What to Do To Amend S.1082/HR 1561: Understanding the Threat to Dietary Suppleme

[Guest guest]

REPOSTING

 

What to Do To Amend S.1082/HR 1561: Understanding the Threat to Dietary

Supplements Part 2: Lets Turn Up the Heat NOW!!! 

 

 

IAHF List:

I've been having extensive discussions with key congressmen about our need

for an amendment and urge you to join me in communicating with congress about

this by utilizing the information contained in Byron Richard's most recent

article, below.

 

 

Congress has to pass this legislation prior to August recess, and our future

access to dietary supplements depends on our successful effort to awaken the

sleeping masses on this issue including the Natural Products Association

(formerly NNFA) which is currently misunderstanding this issue and actively

misleading its entire membership via a statement on the front page of their

website

that rings hollow when juxtaposed against this information. 

 

 

 

I strongly urge you to seek out health food stores in your area that are

members of NPA, and please give them Byron's article. Ask them to compare his

information with what NPA is saying and ask them to communicate with their

Executive Committee and Board of Directors.

 

 

This is a very dangerous situation, analogous to that which existed in 1989

when NNFA was on the wrong side of the NLEA issue (Nutrition Labelling and

Education Act).

 

 

 

Only when large numbers of NNFA members threatened to MUTINY did NNFA do a

180 on that issue, but by then it was TOO LATE to kill the bill, we were lucky

to curb some of its worst excesses, and we did set the stage for building the

grass roots army that was to pass DSHEA in '94, but today S.1082/HR 1561

threatens to scuttle DSHEA, and NPA is asleep at the switch.........

 

 

 

IAHF is planning a return to our Nation's Capital for another round of

lobbying, but first we're lining up meetings and making preliminary contacts

while

making sure we've got you guys cranked up and making the contacts with congress

that we need to back me up. When you go to the Hill as a grass roots guy, you

need phones ringing off hooks and fax machines running out of paper.

 

 

I need each of you to reach out actively to educate your friends, family

neighbors on this issue to get them moving on it. IAHF doesn't have a political

action committee- we're not on that Hill slinging money around- when I go to

the

Hill, I need to know you guys are backing up my efforts with a staggering

volume of calls, and faxes. It wouldn't hurt if you were to personally visit

your

congressman's district office on this issue and I strongly urge you to. Its

THAT important!!!

 

Please let me know of any responses you have from Senators or Congressmen on

this issue, and let me know what you're doing to help roll this boulder

uphill.

 

 

This is for ALL the marbles....and it is NOT a drill.

 

 

Understanding the Threat to Dietary Supplements – Part 2

 

Senate Attempts Damage Control – House Braces for Onslaught 

Byron Richards, CCN

May 16, 2007

NewsWithViews.com

 

<FONT COLOR= " #800040 " BACK= " #ffffff " style= " BACKGROUND-COLOR: #ffffff " SIZE=3

PTSIZE=12 FAMILY= " SERIF " FACE= " GeSenators were taken off guard by the public

outrage over the passing of bill

S.1082 with language that can be used to seriously harass dietary supplements

by enabling the FDA to apply drug-related risk analysis to the safety of food

and food ingredients (and thus dietary supplements).  Senators are also

struggling to defend the fact that they enabled the creation of the

Reagan-Udall

Foundation for the FDA, having been conned into believing this foundation was

for

the purpose of improved safety when in fact its mission is to assist the FDA

to develop the next generation of drugs with drastically reduced safety or

effectiveness testing.  These issues are fully explained in Part 1 of this

article http://www.newswithviews.com/Richards/byron30.htm , if you would like

to

know the details in greater depth.

 

This week the Senate has unleashed a damage control campaign, sending out

numerous e-mails to those who have been complaining over the past few weeks. 

The

goal of these letters is to calm apprehensions about dietary supplements and

seek to convince everyone that dietary supplements are not in any danger.  I

thank those of you who have sent me your Senator’s spin, and no letter was

better than the one I received from my Senator, Norm Coleman (R-MN).  I am

taking

the liberty of answering his form letter publicly, as it is reflective of the

arguments the Senate is using to confuse and pacify the American public.  The

following Coleman statements are extracted from his e-mail.

 

Coleman: 

I am very concerned with the Food and Drug Administration's (FDA) efficiency

in reviewing prescriptions drugs as well as its track record on appropriate

enforcement.  

 

Richards: 

Then why didn’t you vote for the Grassley and Durbin amendments that would

have given some real meaning to drug safety at the FDA?  And why didn’t you

or

any one of your colleagues raise a single question about the Reagan-Udall

Foundation for the FDA and its desire to help the FDA bring drugs to the market

with far less safety and effectiveness testing? 

 

Coleman: 

I understand that concerns have been raised regarding the bill's proposal for

the Reagan-Udall Foundation and dietary supplements. First, I want to assure

you that this bill does not regulate or restrict access to dietary supplements

in any way.   

 

Richards: 

It is true that the bill does not directly state that it intends to regulate

or restrict access to dietary supplements.  However, language within the

section establishing the Regan-Udall Foundation grants the FDA new regulatory

power

to brand food ingredients (and thus dietary supplements) as unsafe utilizing

the Critical Path Initiative drug-related risk assessment technology. 

 

Coleman: 

Second, the bill would establish the Reagan-Udall Foundation as a

non-government entity that would have no control over the FDA, industry, or

consumers.   

 

 

Richards: 

Excuse me Senator – did you read the bill?  The board of directors is

composed of the Commissioner of the FDA, the Director of the National Institutes

of

Health, the Director of the Centers for Disease Control and Prevention, the of the Agency for Healthcare Research and Quality, 4 representatives

from Big Pharma and Big Biotech, 3 representatives from academia (which is

funded

by Big Pharma), 2 more from the FDA and NIH, 2 from consumers groups, and 1

from health care providers.  This means that the FDA/Big Pharma/Big Biotech

voting block always has 13 votes – to at the most 3.  Who are you kidding? 

This

front group foundation is run by the FDA in combination with the industry it

is supposed to be regulating.  This makes the FDA part of the drug business as

a drug company. 

 

Coleman: 

Furthermore, the Foundation will not be involved in drug development but will

help provide new tools for improving safety in regulated product

development.  

 

Richards: 

Now I’m sure you didn’t read the bill.  It says the Foundation will ensure

that “action is taken as necessary to enable the licensing of inventions

developed by the Foundation or with funds from the Foundation; and © executed

licenses, memoranda of understanding, material transfer agreements, contracts,

and

other such instruments, promote, to the maximum extent practicable, the

broadest conversion to commercial and noncommercial applications of licensed and

patented inventions of the Foundation.â€Â Â  Since the Foundation is responding

to

the needs of the Critical Path Initiative, and that initiative is primarily

about the development of new drugs, it is clear that the Foundation will not

only help with drug development but it will have significant business

relationships as a result.  Are you not aware of the fact that non-profits are

the new

vehicle by which multi-national corporations shelter their inventions from

international competition? 

 

Coleman: 

I have also heard concerns with provisions in the mission of the Foundation

related to food and food ingredients.  This has to do with food safety, and not

with dietary supplements.  As the recent disease outbreaks associated with

spinach and peanut butter have shown, food safety tools are lacking.  The

Foundation would undertake research to help make food safer but it would have no

regulatory authority. 

 

Richards: 

Americans do not trust the FDA.  By law, dietary supplements are food and

food ingredients.  I am all in favor of the FDA being better able to identify

contamination in food that poses a risk to human health.  At least we agree on

that point.  The point we don’t agree on is the fact the technology in

question

relies on drug risk analysis and can be used to claim that a nutrient that is

not in any way contaminated is unsafe, thus undermining the very foundation of

food and drug law.  The Foundation is being positioned as a major tool for

the FDA to implement its opinionated use of this technology, which can easily be

used to attack dietary supplements. Since you and every other Senator that

has been questioned on this issue would like to deny there is any problem with

this legislation regarding dietary supplements, why don’t you help put some

language into this legislation that will satisfy all of our concerns.  After

all,

what harm is there in taking some action to SHOW THE PEOPLE that you truly

are not interested in allowing the FDA to have new power to harass dietary

supplements and suppress freedom of choice relating to health care options. The

following simple amendment has been prepared by noted attorney, Jonathan

Emord. 

 

Purpose of Amendment 

 

The purpose of the amendment is to ensure that foods, dietary ingredients,

and dietary supplements are not treated like drugs when evaluated by the Food

and Drug Administration.  Since the turn of the Twentieth Century, the Supreme

Court and most of the lower federal courts have accepted the principle first

articulated by Paracelsus in the 16th Century that dose determines toxicity. 

That bedrock principle underlies all of adulteration law. 

 

The FDA has unilaterally removed that principle from the law of adulteration

as it pertains to dietary ingredients and dietary supplements.  In its place,

FDA has required dietary ingredients and dietary supplements to be treated

like drugs when evaluating whether they are adulterated.  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.  The drug risk-benefit comparison was until recently

reserved exclusively for drugs because under the FDCA foods, food ingredients,

and

dietary supplements are presumed safe in light of their ubiquitous presence in

the food supply and history of safe ingestion. 

 

Consistent with the plain and intended meaning of the Dietary Supplement

Health and Education Act, a dietary supplement is not adulterated unless FDA pr

oves by a preponderance of the evidence that the supplement presents a

significant or unreasonable 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.  FDA’s imposition of

a

drug standard risk-benefit comparison on dietary supplements is not sanctioned

by the Act and exceeds the statutory limits on FDA’s power. 

 

That imposition violates the plain and intended meaning of the dietary

supplement adulteration provision adopted by the Congress in the DSHEA.  This

amendment ends that violation by removing the term “unreasonable†as a

modifier of

risk, making it clear that the focus of the statute is on significant risk,

not on a comparison of risk with benefit.

 

To ensure that the Foundation or Institute created by the bill does not

undermine Congress’s plain and intended meaning, this amendment also prohibits

that

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

ingredients, and dietary supplements by limiting its review to determining

whether

those ingredients or supplements present 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.

 

Changes in Existing Law

(for the law see http://www.fda.gov/opacom/laws/fdcact/fdcact4.htm )

 

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, new matter is printed in italic, 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. 

 

Health Freedom is on the Line   

 

It is vitally important to send the following message to all members of the

House and keep flooding the Senate (as there will be a conference committee). 

It is also important to send this message to Senators Hatch and Harkin (the

original designers of DHSEA) and Kennedy and Enzi (who claim they are not trying

to regulate dietary supplements with this legislation).  These Senators must

hear from the American public as they will determine the fate of this

amendment when it reaches the conference committee.  Success will require

significant

support from the people.  Thank you.

 

To get information on contacting Senators,

http://www.senate.gov/general/contact_information/senators_cfm.cfm

 

To contact your House Representative,

http://www.house.gov/writerep/

 

Please send the following message.

 

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

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,

 

 

  Copyright © TruthInWellness, LLC

 

To read Part 1 of this article,

http://www.newswithviews.com/Richards/byron30.htm

 

Byron J. Richards, Founder/Director of Wellness Resources, is a

Board-Certified Clinical Nutritionist and nationally-renowned health expert,

radio

personality, and educator. He is the author of Mastering Leptin, The Leptin

Diet, and

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

 

You may now read Fight for Your Health free, and/or purchase the book or a

PDF download.  All proceeds from the sale go to defend health freedom. Richards

encourages individuals to take charge of their health, stand up for their

health rights, and not blindly succumb to propaganda from the vested-interests

who

profit from keeping Americans sick. As founder of Wellness Resources, Inc. of

Minneapolis, MN, an independently-owned fine-quality dietary supplement

company since 1985, he has personally developed 75 unique nutraceutical-grade

nutritional formulas. www.wellnessresources.com

 

E-mail: byron

 

 

 

For Health Freedom,

John C. Hammell, President

International Advocates for Health Freedom

556 Boundary Bay Road

Point Roberts, WA

98281-8702 USA

http://www.iahf.com

jham

800-333-2553 N.America

360-945-0352 World