**Butler, Jennie C**

**From:** Williams, Carole A

**Sent:** Thursday, April 06, 2000 1:20 PM

**To:** Butler, Jennie C; \'harristakoma@erols.com\'

**Subject:** FW: APMA statement from April 4 public meeting

More oral statements

\-\-\-\--Original Message\-\-\-\--

**From:** Candace Campbell \[SMTP:candacec@wizard.net\]

**Sent:** Thursday, April 06, 2000 12:33 PM

**To:** CWILLIA1@OC.FDA.GOV

**Subject:** APMA statement from April 4 public meeting

Carole: I am providing my statement as an attachment (Word document) and

in the text of this e-mail in case you can\'t open the attachment. I

know they can be finicky.

Candace Campbell

APMA

ADDRESS TO THE FDA

Public Hearing

April 4, 2000

My name is Candace Campbell. I am the Executive Director of the

American Preventive Medical Association, one of the plaintiffs in the

Pearson case. I think you probably know what I'm going to say. For the

past nine years APMA has asked FDA to approve four dietary supplement

health claims. FDA denied the claims and refused to permit them even

with disclaimers, despite our successful arguments that the First

Amendment prohibited outright suppression of the claims and required

their authorization with disclaimers.

On January 15, 1999, the United States Court of Appeals for the D.C.

Circuit agreed with us and held FDA's four rules suppressing the claims

invalid under the First Amendment. The Court ruled that FDA may not

suppress health claims if it can render them nonmisleading through the

addition of disclaimers. The Court ordered FDA to favor disclosure over

suppression and found "almost frivolous" FDA's arguments to the

contrary. The Court gave the agency precise disclaimer language that

the Court found acceptable for use with each of the four claims FDA

suppressed. In other words, the Court gave FDA a precise road map to

follow to assure full compliance with the First Amendment.

Despite the Court's orders and over one year after the Court's

decision, FDA continues to enforce the four rules the Court held

invalid. My attorney has been told by CSFAN Director Levitt that FDA

will prosecute anyone who uses the claims the Court found wrongfully

suppressed even if those claims are used with the Court's preferred

disclaimers. In short, FDA is continuing to violate the First Amendment

and it is resisting compliance with the Pearson Court's constitutional

order. Where I come from that is called contempt of court.

The Pearson Court's decision is extraordinary in many respects. First,

the Court not only ruled that FDA violated the First Amendment by

suppressing the four health claims rather than disclosing them with

disclaimers, it also spelled out in detail the kinds of disclaimers it

found sufficient to eliminate the potentially misleading connotations

FDA identified. In other words, the Court not only told FDA why its

actions were unconstitutional, it also told FDA precisely how to comply

with the Constitution-by authorizing the claims in a nonmisleading way.

After the Court's clear explanation to this agency, one would have

thought FDA would act immediately to authorize the claims with those

disclaimers. But FDA did not. Instead, FDA has spent over fourteen

months enforcing the very rules the Court invalidated and struggling to

find some legal argument for not complying with the Court's order. FDA

has refused to set a date certain by which it will authorize the claims

with disclaimers despite five letters from our attorney requesting a

date. FDA has refused to allow APMA's members to use the claims with

disclaimers, threatening enforcement action against them if they do.

In today's meeting, FDA does not identify a date by which it will

authorize the claims, rather FDA asks questions which reveal that it

seeks yet another scientific validity test to prevent authorization of

the claims. Moreover, FDA is now trying to redefine the term "health

claim" to exclude treatment claims from those permitted without drug

pre-approval.

To be blunt, this nonsense has got to come to an end. Rather than

follow the law faithfully, FDA is doing everything it can to evade,

circumvent, and disobey the law. Those actions are reprehensible. I

realize from recent communications with the FDA, that you believe that

you are responding with all due haste. Let me assure you, you are alone

in this perception. FDA's duty to comply with Pearson is clear and

immediate. We have suffered nine years of speech suppression and should

not be made to suffer an additional moment. The Court ordered this

agency to authorize the claims with disclaimers. The Court told this

agency what disclaimers it found acceptable. Do what is required of you

and stop these obvious evasive tactics. Authorize all four of the

health claims with the disclaimers the Court has given you and do so

immediately.

It is mind boggling to me that we spent six years and hundreds of

thousands of dollars - not tax dollars - and won a landmark law suit,

yet the agency has yet to comply. If an individual acted with such

impunity, he would be in jail by now. I came here today to urge you to

stop playing games with our Constitution and to stop running roughshod

over our free speech rights. FDA is not above the law.

**[ADDRESS TO THE FDA]{.underline}**

Public Hearing

April 4, 2000

My name is Candace Campbell. I am the Executive Director of the American
Preventive Medical Association, one of the plaintiffs in the *Pearson*
case. I think you probably know what I=m going to say. For the past nine
years APMA has asked FDA to approve four dietary supplement health
claims. FDA denied the claims and refused to permit them even with
disclaimers, despite our successful arguments that the First Amendment
prohibited outright suppression of the claims and required their
authorization with disclaimers.

On January 15, 1999, the United States Court of Appeals for the D.C.
Circuit agreed with us and held FDA=s four rules suppressing the claims
invalid under the First Amendment. The Court ruled that FDA may not
suppress health claims if it can render them nonmisleading through the
addition of disclaimers. The Court ordered FDA to favor disclosure over
suppression and found Aalmost frivolous@ FDA=s arguments to the
contrary. The Court gave the agency precise disclaimer language that the
Court found acceptable for use with each of the four claims FDA
suppressed. In other words, the Court gave FDA a precise road map to
follow to assure full compliance with the First Amendment.

Despite the Court=s orders and over one year after the Court=s decision,
FDA continues to enforce the four rules the Court held invalid. My
attorney has been told by CSFAN Director Levitt that FDA will prosecute
anyone who uses the claims the Court found wrongfully suppressed even if
those claims are used with the Court=s preferred disclaimers. In short,
FDA is continuing to violate the First Amendment and it is resisting
compliance with the *Pearson* Court=s constitutional order. Where I come
from that is called contempt of court.

The *Pearson* Court=s decision is extraordinary in many respects. First,
the Court not only ruled that FDA violated the First Amendment by
suppressing the four health claims rather than disclosing them with
disclaimers, it also spelled out in detail the kinds of disclaimers it
found sufficient to eliminate the potentially misleading connotations
FDA identified. In other words, the Court not only told FDA why its
actions were unconstitutional, it also told FDA precisely how to comply
with the ConstitutionCby authorizing the claims in a nonmisleading way.

After the Court=s clear explanation to this agency, one would have
thought FDA would act immediately to authorize the claims with those
disclaimers. But FDA did not. Instead, FDA has spent over fourteen
months enforcing the very rules the Court invalidated and struggling to
find some legal argument for not complying with the Court=s order. FDA
has refused to set a date certain by which it will authorize the claims
with disclaimers despite five letters from our attorney requesting a
date. FDA has refused to allow APMA=s members to use the claims with
disclaimers, threatening enforcement action against them if they do. In
today=s meeting, FDA does not identify a date by which it will authorize
the claims, rather FDA asks questions which reveal that it seeks yet
another scientific validity test to prevent authorization of the claims.
Moreover, FDA is now trying to redefine the term Ahealth claim@ to
exclude treatment claims from those permitted without drug pre-approval.

To be blunt, this nonsense has got to come to an end. Rather than follow
the law faithfully, FDA is doing everything it can to evade, circumvent,
and disobey the law. Those actions are reprehensible. I realize from
recent communications with the FDA, that you believe that you are
responding with all due haste. Let me assure you, you are alone in this
perception. FDA=s duty to comply with *Pearson* is clear and immediate.
We have suffered nine years of speech suppression and should not be made
to suffer an additional moment. The Court ordered this agency to
authorize the claims with disclaimers. The Court told this agency what
disclaimers it found acceptable. Do what is required of you and stop
these obvious evasive tactics. Authorize all four of the health claims
with the disclaimers the Court has given you and do so immediately.

It is mind boggling to me that we spent six years and hundreds of
thousands of dollars B not tax dollars B and won a landmark law suit,
yet the agency has yet to comply. If an individual acted with such
impunity, he would be in jail by now. I came here today to urge you to
stop playing games with our Constitution and to stop running roughshod
over our free speech rights. FDA is not above the law.