A True History of the FDA

By Laima Jonusiene, MD, Prof of Medicine Desire’ Dubounet, D. Sc. L.P.C.C

There clearly are Frauds and Charlatans plotting and scheming to get money from people selling
deceit. And in Health care people get desperate or they are gullible and become easy targets.

There are some well-intentioned dim-witted people making remedies and devices for sale to the
people. And these people need control, rules and regulations to protect the people.

There are very Rich people who try to push remedies and devices onto people without proper control
and validation of their sales claims. The Extreme Gravity of this Story will really AMAZE You. REALLY !!

There are good professional people who sometimes need upright help in protecting the people.

So there is a dramatic need to make a regulatory body such as the FDA. Dr Wiley in 1906 saw the
dangers of uncontrolled vaccinations, white sugar especially sugar drinks, cocaine in coca cola, heroin
for toothaches, and especially bad food preparing. Dr Wiley said that Americans were committing
suicide by over eating bad foods. He fought to protect the people from bad foods, bad remedies,
addictions and false claims. Dr Wiley and Dr Royal Copeland fought to protect Homeopathy inside the
FDA. Many good people helped build the FDA and many good people work for the FDA to protect us.

JFK found there is a group of Ultra-Rich conspirators who plot to enslave every man woman and child.
JFK was killed before he could expose them. What they fear most is Equal Economic Education.
Lincoln, FDR, JFK, RFK, Martin Luther King were all killed after they fought for equal economic
education. Richard Nixon dealt fully with Watergate and was reelected. On the day after his reelection
he announced the 1972 Equal Education Act to distribute tax money equally. Within days Watergate
was rehashed and Nixon removed in disgrace. The Ultra-Rich stop any who try to discuss Equality.
There is a very BIG EXPOSE’ Story here, Beyond Belief. Read more at: www.equal-chances.com

The Ultra-Rich have bought the FDA and they seek to control the public to only use SINthetic drugs
and they attack drugless therapies. This is a story of the potential of the FDA. There is a need for
someone to tell and document the history of the FDA and the issues of money and control. Here it is:
 TABLE OF CONTENTS

Jenner and Hahnemann revolutionize medicine 1798….. 3

Origins of federal food and drug regulation vaccine act 1813… 4

Advent of Synthetics 1856 7

Food + Drug Act protects homeopathy by Dr Wiley 1906 8

Federal Reserve System secretly provides for the Ultra-Rich 1913 16

Food, Drug, and Cosmetic Act with Dr Royal Copeland protecting the HPUS 1938 18

When they mention Equal Economic Education FDR, JFK, RFK, MLK are killed, Nixon disgraced.. 29

FDA adds medical devices to its control of claims and quality 1976 30

Drug Price Competition and Patent Term Restoration Act 1984.. 31

Nelson writes the PROMORPHEUS that proves SINthetics are an insult to the body 1985 31

The first Energetic Medicine device gets registered EPFX 1989…. 34

Nelson and Turner get the FDA to make acupuncture real medicine 1996 35

Marijuana becomes somewhat legal 2012 38

FDA finally controls trans-fats… 40

FDA ignores evidence about the problems of Sugar 40

8-8-2008 the USA takes away all rights of Privacy + Rupert Murdock buys the Wall St Journal 49

Tobacco Control Act of 2009 makes the FDA protect Tobacco sales 53

Geo Bush Jr sells America to the Drug Co with Pharmaceutical Liability act 2007 60

The FDA launches a main attack on Natural medicine 66

The FDA rejects Electronic drugs CES but then opens the door a crack 73

The FDA constantly tries to Destroy Homeopathy 77

Laws are passed that if you do not take your medication- you are placed in a concentration camp.. 76

The WHPRS- World Health Products Ratings Service provides consumer advice 2011… 78

So where are we and where do we go from here 86

 Jenner and Hahnemann Revolutionize Medicine
Jenner was basically a homeopath. Both Jenner and Hahnemann were developing their ideas of
medicine in the late 1790’s. They had a similar mind that “like would treat like”. Both vaccination and
homeopathy started at the same time of a similar philosophy. Using natural agents with minimum
alteration and what causes a disease might help the body to deal with or remove a disease. Medicine
was advanced by Jenner in 1797 and Hahnemann 1798 who both saw the power of using natural
occurring substances in small amounts to treat disease. Stubborn people still attack vaccination.

But greed drove some people to use inferior and fraudulent items to make remedies that did not work
or sometimes hurt people. In the early 1800s hundreds of people were making and selling untested
remedies, poor vaccinations, untried potions, and unverified medicines. It was BIG BUSINESS and there
were no laws to stop or impede the sales of any remedies. Thousands were reported to have died taking
dangerous vaccinations and other false medicinal compounds. Misunderstanding of homeopathy, lack of
standards, poor education all contribute to poorly made homeopathics. People are hurt by dangerous
toxic plants and poorly made vaccinations. You must understand that this was ages ago and even the
concept of standards and the idea of quality control was foreign and not understood by any of the
masses. There was a distinct need for an agency to provide control, rules, regulations, science, testing,
validation and verification of quality control systems and validation and verification of manufacturer
claims. The people need to know if a company’s products are good + claims are valid or not.
 Origins of Federal Food and Drug Regulations
Because of the extreme dangers to health the law makers sought to make laws to protect the people.
There were few federal laws regulating the contents and sale of domestically produced food and
pharmaceuticals, with one exception being the short-lived

Vaccine Act of 1813.

This act was the first to prohibit barbers from doing surgery. Till then if you needed surgery you went
to the barber.

The Act was the first federal law concerning consumer protection and pharmaceuticals.

It was passed 27-Feb-1813 and repealed 4-May-1822 and the authority to regulate vaccines given to
the states. This was the result of inept government control and an 1821 outbreak of smallpox in
North Carolina, which was traced to contaminated vaccine provided by Dr. John Smith while in the
capacity of the federal agent charged with preserving and distributing genuine vaccine

Success + Failure from 1822 to 1883

Hahnemann coins the word Allopathy meaning someone who treats symptoms only. Allopaths
of this time are using harsh chemicals and heavy metals such as mercury. Mercury vapors are
used to treat sinus infection; the vapors kill the infection but liquefy the brain.
From 1800 to 1890 Homeopathy Flourishes around the World and in America. Before + During
the Civil War there are more Homeopathic Hospitals in the US than Allopathic. After the Civil
War there is a Flu outbreak in America. 10,000 + patients go Homeopaths and 98% of them
LIVE. 10,000 + patients go to Allopath’s and 97% of them DIE.
After the civil war there was a period of financial growth of the chemical companies that starts
to put pressure onto Hospitals and Medical schools to stop doing homeopathy.
 The mid 1800s- Advent of SINthetics
The first medicinal drugs came from natural sources and existed in the form of herbs, plants, roots, vines
and fungi. Until the mid-nineteenth century (1869) nature's pharmaceuticals were all that were available to
relieve man's pain and suffering.

1856 William Henry Perkin discovered the first synthetic dye stuff "Mauve" (aniline, a basic
dye) while searching for a cure for malaria and a new industry was begun.

The first synthetic drug, chloral hydrate, was discovered in 1869 and introduced as a sedative-hypnotic; it
is still available today in some countries. The first pharmaceutical companies were spin-offs from the
textiles and synthetic dye industry and owe much to the rich source of organic chemicals derived from the
distillation of coal (coal-tar). The first analgesics and antipyretics, exemplified by phenacetin and
acetanilide, were simple chemical derivatives of aniline and p-nitrophenol, both of which were byproducts
from coal-tar. The late 1800’s saw many harmful and addictive compounds used by allopaths.

Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting
research into the adulteration and misbranding of food and drugs on the American market. Wiley was
very concerned with the problems he saw developing with the sugar industry. He saw the need to stop
the use of bastardized sugar to get children sugar addicted. Wiley also proposed legislation to control
vaccinations and prevent the use of bad chemicals and other agents in them. Wiley was a chemist but
his appreciation for homeopathy and natural medicine drove his desire to stop profiteers from
bastardizing foods. A true hero of our times Wiley sought to fight gluttony, addiction and negligence.

Aspirin is the most widely-used medicinal compound in the world, and it has a long history. Around 400
BC, Hippocrates, the "father of medicine" and the namesake of the Hippocratic oath taken by all
physicians, administered willow-leaf tea (containing the natural compound from which aspirin is
derived) to women during childbirth to ease pain. German chemist Friedrich Bayer developed aspirin
(acetylsalicylic acid) in 1897, and it became a valuable over-the-counter drug in 1915.

An extract from the bark of the white willow tree had been used for centuries to treat various fevers and
inflammation. The active principle in white willow, salicin or salicylic acid, had a bitter taste and irritated
the gastric mucosa, but a simple chemical modification was much more palatable. This was
acetylsalicylic acid, better known as Aspirin®, the first blockbuster SINthetic drug. At the start of the
twentieth century, the first of the barbiturate family of drugs entered the pharmacopoeia and the rest,
as they say, is history. Wiley saw problems with SINthetics, Sugar Drinks, Vaccinations, addictions to
cocaine heroin, simple food preparations were killing people. Wiley saw the need to protect the people.

Wiley and his Division published its findings from 1887 to 1902 in a ten-part series entitled Foods and
Food Adulterants. Wiley used these findings, and alliances with diverse organizations such as state
regulators, the General Federation of Women's Clubs, and national associations of physicians and
pharmacists, to lobby for a new federal law to set uniform standards for food and drugs to enter into
interstate commerce. Wiley's advocacy came at a time when the public had become aroused to hazards
in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for
increased federal regulations in matters pertinent to public safety during the Progressive Era.[21] The
1902 Biologics Control Act was put in place after diphtheria antitoxin vaccination was collected from a
horse named Jim who contracted tetanus, resulting in several deaths. Wiley, a hero, believed in
Homeopathy and he sought to make the FDA to protect homeopathy, and still it still is.
The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of
Agriculture's Division of Chemistry (later Bureau of Chemistry). Under Harvey Washington Wiley,
appointed chief chemist in 1883, the Division began conducting research into the adulteration and
misbranding of food and drugs on the American market. Wiley made a stand against sugar drinks.
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the
"Wiley Act" after its chief advocate. The Act prohibited, under penalty of seizure of goods, the interstate
transport of food which had been "adulterated", with that term referring to the addition of fillers of
reduced "quality or strength", coloring to conceal "damage or inferiority," formulation with additives
"injurious to health," or the use of "filthy, decomposed, fraudulent or putrid" substances.
Swann says that one of the first major challenges to drug regulation came in 1910 when the government
seized a large quantity of a worthless product called Johnson's Mild Combination Treatment for Cancer.
In U.S. v. Johnson, the Supreme Court ruled against the government, finding that the product's false
claims for effectiveness were not within the scope of the Pure Food and Drugs Act.

Samuel Hopkins Adams (January 26, 1871 – November 16, 1958) was an American writer, best known
for his investigative journalism and muckraking. Working with Lincoln Steffens, Ida Tarbell, and Ray
Stannard Baker. Adams considered himself a freelance writer and used his writings to support himself.
In 1905 Adams was hired by Collier’s Weekly, he prepared articles on patent medicines.[1] In a series of
eleven articles he wrote for Collier's Weekly in 1905, "The Great American Fraud", Adams exposed many
of the false claims made about patent medicines, pointing out that in some cases these medicines were
damaging the health of the people using them. The series had a huge impact and led to the passage of
the Pure Food and Drug Act of 1906. In 1911, the Supreme Court ruled that the prohibition of
falsifications referred only to the ingredients of the medicine. This meant that companies were again
free to make false claims about their products. Adams returned to the attack, and in another series of
articles in Collier's Weekly, Adams exposed the misleading advertising that companies were using to sell
their products. Linking his knowledge of newspapers with patent medicines to expose fraud.

Congress enacted the Sherley Amendment in 1912 to overcome the ruling in U.S. v. Johnson. This
amendment prohibited labeling medicines with false therapeutic claims intended to defraud the
purchaser. But the amendment wasn't ideal. The government still had to prove that there was intent to
defraud. The contention of proof was on the FDA to prove that were was intent to fraud. The fact that
there was negligence of harm was not enough. This was designed to help these businesses get
established but it will backfire later as time goes by.

"To establish fraud, the bureau had to show that the manufacturer knew the product was worthless,
and this proved difficult in many cases," Swann says. For example, Lee Barlett, a former shirt salesman
from Pittsburgh, promoted a medicine called Banbar as being effective for diabetes. Banbar was an
extract of horsetail weed. The government took Barlett to court for selling a misbranded drug and even
showed the death certificates of people with diabetes who had taken Banbar. But the jury ruled in
Barlett's favor.

A patchwork of state laws provided varying degrees of protection against unethical sales practices, such
as misrepresenting the ingredients of food products or therapeutic substances. Although they had no
regulatory powers.

But following is a sample of reasons why we needed a regulatory body like the FDA.
 The 1906 Food and Drug Act and creation of the FDA
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the
"Wiley Act" after its chief advocate.[21] The Act prohibited, under penalty of seizure of goods, the
interstate transport of food which had been "adulterated", with that term referring to the addition of
fillers of reduced "quality or strength", coloring to conceal "damage or inferiority," formulation with
additives "injurious to health," or the use of "filthy, decomposed, or putrid" substances. The act applied
similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength,
quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the
United States Pharmacopoeia or the National Formulary. The act also banned "misbranding" of food and
drugs.[22] The responsibility for examining food and drugs for such "adulteration" or "misbranding" was
given to Wiley's USDA Bureau of Chemistry.[21]

Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of
foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial
decisions, as well as by the creation of the Board of Food and Drug Inspection and the Referee Board of
Consulting Scientific Experts as separate organizations within the USDA in 1907 and 1908 respectively. A
1911 Supreme Court decision ruled that the 1906 act did not apply to false claims of therapeutic
efficacy,[23] in response to which a 1912 amendment added "false and fraudulent" claims of "curative or
therapeutic effect" to the Act's definition of "misbranded." However, these powers continued to be
narrowly defined by the courts, which set high standards for proof of fraudulent intent.[21] In 1927, the
Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug,
and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three
years later.[24]

1913 Federal Reserve System starts the system of control for the Ultra-Rich

The Federal Reserve System (which is no more Federal than Federal Express), often referred to as the Federal
Reserve or simply "the Fed," is the 3rd central bank of the United States and it takes over the top spot. It was
sneaked by the Congress to provide the nation with a safer, more flexible, and more stable monetary and
financial system. But since it owners are unknown and no one ever audits the fed it is used to make money for
it’s owners not the USA. The Federal Reserve was created on December 23, 1913, when President Woodrow
Wilson signed the Federal Reserve Act into law.
 The 1938 Food, Drug, and Cosmetic Act
By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began
mounting a campaign for stronger regulatory authority by publicizing a list of injurious products which
had been ruled permissible under the 1906 law, including radioactive beverages, cosmetics which
caused blindness, and worthless "cures" for diabetes and tuberculosis. The resulting proposed law was
unable to get through the Congress of the United States for five years, but was rapidly enacted into law
following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died
after using a drug formulated with a toxic, untested solvent. The only way that the FDA could even seize
the product was due to a misbranding problem: an "Elixir" was defined as a medication dissolved in
ethanol, not the diethylene glycol used in the Elixir Sulfanilamide.

In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the
Food, Drug, and Insecticide organization. The Insecticide industries were able to politic and get removed
from the law. The name was then changed to the Food and Drug Administration (FDA) three years later.

By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began
mounting a campaign for stronger regulatory authority by publicizing a list of injurious products which
had been ruled permissible under the 1906 law, including radioactive beverages, cosmetics which
caused blindness, and worthless "cures" for diabetes and tuberculosis. A homeopathic tragedy
happened in New England with low does arsenic homeopathic that killed many.

The resulting proposed law was unable to get through the Congress of the United States for five years,
but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy,
in which over 100 people died after using a drug formulated with a toxic, untested solvent. The only way
that the FDA could even seize the product was due to a misbranding problem: an "Elixir" was defined as
a medication dissolved in ethanol, not the diethylene glycol used in the Elixir Sulfanilamide.
 1938 FDA, Dr Royal Copeland and Homeopathy
Dr Royal Copeland and some other homeopaths fought to make sure that homeopathy was kept in the
1938 law. The U.S. Congress passed a law in 1938 declaring that homeopathic remedies are to be
regulated by the U.S. Food and Drug Administration (FDA) in the same manner as nonprescription, over
the counter (OTC) drugs. This means that homeopathic medicines can be purchased without a doctor’s
prescription. Unlike conventional prescription drugs and new OTC drugs, which must undergo thorough
testing and review by the FDA for safety and effectiveness before they can be sold, homeopathic
remedies don’t have to undergo clinical trials. They do have to meet legal standards for strength,
quality, purity, and packaging. In 1988, the FDA required that all homeopathic medicines list on the label
the medical problems they're designed to treat. The FDA also requires the label to list ingredients,
dilutions, and instructions for safe use. Full disclosure and validation of safety is the law.

http://en.wikipedia.org/wiki/Regulation_and_prevalence_of_homeopathy

The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 recognized homeopathic preparations as
drugs, but with significant exceptions. A principal sponsor of the Act was New York Senator and
homeopathic physician Royal Copeland, who ensured that homeopathy's own Homœopathic
Pharmacopœia of the United States (HPUS) be included, as it expressed the "self-professed quality
standards" of the homeopathic profession. The finished Act thus created loopholes for the regulation of
homeopathic drugs, and they are thus exempted from many of the rules regulating other drugs. The
inclusion of HPUS in the Act has since been questioned by "lawyers, doctors, homeopaths, historians,
and Food and Drug Administration (FDA) officials."[51]

Homeopathic remedies are regulated by the Food and Drug Administration (FDA), which regulates
manufacturing and other standards that are appropriate for homeopathic drugs, mainly through The
Homœopathic Pharmacopœia of the United States (HPUS)[52] as administered by the Homœopathic
Pharmacopœia Convention of the United States and section 400.400 of the FDA Compliance Policy
Guidance Manual.[53] Homeopathic drugs must be tested for scope of effect, manufactured, and labeled
according to the Federal FD&C Act and the HPUS before they are considered official homeopathic drugs.
Official homeopathic drugs can be marketed according to their classification in the HPUS. They are not
regulated under the Dietary Supplement Health and Education Act of 1994. Many homeopathic drugs
can be sold "over-the-counter"; however, some are classified as prescription-only under all
circumstances, and some are classified as prescription-only in various low dilutions. As with all drugs,
the labeling requirements are important, as that is one of the primary ways the FDA can regulate drugs.
Homeopathic pharmaceutical techniques are not technologically complicated, and the drugs are
generally considered to be biologically safe because they are so diluted to the point where there are no
molecules from the original solution left in a dose of the final remedy.[54]

The FDA makes significant exemptions for homeopathic remedies as compared to other drugs. Here are
a few:[55]

1. They are not required to submit new drug applications to the FDA.
2. They are "exempt from good manufacturing practice requirements related
to expiration dating".
3. They are exempt from "finished product testing for identity and strength".
4. They may "contain much higher amounts" of alcohol than other drugs,
which may contain "no more than 10 percent...and...even less for
children's medications".
By 2007, in the United States, $3.1 billion were spent on homeopathic medicine[56] and 2.3% of the
persons age 18 or over had consulted a practitioner that year.[57] Homeopathy was first established in
the United States by Hans Birch Gram[58] in 1825 and rapidly gained popularity.[59] The height of its
influence was the end of the 19th century where hardly any city with over 50,000 people was without a
homeopathic hospital. In 1890, there were 93 regular schools, 14 of them were fully homeopathic and 8
of them were eclectic. In 1900, there were 121 regular schools, with 22 of them being homeopathic and
10 eclectic.[60] Teaching of homeopathy in the USA declined rapidly in the 20th century. The last purely
homeopathic medical school closed in 1920, although homeopathic electives continued to be offered by
the Hahnemann Medical School in Philadelphia until the 1940s.[61]

According to one study, in 1990, 0.7% of individuals used homeopathy in the year prior to being
questioned; in 1997, 3.4% had used homeopathy at least once in the previous year. According to the
same study, of those who used homeopathy, 31.7% had seen a homeopathic practitioner in the past
year in 1990 and the number dropped to 16.5% by 1997.[62]

The guidelines for homeopathic medicines are found in an official guide, the Homeopathic
Pharmacopoeia of the United States, which is written by a nongovernmental, nonprofit organization of
industry representatives and homeopathic experts. The Pharmacopoeia also includes provisions for
testing new remedies and verifying their clinical effectiveness. In 1938 the HPUS and the Compendium
of Natural Herbs were both registered as remedy documents. In 1962 the HPUS was supported and
renewed. No one appeared to defend the Compendium, so it was drooped.
51. Suzanne White Junod, Ph.D., "An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and
Federal Drug Regulation", Food and Drug Law Journal 55:161-183, 2001
52. Pharmacopoeia Convention of the American Institute of Homeopathy; American Institute of
Homeopathy; Homoeopathic Pharmacopoeia Convention of the United States; National Center for
Homoeopathy (U.S.) (1979). The homoeopathic pharmacopoeia of the United States(8th ed.). Falls
Church, Virginia: American Institute of Homeopathy. OCLC 5880151.
53. "CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed".
54. Milgrom LR (2007). "Conspicuous by its absence: the memory of water, macro-entanglement, and the
possibility of homeopathy".Homeopathy 96 (3): 209–
19. doi:10.1016/j.homp.2007.05.002. PMID 17678819.
55. Isadora Stehlin, Food and Drug Administration Public Affairs Officer, "Homeopathy: Real Medicine or
Empty Promises?", FDA Consumer, December 1996
56. "The Use of Complementary and Alternative Medicine in the United States: Cost Data". National
Center for Complementary and Alternative Medicine. July 2009. Retrieved 2009-08-16.
57. "Costs of Complementary and Alternative Medicine (CAM) and Frequency of Visits to CAM
Practitioners: United States, 2007". National Center for Health Statistics. July 30, 2009.
Retrieved 2009-08-16.
58. Miller, Timothy (1995). America's alternative religions. State University of New York Press, Albany.
p. 80. ISBN 978-0-7914-2397-4.
59. Frederick Karst, Homeopathy In Illinois, Caduceus, 4:2, 1988, pp. 1-33; p. 5
60. Charles S Cameron, Homeopathy in Retrospect, Trans. Stud. Coll. Phys. Philadelp., 27, 1959, 28-33;
p. 30
61. History of Homeopathy, Creighton University Department of Pharmacology, retrieved 2007-07-23
 62. Eisenberg DM, Davis RB, Ettner SL, et al. (1998). "Trends in alternative medicine use in the United
States, 1990-1997: results of a follow-up national survey". JAMA 280 (18): 1569–
1575. doi:10.1001/jama.280.18.1569. PMID 9820257.
63. Nigenda G, Cifuentes E, Hill W (2004). "Knowledge and practice of traditional medicine in Mexico: a
survey of healthcare practitioners".International journal of occupational and environmental health:
official journal of the International Commission on Occupational Health 10(4): 416–
420. doi:10.1179/oeh.2004.10.4.416. PMID 15702756.
64. Sólo médicos especializados podrán ejercer la homeopatía en Colombia, El Observatorio de la
Universidad Colombiana,19 March 2009
65. Dr. Raj Kumar Manchanda & Dr. Mukul Kulashreshtha, Cost Effectiveness and Efficacy of
Homeopathy in Primary Health Care Units of Government of Delhi- A study
66. Arokiasamy, P; M. Guruswamy, T.K. Roy, H. Lhungdim, et al. "World Health Survey,
2003" (PDF). International Institute for Population Sciences. Retrieved 2007-09-07.
67. Alternative Systems of Medicine: Homeopathy, Traditional Chinese Medicine, and Ayurveda,
retrieved March 21, 2008
b
68. WHO: Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide
Review, 2001, retrieved March 21, 2008

Today validation of safety, quality and claims is the law. And if you cannot then you might get sued and
have to validate your claim.

The inability of Homeopaths to do good research has prevented Homeopathy from flourishing. This has
also left homeopathy open for attack from people who can sue if there is no validation for the claims.
Until homeopathy can embrace science it is threatened with extinction.
 How does the U.S. Food and Drug Administration (FDA)
regulate homeopathic remedies?
Because of their long use in the United States, the U.S. Congress passed a law in 1938 declaring that
homeopathic remedies are to be regulated by the FDA in the same manner as nonprescription, over-the-
counter (OTC) drugs, which means that they can be purchased without a physician's prescription. Today,
although conventional prescription drugs and new OTC drugs must undergo thorough testing and review
by the FDA for safety and effectiveness before they can be sold, this requirement does not apply to
homeopathic remedies.

Remedies are required to meet certain legal standards for strength, quality, purity, and packaging. In
1988, the FDA required that all homeopathic remedies list the indications for their use (i.e., the medical
problems to be treated) on the label. The FDA also requires the label to list ingredients, dilutions, and
instructions for safe use.

The guidelines for homeopathic remedies are found in an official guide, the Homeopathic
Pharmacopoeia of the United States, which is authored by a nongovernmental, nonprofit organization of
industry representatives and homeopathic experts.24 The Pharmacopoeia also includes provisions for
testing new remedies and verifying their clinical effectiveness. Remedies on the market before 1962
have been accepted into the Homeopathic Pharmacopoeia of the United States based on historical use,
rather than scientific evidence from clinical trials.

The U.S. Congress passed a law in 1938 declaring that homeopathic remedies are to be regulated by the
U.S. Food and Drug Administration (FDA) in the same manner as nonprescription, over the counter
(OTC) drugs. This means that homeopathic medicines can be purchased without a doctor’s prescription.
Unlike conventional prescription drugs and new OTC drugs, which must undergo thorough testing and
review by the FDA for safety and effectiveness before they can be sold, homeopathic remedies don’t
have to undergo clinical trials. They do have to meet legal standards for strength, quality, purity, and
packaging. In 1988, the FDA required that all homeopathic medicines list on the label the medical
problems they're designed to treat. The FDA also requires the label to list ingredients, dilutions, and
instructions for safe use.

Source: Homeopathy | University of Maryland Medical

Center http://umm.edu/health/medical/altmed/treatment/homeopathy#ixzz3IPoHgxZ4
University of Maryland Medical Center
Follow us: @UMMC on Twitter | MedCenter on Facebook

President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C Act) into law
on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by
mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic
claims in drug labeling without requiring that the FDA prove fraudulent intent. The law also authorized
factory inspections and expanded enforcement powers, set new regulatory standards for foods, and
brought cosmetics and therapeutic devices under federal regulatory authority. This law, though
extensively amended in subsequent years, remains the central foundation of FDA regulatory authority to
the present day.[21]
 Regulation of human drugs and medical devices after 1938

Early FD&C Act amendments: 1938-1958

Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under
the supervision of a medical professional, and the category of "prescription-only" drugs was securely
codified into law by the 1951 Durham-Humphrey Amendment.[21] While pre-market testing of drug
efficacy was not authorized under the 1938 FD&C Act, subsequent amendments such as the Insulin
Amendment and Penicillin Amendment did mandate potency testing for formulations of specific
lifesaving pharmaceuticals.[24] The FDA began enforcing its new powers against drug manufacturers who
could not substantiate the efficacy claims made for their drugs, and the United States Court of Appeals
for the Ninth Circuit ruling in Alberty Food Products Co. v. United States (1950) found that drug
manufacturers could not evade the "false therapeutic claims" provision of the 1938 act by simply
omitting the intended use of a drug from the drug's label. These developments confirmed extensive
powers for the FDA to enforce post-marketing recalls of ineffective drugs.[21] Much of the FDA's
regulatory attentions in this era were directed towards abuse of amphetamines and barbiturates, but
the agency also reviewed some 13,000 new drug applications between 1938 and 1962. While the
science of toxicology was in its infancy at the start of this era, rapid advances in experimental assays for
food additive and drug safety testing were made during this period by FDA regulators and others.[21]

Expansion of premarket approval process: 1959-1985

In 1959, Senator Estes Kefauver began holding congressional hearings into concerns about
pharmaceutical industry practices, such as the perceived high cost and uncertain efficacy of many drugs
promoted by manufacturers. There was significant opposition, however, to calls for a new law
expanding the FDA's authority. This climate was rapidly changed by the thalidomide tragedy, in which
thousands of European babies were born deformed after their mothers took that drug - marketed for
treatment of nausea - during their pregnancies. Thalidomide had not been approved for use in the U.S.
due to the concerns of an FDA reviewer, Frances Oldham Kelsey. However, thousands of "trial samples"
had been sent to American doctors during the "clinical investigation" phase of the drug's development,
which at the time was entirely unregulated by the FDA. Individual members of Congress cited the
thalidomide incident in lending their support to expansion of FDA authority.[25]
http://www.downloads.imune.net/medicalbooks/Birth%20defects%20blamed%20on%20SINthetic%20Morning%2
0Sicness%20Drugs%20a%20History%20and%20Comparison%20with%20Natural%20Medicne.pdf
http://www.downl oads .imune.net/medicalbooks /Bir th%20de fects %20blamed %20on%20 SINthet ic%20M orn ing%20 Sicnes s %20Drugs %20a %20His tory %20and%2 0Comparis on%2 0with% 20Natural %20M edicne.pdfhttp ://www.downloads .im une.net/medicalbooks /Bir th%20de fects %20blamed% 20on%20 SINthet ic%20M orni ng%20 Sicnes s %20Drugs %20a %20His tory %20and%20Co mparis on%20w ith%2 0Natural% 20M edicne.pdf

http://www.downloads.imune.net/medicalbooks/Scientific%20Proof%20that%20Synthetic%20Foods
%20and%20Drugs%20are%20an%20Insult%20to%20the%20Body.pdf
http://www.downloads.imune.net/medicalbooks/Scientific%20Proof%20that%20Synthetic%20Foods
%20and%20Drugs%20are%20an%20Insult%20to%20the%20Body.pdf
The 1962 Kefauver-Harris Amendment to the FD&C act represented a "revolution" in FDA regulatory
authority.[26] The most important change was the requirement that all new drug applications
demonstrate "substantial evidence" of the drug's efficacy for a marketed indication, in addition to the
existing requirement for pre-marketing demonstration of safety. This marked the start of the FDA
approval process in its modern form. Drugs approved between 1938 and 1962 were also subject to FDA
review of their efficacy, and to potential withdrawal from the market. Other important provisions of the
1962 amendments included the requirement that drug companies use the "established" or "generic"
name of a drug along with the trade name, the restriction of drug advertising to FDA-approved
indications, and expansion of FDA powers to inspect drug manufacturing facilities.

These reforms had the effect of increasing the time required to bring a drug to market.[27] In the mid-
1970s, 13 of the 14 drugs the FDA saw as most important to approve were on the market in other
countries before the United States.[27]

The Medical Device Regulation Act or Medical Device Amendments of 1976 was introduced by the
94th Congress of the United States. Congressman Paul G. Rogers and Senator Edward M.
Kennedy were the chairperson sponsors of the medical device amendments.[1] The Title 21
amendments were signed into law on May 28, 1976 by the 38th President of the United
States Gerald R. Ford. All medical devices must be properly registered. The FDA now controls quality
control and manufacturer claims.
One of the most important statutes in establishing the modern American pharmaceutical market was
the 1984 Drug Price Competition and Patent Term Restoration Act, more commonly known as the
"Hatch-Waxman Act" after its chief sponsors. This act was intended to correct two unfortunate
interactions between the new regulations mandated by the 1962 amendments, and existing patent law
(which is not regulated or enforced by the FDA, but rather by the United States Patent and Trademark
Office). Because the additional clinical trials mandated by the 1962 amendments significantly delayed
the marketing of new drugs, without extending the duration of the manufacturer's patent, "pioneer"
drug manufacturers experienced a decreased period of lucrative market exclusivity. On the other hand,
the new regulations could be interpreted to require complete safety and efficacy testing for generic
copies of approved drugs, and "pioneer" manufacturers obtained court decisions which prevented
generic manufacturers from even beginning the clinical trial process while a drug was still under patent.
The Hatch-Waxman Act was intended as a compromise between the "pioneer" and generic drug
manufacturers which would reduce the overall cost of bringing generics to market and thus, it was
hoped, reduce the long-term price of the drug, while preserving the overall profitability of developing
new drugs.

The act extended the patent exclusivity terms of new drugs, and importantly tied those extensions, in
part, to the length of the FDA approval process for each individual drug. For generic manufacturers, the
Act created a new approval mechanism, the Abbreviated New Drug Application (ANDA), in which the
generic drug manufacturer need only demonstrate that their generic formulation has the same active
ingredient, route of administration, dosage form, strength, and pharmacokinetic properties
("bioequivalence") as the corresponding brand-name drug. This act has been credited with essentially
creating the modern generic drug industry.[28]
In 1982 thru 1985 Nelson writes the scientific proof that Synthetics are SINthetics and ‘Any Synthetic is
an Insult to the Body. He proves that Natural medicines are the best way to treat the body. There is
incredible evidence for this including a Nobel Prize treatise.

This disturbs the profit of the Synthetic – SINthetic medicine cartel which use patents to protect their
income. Only patented medicines can be protected because of discrepancies in the law. The Chemical
cartel seek to stop any discussion of synthetics being and insult. The get the FDA to trump up false
charges against Nelson to try to stop his exposure of the truth.
http://syntheticissinthetic4u.com
Sworn on the Altar -- https://www.youtube.com/watch?v=Z14C9n8XGCQ
 FDA reforms in the AIDS era

Concerns about the length of the drug approval process were brought to the fore early in the AIDS
epidemic. In the mid- and late 1980s, ACT-UP and other HIV activist organizations accused the FDA of
unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged
large protests, such as a confrontational October 11, 1988 action at the FDA campus which resulted in
nearly 180 arrests.[29] In August 1990, Dr. Louis Lasagna, then chairman of a presidential advisory panel
on drug approval, estimated that thousands of lives were lost each year due to delays in approval and
marketing of drugs for cancer and AIDS.[30]

Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life
threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment
options.[31] The first of these new rules was the "IND exemption" or "treatment IND" rule, which allowed
expanded access to a drug undergoing phase II or III trials (or in extraordinary cases even earlier) if it
potentially represented a safer or better alternative to treatments currently available for terminal or
serious illness. A second new rule, the "parallel track policy", allowed a drug company to set up a
mechanism for access to a new potentially lifesaving drug by patients who for various reasons would be
unable to participate in ongoing clinical trials. The "parallel track" designation could be made at the time
of IND submission. The accelerated approval rules were further expanded and codified in 1992.[32]

All of the initial drugs approved for the treatment of HIV/AIDS were approved through accelerated
approval mechanisms. For example, a "treatment IND" was issued for the first HIV drug, AZT, in 1985,
and approval was granted just two years later in 1987.[33] Three of the first five drugs targeting HIV were
approved in the United States before they were approved in any other country.

Challenges to FDA authority by states

In two instances, state governments have sought to legalize drugs which have not been approved by the
FDA. Because federal law overrules conflicting state laws, federal authorities still have the authority to
seize, arrest, and prosecute for possession and sales of these substances, even in states where they are
legal under state law.

The first wave was the legalization by 27 states of laetrile in the late 1970s. This drug was used as a
treatment for cancer, but scientific studies both before and after this legislative trend found it to be
ineffective.[34][35] Federal law enforcement prevented interstate shipment, making the drug infeasible to
manufacture and sell. Further studies based on a Mexican formulation also showed no effectiveness in
treating cancer, but did find that some patients experienced symptoms of cyanide poisoning. Though
the political movement died out in the 1980s, FDA enforcement actions against laetrile purveyors
continued into the 2000s.[35]

The second wave concerned medical marijuana in the 1990s and 2000s. Though Virginia passed a law
with limited effect in 1979, a more widespread trend began in California in 1996. The Obama
Administration de-prioritized enforcement of federal law against patients using the drug in compliance
with state law, resulting in a de facto legalization. Recreational marijuana is now legal in some places.

Twenty-three states and the District of Columbia currently have laws legalizing marijuana in
some form.
Four states have legalized marijuana for recreational use. Alaska and Oregon will become the
next states where recreational marijuana is legal after voters approved cannabis ballot measures
set to become effective in 2015. District of Columbia voters also recently overwhelmingly
approved a ballot initiative legalizing recreational-purpose marijuana that will be subject to
Congressional review. Colorado and Washington previously passed similar ballot measures
legalizing marijuana in 2012.
Other states have passed medical marijuana laws allowing for limited use of cannabis. Some
medical marijuana laws are broader than others, with types of medical conditions that allow for
treatment varying from state to state. In some states, criminal penalties have been eliminated for
small amounts of marijuana.
The map below show states legalizing marijuana use for medical and recreational purposes.
Information below is current as of Jan. 20, 2015.

Marijuana Legalization Status

Medical marijuana legalized
Marijuana legalized for recreational use
No laws legalizing marijuana
http://medicalexposedownloads.com/PDF/Barack%20Obama%27s%20comments%20that%20marijua
na%20is%20no%20more%20dangerous.pdf

Dangers of weed
https://www.youtube.com/watch?v=fuJPrjEAzeE

Further information: Medical cannabis in the United States

 http://youtu.be/Ah88gjejCTU short story of sugar
http://www.downloads.imune.net/medicalbooks/The%20story%20of%20Sugars%20with%20Key%20
Articles%20from%20The%20New%20England%20Journal%20of%20Medicine.pdf

http://www.downloads.imune.net/medicalbooks/Why%20Not%20Dextrose%20Sugar%20Diabetes.pdf

http://www.downloads.imune.net/medicalbooks/More%20of%20the%20Mounting%20Evidence%20t
hat%20Dextrose%20High%20Glycemic%20Sugars%20Causes%20and%20or%20Aggravates%20Cancer
%20and%20Many%20More%20Diseases.pdf
Recent and ongoing reforms

Critical Path Initiative

The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the
sciences through which FDA-regulated products are developed, evaluated, and manufactured. The
Initiative was launched in March 2004, with the release of a report entitled Innovation/Stagnation:
Challenge and Opportunity on the Critical Path to New Medical Products [21].

Patients' rights to access unapproved drugs

A 2006 court case, Abigail Alliance v. von Eschenbach, would have forced radical changes in FDA
regulation of unapproved drugs. The Abigail Alliance argued that the FDA must license drugs for use by
terminally ill patients with "desperate diagnoses," after they have completed Phase I testing.[36] The case
won an initial appeal in May 2006, but that decision was reversed by a March 2007 rehearing. The US
Supreme Court declined to hear the case, and the final decision denied the existence of a right to
unapproved medications.
Post-marketing drug safety monitoring

This article may need to be updated. Please update this article to reflect recent events or
newly available information, and remove this template when finished. Please see the talk page
for more information. (April 2009)

The widely publicized recall of Vioxx, a non-steroidal anti-inflammatory drug now estimated to have
contributed to fatal heart attacks in thousands of Americans, played a strong role in driving a new wave
of safety reforms at both the FDA rulemaking and statutory levels. Vioxx was approved by the FDA in
1999, and was initially hoped to be safer than previous NSAIDs, due to its reduced risk of intestinal tract
bleeding. However, a number of pre- and post-marketing studies suggested that Vioxx might increase
the risk of myocardial infarction, and this was conclusively demonstrated by results from the APPROVe
trial in 2004.[37] Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the
market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should
be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a
given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers,
medical journals, consumer advocacy organizations, lawmakers, and FDA officials[38] for reforms in the
FDA's procedures for pre- and post- market drug safety regulation.

In 2006, a congressionally requested committee was appointed by the Institute of Medicine to review
pharmaceutical safety regulation in the U.S. and to issue recommendations for improvements. The
committee was composed of 16 experts, including leaders in clinical medicinemedical research,
economics, biostatistics, law, public policy, public health, and the allied health professions, as well as
current and former executives from the pharmaceutical, hospital, and health insurance industries. The
authors found major deficiencies in the current FDA system for ensuring the safety of drugs on the
American market. Overall, the authors called for an increase in the regulatory powers, funding, and
independence of the FDA.[39][40] Some of the committee’s recommendations have been incorporated
into drafts of the PDUFA IV bill which was signed into law in 2007.[41]
Pediatric drug testing

Prior to the 1990s, only 20% of all drugs prescribed for children in the United States were tested for
safety or efficacy in a pediatric population. This became a major concern of pediatricians as evidence
accumulated that the physiological response of children to many drugs differed significantly from those
drugs' effects on adults. The reasons for the dearth of clinical drug testing in children were
multifactorial. For many drugs, children represented such a small proportion of the potential market,
that drug manufacturers did not see such testing as cost-effective. Also, because children were thought
to be ethically restricted in their ability to give informed consent, there were increased governmental
and institutional hurdles to approval of these clinical trials, as well as greater concerns about legal
liability. Thus, for decades, most medicines prescribed to children in the U.S. were done so in a non-FDA-
approved, "off-label" manner, with dosages "extrapolated" from adult data through body weight and
body-surface-area calculations.[42]

An initial attempt by the FDA to address this issue was the 1994 FDA Final Rule on Pediatric Labeling and
Extrapolation, which allowed manufacturers to add pediatric labeling information, but required drugs
which had not been tested for pediatric safety and efficacy to bear a disclaimer to that effect. However,
this rule failed to motivate many drug companies to conduct additional pediatric drug trials. In 1997, the
FDA proposed a rule to require pediatric drug trials from the sponsors of New Drug Applications.
However, this new rule was successfully preempted in Federal court as exceeding the FDA's statutory
authority. While this debate was unfolding, Congress used the 1997 Food and Drug Administration
Modernization Act to pass incentives which gave pharmaceutical manufacturers a six-month patent
term extension on new drugs submitted with pediatric trial data. The act reauthorizing these provisions,
the 2002 Best Pharmaceuticals for Children Act, allowed the FDA to request NIH-sponsored testing for
pediatric drug testing, although these requests are subject to NIH funding constraints. Most recently, in
the Pediatric Research Equity Act of 2003, Congress codified the FDA's authority to mandate
manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly
funded mechanisms proved inadequate.[42]

Rules for generic biologics

Since the 1990s, many successful new drugs for the treatment of cancer, autoimmune diseases, and
other conditions have been protein-based biotechnology drugs, regulated by the Center for Biologics
Evaluation and Research. Many of these drugs are extremely expensive; for example, the anti-cancer
drug Avastin costs $55,000 for a year of treatment, while the enzyme replacement therapy drug
Cerezyme costs $200,000 per year, and must be taken by Gaucher's Disease patients for life.
Biotechnology drugs do not have the simple, readily verifiable chemical structures of conventional
drugs, and are produced through complex, often proprietary techniques, such as transgenic mammalian
cell cultures. Because of these complexities, the 1984 Hatch-Waxman Act did not include biologics in the
Abbreviated New Drug Application (ANDA) process, essentially precluding the possibility of generic drug
competition for biotechnology drugs. In February 2007, identical bills were introduced into the House to
create an ANDA process for the approval of generic biologics, but were not passed.[43]
Permission to Eavesdrop the World 8-8-2008
The media is owned by the Ultra –Rich and they do not all certain discussions
 http://indavideo.hu/video/Master_Echelon_Super_System_the_Movie

http://indavideo.hu/video/TV_Media_and_the_Ultra-Rich

911 story of taking away privacy https://www.youtube.com/watch?v=-OgP0Ul_xko

911 story of conspiracy https://www.youtube.com/watch?v=lLjaCALSpU0

 FDA Tobacco Control + Protection Act of 2009
The Family Smoking Prevention and Tobacco Control Act, commonly referred to as the Tobacco Control Act gives
FDA authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health.
It was signed on June 22, 2009, ushering in a new era of tobacco control by
recognizing that almost all new users of tobacco products are under age 18 – the
minimum legal age to purchase. But no attempt to stop reckless endangerment is
allowed, encouraged, or even discussed. Such discussion is not allowed.
The Tobacco Control Act aims to curb the trend of new users becoming addicted before they are old enough to
understand the risks and ultimately dying too young of tobacco-related diseases.

http://indavideo.hu/video/Number_One_Crime_Against_Children

http://indavideo.hu/video/Proof_of_the_Ultra-Rich_Plot_to_control_us_-
_Unprosecuted_reckless_endangerment_of_Tobacco_use
Since most new smokers are under the age of consent, anyone leaving cigs on
the table for a minor to steal is guilty of reckless endangerment

http://indavideo.hu/video/Sugar_Coated_Message_to_get_Smokers_to_Quit
A U.S. Supreme Court decision has just given drug companies total liability protection for injuries and
deaths caused by government mandated vaccines. The National Vaccine Information Center (NVIC)
called the decision a "betrayal" of the American consumer.

In a 6-2 decision, the Court majority voted to reject substantial evidence that current law was fully
intended to protect an American's right to sue a pharmaceutical corporation for injuries that could have
been prevented if the company had elected to make a safer vaccine.

The court decision leaves parents with no way to hold vaccine makers accountable and no feasible way
to get compensation for the injuries suffered by their children; furthermore, the decision removes all
financial incentive for multi-national drug companies to make vaccines as safe as they can be.

According to EON:

"Hannah Bruesewitz was brain injured by DPT vaccine as a child but she was denied compensation by the
U.S. Court of Claims, which administers the federal vaccine injury compensation program created by the
1986 Act that has turned away two out of three plaintiffs.
Her attorneys then sued in civil court, providing evidence that Wyeth-Lederle had the technology to
produce a less reactive, purified pertussis vaccine but declined to do so."
The Supreme Court ruled against Hannah's family. Hannah, now 19, showed no symptoms of a seizure
disorder before the vaccination, and a multitude of tests haven't indicated any other cause.
Seizure disorders used to be listed on the Vaccine Injury Table, which is used by the National Vaccine
Injury Compensation Program, but the listing was removed a month before the Bruesewitzes originally
filed a vaccine injury petition in April 1995.
The Homeland Security Act

A key provision of the ‘Homeland Security Act’ grants

immunity to the pharmaceutical companies for present and
future product liability claims for vaccines. Further plans for
‘medical litigation reform’ include limiting product liability
lawsuits against drug companies.

Eli Lilly Payback Provision in the Homeland

Security Bill
The conservative argument in favor of the special Eli Lilly President Bush (left) and the Director of the
Office of Homeland Security Tom Ridge
Payback Provision of the Homeland Security bill is essentially
this: there's no scientific evidence linking the vaccine
preservative thimerosal to autism--only anecdotal (which is true). The evil trial lawyers, however,
will use this anecdotal evidence to bankrupt

The 114.5 Trillion dollar super-skyscraper is the amount of money the U.S. Government
knows it does not have to fully fund the Medicare, Medicare Prescription Drug Program,
Social Security, Military and civil servant pensions. It is the money USA knows it will not
have to pay all its bills.

FDA Receives Strong Industry Commitment

for its Antibiotic Resistance Strategy
For Immediate Release: March 26, 2014
Media Inquiries: Siobhan DeLancey, 202-510-4177, siobhan.delancey@fda.hhs.gov
Trade Press Inquiries: Megan Bensette, 240-506-6818, megan.bensette@fda.hhs.gov
Consumer and Industry Inquiries: AskCVM@fda.hhs.gov

The U.S. Food and Drug Administration is announcing today that since December 2013, when FDA
announced finalGuidance for Industry #213, all but one animal drug company have committed in
writing to seek withdrawal of approvals for any production uses of affected drug applications and
change the remaining therapeutic uses of their products from over-the-counter (OTC) to use by
Veterinary Feed Directive (VFD) or prescription.

On December 11, 2013, the FDA announced the implementation of its plan to help
 FDA Criticism
Main article: Criticism of the Food and Drug Administration

The FDA currently has regulatory oversight over a large array of products that affect the health and life
of American citizens.[21] As a result, the FDA's powers and decisions are carefully monitored by several
governmental and non-governmental organizations. There are many criticisms and complaints lodged
against the FDA from patients, economists, regulatory bodies, and the pharmaceutical industry. A $1.8
million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major
deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall,
the authors called for an increase in the regulatory powers, funding, and independence of the FDA.[44][45]

Nine FDA scientists appealed to then president-elect Barack Obama over pressures experienced during
the George W. Bush presidency, from management to manipulate data, including in relation to the
review process for medical devices. Characterized as "corrupted and distorted by current FDA managers,
thereby placing the American people at risk," These concerns were also highlighted in the 2006 report[44]
on the agency as well.[46]

A recent analysis of the economic discourse regarding certain FDA-administered restrictions finds that
published statements by economists very preponderantly support liberalization. The three FDA
restrictions under analysis are the permitting of new drugs and devices, the control of manufacturer
speech, and the imposition of prescription requirements. Additionally, some economists have argued
that in the increasingly complex and diverse food marketplace, the FDA is not equipped to adequately
regulate or inspect food.[47]

However, when asking the question whether economists or fundamental economic reasoning favor
liberalization of the restrictions, the consensus is disagreement. Economist Daniel Klein suggests,
"taboos surround the issue, particularly taboos against the critical examination of fundamentals." He
contends, "that there is no market-failure rationale for the restrictions.” Many economists that publish
statements regarding the FDA "exhibit a sort of intellectual schizophrenia. In their heart of hearts, they
seem to agree that there is no respectable market-failure rationale." Perhaps, certain factors
surrounding the political and sociological culture of the regulations keep some economists from
speaking openly.[48]

Regulation of living organisms

With acceptance of premarket notification 510(k) 033391 in January 2004, the FDA granted Dr. Ronald
Sherman permission to produce and market Medical maggots for use in humans or other animals as a
prescription medical device. Medical maggots represent the first living organism allowed by the Food
and Drug Administration for production and marketing as a prescription medical device.
In June 2004, the FDA cleared Hirudo medicinalis (Leeches) as the second living organism to be used as a
medical devices. Money seems to influence legality too much sometimes.
Rogue FDA agents Dennis Hudson and Spencer Morrison lead an attack of terror on Natural Medicine

http://medicalexposedownloads.com/PDF/NOTICE_THE_1990_FDA_raids.pdf
The Ultra-Rich has taken over ownership of the USA, and if the trend
continues it looks bad for the little guy.
 Allegations that unsafe drugs are approved
Some critics believe that the FDA has been too willing to overlook safety concerns in approving new
drugs, and is slow to withdraw approved drugs once evidence shows them to be unsafe. Rezulin
(troglitazone) and Vioxx (rofecoxib) are high-profile examples of drugs approved by the FDA which
were later withdrawn from the market for posing unacceptable risks to patients.

Troglitazone is a diabetes drug that was also available abroad at the time the FDA approved it. Post-
marketing safety data indicated that the drug had dangerous side-effects (in this case liver failure).
The drug was pulled off that market in the UK in 1997, but was not withdrawn by the FDA until 2000,
before which time it is claimed that thousands of Americans were injured or killed by the drug.[33]

In the case of Vioxx, a pre-approval study indicated that a group taking the drug had four times the
risk of heart attacks when compared to another group of patients taking another anti-
inflammatory, naproxen.[34] The FDA approval board accepted the manufacturer's argument that this
was due to a previously unknown cardioprotective effect of naproxen, rather than a risk of Vioxx, and
the drug was approved. In 2005, the results of a randomized, placebo-controlled study showed that
Vioxx users suffered a higher rate of heart attacks and other cardiovascular disorders than patients
taking no medication at all.[35] The manufacturer, Merck, withdrew the drug after disclosures that it
had withheld information about its risks from doctors and patients for over five years, resulting in
between 88,000 and 140,000 cases of serious heart disease of which roughly half died.[36] David
Graham, a scientist in the Office of Drug Safety within the CDER, testified to Congress that he was
pressured by his supervisors not to warn the public about dangers of drugs like Vioxx. He argued
that an inherent conflict of interest exists when the office responsible for post-approval monitoring of
drug safety is controlled by the same organization which initially approved those same drugs as safe
and effective. He said that after testifying against Vioxx, he was "marginalized by FDA management
and not asked to participate in the evaluation of any new drug safety issues. It's a type of
ostracism."[33] In a 2006 survey sponsored by the Union of Concerned Scientists, almost one-fifth of
FDA scientists said they "have been asked, for non-scientific reasons, to inappropriately exclude or
alter technical information or their conclusions in a FDA scientific document."[37]

Allegations of undue pharmaceutical industry influence

In a 2005 interview, Dr. David J. Graham, associate director of the FDA's Office of Drug Safety, was
asked "What Specifically do you believe is broken in the FDA and what needs to be done to fix it?
What must be done to improve the drug vetting system ?" his response: " FDA is inherently biased in
favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent
and advance. It views its primary mission as approving as many drugs it can, regardless of whether
the drugs are safe or needed"[51][52]
 Critics have disputed the claim that the Prescription Drug User Fee Amendment has improved the
speed of drug approvals.[53] Former Editor of The New England Journal of Medicine, Marcia Angell,
has stated that "It's time to take the Food and Drug Administration back from the drug companies....
In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees
came to about $300 million, which the companies recoup many times over by getting their drugs to
market faster."[54]

Allegations of bias against gay men in blood donation process

Blood collecting organizations, such as the American Red Cross, have policies in accordance with
FDA guidelines that prohibit accepting blood donations from any "male who has had sex with
another male since 1977, even once". The inclusion of homo- and bisexual men on the prohibited list
has created some controversy,[55] but the FDA and Red Cross cite the need to protect blood
recipients from HIV as justification for the continued ban.[56] Even with PCR-based testing of blood
products, a "window period" may still exist in which an HIV-positive unit of blood would test negative.
All potential donors from HIV high-risk groups are deferred for this reason, including men who have
sex with men. The issue has been periodically revisited by the Blood Products Advisory Committee
within the FDA Center for Biologics Evaluation and Research, and was last reconfirmed on May 24,
2007. Documentation from these meetings is available.[57]

However, in 2006, the AABB, America's Blood Centers and American Red Cross recommended to
the FDA that the deferral period for men who had sex with other men should be changed to be
equivalent with the deferral period for heterosexual's judged to be at risk.[58] The FDA chose to
uphold the blood ban. Female sexual partners of MSM (men who have sex with men) are deferred
for one year since the last exposure. This is the same policy used for any sexual partner of someone
in a high-risk group.[59] The intent of these policies is to ensure that blood is collected from a
population that is at low risk for disease, since the tests are not perfect and human error may lead to
infected units not being properly discarded. The policy was first put in place in 1985.[60]

See also: MSM blood donor controversy

Criticism of FDA's rejection of medical cannabis

In April 2005, the FDA issued a statement asserting that cannabis had no medical value and should
not be accepted as a medicine, despite a great deal of research suggesting the opposite.[61] The
supporters of medical cannabis legalization criticized the FDA's statement as a politically motivated
one instead of one based on solid science. A group of congressmen led by Maurice Hinchey wrote a
letter to FDA's commissioner Andrew von Eschenbach, expressing their disapproval of the FDA's
statement and pointed out the FDA's rejection of medical cannabis was inconsistent with the findings
of the Institute of Medicine, which stated cannabis does have medical benefits.[62] While the FDA has
not approved marijuana it has approved THC (a compound found in cannabis) as an active
ingredient for medicinal use.[63] Critics argue that this approval is a politically motivated attempt to
allow special interest groups to have patents over the substance,[64] perhaps because the patents on
previously patented competing substances have expired.

Allegations regarding management and FDA scientists

Nine FDA scientists appealed to President George W. Bush and at the time, President-elect Barack
Obama over pressure from management to manipulate data, mainly in relation to the review process
for medical devices. These concerns were highlighted in a 2006 report[2] on the agency as well.[65]
http://indavideo.hu/video/If_you_refuse_vaccination_then_your_camp_will_be_concentration
Even though the FDA was designed to protect Homeopathy, there are those in the FDA who have
sought to destroy Homeopathy. The lack of scientific minds behind homeopathy and a deficiency of
interest in a true double blind approach to research has hurt Homeopathy. There have been some
researchers and authors interested in both like Desire’ Dubounet and IMUNE, but they have
received little support from the homeopathic community. Homeopathy is persecuted but there is
science to support it and cut through a mound of myths and misconceptions.
http://www.downloads.imune.net/medicalbooks/The%20Trivector%20Analysis%20of%20Homeopathy
%20-%20A%20Three-
Dimensional%20Description%20of%20Voltammetric%20Polarographic%20Measures.pdf
http://indavideo.hu/video/Misconceptions_of_Homeopathy_from_the_BBC
http://indavideo.hu/video/IMUNE_on_the_Science_of_Homeopathy_and_a_early_Demo_of_the_QQC
http://www.downloads.imune.net/medicalbooks/Scientific%20Research%20In%20Homeopathy%202012.pdf
The FDA does not do consumer reports. A company might be in compliance in one way and doing a
deciet in another. A true consumer report was very needed in alternative medicine. A group german
doctors, lawyers, and scientists got together in 2011 to start a true consumer report for health
products. They formed the independent World Health Product Rating Service. The public needs to
be able to sort out wheter a companiy’s claims are valid or not.
We at Medical Expose’ work to expose all frauds in Medicine.
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What to do:
 The battle with the Ultra-Rich is the most important battle for the people ever. As JFK said before he
died “There is a Plot to enslave every man woman and child”. This covert clandestine Plot has brought
us very close to slavery of the world’s population. The Ultra-Rich own the media, listen to everything we
say and they fully control the FDA and the law itself. We cannot and will not beat them in court.

The secret surreptitious nature of this plot is their demise. Discussion of ideas can break up secrets.

If we simply talk about Equal Economic Education, it will break the back of the Ultra-Rich.

If we simply talk about the fact that all SINthetic medicines are an Insult to the body, it will make people
think before they take a drug.

If we ask why no one is ever charged with reckless endangerment for allowing a child to become
addicted to tobacco, perhaps the law will have to stop this crime.

If more people know about the dangers of Processed Sugar, they can start to switch to natural fruit for
sweetness.

If they see the control of the media by the Ultra-Rich, maybe we can expand our mind beyond their
control.

If people saw through the manipulation of our minds with xenophobia to make war to feed the war
machine, maybe tolerance for our fellow man can improve.

If people realized that their sexual identity is a Big Head choice, not a Little head choice, maybe we could
stop thinking with our little heads so much.

If we learn to think critically we can see through the greed of the Ultra-Rich.

https://www.youtube.com/watch?v=oCvLiElSIRM