Time: Sat Jul 26 07:21:58 1997
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Date: Sat, 26 Jul 1997 07:07:17 -0700
To: (Recipient list suppressed)
From: Paul Andrew Mitchell [address in tool bar]
Subject: SLS: FDA COMMENTS DEADLINE- FORM LETTER TO FAX/EMAIL (fwd)
<snip>
>
>John Lesso- Please post to website under EMERGENCY ALERT/FAX IN FORM LETTER
>BEFORE AUGUST 4
>
>
>RED ALERT VITAMIN CONSUMERS: COMMENTS PERIOD ENDS AUGUST 4th ON REPORT
>WHICH THREATENS TO GIVE FDA MORE POWER- CREATE OTC DRUG CATEGORY FOR HERBS/
>BOTANICALS. PLEASE FORWARD!!!
>
>On August 4th, the comments period ends on the draft report on the US
>Commission on Dietary Supplement Labels. Following this message I have a
>form letter which I urge you to fax or mail in to the Commission on Dietary
>Supplements, as well as to your Senators and Congressmen.
>
>The reason you must do this is simple: we must try to extend the comments
>period so that more people can have the time necessary to procure copies of
>the 77 page draft report in order to have sufficient time to review it,
>discuss it, and draft comments to its many highly controversial
>recommendations, which includes creating an Over the Counter (OTC) drug
>category for herbs and botanicals and giving broad new powers to the FDA
>that they would use against the dietary supplement industry (to the
>detriment of consumers).
>
> When the pharmaceutical industry wants to try to push their agenda past
>consumers, they often wait until the summer when people are on vacation and
>its much harder to get organized in opposition. As a lobbyist working to
>defend the rights of dietary supplement consumers, I've seen this happen
>time and time again.
>
>The Report of the Commission on Dietary Supplement Labels doesn't carry the
>force of law, however this report is STILL very dangerous to consumers
>because legislators who know nothing about health freedom issues will be
>influenced by it, and will get behind a legislative push to give FDA added
>new powers to attack the dietary supplement industry and to create an OTC
>drug definition for herbs and botanicals. This is Codex harmonization. We
>worked hard to define dietary supplements and herbs as foods under DSHEA,
>and it is unwise to blur the line between foods and drugs that we worked so
>hard to create.If we don't push for an extension on the comments period on
>the Report of the Commission on Dietary Supplement Labels, we will be
>allowing a blueprint to stand unchallenged which will be used to guide a
>legislative campaign that will hasten the destruction of health freedom in
>the US.
>
>Please forward this alert widely, copy the enclosed form letter to your
>word processor, fax it in to the Commission on Dietary Supplement Labels,
>your Senators and Congressmen, and set up tables in front of your health
>food store to get people to sign lots of them which you can send in en
>masse. Go on the radio to talk about this, and discuss it in usenet and on
>online mailing lists. Remember, its summer. Each of us has to work 10x
>harder to compensate for all the people who aren't around to help right now
>
>
>NO TO OTC DRUG CATEGORY FOR HERBS AND BOTANICALS
>THESE COMMENTS SUBMITTED UNDER PROTEST TO DIETARY SUPPLEMENT LABEL
>COMMISSION PRIOR TO UNFAIR AUGUST 4, 1997 DEADLINE
>
>To: Kenneth D. Fisher, Ph.D. Executive Director, Commission on Dietary
>Supplement Labels
>Office of Disease Prevention and Health Promotion
>R. 728G Hubert H. Humphrey Building
>200 Independence Ave. S.W. Washington, D.C. 20201
>Ph. 1-202-401-5811 Fax: 1-202-205-0463 Date:
> 1997
>
>Dear Dr. Fisher:
>
>I understand that the Commission was (supposedly) created "as an
>independent agency under the executive branch" by the passage of the
>Dietary Supplement Health and Education Act of 1994 to..."conduct a study
>on, and provide recommendations for, the regulation of label claims and
>statements for dietary supplements, including the use of literature in
>connection with the sale of dietary supplements and procedures for the
>evaluation of such claims." I understand that in making its
>recommendations, the Commission is to..."evaluate how best to provide
>truthful, scientifically valid, and not misleading information to consumers
>so that such consumers may make informed and appropriate health care
>choices for themselves and their families." (How can the Commission be said
>to have been "independent under the executive branch" when it was set up
>under HHS, the same cabinet dept. which includes FDA??? Was the Commission
>legally established in accordance with the Federal Advisory Committee Act,
>PL 92-463? Were all meetings TRULY open? Shouldn't it have been set up as a
>TRULY "independent agency"???)
>
>I gather that if I call the Commission's Information Response Center at
>301-650-0382, they will send me the 77 page draft report of the Commission
>on Dietary Supplement Labels. Given the time constraints in obtaining this
>report fast enough to read it in entirety in order to file comments prior
>to your August 4, 1997 deadline, I am formally requesting an extension on
>the comments period in order to allow me sufficient time to procure the
>report, read it as well as to draft more extensive comments. I am
>appraising my Senators and Congressmen of the following concerns about the
>draft, which were called to my attention by International Advocates for
>Health Freedom:
>
>On p.ii, pp.16-17, and p.20 I feel that you should strike all references to
>ephedra posing a "safety issue" given the fact that a Medline Search
>indicates that you have no peer reviewed evidence to support your
>contention that ephedra has caused death, and given the fact that we are
>currently undergoing a comments period with regards to ephedra regulation.
>I do not feel that it is appropriate for you to cite ephedra as an example
>of an "unsafe" product being marketed. A search of Medline turned up zero
>reports of deaths caused by ephedra, and several reports of death caused by
>ephedrine, and pseudoephedrine products, including many commonly used OTC
>drugs such as children's cough syrup. If FDA is concerned with safety, let
>FDA regulate ephedrine, and pseudoephedrine products which have been
>documented to cause death. Leave ma huang/ephedra alone. We don't need or
>want the FDA's double standards incorporated into this report. This
>information comes from the affadavit of Miloslav Nosal, a biostatistician,
>who is serving as an expert witness in a lawsuit filed by Freedom of Choice
>in Health Care against the Canadian HPB.
>
>I feel strongly that the creation of an OTC drug category for herbs and
>botanicals (as described on p.vii in your report), is not in the long range
>best interests to consumers. Foods are not drugs. By law, DSHEA established
>a food definition for dietary supplements. We object strongly to the
>proposal to create an OTC drug category for herbs and botanicals. Our gains
>under DSHEA would be put at risk if an OTC drug category were created. We
>feel that expanded health claims should be allowed under DSHEA based on
>overwhelming scientific evidence attesting to both the safety and efficacy
>of dietary supplements for many medical conditions, and we feel that to
>deny these truthful claims violates our first amendment rights to free
>speech. We favor a split label in which FDA can say what they want on their
>half, and the manufacturer can offer validated information on the other
half.
>
>We object to a comments period which effectively excludes the views of
>millions of concerned dietary supplement consumers who have not had
>sufficient time to procure your draft report, much less to read it and to
>submit comments. Given the enormous consumer push behind DSHEA, we feel
>strongly that consumers are being largely disenfranchised, and we would
>like the comments period to be extended until the end of October, 1997. We
>are outraged by the ongoing push to regulate foods as "drugs." We would
>like until the end of October to review your draft report and to file
>comments. I am appraising my Senators and Congressmen of these concerns.
>
>Signed:
>
>
>Address:
>
>City: State: Zip:
>
>
>(Info courtesy I.A.H.F. 800-333-2553,
>http://www.pnc.com.au/~cafmr/hammell/index.html, jham@concentric.net)
>******************************************
>International Advocates for Health Freedom
>John C. Hammell, Legislative Advocate
>2411 Monroe St.#2 Hollywood, FL 33020 USA
>800-333-2553, 954-929-2905, FAX 954-929-0507,
>FAX ON DEMAND 954-927-8795,jham@concentric.net
>http://www.pnc.com.au/~cafmr/hammell/index.html
>
>
========================================================================
Paul Andrew Mitchell : Counselor at Law, federal witness
B.A., Political Science, UCLA; M.S., Public Administration, U.C. Irvine
tel: (520) 320-1514: machine; fax: (520) 320-1256: 24-hour/day-night
email: [address in tool bar] : using Eudora Pro 3.0.3 on 586 CPU
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As agents of the Most High, we came here to establish justice. We shall
not leave, until our mission is accomplished and justice reigns eternal.
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