From: LEF Email List1 [mailto:nsantini@directnet1.net]
Sent: Wednesday, March 22, 2000 9:20 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.
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