Re: House - UPDATE TO S 1082/ SUPREME COURT ACTION DSHEA

[Guest guest]

From Hammell at IAHF.COM...

What Just Happened:

On Monday, May 14, 2007 the Supreme Court denied the Writ of

Certiorare in the Ephedra Case (See

http://www.supremecourtus.gov/orders/courtorders/051407pzor.pdf

see 06-922 Nutraceutical et al v Echenbach, Comm'R, FDA et al

WHAT THIS MEANS

By taking this action, the Supreme court has effectively

repealed DSHEA because this now means that the FDA can do the

same sort of flawed, drug based " risk/benefit " assessment that

they used to (fraudulently) ban ephedra to ban ANY dietary

supplement on equally flawed grounds (on a whim). In other

words, the Supreme court intends to allow the FDA to regulate

foods as DRUGS despite congressional intent with DSHEA that

dietary supplements be regulated as FOODS and NOT as DRUGS.

The following article by Byron s helps provides a solid

understanding of the issues and the actions of congress.

---------------------------------------------------------------

This article is posting on NewsWithViews tonight. It is Part 1

of 2, The Emord amendment and whatever strategy we come up

with can post in a few days. This needed to get out right away

due to the timeliness of the Supreme Court decision.

Permission to reprint.

Understanding the Threat to Dietary Supplements - Part 1 The

FDA is Acquiring New Powers to Suppress Alternative Health

Byron s, 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 (to come soon) explains the steps

Americans need to take to preserve their health freedom.

Leading health freedom attorney, 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 InitiInitiative 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 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 drudrugs. 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 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:

`( 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.

> >

> > PLEASE SEE http://www.newstarget.com/021853.html

> > http://www.newstarget.com/021852.html

> >

> > U.S. Senators financially enslave Americans as Indentured

Servants

> > to Big Pharma

> >

> > SAMPLE LETTER TO SEND TO YOUR SENATORS AND REPRESENTATIVES:

> >

> > HR 1561 (senate bill S.1082) - Please Amend to Protect Dietary

> > Supplements

> > May 16, 2007

> > The Honorable (Representative or Senator First and Last Name)

> > Address

> >

> > Dear Representative (or Senator) Last Name;

> >

> > The Senate has recently passed bill S1082, commonly known as the

> FDA

> > Revitalization Act. I am concerned that the legislation, as

> > currently written, opens the door for considerable regulatory

> > confusion enabling the FDA to use this legislation to undermine

my

> > access to safe and effective dietary supplements.

> >

> > There must be no confusing the safety of drugs and the safety of

> > food and food ingredients -- which are governed by different

laws.

> I

> > am sure you and other members of Congress are not intending to

> > create such concern among the 150 million Americans who rely on

> > dietary supplements to assist their health, and this matter is

> > easily corrected with the following amendment, which will not in

> any

> > way stop the FDA from identifying truly contaminated food that

> poses

> > a risk to human health.

> >

> > Changes in Existing Law

> >

> > The following provides a print of the existing statute or part

or

> > section thereof to be amended or replaced (existing law proposed

to

> > be omitted is enclosed in black brackets, existing law in which

no

> > change is proposed is shown in roman):

> >

> > CHAPTER IV -- FOOD

> >

> > SEC. 402

> > (f) --

> > (1) If it is a dietary supplement or contains a dietary

ingredient

> > that --

> > (A) presents a significant [or unreasonable] risk of illness or

> > injury under --

> > (i) conditions of use recommended or suggested in labeling, or

> > (ii) if no conditions of use are suggested or recommended in the

> > labeling, under ordinary conditions of use:

> >

> > Changes in Proposed Bills

> >

> > Proposed amendment to S 1082 and HR 1561:

> >

> > The bills are hereby amended to prohibit the Foundation or

> Institute

> > from evaluating the health benefit or efficacy of foods, dietary

> > ingredients, and dietary supplements and to limit review of

foods,

> > dietary ingredients and dietary supplements to a determination

of

> > whether they are safe. In assessing whether dietary ingredients

and

> > dietary supplements are safe, the Foundation or Institute shall

not

> > compare product risks with health benefits or efficacy. Instead,

> the

> > Foundation or Institute shall determine whether the product

> presents

> > a significant risk of illness or injury under conditions of use

> > recommended or suggested in labeling, or if no conditions of use

> are

> > recommended or suggested in labeling, under ordinary conditions

of

> > use.

> >

> > Please help preserve my rights and support this amendment.

> >

> > Sincerely,

> > (Your name here)

> >

>