Why FDA is now promoting a new LAW not Regulation

[Guest guest]

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<arnoldgore

Why FDA is now promoting a new LAW not Regulation

 

 

I think part of your misunderstanding of the problem many of us are fighting

is explicitly framed by your comment below on FDA's desire to live with and

uphold the Dietary Supplement Health Education Act of 1994 (DSHEA). THIS

statement is completely FALSE and counter to everything FDA has done since

passage of

this law.

 

You Wrote:

Bear in mind too that the Dietary and Health Supplement

Act of 1994 is a ''law'' enacted by the federal legislature

(congress) and cannot be overturned by the FDA. In fact in that

regard, the FDA is required to uphold the law and to do so vigorously

and in a positive manner. What the FDA as an agency of the federal

government can do is promulgate regulations which have the force of

law but which are not laws, so long as they do not conflict with

existing federal law. What that means is that the FDA cannot ammend

the Dietary and Health Supplement Act even if it wanted to. The FDA

can interpret laws by adding regulations to strengthen them. That is

in fact what it is doing. The supplement industry has had one hell of

a party at our expense for a decade. These regulations will not

affect manufacturers who are currently selling a good product one

bit. Whom it will affect will be those hundreds of private label

 

 

During 1993 7 1994 (before passage) they fought it, then ignored it and

appealed it to the Federal Courts where FDA was rebuked by the Wasbington,DC

Circuit Court of Appeals, Pearson v. Shalala deciding 11-0 in January 1999,

which

rejected FDA's argument that heath claims lacking " significant scientific

agreement " are inherently misleading, even if truthful, because they can

sway

consumers making it impossible for them to rationally evaluate it. This

overweening

protection of the consumer for their own good could not be justified. By not

appealing to the Supreme Court, FDA accepted the ruling as settled law.

Nevertheless thet still refused to allow these claims for Dietary

Supplements. As

late as March 2000, 14 months AFTER the decision and court order to allow

truthful claims held a public hearing on the subject: " Should health claims

be

allowed? " NOT how to allow health claims that the law said had to be

allowed. FDA

Commissioners repeatedly IGNORED this Court Decision and the hated DSHEA law

without having to be accountable. Then Commssioner Mark McClellan announced

that

he would comply with the vourt order and allow supplement claims as the law

allowed. This threatened the monopolistic hold prescription drugs had on

consumers choice of medical treatment.

 

At this point FDA ralized the only way to continue protecting the

prescription drug monopoly on medical treatments was to get a NEW law passed

rolling back

DSHEA, thus presenting the courts with a new law to interpret. That is the

reason for S.722 the Dietary Supplement Safety Act. By blowing up the few

cases

of ephedra abuse and feeding the compliant media stories about dietary

supplement dangers, they hope to get a new law passed. In doing so, they

would like

to enlist some of the alternative medical consumers who may feel supplement

manufacturers are making too much money on some of their patented

supplements

that carry high price tags like MSN, Shark Cartilage etc.

 

The bigger supplement manufacturers probably will be able to afford the FDA

imposed regulaions that will eventually raise prices of supplements and

drive

out the small producer, such as the small Freeda Vitamin Company, I do not

know

if the highly regarded and meticulous Standard Process Laboratories, a

producer

products that every doctor , nutritionist, naturpathsupplements from

Organically raised foods and livestock with minimal heat in processing will

be able to

financially meet the new regulations of FDA, but I do not want to find out.

These supplements are among the best and the most likely to be unable to

comply

with a very expensive cost of compliance with new regulations, actually

designed to force out the little guy, some of whom abuse the right to market

and

produce supplements. Empowering FDA to go after the " bad manufacturers " is

not

something I and many others can trust to be handled fairly.

 

FDA has always argued that they are only tying to protect the consumer, do

you really think they have changed and now that is their real goal? Some of

us

have been here before and seen that they usually override and ignore

consumer

requests i they want to use alternative medical products, as they did in

attempts to drive out compounding pharmacies, whose formulations of doctors

prescriptions have usually not gone through FDA's New drug approval process

that is

tremendously expensive- probably $1 Millon dollars minimum.

Arnold