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Victory For Health Freedom

Dietary Supplements Exempted
From Harmonization Language
In FDA Reform Act

(Form letter at end to help pass HR 2868 Consumer Health Free Speech Act)

By John C. Hammell, Founder
International Advocates For Health Freedom (IAHF)



A major battle has been
won in our war to protect
health freedom.

Next on the agenda: Stop the
FDA from regulating herbs
as "drugs".

On Nov. 9, 1997, a potential disaster for health freedom in the U.S. was averted at the last minute. This victory was achieved by a massive grass roots campaign, which forced a change in an enabling clause of the FDA Reform Bill (S.830). If left unchallenged, this clause would have allowed the FDA to regulate many dietary supplements as drugs by harmonizing American law with that of the European Union, where supplements are regulated as drugs.

Harmonization is a technical term derived from trade law. It doesn't mean to make harmonious, or compatible; it means "to make the same as". Some American herb companies don't feel threatened by harmonization because they have entered into partnerships with European pharmaceutical companies. In August, 1997, the "Tan Sheets" (an industry trade publication) reported that some of these companies are applying for use patents for popular herbs such as saw palmetto and gingko in an attempt to dominate the American market. These companies have been supporting the FDA's move to regulate herbs as over-the-counter (OTC) drugs because it will be easier for them than for smaller companies to get OTC drug approval to make therapeutic claims for dietary supplements.

As most Foundation members know, regulatory burdens in Europe limit the availability of high-potency supplements and Europeans pay up to five times more than people in the United States for the few dietary supplements they are allowed to buy.

The FDA Reform Bill, if not amended, could have given the FDA the same regulatory authority that now exists in Europe. We had to amend this bill, but had virtually no public support!

The odds against us were overwhelming. In addition to fighting the government, we were up against the companies who favor OTC drug status for herbs, as well as organizations funded by these companies. These forces spent a good deal of money trying to convince both Congress and the public that the harmonization clause in the FDA Reform Act posed no threat to the American people.

How The Last-Minute Victory Was Achieved

I began sounding the alarm about the harmonization clause in the FDA Reform Act in the middle of August, but the only organizations who took action were the Life Extension Foundation (LEF), the National Health Federation (NHF) and the Welch Foundation. Individuals who assisted me in this battle were Suzanne Harris and Peter Ludwell of the Law Loft, Dr. Julian Whitaker, Maury Silverman, Patrick Von Mauck of NHF, longtime health activist Clinton Miller, and Saul Kent and Bill Faloon of LEF.

The FDA Reform Act contained some good provisions that would force the FDA to start approving lifesaving drugs faster, and allow medical device manufacturers to sell their products abroad after going through the FDA approval process. Since both Congress and the public want quicker approval for these drugs, and Congress wanted to help the medical device manufacturers, this enabled the bill to steamroll through both Houses of Congress virtually unopposed. The problem we had with this bill is that it included language that could have led to the harmonization of FDA regulations with those in Europe. But since everyone wanted FDA "reform", it wasn't possible to stop the bill itself from passing.

The only chance we had was to amend the harmonization language in the bill in the Conference Committee, whose job it was to reconcile differences in the House and Senate versions of the bill. The harmonization language had to be amended to exclude dietary supplements, but virtually no one was paying attention to this seemingly minor issue. In addition, a conference staff member informed me that Senator Kennedy opposed our effort to amend this language out of fear that it would tie the hands of the FDA.

Members of organizations like Life Extension Foundation and National Health Federation flooded Congress with faxes, letters, email and phone calls demanding that the harmonization language in the bill be amended to exempt dietary supplements. At the peak, we were flooding Congress with thousands of faxes, letters and phone calls. Congressional staff referred to us as the "vitamin people" and said we were the most politically active group on Capitol Hill. What they didn't know is that we had only been able to reach a tiny fraction of health activists in the U.S., who would have been outraged if they knew that Congress was about to legislate away our health freedom.

The blitz paid off. At the last minute, the Conference Committee voted to exempt dietary supplements from harmonization in the FDA Reform Act. For the moment, we've been saved from a threat that would have given the Codex Alimentarius Commission tremendous power over the health and welfare of the American people.

I want to thank everyone who sent faxes, letters, and email to their Congressional representatives to protest against harmonization. The citizenry spoke and Congress listened. Ours was a TRUE grass roots effort. We had virtually no money to work with, but we did have an army of committed health activists who were not about to let the FDA gain drug-like regulatory powers over dietary supplements. To see the complete amended language of the bill access the IAHF website www.iahf.com or access it from The Life Extension Foundation's website (www.lef.org).

Help From Rep. Ron Paul

We were helped enormously in our efforts to persuade the Conference Committee to exempt dietary supplements from the harmonization language in the FDA Reform Act by congressman Ron Paul (R) of Texas. Rep. Paul played a critical role in turning the tide against harmonization by working closely with me (Fig. 1) to draft a letter urging members of Congress to oppose the FDA Reform conference report unless all references to harmonizing U.S. regulation of supplements with European law were nullified. Since the conference report would determine the wording of the FDA Reform Act, which would then be sent to President Clinton to sign, it was critical to get the offensive language nullified. If not, the only chance of avoiding harmonization with the Europeans from being written into U.S. law would have been a Presidential veto, (which would have been impossible because the bill had passed the Senate by the overwhelming 98-to-2 vote).

Reps. Paul and Helen Chenoweth (R) from Idaho signed a letter on Oct. 31 (Fig. 2), which was then circulated to every member of Congress. On the back of the letter was a reprint from The European (Fig. 3), a newspaper published in Canada covering European news, which explained some of the dangers to health freedom in the U.S. of harmonization with Europe. This letter helped to educate members of Congress about the reasons for nullifying the harmonization language in the reform bill, which led to an eleventh-hour decision to add language which neutralized the threat.

Along with Congressman Paul's "Dear Colleague" letter, another major factor in achieving this victory was the research of Suzanne Harris, J.D. and Peter Ludwell of the Law Loft in Colorado. Their response to the FDA's Advanced Notice of Proposed Rulemaking (ANPR) from the July 7, 1997 Federal Register (Vol.62, #129 pp.36243-36248) helped me to explain the harmonization threat to Congressman Paul and others on Capitol Hill. In her response to the ANPR, Harris alerted Congress to that fact that by "sleight of hand", the FDA is attempting to give the Codex Commission even more power over the health and welfare of the American public than even the most expansive reading of our current agreements warrant.

The nullification of harmonization language for dietary supplements in the FDA Reform Act is a major victory for the American consumer. It blocks a direct pathway to the erosion of freedom of choice in healthcare in this country, and represents a major loss for the organizations and companies who have been trying to obstruct our efforts to win this victory.

Fighting The FDA's Efforts To Turn Herbs Into "Drugs"

It now looks as if the Commission on Dietary Supplement Labels will be issuing their final report just before Thanksgiving. To follow this, check the following web site after 3 pm, Nov. 24 (http://web.health.gov/dietsupp). The report is expected to recommend the expansion of the OTC drug category to include herbs, a move that harmonizes with Codex, will threaten access to affordable herbs, and ultimately will threaten access to many other dietary supplements.

Additionally, in the near future, the FDA is expected to announce new Good Manufacturing Practice (GMP) regulations, which a growing number of industry analysts feel will have a negative impact on small- to mid-sized supplement manufacturers, and could drive them out of business. These impending actions on the part of the FDA make it clear that we must continue to remain vigilant, and highlight the need for affirmative action to protect freedom of choice in healthcare in the United States.

A NEW BILL THAT MUST BE PASSED

The next step in our crusade to protect our vitamins, minerals, amino acids and herbs is to help pass a critically important bill -- The Consumer Health Free Speech Act (HR 2868). This is Ron Paul's new bill to change the overly broad definition of "drug" in the Federal Food, Drug & Cosmetics Act (FDCA) to exclude foods, which, in turn, would exclude dietary supplements. Passage of this bill will enable legitimate health claims to be made for dietary supplements based upon scientific evidence, and would effectively block any attempts to regulate herbs (and other dietary supplements) as "drugs". Herbs are not drugs, and no herb company should have to jump through FDA hoops to make valid health claims for them. HR 2868 will help consumers by allowing companies to make such claims, which will help keep supplement prices down.

It is important to know that attorney Milton Bass, who has been working very hard for health freedom for the past 40 years, played a significant role in shaping the language of HR 2868. Milt's free speech lawsuit against the FDA, which would overturn the unconstitutional parts of the Food & Drug Act, is currently pending in the U.S. Court of Appeals, having advanced further in the courts than any other free speech lawsuit.

HR 2868 has been crafted to provide the simplest, most easily understood changes in the current law, which would protect our supplements from the FDA and the large pharmaceutical companies. Its message, in short, is that "foods are not drugs"! It accomplishes this by adding the words "other than food" to the definition of "drug" in the Food & Drug Act. It also protects us against overly aggressive regulatory actions by the FDA by increasing the legal burden required for the agency to challenge health claims. This is achieved by requiring that a health claim for foods (and dietary supplements) be determined "false" and "misleading", instead of "false" or "misleading" before regulatory action can be taken.

To obtain a copy of Ron Paul's bill (HR 2868), call the House Documents Room (800-972-3524) through which you can also reach any member of Congress. Congress is out of session until January 28. This is a good time to contact your Congressional representatives and Senators (while they are in their district offices) to urge them to support this bill. Right now, the pressing need is for co-sponsors of HR 2868. At the end of this article is a form letter to help you persuade your representatives to sign on as co-sponsors of the bill.

Fighting For Healthcare Freedom In Canada

Canadian consumers should urge passage of the Reform Health Freedom Amendment, (formerly known as the Foods are Not Drugs Amendment, originally proposed by Freedom of Choice in Health Care. The RHFA is a private members' bill introduced by Dr. Grant Hill of the Reform Party. It can only be passed into law if enough consumers participate in its passage. Get a copy of the bill by calling Grant Hill's office at 613-995-8471, or by faxing your request to 613-996-9770.

The Threat To Health Freedom Continues

Americans should know that the Canadian government has restricted the sale of more than 160 entirely safe products currently available in the United States. (All dietary supplements are regulated as "drugs" there, and "user fees" of up to $300,000 are required before manufacturers can register their products. In Canada they are attempting to create an anti consumer category called the "third category", while in the U.S. they are attempting to expand the OTC drug category to include herbs. Among the groups lobbying for these moves is a shadowy organization called the European-American Phytomedicines Coalition, represented by a multinational law firm.

Don't be lulled into a false sense of security by assertions that expanding the OTC drug category to include herbs would be innocuous. (Through this same process Norwegians were conned, and health freedom there was severely curtailed, with draconian maximum potency limits, and access to many products cut off entirely.) Your efforts in the U.S. to get co-sponsors for the Consumer Health Free Speech Act, are critical in preserving free access to dietary supplements at affordable prices, and allowing truthful health claims to be made for dietary supplements.

What You Should Do!

1) Call the U.S. Capital Switchboard (202-224-3121) to be connected to your Senators and Congressional representatives. Ask them for their fax numbers. Send a copy of the letter below supporting Ron Paul's bill (HR 2868) to your representative and two Senators. Address them as follows: The Honorable (your Senators Name) United States Senate, Washington DC, 20510; The Honorable (your representatives' name) United States House of Representatives, Washington DC 20515.

2) Email the form letter for HR 2868 to your Congressman, and to both Senators (ask your senators to sponsor a Senate Companion Bill. Because our first order of business will be to attempt to get a hearing in the Health and Environment Subcommittee of the House Commerce Committee, we need to key on that subcommittee, and also on the House Commerce Committee. It helps to have a US Congress Handbook- Get one by calling 800-229-3572

For individual Congressional email addresses see:

http://dc.yahoo.com/text/Capitol_Hill/Legislative_Branch/Congressional_E_Mail_Addresses/

For names of members of the House Commerce Committee:

http://www.house.gov/commerce/

To email all members of Congress in one shot, got to this url after copying the form letter for HR 2868 to paste into their form:

http://www.yes.ucla.edu/cgi-shl/dbml.exe?Action=Query&Template=/yes/voices/emailcong.cfm&recipientlist=all

note: This service might be discontinued by the time you get this although its current on 1/12. If for any reason this doesn't work, you will have to send to individual email addresses.

I will be making up specific email lists for the House Commerce Committee, the Health and Environment Subcommittee of the Commerce Committee, and for the Senate Labor Committee. When completed they will be posed in the IAHF website at www.iahf.com under the United States section.

3) Send a copy of this letter to President Clinton at the White House:

The White House
1600 Pennsylvania Ave.
Washington DC, 20500

White House comments line: 202-456-1111
White House fax line: 202-395-1232
White House email address: president@whitehouse.go

4) Photocopy, mail, e-mail, or fax copies of this letter to everyone you know who believes that foods are not drugs, and who would like to preserve freedom of choice in healthcare in the United States, Canada, and the rest of the world!

PLEASE CO-SPONSOR THE CONSUMER HEALTH FREE SPEECH ACT (H.R.2868)

The Honorable

United States House of Representatives
Washington, D.C. 20515

Dear Representative

The Health Free Speech Act, recently introduced into the House by Rep. Ron Paul (R) Texas is needed to preserve freedom of choice in healthcare in the United States. This will help Americans to learn about the scientific advances in nutrition occurring today by allowing truthful health claims for dietary supplements. The bill proposes the following changes:

FIRST: The present definition of the term "drug" in the Food Drug & Cosmetic Act (FDCA) is so overly-broad that it includes foods, herbs, and dietary supplements. The present flawed definition reads: "The term 'drug' means articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man..."

Congressman Ron Paul's simple 5-word bill would add the three words "other than food" immediately following the word "articles" so that it would read:

"The term 'drug' means articles, other than food, intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man..."

Adding these three words would exempt all foods (which includes herbs and other dietary supplements) from being regulated as drugs by the FDA. It would also prevent the FDA from banning truthful health claims based upon scientific evidence for these foods simply because they haven't been approved as "drug" claims by the FDA.

Scientific research in nutrition has been exploding in recent years showing that herbs and other dietary supplements are safe-and-effective in preventing many diseases. However, the flawed definition of the term 'drug' makes it a federal crime for the dietary supplement industry to give this truthful information to consumers in labeling herbs or other dietary supplements.

Section 403 of FDCA says: "Sec.403. A food shall be deemed to be misbranded if its' labeling is false or misleading in any particular..."

SECOND: By changing the "or" to an "and" it will set a higher and fairer standard that the FDA must meet before limiting or banning the sale of herbs or other dietary supplements by claiming they present an unreasonable "risk". The Paul amendment (HR 2868) will require the FDA to prove that the risk is both significant AND unreasonable.

Name __________________________________________ Date _________________

Address ______________________________________________________________

City ___________________________ State ________________ Zip __________

(cc this to both Senators, and ask them to sponsor a Senate companion bill!)

Information provided courtesy IAHF
www.iahf.com