[NewswithViews] Understanding Threat to Dietary Supplements

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Misty L. Trepke

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UNDERSTANDING THE THREAT TO DIETARY SUPPLEMENTS

PART 1

By Byron J. Richards, CCN

 

May 15, 2007

 

NewsWithViews.com

 

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.

 

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 they

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 ¼ 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 a 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% 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. ©

Duties of the Foundation- The Foundation shall-

 

 

(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 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).

 

Related articles:

 

1, Fight for Your Health: Exposing the FDA's Betrayal of America

(read free – documents FDA corruption)

2, Senators Chose Big Pharma over Best Interests of U.S. Citizens 5-

9-07 (Key drug safety amendments lose, Big Pharma wins)

3, S1082 – Senate Stabs Americans in the Back 5-7-07 (The Senate

shoots down fair drug pricing for Americans)

4, What is Really Going On at the FDA 5-7-07 (S1082 - explains the

user fee scam and anti-American FDA activities)

5, S1082 - The Voice of the People is Being Heard 5-4-07 (Citizens

are flooding the Senate – Why FDA wants to be a drug company)

6, Senators Bribed by Big Pharma vs. Senators not Bought Off 5-2-07

(S1082 – Big Pharma vs American Citizens – Senators used as pawns)

7, Dietary Supplements Threatened, Freedom in Danger 4-30-07 (S1082 –

How drug-safety legislation threatens dietary supplements)

8, U.S. Health Freedom on Verge of Collapse 4-25-07 (An overview of

S1082 and how it undermines health freedom)

 

© 2007 Truth in Wellness, LLC -