do not have the resources nor lime to battle a federal agency that we suspect is, more interested in protecting the private interests of the pharmaceutical industry than it is in protecting public health. We are left to reach only one conclusion about this: in order to protect the profits of the pharmaceutical industry, the FDA is willing to trample free speech rights, public health, and family farmers. We request your assistance and input on this issue before it spins out of control and has a negative and chilling impact on agricultural, public health, and freedom of speech issues. The King Family 1-877-937-5464 November, 2005."
The FDA is tackling more than just the family farm or the one-man Internet health supplement entrepreneur. It will go after any business owner who sells any products in which health-related claims are made. In 1990 the FDA raided and ransacked 57-year old Sissy Harrington-McGill's pet storewithout the benefit of a search warrant as required by the 4th Amendment because literature McGill gave to her customers claimed that vitamins help keep pets healthy.
What is even more shocking is that when McGill's day in court arrived, she exercised her 7th Amendment rights to demand a jury trial. The federal judge denied her request, telling her he would decide her case. McGill was convicted of violating the Health Claims Acta law that had not even been enacted when the FDA broke into her store, was still not enacted when the judge sentenced her to 179 days in jail and fined her $10,000; nor was it enacted 114 days later when the judge was forced to free her from jail for breaking a law that did not exist. In fact, the Democratically-controlled Congress in 1990 could not muster the votes to enact the bill into law. McGill filed a lawsuit against the FDA. Even though her constitutional rights were violated twice by the FDA and once by a federal judge, it is not likely she will even see a cash award. But the FDA succeeded in doing what it was trying to doit closed McGill's business because she mentioned the health benefits of vitamins.
In 1992 the unlocked office door of Dr. Jonathan Wright's natural health clinic in Kent, Washington was kicked in by FDA agents wearing kevlar vests who rushed into the waiting room with drawn guns, shouting at the patients and office personnel to "Freeze!" and "Put Up Your Hands!"
What crime did Dr. Wright commit? The FDA had previously banned a contaminated batch of Vitamin B pills found in another State. Wright was not connected to that incident, nor had he ever sold contaminated vitamins. The FDA knew that, but they decided that since Dr. Wrighta M.D.practiced nutritional medicine and preventative health methodology, his clinic should be raided and checked out. Wright's patients were treated like criminals. Wright's employees were held at gunpoint while the FDA agents ransacked his office. Computers, files, records, mailing lists, supplies, were all confiscated. About all that was left were the carpets, pictures on the wall, empty file cabinets and desks. No charges were ever filed against Wright or any of his employees, but none of his files or equipment were ever returned. The FDA accomplished what it set out to doit closed down Wright's nutritional medical practice.
In May and September, 1993 approximately 40 natural healing clinics, health food stores and independent vitamin manufacturers had a "Wright-experience" as commando-garbed FDA agentssometimes accompanied by DEA and IRS agentsraided their businesses. Seized by the FDA and/or DEA were any controlled substances that could legally be prescribed by the medical doctors who operated the clinics, vitamins, herbs and other nutritional supplementsincluding shark cartilage which had become the latest health fad. The IRS seized both personal and company financial records and bank accountsand the personal and corporate automobiles, office or home electronic equipmentand anything else of value. The government very carefully stripped the "suspects" of any means to raise funds that could be used to hire lawyers.
But, just as it was with Dr. Wright, no charges were ever filed against any of the victims of the FDA's latest outrages. Among those raided in September was Dr. Kurt Donsbach. the author of several self-help nutrition books. His home was raided and his personal checking account was arbitrarily seized. Tragically, long before the passage of the Patriot Act, the Bill of Rights was been thumbed by the unconstitutional federal enforcement agencies of the bureaucracy as it enforced edicts emanating from the AMA. None of the seized items were returned.
The raids demonstrate not only an erosion of the principles of the rule of law, but a federal bureaucracy that is no longer controlled by the principles of democratic governance. Continually, we see policy agencies of government are being controlled and manipulated by the special interest groups that are legally allowed to bribe elected officials by contributing large sums of money to their reelection campaigns, thereby gaining political favors that should never have been granted either by the politician or the bureaucratic minion playing the inside-the-beltway favor game.
One of the two most dangerous lobbies affecting the American people today is the AMA. The mainstream, orthodox medical community has a vested interest in codifying Codex Alimentarius as quickly as possiblewith or without the needed legislation ever being proffered by Congress. Why?
Because it is becoming increasingly clear that as they realize what's going on, the American people have a problem with an international agency of the UN limiting their ability to buy vitamin supplementsand herbal remedies that have proven they work but are banned not because they have adverse side affects but because the pharmaceutical industry will lose money if more effective, safer and cheaper nutrients will cure or alleviate medical problems experienced by those who currently must rely on traditional medical practitioners who, themselves, rely on surgery and chemical drugsmany with adverse side affects as bad, or worse, than the medical problems they purport to alleviate. For example, FDA-approved Lamisil tablets are designed to treat mild to severe toe nail fungus infections. Is nail fungus a life-threatening condition? Of course not. You simply have thick, ugly toe nails. However, the side affects to using Lamisil can be life threatening. The side affects include possible liver damage. Tell me, which is worse? Liver damage or ugly toenails? So, why aren't the commando-style FDA agents storming the local podiatrist's office? Because Big Pharma created Lamisil and the FDA approved it. Need I say more?