Errors-To: <>
Date: Sat, 13 Jun 1998 22:53:25 -0400
From: John Hammell <>

LIST: Please join me in pumping the form letter contained at the end of this message nationwide! This mssg demonstrates that we _ARE_ under attack as TEXAS attacks EPHEDRA!

Susan and Ron- This attack on Ephedra is only the tip of the iceberg, unfortunately. Clint Miller was undoubtedly in Austin on June 3rd. His clients are Enrich and Nature's Sunshine, two big multilevels which have a lot of ephedra products. I will call him to find out what happened, and to find out if anything can be done in Texas at this time. Ephedra has been virtually banned in Canada. The so called "National Council Against Health Fraud" (a pharamceutical shill group) has been encouraging anti supplement action of this type in several states (as well as federally)...

I spent several hours today in a local health food store handing out copies of my form letter for the current FDA comments period which ends August 27. I am doing new things each week to get more groups to pump this form letter in, but will need to do even more. CFH has a blurb in their website, but they don't grasp the big picture due to the fact that Suzanne Haeger is being led down the primrose path by Loren Israelson, the attorney for Nature's Way, who is also legal counsel to the European American Phytomedicines Coalition... his agenda keeps Haeger in the dark, so she doesn't grasp the tie in between the FDA's current comments period and EEC 65/65 in the EU. (The current comments period and the court battle over Cholestin (which begins monday in Salt Lake City) are part of a massive FDA harmonization campaign... People forget all to quickly what FDA said in the Federal Register on July 7, 1997 (almost one year ago) Vol 62. #129, pp.36243-36248) when they unequivocally stated their intention to harmonize their regs to emerging Codex standards...

Also, people need to look at the ESCOP website (herbs). ESCOP vows to force the harmonization of laws world wide pertaining to herbal products.

People better take FDA's current comments period a lot more seriously than they are or FDA will take a SHARK LIKE BITE out of DSHEA... We are going to have to get HR 2868 reintroduced next year. More people should donate to Congressman Ron Paul so he'll get reelected... We haven't had a Congressman like him since the founding fathers. No one else in Congress cares as deeply about our access to dietary supplements as Ron Paul. He is the only member of Congress who takes no donations from multinational corporations. All his donations come from the grass roots.

Date: Fri, 12 Jun 1998 23:22:05 -0700
From: Ron & Susan Hart
Organization: Independent Representatives
X-Mailer: Mozilla 4.05 [en] (Win95; U)
To: John Hammell
Subject: TEXAS

John - Have you seen this? It looks familiar - Have you sent out warnings about
this before?

> 19980327225446.AAA.910eec30
> A few doctors in Texas are trying to stop you from making a living...
> A few doctors in Texas think they know better Than 5,000 years of research...
> A few doctors in Texas are playing politics with your life!
> Dear Friend,
> In a few days, a small group of doctors will meet in Austin and what they decide will effect you and your family dramatically. The Texas Board of Health, without even wanting to see the professional clinical studies to the contrary, has decided the natural herbal extract Ephedra should be gotten by prescription only. This is under the accusation that these products are being misused and abused by children. Can you believe this? A natural herbal extract that has been used for thousands of years by the Chinese to treat asthma and other respiratory problems, and aid in weight loss to be under the control of insurance companies and doctors. What will they take away next lavender, St. John's Wort...Golden Seal... Ginseng?
What about all the people who use products containing this natural
> herbal extract to lead better and healthier lives? What about all the families in Texas-single mothers, young families, older Texans-who provide for themselves and their families by selling health products that contain ephedrine? (Ma Huang, natural ephedrine commonly known as Ephedra.) Do these bureaucratic doctors care about your family? No way! This small group of doctors is being reactionary. These bureaucrats are ignoring the clinical studies done by numerous independent labs that say Ephedra is safe when used properly and more than that-it's effective. Isn't it time we stood up to the arrogant doctors who make a name for themselves by jumping on any bandwagon coming or going regardless of what it will do to the families of Texas?

Aren't you tired of useless regulations heaped on us by bureaucrats playing political games with our lives? I surely am and I'll tell you what I'm doing about it. We have proposed responsible regulations that restrict the purchase of these products by children, which we have already implemented on our own labeling. This is a simple at direct solution that has already been adopted in other states. On June 3, the Texas Board of Health meets in Austin to hear public comment on their decision to regulate this safe and effective herbal extract I want you to join me and send these bureaucrats a message from the families of Texas We're not going to take it anymore! I've enclosed an easy to use, step-by-step Action Guide for you and your family to use to make a difference in this issue so crucial to our way of life in Texas. But, we don't
> have much time.
> FIRST Sign the enclosed letters to Gov. Bush, Lieutenant Governor Bullock, Commissioner Archer and Chairman Wilkerson of the Texas Board of Health letting them know you oppose their decision to make the natural herbal extract Ephedra only available by prescription. (I've enclosed addressed and stamped envelopes for your convenience.)
> SECOND Call Governor Bush's voice-mail comment line at (512)463-2000 and record a message letting Governor Bush know you don't want this small group of doctors on the Texas Board of Health deciding how you live your life. Tell him you do not agree with the Texas Board of Health's decision regarding Ephedrine and would appreciate his help in defeating this ridiculous regulation.
> THIRD Join us in Austin on June 3, 1998 for a Texas Family Rally. We'll have a hoe-down to let the Texas Board of Health know their irresponsible decision on this safe and effective natural herbal extract affects real people and real lives. We'll have a cookout and show them the families of Texas are sick and tired of government bureaucracy intruding in our lives. Please join us June 3, 1998 and bring your family and friends. We've also setup a toll-free number to help you get started. Call one of our Family Line today at (888) 629-3438 with any questions you may have on how you can help. We need you and Texas needs you. Stand up for your family and your rights today! Your Friends, Texans Against Irresponsible Regulation. P.S. We really need your help on this one.

Please sign the
> letters and mail them TODAY. Time is of the essence. And, make sure you, your friends, and family put in a call to the Governor's comment line immediately! We look forward to seeing you and your family in Austin Wednesday, June 3. We'll have a great day and your presence will make the difference. If we hurry, and with your help, together we can win!

BY AUGUST 27,1998 [Docket No. 98N-0044] RIN 0910-AA59
Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Proposed Rule and Dietary Supplements: Comments on Report of the Commission on Dietary Supplement Labels; Notice

Submit written comments to: Dockets Management Branch (HFA-305) FDA 200 C. St. SW, Washington DC 20204, 202-205-4697 or send them to LEF Box 229120, Hollywood, FL 33022 Dept IAHF

To Whom it May Concern at FDA:
A Supreme Court  decision on June 28, 1993 renders your proposed rule to limit manufacturers ability to properly inform the American public on the health benefits of dietary supplements utterly and completely illegal. (It puts Section 403 (r)(6) of the Food, Drug, and Cosmetic Act pertaining to structure-function claims in question, and it means that the so called Commission on Dietary Supplement Labels (whose advice you were following when you drafted your proposed rule) has utterly and completely ignored the Supreme Court Decision of Daubert v. Merrill Dow. (We hereby put you on notice that the Supreme Court is the highest court in America, and the Commission on Dietary Supplement Labels (CDSL), Congress, and the FDA are required by law to not only be aware of their decisions, but to abide by them when proposing new regulations such as this.)

Under Daubert, the "General Acceptance Test" (an equivalent phrase to significant scientific agreement) was replaced by the Federal Rules of Evidence for admitting scientific testimony at a Federal Trial. As a Federal Agency FDA ought to formulate its proposed rules in accordance with this decision, but has failed to.

Given the Daubert decision, rather than find in favor of the so called "significant scientific agreement" standard, what CDSL should have done as to define what kinds and combinations of studies validate claims based on significant scientific evidence. Rather than recommend arbitrary and capricious limits on health information provided at the point of sale through labels and labeling of dietary supplements, CDSL should have recommended the adoption of the "gradation of claims" proposal recommended in comments to the CDSL by Durk Pearson and Sandy Shaw, Jonathan Emord and Associates, International Advocates for Health Freedom, and many others. This proposal allowed for a gradation of claims, depending on the amount of evidence supporting them, and the consumer can then be in a position to make their own decisions- but you have no legal right to withhold truthful information, and your proposal severely BLOCKS our access to information that we need in order to make better health choices for ourselves and our families.

In your proposed rule you say that it would be illegal to suggest anything but drugs to reduce nausea associated with chemotherapy. This is arbitrary and capricious. What about ginger to reduce nausea? What about co-enzyme Q-10 and vitamin E to reduce chemotherapy-induced heart muscle damage; melatonin to reduce chemotherapy-induced immune system damage; and n-acetyl-cysteine to reduce chemotherapy induced liver damage??
Since you are ruling it "illegal" to use the words "protects against cancer", you will also consider it "illegal" to use the words "protects against heart attacks." This means folic acid can be promoted to "lower homocysteine levels" but it would be "Illegal" to say that folic acid "protects against heart attacks" even though The New England Journal of Medicine (April 9, 1998) recommends the use of folic acid to lower heart attack risk (!!!) Since when did the FDA become the sole repository of truth?

In light of the fact that your proposed rule is of questionable legality in view of  the Daubert decision, I hereby call for its immediate withdrawal, and demand that my Congressman address this outrage by cosponsoring HR 2868 The Consumer Health Free Speech Act, which removes food from the current, overly broad statutory definition of drug. This will allow us to make therapeutic claims on dietary supplements, something which you have no legal right to block with this proposed rule. Now that I have appraised you of the Daubert decision, please let me know precisely how you  intend to artfully dodge the law by utterly ignoring it?
(cc to my Senators and Congressman)
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Provided by International Advocates for Health Freedom,,   fax 954-929-0507
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International Advocates for Health Freedom
John C. Hammell, Legislative Advocate
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