Fwd: Hilights [Fwd: WPL FDA TO HOLD SPECIAL HEARING]

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Lifplus@... wrote:

> PLEASE PASS THE FOLLOWING TO YOUR E MAIL DISTRIBUTION LISTS...THANKS

>

> 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 land Ave SW, Washington, DC. This building is

> one block east of the L'Enfant Metro Station. (land 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. , 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 land Ave., SW., Washington, DC.

> Building entrances are located on the land 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 land 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@... 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. , 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@.... 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@...

>

> 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. , 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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