Immediate action needed - S1082/H1561 Subtitle B Oppose new action

[Guest guest]

Go to

http://www.democracyinaction.org/dia/organizationsORG/NHFA/campaign.j

sp

 

( may need to cut and past URL ).

and take immediate action to ammend S1082 / H 1561 - thanks !!!

 

Colleagues and Friends of Texas Health Freedom,

Please take a moment to contact your Congressperson and let

them hear your voice on this important issue. See the link below.

Many thanks to Diane Miller of National Health Freedom Action for

her indepth analysis.

 

Peter McCarthy, ND

Chair, TX Health Freedom Coalition

-----Forwarded Message-----

National Health Freedom Action

Jun 8, 2007 3:16 PM

" texascam "

OPPOSE S1082/H1561 Subtitle B: The Reagan-Udall Foundation

 

 

OPPOSE S1082/H1561 Subtitle B: The Reagan-Udall Foundation

 

Unless Amended to Protect Dietary Supplements

 

National Health Freedom Action is sending you this alert to

encourage you to help preserve the foundation of the Dietary

Supplement Health and Education Act of 1994 (DSHEA) and write to

your Congressman from our website and let them know that you oppose

S1082/H.R.1561 unless it is amended. Click here to write to your

Congressman directly:

http://www.democracyinaction.org/dia/organizationsORG/NHFA/campaign.j

spcampaign_KEY=11757 & t=NewNHFAtemplate.dwt

 

 

S1082/H.R. 1561 sets up a non-profit corporation called the Reagan-

Udall Foundation that would give the FDA a new and expanded role to

be part of a Foundation with the purpose of implementing goals of

the FDA in the area of new drug development. This means that the

same organization that will be developing drug evaluation technology

is also enmeshed in the agency that regulates the drug approval

process, thus creating a situation that could potentially reduce the

safety of the drugs and products made available to the public.

 

 

In addition to being focused on drug assessment technology

development, the Senate added language to the bill which included

food safety. The addition of amendments that include food safety,

and the language of the original bill that included food and dietary

supplements in the purpose of the Reagan Udall non-profit, are

completely unacceptable to freedom advocates because it could mean

down the road that foods, dietary ingredients and dietary

supplements would be at risk for being treated like drugs when

evaluated by the FDA with their new drug tools.

 

 

Foods and dietary supplements in the U.S. are not currently

regulated as drugs, but are regulated as foods under DSHEA. Notably

because of this, they are evaluated differently. Foods and dietary

supplements are considered food nutrients generally regarded as safe

and the evaluation of their safety is based on whether they cause a

significant risk of harm as opposed to being evaluated under the

toxic drug risk/benefit assessment. Risk/benefit analysis is

reserved for toxic substances and the FDA approves drugs for market

if the benefit justifies the risk. These foundational differences

of drug and food safety assessments have recently been challenged in

the Ephedra cases and because the Supreme Court has denied hearing

the Ephedra case May 2007, there is a real possibility that drug

assessments might be applied to foods in the future.

 

 

With a drug, a consumer has to choose whether they want to be harmed

by the substance, in trade for getting a measured benefit. And the

drug companies have to disclose side effects. But that is not the

nature of food. Food is not generally toxic. Benefit of food

should always be the consumer’s opinion and the government should

only block food from the market if they have shown harm. Because of

the assumption that food is safe we have a wide variety of foods and

supplements in the marketplace. If foods and dietary supplements

were ever to be evaluated as drugs with technology developed for

drugs and a risk/benefit analysis, it would no longer be up to the

consumer to decide whether a food or dietary supplement were risky

or beneficial to them. The FDA would be deciding that before they

would be allowing them on the market. We then run the risk of

natural products being incorrectly assessed as harmful because of a

drug analysis being applied to them and losing access to many

wonderful foods and nutrients that we currently use.

 

 

Foods and dietary supplements should continue to be treated as food

(DSHEA) and evaluated under food standards and technology instead of

with toxic drug risk/benefit assessment tools. To accomplish this,

an amendment must be added to the current bill S1082/H.R.1561. The

following amendments are being recommended and drafted by the law

firm of Emord and Associates in Washington DC:

 

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.â€

 

This bill passed the Senate May 2007 and is now in the House. We

need as many people as possible to email, write or call your

legislators to demand that the above amendment be added. Click here

to write to your Congressman directly:

http://www.democracyinaction.org/dia/organizationsORG/NHFA/campaign.j

sp?campaign_KEY=11757 & t=NewNHFAtemplate.dwt

 

 

Prepared by Diane Miller, Director of Law and Public Policy,

National Health Freedom Action.