Amend FDA Revitalization Act in House-to preserve DSHEA

[Guest guest]

The FDA Revitalization Act authorizing an independent foundation under the

FDA to develop new drugs and possibly test for safety has passed the Senate

and now will go to the House of Representatives. Contact your congessmember and

the members of the dietary supplement caucus listed below to amend the bill

to eliminate reference to regulating food and food ingredients, since these

are presumed to be safe unless adulterated. The regulation of dietary

supplements as foods is the underlying basis for the availability of

supplements.

arnold

IAHF List:

Here is Byron Richard's latest report on S.1082. Below Byron's information

you'll see a list of Congressmen who are in the Dietary Supplement Caucus.

They'd be the best people to approach in the House to try to get our amendment

there, and it would be easier to get our amendment in the House than the

senate.

You'll be glad to know that lots of people have been calling Congress and

that at the very least we did succeed in getting statements from some key

senators put into the congressional record which express that the intent of

this

bill is to not impact DSHEA..... the problem is they can have these sort of

colloquys all day long, yet unless we get our specific amendment, FDA could

just ignore them and draft implementing regs that screw us. So we must keep

making our calls and sending our faxes.....

BYRON RICHARDS UPDATE: The Senate finished debate today on S1082. Dorgan

offered a new Amendment to demand true anti-counterfeit technology to the bill.

Enzi and Dorgan debated – with Dorgan tearing him to pieces – although I

doubt it will matter. Also, Sherrod Brown discussed his amendment to prevent

Big Pharma from gaming a citizen’s petition system that Big Pharma uses to

delay generic drug competition (some aspect of this may make it into the

legislation). Durbin offered an amendment for meaningful changes to FDA

advisory

panels. This is a really good amendment and is unlikely to go anywhere.

Thus, Kennedy and Enzi are stonewalling all meaningful change to protect Big

Pharma. THIS BILL IS GOING TO PASS – even people like Dorgan say they will

support it as they feel, depite its shortcomings, it is better than the current

state of affairs. So it is definitely a matter of what amendments get added

to it that will make a difference. We must keep telling people to support our

amendment to protect dietary supplements and functional foods. Here is my

current wording: Please keep up the pressure to protect dietary supplements,

functional foods, and access to your natural health options. To get

information on contacting your Senators, click _here_

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

People’s Amendment:S.1082 - Please

Amend to Protect Dietary Supplements May 7, 2007 The Honorable (Senator First

and Last Name) Address

Address Dear Senator Last Name; The issue of drug safety is of the utmost

importance to myself and all Americans. I am concerned that the legislation, as

currently written, opens the door for considerable regulatory confusion

enabling the FDA to use S.1082 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. This

bill authorizes the creation of a new regulatory category that enables the FDA

and the Reagan-Udall Foundation for the FDA to attack dietary supplements and

functional foods. I am sure you and other Senators were 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 a

simple

amendment. Proposed amendment to S1082:

“The bill, S1082, is hereby amended to eliminate any reference to the terms

food or food ingredients within Subtitle B - Reagan-Udall Foundation for the

Food and Drug Administration, such that food and food ingredients will not be

subject to any jurisdiction or control by the Reagan-Udall Foundation for

the Food and Drug Administration.â€

Intent of amendment:

To eliminate from the bill any possibility that food or food ingredients

would be treated like drugs either for safety review purposes or for assessment

of their efficacy. It is a fundamental tenet of food and drug law that foods

and food ingredients are presumed to be safe and have to be established to be

adulterated only if they present a significant or unreasonable risk of

illness or injury.

Johns addition to Byron's Update:

In addition to your senators, please also contact the members of the Dietary

Supplement Caucus to ask them to sponsor our amendment when this legislation

gets introduced in the House (they'll probably just introduce the Senate

bill as a House bill:

DIETARY SUPPLEMENT CAUCUS

Congressman Ron Paul

Congressman Dan Burton

Congressman Peter De Fazio

Congressman Chris Cannon

Congressman Frank Pallone

Reead them all via 202-225- 3121 Capital Switchard, ask for their fax

numbers. Explain to them that when S.1082 gets introduced in the House that we

need

this amendment. 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