**Butler, Jennie C**

**From:** Latham, Jeanne E

**Sent:** Wednesday, April 12, 2000 8:06 AM

**To:** Butler, Jennie C

**Subject:** FW: April 4 Meeting

Hi Jennie,

You may already have this comment, but I thought I would send it to you
anyway.

Thanks and have a super day! Jeanne

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

From: Wilkening, Virginia L

Sent: Friday, March 31, 2000 10:32 AM

To: Kulakow, Naomi; Latham, Jeanne E; Williams, Carole A

Subject: FW: April 4 Meeting

FYI

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

From: Anderson, Ellen M -Banyan

Sent: Friday, March 31, 2000 9:57 AM

To: Larsen, Lynn A; Wilkening, Virginia L; Hoadley, James E -Banyan

Subject: April 4 Meeting

Lynn, Jim, Virginia \-- I received the attached announcement about the
April 4

meeting and FDA\'s attempt to delude and exclude the American people. A
couple

of sections are included below to give you the flavor, and the entire

announcement is attached should it be needed. \-- Ellen

FDA TO HOLD SPECIAL HEARING

Foundation Supporters In Washington DC Area Urged to Attend

The FDA has been overwhelmed by demands from Congress, the Courts and
the

people to abide by the First Amendment as it relates to dietary
supplement

health claims. In response, the FDA is holding a public meeting on April
4,

2000

from 10:00 am to 6:00 pm at the Department of Education, Barnard
Auditorium

(Federal Building 6),400 Maryland Ave SW, Washington, DC. This building
is

one block east of the L\'Enfant Metro Station. (Maryland Ave. exit)

The purpose of this meeting is to discuss implementation of health
claims

ordered by a Federal Appellate Court in the First Amendment lawsuit

victory won by Durk Pearson and Sandy Shaw against the FDA on January
15,

1999\. The FDA is seeking public comment on whether dietary supplements
can

have disease-specific treatment claims attached, or if they are to be

limited only to disease risk reduction. If you have any grievances you

would like to redress to the FDA, this is your opportunity.

To attend the meeting, you must complete the registration form at the
end

of this article and fax or mail it to Carole A. Williams, Office of

Consumer Affairs, FDA, 5600 Fisher\'s Lane, Rockville, MD 20857. FDA

encourages you to fax this information to them at: 301-827-3052. You can

phone them at 301-827-4421 for additional information.

The FDA says you must send them your registration by March 28, a ploy we

believe is designed to preclude most people from being able to
participate

in this public hearing. We urge all Foundation members to make an effort

to attend this important event. If the FDA tries to deny you access, you

should state that your Constitutional civil rights will be violated if

they do not allow you to attend this public hearing to determine what

types of health claims you are allowed to hear under the First
Amendment.

The FDA\'s failure to allow citizens access to this meeting to discuss

these critically important First Amendment issues will in effect, be
still

another overt act by the FDA to suppress free access to information by
the

public.

The FDA has only given a one-week notice to apply to attend to this

meeting, which is unusually short. It\'s obvious the FDA would like to
be

able to tell Congress that the public has no interest in this area. When

we tried faxing the FDA\'s special reservation line today, it did not
pick

up. We encourage all those who are going to attend to bring cameras and

tape recorders to document any attempt by the FDA to deny the public

access the this hearing.

Return-Path: \<kkash@netzero.net\>

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Subject: \[Fwd: friends in DC area\]

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Date: Thu, 23 Mar 2000 09:56:39 -0800

From: \"Renee D. Uhl\" \<ruhl@wilmington.net\>

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Subject: friends in DC area

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The summary of below\--re FDA regulating availability of supplements.

FDA is holding one day mtg in DC area for public comment. Only read

further is you may be interested in attending the meeting. ren

\-\-\-\-\-\-\-\-\-\-\-\-\--D618E21BCEEDAE10502DE597

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Message-ID: \<003201bf9487\$56b595e0\$b44979a5@h.s.khal\>

From: \"hari\" \<windspirit@mindspring.com\>

To: \"Acup Ass of NC\" \<aanc-all@covecreek.org\>,

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Subject: Fw: FDA ALERT

Date: Thu, 23 Mar 2000 00:19:15 -0500

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

From: LEF Email List1 \<nsantini@directnet1.net\>

To: List Member \<windspirit@mindspring.com\>

Date: Wednesday, March 22, 2000 9:29 PM

Subject: FDA ALERT

\>LEF Email List1 - http://www.lef.org

\>

\>FDA TO HOLD SPECIAL HEARING

\>Foundation Supporters In Washington DC Area Urged to Attend

\>

\>The FDA has been overwhelmed by demands from Congress, the Courts and
the

\>people to abide by the First Amendment as it relates to dietary
supplement

\>health claims.

\>

\>In response, the FDA is holding a public meeting on April 4, 2000 from

\>10:00 am to 6:00 pm at the Department of Education, Barnard Auditorium

\>(Federal Building 6),400 Maryland Ave SW, Washington, DC. This
building is

\>one block east of the L\'Enfant Metro Station. (Maryland Ave. exit)

\>

\>The purpose of this meeting is to discuss implementation of health
claims

\>ordered by a Federal Appellate Court in the First Amendment lawsuit

\>victory won by Durk Pearson and Sandy Shaw against the FDA on January
15,

\>1999. The FDA is seeking public comment on whether dietary supplements
can

\>have disease-specific treatment claims attached, or if they are to be

\>limited only to disease risk reduction. If you have any grievances you

\>would like to redress to the FDA, this is your opportunity.

\>

\>To attend the meeting, you must complete the registration form at the
end

\>of this article and fax or mail it to Carole A. Williams, Office of

\>Consumer Affairs, FDA, 5600 Fisher\'s Lane, Rockville, MD 20857. FDA

\>encourages you to fax this information to them at: 301-827-3052. You
can

\>phone them at 301-827-4421 for additional information.

\>

\>The FDA says you must send them your registration by March 28, a ploy
we

\>believe is designed to preclude most people from being able to
participate

\>in this public hearing. We urge all Foundation members to make an
effort

\>to attend this important event. If the FDA tries to deny you access,
you

\>should state that your Constitutional civil rights will be violated if

\>they do not allow you to attend this public hearing to determine what

\>types of health claims you are allowed to hear under the First
Amendment.

\>The FDA\'s failure to allow citizens access to this meeting to discuss

\>these critically important First Amendment issues will in effect, be
still

\>another overt act by the FDA to suppress free access to information by
the

\>public.

\>

\>The FDA has only given a one-week notice to apply to attend to this

\>meeting, which is unusually short. It\'s obvious the FDA would like to
be

\>able to tell Congress that the public has no interest in this area.
When

\>we tried faxing the FDA\'s special reservation line today, it did not
pick

\>up. We encourage all those who are going to attend to bring cameras
and

\>tape recorders to document any attempt by the FDA to deny the public

\>access the this hearing.

\>

\>Please forward this alert to anyone you know in the Washington, D.C.
area

\>who might want to attend, or submit written comments. For complete

\>details, please check out the Home Page of our Website (www.lef.org)

\>

\>What follows is a summary of this meeting from the FDA along with a

\>registration application:

\>

\>The Food and Drug Administration (FDA) is announcing a public meeting
to

\>solicit comments on two topics pertaining to health claims in dietary

\>supplement labeling. The first topic concerns implementation of the
recent

\>court of appeals decision in Pearson v. Shalala (Pearson). In Pearson,
the

\>U.S. Court of Appeals for the D.C. Circuit held that FDA\'s decision
not to

\>authorize four health claims for dietary supplements violated the
First

\>Amendment because the agency did not consider whether the claims,
which

\>failed to meet the \`\`significant scientific agreement\'\' standard
of

\>evidence by which the health claims regulations require FDA to
evaluate

\>the scientific validity of claims, could be rendered non-misleading by

\>adding qualifying language. The second topic on which we are
requesting

\>comments is whether claims about an effect on an existing disease may
be

\>made as health claims, or whether such claims should subject the
product

\>to regulation as a drug. We are holding this meeting to give the
public an

\>opportunity to provide information and views on these topics.

\>

\>DATES: The meeting will be held on April 4, 2000, from 10 a.m. to 6
p.m.

\>Please register by close of business, March 28, 2000. Late
registrations

\>will be accepted contingent on space availability. Submit written
comments

\>by April 19, 2000.

\>

\>ADDRESSES: The meeting will be held at Department of Education,
Barnard

\>Auditorium (Federal Building 6), 400 Maryland Ave., SW., Washington,
DC.

\>Building entrances are located on the Maryland Ave., SW. and C Street,
SW.

\>between 4th and 6th Streets, SW. Federal Building 6 is one block east
of

\>the L\'Enfant METRO Subway Station\'s Maryland Ave. exit. Submit
written

\>comments to the Dockets Management Branch (HFA-305), Food and Drug

\>Administration, rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. You
may

\>also send comments to the Dockets Management Branch at the following

\>e-mail address: FDADockets@oc.fda.gov or via the FDA Internet at

\>http://www.accessdata.fda.gov/scripts/oc/dockets/comments/

\>commentdocket.cfm.

\>

\>FOR FURTHER INFORMATION CONTACT: To register for the public meeting

\>contact: Carole A. Williams, Office of Consumer Affairs (HFE-88), Food
and

\>Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-827-4421,

\>FAX 301-827-3052, e- mail pubmtg@oc.fda.gov. For general information:

\>Jeanne Latham, Center for Food Safety and Applied Nutrition (HFS-800),

\>Food and Drug Administration, 200 C St. SW., Washington, DC 20204,

\>202-205-4697, FAX 202-205-4594, e-mail JLatham@cfsan.fda.gov

\>

\>For complete details, please check out the Home Page of The Life
Extension

\>Foundation\'s Website: www.lef.org What follows is FDA\'s Official

\>Registration form: Registration Form Public Meeting on Implementation
of

\>Pearson Court Decision and Expansion of Health Claims to Cover Claims
of

\>Effects on Existing Diseases

\>

\>Instructions: To register, complete this form and mail or fax it to
301-

\>827-3052 by March 28, 2000.

\>

\>Name\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\>

\>Title\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\>

\>Company\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\>

\>Address\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\>

\>Telephone\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\>

\>Fax\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\>

\>E-mail\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--

\>

\>Please indicate the type or organization that you represent:

\>

\>Industry \_\_\_\_\_\_

\>

\>Government \_\_\_\_\_\_

\>

\>Consumer Organization \_\_\_\_\_\_

\>

\>Media \_\_\_\_\_\_

\>

\>Healthcare Professional \_\_\_\_\_\_

\>

\>Law Firm \_\_\_\_\_\_

\>

\>Educational Organization \_\_\_\_\_\_

\>

\>Other (specify)\_\_\_\_\_

\>

\>Do you wish to make an oral presentation? Yes\_\_\_\_ No\_\_\_\_

\>

\>If yes, you also must submit the following:

\>

\>1. A brief statement of the general nature of the views you wish to

\>present,

\>

\>2. The names and addressed of all persons who will participate in the

\>presentation, and

\>

\>3. An indication of the approximate time that you request to make your

\>presentation.

\>

\>The FDA may limit the time allotted for each presentation depending on
the

\>number of people who register to make presentations. Times to speak
will

\>be from 5 to 10 minutes, depending on the number of speakers who
register.

\>

\>Send this application to Carole A. Williams, Office of Consumer
Affairs,

\>FDA, 5600 Fisher\'s Lane, Rockville, MD 20857. FDA encourages you to
fax

\>this information to them at: 301-827-3052. You can phone them at

\>301-827-4421 for additional information.

\>

\>

\>\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

\>To unsubscribe, write to lifeextension1-unsubscribe@listbot.com

\>Start Your Own FREE Email List at http://www.listbot.com/links/joinlb

\>

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