FDA to hold special public meeting! You're invited!

greenspun.com : LUSENET : TB2K spinoff uncensored : One Thread

> > > >FDA TO HOLD SPECIAL HEARING > > > >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. 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 some tried faxing the FDA's special reservation line > >today, it did not pick up. Encourage all those who go 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 > > > >Below is the 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. > > > >

-- ... (...@...com), March 24, 2000

Answers

An attempt at formating:

FDA TO HOLD SPECIAL HEARING

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. 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 some tried faxing the FDA's special reservation line today, it did not pick up. Encourage all those who go 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

Below is the 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.

-- David L (bumpkin@dnet.net), March 24, 2000.


In my view, there should be no restriction on the health claims that may appear on dietary supplement labels, so long as the labels carry an advisory that those claims are not approved by the FDA.

I don't think what the public says at the upcoming hearing will have much effect on the FDA. But it is important that people who feel that the FDA is abusing its powers, be counted at the hearing and/or urge their legislators to apply pressure to the FDA.

-- David L (bumpkin@dnet.net), March 24, 2000.


The FDA has been itching to control supplements completely and urn them into "drugs." Talk about violating civil rights. They'll probably knock on your door in the morning if you try to drink apple cider vinegar and honey.

-- Mara (MW@aol.com), March 25, 2000.

The FDA would like to regulate everything, for they are friends of the powerful corporations who want to control everything. The public should write, call, send an email or fax, to one of the addresses above just to express their opinions.

-- gilda (jess@listbot.com), March 25, 2000.

The FDA needs to be shut down. It's only function is to serve as an agent for the Food and Pharmaceutical industries.

During approval periods when a product comes up for review to release for public consumption it is not unusual to find top level execs on the FDA approval panel that were just recently employed as high level execs by the manufacturer of the product up for approval. When the product is approved the exec on the FDA approval panel goes back to his old company. IE: Monsanto exec leaves company, gets job with FDA,one month later sits on approval panel, gives AOK to Monsanto product, FDA exec quits next day and goes back to Monsanto. This is done ALL the time.

nancy

-- NH (new@mindspring.com), March 25, 2000.



Moderation questions? read the FAQ