The article provided following this message was written specifically by Suzanne Harris, JD to counter a slew of misinformation being circulated by Citizens for Health which attacks the IAHF position on the threat posed by the harmonization language in S.830, the FDA Reform Bill. CFH really disgusts me. While I was on Capital Hill for three weeks, actively working to defend your health freedom, what was CFH doing? They were hard at work building a website specifically to attack me, due to the fact that I oppose their efforts to expand the OTC drug category to include herbs (which threatens the business interests of a number of CFH's biggest supporters.)
While I was on the Hill trying to defend your rights, CFH was faxing spin controlled lies to members of Congress which challenged our assertion that the harmonization language in S.830 constitutes Codex harmonization, and poses a serious threat to our health freedom. Suzanne Harris wrote the following article specifically to educate members of Congress, and I passed it out all over Capital Hill specifically to counter CFH's lies. It helped us to get the harmonization language of S.830 amended to exclude dietary supplements. This is the first chance I've had to send it to you.
Please read this article carefully, and make copies to distribute to all the health food stores in your area. Soon I'll have a form letter available for HR 2868, a bill that will allow us to make therapeutic claims on dietary supplements. Many health food stores have been misled on this issue by propaganda being circulated CFH and by a company desiring to get the OTC drug category expanded to include herbs. They would have the health food stores believe that I am a despicable liar, and that there is no threat to health freedom posed by expanding the OTC drug category. They have been sending flyers to all the health food stores which attack me. The most amazing part about all of this is that simultaneous to attacking me, and claiming that I am way off base with my message, while sitting in their Colorado office, CFH is trying to claim credit for my recent success on Capital Hill!
Please help me wake up your local health food store with the truth. We must get cosponsors on the Consumer Health Free Speech Act HR 2868. Now is the time (while Congress is recessed) to call your Congressman's district office near your home and make an appointment to educate him on this issue. HR 2868 directly counters the effort on the part of the traitor herb companies to create an OTC drug category for herbs. HR 2868 allows us to make therapeutic claims on dietary supplements. Foods are NOT DRUGS!!!
- John Hammell
by Suzanne Harris, JD The Law Loft
QUESTION: DO THE CURRENT VERSIONS OF THIS BILL CONTAIN HARMONIZATION LANGUAGE?
ANSWER: Yes, both the version passed by the House and the version passed by the Senate, contain Harmonization language.
QUESTION: WHAT IS HARMONIZATION AND WHY SHOULD I BE CONCERNED ABOUT IT?
ANSWER: Harmonization is a term that comes to us from trade law. It does not mean make harmonious or compatible. It does mean make alike. Thus harmonizing American Law to International Standards means making American law the same as internationally drafted laws or to internationally drafted regulations.
Although the term harmonization has been around in the trade law area for at least thirty years, it has taken on a new and ominous meaning in the recent past. When the United States ratified both the results of the Uruguay Round of the General Agreement on Tariffs and Trade and the North American Free Trade Agreement, the US signed on to several international agreements WITHIN these agreements that pledged the United States to enter into a continuing process designed to harmonize American Food and Drug law to internationally achieved standards. For example, there is a language in the Sanitary Phytosanitary Agreement within the new GATT agreement that pledges each member country to harmonize its food safety laws to internationally achieved standards. In addition, these agreements created new international bureaucracies that are designed to monitor the process of international harmonization. The GATT agreement also created a new international court with jurisdiction to assure that member nations were complying with the obligations contained in these agreements.
Whenever a major shift in the location of the law and regulation making processes takes place, every American who cares about the preservation of his or her rights, has to be concerned about these changes and to ask if the new process will: adequately protect his or her rights, is based on principles of representative government, contains protections against industrial interests overcoming consumer interests, provides for accountability of the new decision makers to the American public.
QUESTION: DO THE TWO VERSIONS OF S.830 THAT ARE CURRENTLY IN CONFERENCE COMMITTEE CONTAIN LANGUAGE THAT FOSTERS HARMONIZATION OF AMERICAN LAWS AND REGULATIONS TO FOREIGN MODELS?
ANSWER: Y E S. Both the House and Senate versions of S.830 contain harmonization language. Section 202 of the Senate bill gives the FDA a "green light" to harmonize American food, drug and medical device law to the laws of the European Union and to enter into agreements that are part of the staged introduction of harmonization called MRA's, mutual recognition agreements. The Senate's S.830 also tells the FDA to ensure that the process of international harmonization of regulatory requirements is continuous.
Giving the FDA a "green light" to engage in these kinds of activities is dangerous to our health freedom for several reasons. The first reason is that most parts of the world classify dietary supplements and botanicals as drugs rather than as foods. Re-positioning American dietary supplements as even the lesser and easier to get class of drugs called over-the-counter drugs would mean higher prices, fewer products and restriction of access to products for self limiting medical conditions. There is a great danger here that health freedom would eventually disappear through either a gradual or rapid process of harmonization.
Right now the European Union is considering a major re-write of the way it regulates foods, including dietary supplements. Virtually all commentators think that the EU intends to introduce greater restrictions on access to dietary supplements and botanicals throughout the EU. Right now the EU is operating under a general definition of drug that is broadly drawn and clearly includes dietary supplements and botanicals within the definition of a drug. There are even recent cases coming out of the EU where herbal teas have been attacked at the EU level as drugs. Every American who cares about health freedom here at home, should be concerned about the idea of harmonizing our laws, which generally treat dietary supplements including botanicals as foods, to the emerging laws of the EU, which are almost certain to treat these products as drugs under conditions that are even more restrictive than those used in the EU in the past.
QUESTION: AREN'T WE PROTECTED BY THE HATCH BILL?
ANSWER: NOT REALLY. All legislation, including the Hatch Bill now known as DSHEA, with very few exceptions exists as part of a legislative continuum. This means that over time the language of the law changes gradually for better or worse. S.830 contains language that could seriously erode the benefits of the Hatch Bill. One section allows a stakeholder to pick the classification for a product as food or drug simply by filing a petition stating his preference. If the FDA fails to respond to that petition within 60 days, the stakeholder gets the classification that it wants. This means that single manufacturer could change a product from a food to a drug just by paying a fee and filing an application. While this may not have been the drafters' intention in writing the bill, both bills are so poorly written that this could easily be the result.
Nor does the Hatch Bill (DSHEA) truly protect us from the threat of International Harmonization. The Hatch Bill contains a series of circumstances under which the FDA can seek to remove even old dietary supplements from the marketplace. The recent draft Comments of the Presidential Commission on Dietary Supplements Labels (which was created by DSHEA) contains recommendations that these product removing powers be better enforced and better funded. The draft comments also suggest that botanicals be classified as over-the-counter drugs "in the interest of better consumer information labeling".
The real point here is that it takes constant vigilance to protect our health freedom. Those who let key steps like the passage of harmonization language in S.830 pass without notice are likely to find themselves waking up too late to do anything to protect health freedom. Recently the FDA has announced that it wants to harmonize America's food regulations to internationally achieved standards at CODEX by systematically replacing its regulations with the ones that the international Codex Commission writes.
QUESTION: ISN'T AMERICAN LAW LIKE DSHEA SUPERIOR TO INTERNATIONAL STANDARDS, GUIDELINES AND RECOMMENDATIONS?
ANSWER: Not exactly. We are being hit by a one, two, three punch here. This is how it works. Food safety laws that set standards that are higher than those recommended by international reference standard setting bodies like the Codex Alimentarius Commission can be attacked through a new type of international judicial proceeding at the World Trade Organization. Any nation that sets a standard higher than a reference standard set by Codex runs the risk of having the Dispute Settlement Body at the World Trade Organization decide that the higher standard constitutes an unfair trade barrier. Once such a decision has been finalized, any nation that refuses to lower its standards runs the risk of incurring trade sanctions against its products.
So, are domestic laws safe from international attack, so long as they are lower than international food standards? NO! The two punch comes from the fact that each nation that signed on to the results of the Uruguay Round of the GATT also agreed to participate in processes designed to lead eventually to harmonization of food safety laws on an across the board basis. Presently every nation that is part of the WTO must file any changes to its food safety laws that could affect international trade and that aren't harmonized to international standards with the committee on Sanitary and Phytosanitary Measures at the WTO. The committee on Sanitary and Phytosanitary Measures has as its mission the monitoring of internationalization of food safety standards and the promotion of international harmonization.
The three punch comes from the concept of equivalency, that is the mutual recognition of equivalency agreements. Under these same agreements, the US and other nations have agreed that they will enter into mutual recognition of equivalency agreements as a step on the road to international harmonization. MRA's are designed to expedite and facilitate eventual harmonization of our laws with international standards by getting our food safety regulators to perform functions for foreign regulators and visa versa. The sectoral MRA agreements announced by President Clinton at the G7 (plus Russia) meeting in Denver this summer contain statements that admit that the eventual goal of these MRA's is the total harmonization of US and EU Laws in the food and medical device sectors covered by these agreements. This is one of the major reasons why it is so important that we NOT give the FDA a carte blanche to enter into MRA's with the European Union in ALL aspects of the food and drug law as the current language in the Senate's version of S.830 would do.
QUESTION: IS THERE ANY HOPE HERE?
ANSWER: YES. Since the process of harmonization either directly to international standards or indirectly through the use of MRA's requires some degree of Congressional approval (legislative enablement) it is very important that we NOT allow Congress to tell the FDA to just do what ever it feels like doing in the area of harmonization. At minimum we must ask Congress to keep strict control over this process and to carefully limit and monitor what the FDA does in the name of harmonization. We must tell Congress that we do not want the FDA to harmonize our laws on dietary supplements including botanicals to EU standards or to any other foreign standards. Nor can we let them tie the process of the evolution of our laws to what happens in foreign countries or at international forums.
At the same time, we have to be constantly alert to the possibility of sneak attack, that is to any initiative that pretends to be domestically based like the recommendations of the President's Commission on Dietary Supplement Labels that in fact provides an excuse for making our laws more like those that are evolving in Europe or at the international level.
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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, firstname.lastname@example.org