Stop FDA Regulation of supplements with amendment to bill-contact congress

May 17, 2007

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 â€“ Part 2Senate Attempts

Damage Control â€“ House Braces for Onslaught

Byron Richards, CCN

May 16, 2007

NewsWithViews.com

Senators 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 Senatorâ€™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 didnâ€™t you vote for the Grassley and Durbin amendments

that would have given some real meaning to drug safety at the FDA? And why

didnâ€™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 â€“ 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 Director 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 â€“ 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 Iâ€™m sure you didnâ€™t read the bill. It says the Foundation

will ensure that â€œaction is taken as necessary to enable the licensing of

inventions developed by the Foundation or with funds from the Foundation; and

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€ 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 donâ€™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 donâ€™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 FDAâ€™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

proves 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. FDAâ€™s imposition

of a drug standard risk-benefit comparison on dietary supplements is not

sanctioned by the Act and exceeds the statutory limits on FDAâ€™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 â€œunreasonableâ€ 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 Congressâ€™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_

(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 â€“ FOOD

SEC. 402

(f) â€“

(1) If it is a dietary supplement or contains a dietary ingredient that â€“

(A) presents a significant [or unreasonable] risk of illness or injury underâ€”

(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, click _here_

(http://www.senate.gov/general/contact_information/senators_cfm.cfm) .To

contact your House Representative, click _here_

(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

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 â€“ 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