THE FOOD & DRUG ADMINISTRATION'S NEW GMP'S FOR NATURAL HEALTH SUPPLEMENTS

Compiled By Arthur M. Evangelista, Ph.D., a former FDA Investigator
Web Site: http://www.qualityassurance.synthasite.com



Posted: 14 November 2008


My background and experience primarily consists of two major areas of expertise in public safety and health.

One area of expertise embraces emergency trauma and medical services, having graduated Magna Cum Laude from the N.J. College of Medicine & Dentistry's School of Allied Health Professions. I was also a member with the N.Y. Academy of Sciences for several years.

My other field of expertise is in law and regulatory enforcement.

Combining these two major occupational fields of medicine and law enforcement, led to my induction as a federal investigator for the U.S. Food & Drug Administration's Investigations Branch.

Leaving the Food & Drug Administration in the early 90's after uncovering investigative and administrative corruption and malfeasance, I filed charges against a supervisor for illegally altering an investigative report.

Hence, I founded the Public Health and Medical Fraud Research Cooperative, which includes the Quality or GMP and Regulatory Affairs Unit. Our research group provides assistance to small manufacturers of natural remedies and supplements, including novel devices, for the natural mitigation or cure of illness or injury. Our Quality & Regulatory Unit, provides GMP and specialty services in quality assurance and regulatory affairs relevant to the Food & Drug Administration, and also for OSHA safety standards.

We also provide a special security expertise to prevent or expose investigative and regulatory malfeasance, when these natural health firms are inspected.

Additionally, we investigate government, political, and regulatory malfeasance and corruption, affecting the public health or benefit, and also corruption and fraud within the allopathic medical and pharmaceutical industries.

As some of you may know, new Good Manufacturing Practices (GMP's) have been recently enacted by the Food & Drug Administration. This is a total nightmare. These new regulations specifically target the natural health and supplement industry, which began this past June, and will be at full enforcement by June of 2010.

Under the pretense of regulating these natural and healthy products for the public good, these regulations, in essence, are directly and absolutely contradictory to preserving and advocating for the public health, and are precisely intended to eradicate any competition to the pharmaceutical industry.

The new regulations, are in fact, designed to put 60 to 70 % of the natural health supplement and herbal firms out of business. This tyrannical enactment is the pharmaceutical cartel's best dream come true, and I will expose some of the reasons why and how this has occurred.

But before I begin, please note that this information is based upon first-hand experience and investigative observation, and is accurate and thoroughly researched. Anyone can find this information. Also note that these issues are one component of a larger, more insidious agenda by the government-corporate-military complex. This coalescing structure is, by definition, the very basis of fascism. Whereas, the corrupt corporate interests have overpowered the public interests, which is at the core of these issues. Let's take it step by step...

First, let's look at the obvious. The pharmaceutical industry requires sick people in order to be profitable. That, in and of itself, should raise a bright red flag, with the words, "criminal conspiracy" written across it.

The pharmaceutical investment industry was artificially created and strategically developed over an entire century by the same investment and banking groups that control the global petrochemical and chemical industries.

Some pharmaceutical firms or conglomerates also own food firms, are directly coupled with chemical manufacturers, perform biotoxic and other work for the government, and collaborate with numerous other associated industries, including the involvement of major media advertising outlets. We have all seen the drug commercials on television.

Now, listen closely...It is not in the financial interests of the pharmaceutical industry to prevent common diseases - the maintenance and expansion of diseases is a necessary precondition for the financial growth of this drug industry.

Because of this "precondition" by the pharmaceutical-government cartel, vitamins and other valuable natural health therapies that effectively prevent and cure diseases are incompatible with the very nature of this pharmaceutical industry's "business of disease."

If people would assert their liberty and freedom to naturally maintain their own health, the pharmaceutical cartel would literally be forced to contend with the precarious realities of its own business organization, and restructure prescribed drug use for emergency purposes only, or use prescription drugs as a last resort, thereby placing this industry back into perspective for the public good.

The survival of the pharmaceutical industry, in its current state, is dependent on the elimination, by any means, of effective natural health therapies. Consequently, it is necessary to also unlawfully ban the dissemination of honest and accurate information about natural health therapies. Its a two-fold process.

To that end, the pharmaceutical industry has placed its lobbyists in key political and government positions and in key markets within the leading drug export nations. Inclusive in the criminal network, is the corruption of the Food & Drug Administration, and, subsequently, our current U.S. corporate-government as a whole.

That's the first reality for us to grasp and understand.

Secondly, additional collaborators and co-conspirators with this drug industry, are members of the organized allopathic medical community. This comprises our system of medical education in the U.S., and includes associated agencies like the AMA, the Dental Association, most public health organizations, state and federal agencies, and others.

At the onset, and throughout a medical doctor's education, what is taught in addition to anatomy and physiology, is an education literally based upon pharmaceutical "drug trafficking". The drug firms posses a large stake in the education of medical doctors in the U.S., which is exemplified by the enormous amount of toxic and unnecessary prescription drugs heaped upon an unsuspecting public. Remember, too, that doctoring is also a business.

Pharmaceutical companies know that the doctor's business can substantially help support their prescription drug trade. This is done by specifically limiting the physician's knowledge base regarding natural cures, and primarily teaching drug treatments. The doctor only knows or performs what he is taught or told. It's a form of brainwashing.

Now, let's toss in 99 % of the major public health organizations, like the Diabetes Association, the American Cancer Society, and most of the others, that are also imbedded deeply in this medical fraud and corruption. Much of this known fraud is built upon the stealthy drug and chemical companies' controlling and infecting influences and enormous cash contributions.

Following the cash flow will provide some good information on who the stakeholders are. All one has to do is to look up the names of major contributors to these so-called public health associations. This pharmaceutical and corporate funding apparatus is very influential and further generates the fraud and public deception. I call this treason at the public health level.

Third, are the insidious and infamous revolving door issues, among federal and state agencies and regulatory authorities, with the corporations these agencies are supposed to be regulating.

Corporate workers receive jobs within the government, and government workers receive jobs in the corporate structure. Nowadays, this malfeasance and conflict of interest is basically unenforced. It is rampant, and a grave danger to us all on every level.>[? Going on for years, we now have almost a complete and total enmeshment of the corporate and government bodies...and this corruption is across the board to the highest levels of public office. Whereas the corporate interests and political-government interests have become one-and-the-same. One result, is a deceived, debilitated, ignorant, and at-risk public.

Fourth, is in regard to the enforcer of this criminal enterprise. The Food & Drug Administration is a component of the corporate-government. The FDA, acting on corporate-government orders and pharmaceutical-related guidance, is the regulatory agency that has the strongest "visible" influences on public health.

Today, the FDA is working directly against the public health and public good, primarily by their advocating and enmeshment with corporate interests. On the whole, the U.S. government has basically been fabricated into an organized crime syndicate.

The Food & Drug Administration's far reaching public influences include its oversight on products that comprise more than one-quarter of the gross national product. Thus, for every dollar spent in the U.S., twenty five cents of that is earmarked for a FDA regulated product; ...and the list is expanding.

Just one of the results of this regulatory and criminal malfeasance and corruption, are the adverse effects and deaths from prescription drug applications. The myriad of pharmaceutical drugs cause a staggering 200,000 deaths and injuries per year.

Between allopathic medical doctors, hospitals, and prescription drugs, this figure increases to close to one million deaths and injuries per year from extreme depraved indifference. Do the math.

The FDA allows this carnage to continue, because these drug interests have the control, money, and infecting influence upon the government machinery to enact their will. It is grossly counterproductive to any actual public health benefit. It is part of that bigger agenda I mentioned previously.

Vaccines are another such criminal act. First of all, vaccines do not work. Not only do vaccines not work, their ingredients are known to be extremely life threatening and dangerous. They cause of hundreds of thousands of debilitating illnesses, many with long term and serious health consequences.

You should also know that many of diseases contracted by people, are the very diseases they were supposedly vaccinated against. Do a little historical research, see what you find. Then, ask the forensic question: Who benefits financially, and who suffers ?

The people responsible for this corruption know that these products are dangerous and ineffective. The bigger picture I spoke of, reveals that the stealthy, insidious agenda that encourages this rampant and destructive mechanism has to do with a term coined by former president George H.W. Bush, back in the early nineties. That term ? "The New World DisOrder".

What this term translates into, includes a massive and deceptive political agenda to keep the population "dumbed down" and clueless. This is accomplished through the use of controlled media, unnecessary drug applications, food toxins, dangerous biologics and biotoxins, chemical poisons, continued archaic medical practices, war, and starvation, ...and, all used as weapons.

All of these are politically orchestrated and are interconnected. None of this agenda is by any accident of nature or by any coincidence. They are contrived by conspiratorial acts between government, corporations, and their banking cohorts.

One aspect of this oppressive turn of events, is the determined prevention of natural and healthy non-prescription drug remedies and the required public information for maintaining health and curing illness. Information is empowerment. Think about that.

Healthy, natural foods grown locally are important for health. Foods such as healthy meat from field fed cattle, without the hormones or drugs, and whole, natural milk, and other food items from back-to-nature's basics, such as explained by the Weston A. Price Foundation. ...all these things that are now severely restricted or prevented by the USDA, FDA, the federal Public Health Office, and its mother agency, the Dept. of Health and InHuman Services.

Another example is the currently emerging nano-technology. Independent, non-industry testing has shown that much of this technology enables the toxins and other poisons in our corporate-processed foods and our environment, to become hundreds of times more toxic or lethal.

This is due to the infiltration ability of these nano-particles into our bodies and organs. So far, this corporate malfeasance and depraved indifference is unregulated and remains unabated, ...on purpose.

Although, the FDA made one move. This was to attack colloidal silver, a very beneficial and effective anti-viral and anti-infectant used by those who understand natural health. This is not really nano-technology in the true sense, but simply micro-sized particles of silver in a solution. Pathogens cannot live in the presence of silver. Colloidal silver is used instead of the drug industry's damaging prescription antibiotics, which, as you may know, poses another problem.

When going after the colloidal silver supplement makers, the FDA did not mention or include any other drug or chemical manufacturer of nanotechnology, even though these other products can be powerfully toxic and dangerous to humans and animals, alike.

Recently, independent advocate groups have been putting pressure on the FDA to investigate this developing issue created by the major chemical and pharmaceutical industries. As such, the FDA purposefully appears to be stalling in its efforts to address this growing concern.

Another example of criminal malfeasance, is that pharmaceutical companies cannot produce toxic-free chemical drugs. When these drugs, and their side or lethal effects, receive some media exposure or just minimal public attention, the FDA, in some cases, simply has the firm add a feigned warning to the labeling, ...maybe.

Occasionally, in very rare cases, when media exposure or whistleblowers garnish more attention to a particular issue, or when public alarm becomes too great to ignore, the FDA may reluctantly pull it off the market, but only after thousands have suffered or perished from the product.

In order for a drug to be pulled from the market, this practically must be a forced issued, precipitated by copious public outrages and media attention, before any formal FDA actions are taken. Plus, this type of action is often done reluctantly and with little regulatory oversight, leaving most of the issue to the drug or chemical firm, itself.

Of course, incidental fines may, if rarely, be imposed. These fines, even if in the millions, do not even make a small dent in the billions of profits. It's simply a facade. It's more for public show, than for any enforcement action.

In addition to my previous statements regarding criminal influences, another issue is the Prescription Drug User Fee Act (PDUFA) which has allowed the FDA to receive well over $900 million from drug industry funding since 1992. And this industry funding was devoted to the review of new drug products from the industry. The conflict of interest is a no-brainer.

This same reluctant, mindless, or hands-off approach is not applied to natural health products made from God-created ingredients. Many of these natural health remedies could be found growing in the field or woods behind one's home, like my grandmother used to gather.

For the most part, having any side effect or problem with a vitamin or herbal extract is extremely rare. Research indicates that any adverse issues with supplements is caused mostly caused by individual irresponsibility rather than the product, itself.

Although, with supplements, just one incident may provide the excuse the FDA (and drug firms) require to compel arbitrary, heavy-handed enforcement actions and to begin their media crucifixion. The pharmaceutically infected FDA will most likely remove the product, forever. This occurs if this natural product affects or interferes with the profits of a pharmaceutical concoction, which attempts the same health applications, but at a much greater public health risk and cost.

One example was with the removal of the supplement, tryptophan, from the market some years back. Tryptophan was an excellent natural sleep aid. It is naturally present in turkey meat and natural milk, when the milk is warmed. Although there may have been a tainted batch of tryptophan imported from, guess who... China, except we cannot get all the data on this supposed incident.

Instead, the FDA removed all the tryptophan, regardless of manufacturer, and subsequently prevented its use. In reality, tryptophan's untimely demise as a safe, useful, and natural sleep supplement appears to be a fabrication which coincided with the marketing of a pharmaceutical drug and sleep aid released during that same time-frame.

The vitamin and health supplement industry faces grave actions from the corporate-government and from the newly devised GMP's.

The purchased servants in these government agencies and facilities have said that the Food and Drug Administration doesn't need direct evidence of human harm before taking steps to curb sales of a dietary supplement, an advisory panel reported. Now the cow pies are flying, because no idiot could think of this insanity on their own.

The report promised (and did) to augment new FDA efforts to crack down on (so-called) risky supplements - and challenges standing intelligent assumptions that the agency must prove an ingredient unsafe before pulling it off the market.

Let's pause a moment and ask some questions...Why hasn't the FDA used its enforcement powers, such as told here, against dangerous prescription drugs? Why do we still have sodium fluoridated water supplies ? Why are they increasing MSG and aspartame ingredients in our food ? Etc, etc, etc.....

You're right, this makes no sense at all. It does, however, require some perverted individuals to discuss this approach in a quiet boardroom somewhere. This constitutes a conspiracy by definition.

Now you're beginning to get the picture.

With supplements, proof of harm is unnecessary, concluded a panel at the National Research Council.

In a carefully worded deception, "You don't have to have proof of harm," voiced Barbara Schneeman, the vice provost and a nutritionist at the University of California at Davis, who headed the panel.

In the recent past, the FDA needed to demonstrate significant or unreasonable risk from a product, something the panel insisted, can be done with less evidence FDA seniors were provided with step-by-step instructions on how to evaluate (falsify) supplement safety, even when their is not any clear or substantiated human data to base their decision on.

This panel of puppets said, "...it's certainly our hope this is going to allow the FDA to be more effective in identifying substances (specifically supplements) that could pose a risk for harm to human health," Schneeman explained. All without any real evidence of harm or adverse effect.

Contrary to frequent claims by natural health professionals, or any common sense, neither an absence of reported of side effects nor a product's long history of use automatically mean it's safe, the report cautioned.

This my friends, is false and grossly misleading, and an unlawful or arbitrary application of authority, and a sure display of drug industry control.

The supplement, St. John's Wort, is a recent example of how science is perverted by conflict of interest or industry criminal influences. One study, provided through Duke University, said St. John's Wort was ineffective for use as a calming supplement or as a natural anti-depressant.

I personally know people who use St. John's Wort, plus, I had used it to help suppress migraines, and it worked. Suspicions about this "test" led me to perform an investigation into the drug specialist conducting these tests to see if there were any ties to the drug industry, especially since these criminals were reporting exactly the opposite of what many individuals had beneficially and personally experienced and reported.

This is what we found: The chief medical specialist, Dr. Jonathan Davidson at Duke, was receiving money from the pharmaceutical firms which stood to benefit by the adverse results fabricated and falsified by this perverted study.

Steeped in conflict of interest, Dr. Davidson held stock in Pfizer, American Home Products, GlaxoSmithKline, Proctor and Gamble, and Triangle Pharmaceuticals. He has received speaking fees and stipends from these same drug firms, in addition to money received from the American Psychiatric Association, Forest Pharmaceuticals, Eli Lilly, Solvay, Novartis, Wyeth-Ayerst, and Organon to name a few.

Here's what it is... The drug firm simply did not want this natural remedy to compete with its own anti-depressant drug profits. It doesn't take a rocket scientist to figure this out, once you have >b>all the facts. Suicide rates, illness, and injury then skyrocketed from certain drug prescription anti-depressant use in recent years, as we have seen.

Now, let me add...

This fictitious test scenario, repeated and publicized hundreds of times per year, in turn, can cause a false psychological acceptance on pharmaceutical drugs, by the unassuming or uninformed public, who accept this information at face value. This, the public can no longer afford to do.

Dangerous prescription drugs for continued treatments (not cures, mind you) are also used for many of the very illnesses or injuries created by other drug products manufactured by these very same drug cartel companies.

Their unspoken pact is to keep each other rolling in cash and influence, and keeping us sick and in the dark. This is enforced by the corporate-backed, Food & Drug Administration.

Misinformation, disinformation, and no information is controlled by the few corporate firms whose interests span multi-national companies, and include the infiltration and control of key government personnel, and their agencies.

The general public rarely hears the truth. Besides, public news media, today, is a joke. The public is prevented from receiving the information required, not only to stay healthy, but also to remain a free people in a democratic republic, as well. These events are all interconnected. I urge every citizen to look into these issues.

The major network media is just as culpable for spinning out misinformation as well as the withholding of accurate and honest reporting. Telling the truth would justly land 60 % of these responsible parties in prison, or reduce their status to gutter cleaners. Without information, we cannot have freedom or liberty, or good health. Thus, the secrecy of our government becomes more obviously troubling and dangerous.

Essentially, the FDA prevents people from having access to free, accurate, and truthful natural health information. Their drug definitions are insane and purposefully restrictive in every sense of the word. Any data about natural cures or wholesome foods and supplements that maintain health, is strictly prohibited.

Conversely, we are bombarded by relentless deadly drug commercials, perverted testing results, overblown flu scares, and unlawful vaccine regulations that are forced upon us and our children. This insanity subjects all of us to a profiteering agenda of destruction.

As such, all the evidence indicates that the FDA is a seriously compromised and corrupted pharmaceutical strong-arm, and is part of a criminal enterprise connected to the New World DisOrder.