FDA acquiring new powers to suppress alternative health

May 16, 2007

http://www.newstarget.com/021851.html

NewsTarget.com

Originally published May 15 2007

FDA acquiring new powers to suppress alternative health

by Byron Richards

Part 1 of Byron Richards' " Understanding the Threat to Dietary Supplements. "

Your right to have free access to safe and highly effective dietary

supplements is under an intense multi-pronged FDA attack. On May 14, 2007

the Supreme Court sided with the FDA by deciding not to hear the case of

Nutraceutical v FDA, letting stand a federal appeals court ruling that

permits the FDA to use drug-related risk/benefit analysis to determine if a

nutrient is safe. This is the exact same point the FDA is trying to get put

into law through Senate bill S.1082 and HR.1561, which consumers have

flooded the Senate on over the past few weeks. And it is the same point the

FDA is seeking to help implement on an international basis through Codex.

The Supreme Court denial to hear this case is a dramatic turn of events that

means there is very little time left to act to preserve free access to

dietary supplements.

The first part of this article explains this issue in depth so that

Americans can understand what is taking place. The second part explains the

steps Americans need to take to preserve their health freedom.

Regulatory trickery: The FDA's strategy for outlawing supplements

Leading health freedom attorney, Jonathan Emord, has been handling the

Supreme Court petition for Nutraceutical Corporation. He has also been

helping us prepare amendments to neutralize the threat posed by current FDA

reform legislation (S.1082/HR.1561). On May 11, 2007, I received an email

from Mr. Emord explaining the significance of the Supreme Court case:

" In particular, FDA for the first time in its history now holds a dietary

ingredient or dietary supplement adulterated at every dose level if at some

dose level it can be shown to present even an infinitesimal risk if it

concludes there to be no substantial health benefit from the supplement.

Because all dietary ingredients, dietary supplements, and foods present a

risk to health at some level of ingestion, the FDA's new position permits

the agency to declare any dietary ingredient or dietary supplement

adulterated at its whim or caprice. "

This abhorrent FDA strategy is now the prevailing legal precedent in the

land. The FDA has also launched a sneak attack on dietary supplements

through Senate bill S1082, seeking to slip wording into the bill that would

allow this exact strategy to become law. Language within the bill allows the

FDA to use drug-related risk assessment to brand dietary supplements as

unsafe, overturning fundamental principles of food and drug law.

Under current law, it is up to the FDA to show that a food, food ingredient,

or dietary supplement is adulterated and poses a risk to human health. The

FDA is seeking to redefine the term " adulterated. " Please take the time to

read and understand the substance of these issues -- the future of health

freedom in America depends on enough people understanding what is at stake.

Within 1-2 weeks the House is likely to take up the same legislation that

the Senate recently passed (S.1082). We must be ready to take action.

Basic Food Adulteration

It is rather easy to understand that a food or food ingredient that is

contaminated by bacteria, parasites, fungal toxins, lead, or other chemicals

may pose a risk to human health and therefore be adulterated. One example is

the infectious E. coli that caused the recall of spinach last summer.

Industries constantly lobby the EPA and the FDA to ensure that various

levels of chemicals, whether used as pesticides (like organophosphate nerve

toxins) or found in the water (like perchlorate or PCBs) will be acceptable

at certain levels in the food supply. Natural health advocates argue that

not only are many of the government-sanctioned levels of toxins acutely

detrimental to health, but the bio-accumulation of these poisons over the

course of a lifetime is a primary cause of obesity, cancer, and heart

disease.

Government regulatory agencies invariably side with the profits of industry,

and when they don't industry files ridiculous law suits that tie issues up

in court forever -- all at the expense of human health. More insidiously,

the FDA even acts to promote adulteration of food to support the economic

priorities of the White House and its industry friends, as is the case with

genetically modified crops wherein a toxin is now in every single cell of

the genetically altered food.

It is FDA management's opinion, whose employees are a revolving door with

the industries they regulate, that such toxins in food are safe. The FDA

shocked many people last fall when it approved an industry-favorable

cocktail of live viruses be added to the food supply. Thus, the EPA and the

FDA do a poor job of establishing criteria for and managing even obvious

adulteration of food and food ingredients, a problem that has been part of

FDA culture since its inception 100 years ago.

On an international basis, the FDA-supported Codex Alimentarius is seeking

to set international standards for food adulteration so low, including the

elimination of true organic standards, that many contaminants that are

adverse to health (such as the level of mycotoxin allowed in food) will be

sanctioned as legal for the purpose of international trade. While Codex is a

United Nations group, the members concocting these international guidelines

are typically responding to the wishes and financial interests of

multi-national corporations.

Adulteration of Food Itself

Another aspect of adulteration is the food or dietary supplement ingredient

itself, as different from some type of contamination. For example, certain

mushrooms are poisonous in small amounts and are thus unsafe. In general,

food and food ingredients are considered safe unless proven otherwise.

Indeed, courts in the United States have recognized time and again that food

and food ingredients are inherently safe. Under current law it is up to the

FDA to prove that a specific ingredient poses a risk, based on a

preponderance of evidence -- not based on FDA opinion. This is much

different than drug safety law, wherein the drug company must prove that the

benefit of a drug, which is inherently toxic, outweighs the risk.

The recent Supreme Court case involves the herb Ephedra, wherein a high dose

may have adverse cardiovascular side effects. However, there is no evidence

that lower doses cause any harm at all. The herb has been in traditional use

for several thousand years. The FDA has no proof that it poses any harm

whatsoever in smaller amounts. By using drug-related risk/benefit analysis

the FDA stated it had the authority to remove Ephedra at any dose -- thus

overturning basic fundamentals of food and drug law. As long as this case

stands the FDA has the legal precedent to do this with any herb or vitamin

it chooses.

The FDA's next step is to make this type of risk analysis into actual law.

The language in S1082 is cleverly worded so that food and food ingredients

(and thus dietary supplements) are lumped into the same category as drugs

for safety review purposes. The FDA is slyly seeking to change existing law

so that if the FDA determines even a small risk in any dietary supplement

ingredient it can brand the ingredient as unsafe, even if the commonly

consumed dose poses no threat to safety at all.

Let's take water as an example. We now know that too much water can kill

athletes or those in military training when consumed at an amount greater

than 1.25 gallons over a two hour period. Under the new wording in S1082, if

the FDA, IN ITS OPINION, decided that the benefits of water were not

adequate to warrant this risk, it could remove water from the market (even a

sip of water). This is based on drug-related risk/benefit analysis. While it

is unlikely FDA would ever try to remove water from the market, this same

ludicrous logic can be applied to any dietary supplement ingredient -- thus

gutting the law known as DSHEA that gives Americans access to natural health

options.

In recent days, many Americans flooded the Senate with objections to this

language and a proposed amendment to correct the problem, which Senator Enzi

refused to place into the bill. Some progress was made in that Senators

Hatch, Harkin, Kennedy, and Enzi went on record insisting that bill S1082

will not affect dietary supplements or alter DSHEA (Dietary Supplement

Health and Education Act of 1994). However, the problematic language remains

in the version of the legislation passed by the Senate. The battle now moves

to the House. If this language becomes law, the FDA will gain new regulatory

power to remove dietary supplements based on highly-opinionated risk

assessment (toxicology) criteria. It has long been a goal of the FDA to have

dietary supplements regulated as drugs, against the wishes of the great

majority of Americans.

The Critical Path Initiative and the Reagan-Udall Foundation for the FDA

The FDA would implement this draconian dietary supplement strategy using

highly advanced technology being developed by the Critical Path Initiative.

In order to fully understand the threat to dietary supplements it is

necessary to understand this approach. The Critical Path Initiative is the

FDA's attempt to invigorate the sagging pharmaceutical industry. Its purpose

is to modernize drug development and bring new drugs to the market with less

cost and significantly less testing for safety or effectiveness. The

Critical Path Initiative utilizes cutting edge science relating to genes

(genomics), proteins (proteomics), and cells.

The technology is on the one hand exciting, as well as unproven and very

risky. The Critical Path Initiative is being driven by multiple forces (Wall

Street, the next wave of drugs, and the dream of treating untreatable

diseases). The FDA is gambling that the Critical Path Initiative is the

future. FDA Commissioner Andrew von Eschenbach, M.D. has stated that this

initiative is the top priority of the FDA for many years to come. The

recently promoted second in command at the FDA, Janet Woodcock, has focused

on the Critical Path Initiative from its inception several years ago.

From a practical standpoint of drug safety today, wherein several million

Americans are injured each year requiring medical attention and over 100,000

Americans die from drug errors and side effects, the Critical Path

Initiative is a pie-in-the-sky pipe dream. Proponents of it promise to solve

these existing drug safety issues by turning the practice of medicine over

to FDA computers.

The goal of the FDA is to use the Critical Path Initiative to radically

change the drug approval and monitoring process from one based on extensive

human clinical trials to one based on biomarkers. A biomarker is like a

signpost. Some biomarkers indicate toxicity (risk assessment and analysis

technology) and other biomarkers indicate a positive change in a cell or a

defined clinical event (like tumor shrinkage). The FDA has undertaken a

massive campaign, including the development of its own software, to analyze

biomarkers and set up standards for drug development and disease treatment.

This means that the current safety and effectiveness testing based on

rigorous clinical trials will be replaced. It also means that a physician's

clinical judgment will be of secondary importance compared to FDA

supercomputers (doctors will soon be lining up to join the health freedom

movement). Simply because a biomarker looks good in a computer does not mean

that a positive change is being produced or will be produced in the

individual -- especially in the long term. The focus of drug development

will shift to drugs that target biomarkers as compared to drugs that

demonstrate they improve human health.

Many cellular proteins and protein-related pathways play both a positive and

negative role in cell chemistry -- depending on what the cell is trying to

do. Thus, using risk assessment for biomarkers is incredibly complex and

fraught with potential error -- simply because we are still in our infancy

of knowledge in terms of understanding how signaling pathways in cells work.

The net result is that new and powerful biological drugs will come to the

market faster with much less human testing for safety or effectiveness, and

then the FDA will monitor the drugs as they are being used by patients and

try to figure out if they are safe or not. Both Kennedy and Von Eschenbach

make wild claims that this unproven technology will help drug safety, which

at this time is nothing but unsubstantiated propaganda.

Under the Clinical Path Initiative, patients entering the doctor's office

for the " best possible care " will instead receive the latest FDA/Big Pharma

drug experiment with extremely expensive biotech drugs. As Von Eschenbach

stated on May 1, 2007, patients should be happy about this because this new

science will " explore the unique genetic and biologic features of

individuals that will determine how he or she responds to treatment. "

Translated to English that means your DNA will not only be profiled, it will

be in a government-controlled supercomputer in order for you to receive

medical care.

The purpose for creating the Reagan-Udall Foundation for the FDA in bill

S1082 is to facilitate collaboration between Big Pharma, Big Biotech,

academic research, and the FDA to get the funding for and carry out the

extensive research required to move the Critical Path Initiative forward.

The foundation will be under the direction of the FDA and will hold patents

and licenses relating to the drugs or devices that are developed. This

concept is being patterned after a smaller Critical Path operation known as

C-Path, wherein the FDA works with Big Pharma to develop drugs.

FDA Commissioner Andrew von Eschenbach has been heavily and financially

involved with Big Biotech companies for many years (leading the elder

President Bush's C-Change). It is no secret that the FDA is now headed by a

biotech representative who has a top priority of bringing drugs to the

market faster and a documented history of conflicts of interest. No person

in the civilized world should be duped into thinking this means improved

safety.

Von Eschenbach will argue that the cost and complexity of developing the

next generation of drugs and standardizing the drug development is far too

costly for any one drug company -- which is true. This is the main reason

Von Eschenbach took the top job at the FDA, to push the Big Biotech plan

known as Critical Path (not because his passion or experience is in food or

drug safety). One main problem with the Critical Path Initiative is that the

FDA becomes a drug company with an important stake in the success of the

drugs it approves and licensees for use. This creates major conflicts of

interest in multiple ways, with true safety and effectiveness left as large

question marks.

If this is what Americans want in the name of progress then that should have

been what Senators openly debated and voted on. This could have lead to

truly adequate safeguards being built into the law. Senators spent no time

at all debating the Reagan-Udall Foundation for the FDA and its major safety

and discrimination implications. Instead, this part of S1082 was

rubberstamped. It is quite likely that 90 percent of the Senators do not

understand what I have just explained. It doesn't take a crystal ball to

realize that Senators' ignorance is likely to result in increased injuries

and deaths and will eventually require the " Biomarker Fraud Act of 2012. "

Never Underestimate the FDA's Desire to Attack Natural Health

A great concern is that language written into S1082 gives FDA new regulatory

power that can be used to attack dietary supplements. The problematic

language in S1082 occurs in Subtitle B -- The Reagan-Udall Foundation for

the Food and Drug Administration, as follows:

(b) Purpose of Foundation- The purpose of the Foundation is to advance the

mission of the Food and Drug Administration to modernize medical,

veterinary, food, food ingredient, and cosmetic product development,

accelerate innovation, and enhance product safety.

(1) taking into consideration the Critical Path reports and priorities

published by the Food and Drug Administration, identify unmet needs in the

development, manufacture, and evaluation of the safety and effectiveness,

including postapproval, of devices, including diagnostics, biologics, and

drugs, and the safety of food, food ingredients, and cosmetics;

Earlier versions of S1082 did not contain the food and food ingredient

language, nor does the current companion bill sitting in the House (HR

1561) -- although now that the Senate has passed S1082 it is likely that the

House will take up the full Senate version and work from there. My point is

that sneaking the words food and food ingredients into this legislation is a

recent change.

In January of 2007 the FDA issued a press release on the Critical Path

Initiative. The FDA now wants to use the Critical Path risk assessment

technology to help determine adulteration of food and food ingredients, such

as identifying bacterial contamination (a valid use) AS WELL AS ASSESSING

THE SAFETY OF FOOD AND FOOD INGREDIENTS (a use that can be used to

frivolously attack dietary supplements with drug-based risk/benefit

analysis). The FDA is trying to expand the role of the Critical Path

Initiative from a new drug development initiative into new regulatory tools.

The FDA states:

" The Critical Path Initiative is not limited to the sciences that support

human medical product development. Scientific advances hold the potential to

improve the tools FDA uses to evaluate the safety and efficacy of human and

veterinary products as well as the safety and nutrition of food and food

ingredients (e.g., new rapid tests for biological and chemical contamination

of animal-derived foods, technologies for detecting and mitigating the

microbial contamination of food, analysis technologies [i.e., drug based

risk/benefit analysis] for assessing the safety and nutritive value of foods

and food ingredients). "

Based on the recent additions of " food " and " food ingredients " to the S1082

legislation and this FDA document it can be seen that the FDA wants to use

the Critical Path Initiative technology to not only look for contamination

of food (a good use) but also to evaluate safety of food and food

ingredients. As I explained in the preceding sections, this technology is

based on risk assessment and analysis (toxicology) using biomarkers and will

fall heavily on FDA OPINION using drug-related risk/benefit analysis.

There are two very important questions: What biomarkers will be used? and,

How will biomarkers be set up to determine the level that is toxic?

Unfortunately, the answer to the second question is based primarily ON THE

OPINIONS OF WHOEVER IS SETTING THE STANDARDS, which is in this case the FDA.

For example, let's say you developed an invention to test the volume level

of a stereo. In this analogy " volume " is a biomarker. You can plainly test

for various volume levels, ranging from soft to loud. At what level is the

volume a problem? Do we set the level based on shattering ear drums? What

you think is nice? What a neighbor thinks is correct? In others words, the

threshold for a " toxic " volume level is easily influenced by opinion or

government policy -- not science.

Now remember, biomarkers are changes in proteins at the cellular level.

Food, food ingredients, and dietary supplements obviously change proteins at

the cellular level and will thus change a wide variety of biomarkers.

Dietary supplements are indeed powerful changers of biomarkers. In a normal

and sane world, this ability to see what dietary supplements do would be

used to help individuals prevent and treat disease. In the anti-competitive

FDA police-force world this same technology will be used to get competition

off the market. The FDA can set the " volume " knob for health-related

biomarkers based primarily on opinion and say " we only allow soft music,

everything else requires a prescription. "

Let's take a specific example. NF KappaB is a protein that operates within a

cell -- in reality it is the brain of a cell that manages cellular stress.

NF KappaB levels go up and down and do various things -- all towards the

goal of maintaining healthy cellular function. Many nutrients directly

modulate NF kappaB, which is how they work to help a cell repair itself,

reduce inflammation, and maintain normal healthy function. In almost every

type of cancer, NF KappaB is hijacked and the cell's natural defense system

is taken over -- like a terrorist attack. In this case, the volume knob on

NF KappaB is now set in such a way that the music sounds like a loud blaring

rock station and the excessive NF KappaB is the actual force driving the

cancer process.

Drugs are designed to knock out this hyped-up NF KappaB signal, resulting in

death to cancer cells. The problem is of course that most drugs are not

specific only to cancer cells, and interruption of NF KappaB in healthy

cells also results in healthy cell death. Surviving cancer treatment is

often a race between killing enough cancer cells before killing too many

healthy cells. Along comes green tea. Green tea polyphenols, like many

nutrients, change NF KappaB. Mother Nature has empowered green tea with

wisdom that no drug possesses. Green tea can tell the difference between a

cancer cell and a healthy cell. Green tea will take its best crack at

turning off excessive NF KappaB in a cancer cell and thereby help induce the

cancer cell to die. Amazingly, green tea will not bother the NF KappaB in a

healthy cell, other than to assist it in normal and healthy cell function.

This does not mean that green tea is a cure for cancer or even a treatment

for cancer -- but it sure won't hurt someone who takes it who has cancer.

It will be easy for the FDA to say, with the new powers proposed in S1082,

that green tea is unsafe because it changes biomarkers related to cancer.

The statement is factual. It is the OPINION of the FDA that the change is a

problem. The language in S1082 gives the FDA the regulatory power to make

that opinion stick, thus setting back natural options for health fifty

years.

You may find it hard to believe that the FDA would follow this path when so

many people are in need of natural and safe health options. Yet, the FDA is

already working with Codex on an international basis to help establish risk

analysis (toxicology) for dietary supplements. FDA scientists are heavily

involved with the Codex Committee on Nutrition and Foods for Special Dietary

Uses (CCNFSDU). In the upcoming meeting in Germany in Nov 2007 an

FDA-supported plan will be presented in an effort to help establish the

application of risk analysis to guide CCNFSDU to set " Safe Upper Limits " for

dietary supplements. Safe Upper Limits, as currently viewed by Codex, are a

public health scam; they are a politically correct strategy for branding

dietary supplements as drugs based on drug-related risk analysis technology.

The FDA and Codex goal is to remove therapeutically useful dietary

supplements from the free market so they don't compete with drugs. Another

goal is to make all useful nutrients into prescriptions to give Big Pharma a

total monopoly on all health options.

We must educate our legislators and get them to help us preserve our right

to have free access to helpful dietary supplements. Coming soon -- Part 2

(the take action plan).

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