Return-Path: jham@concentric.net Errors-To: Date: Thu, 11 Sep 1997 08:40:22 -0400 (EDT) X-Sender: jham@pop3.concentric.net To: Vermont@Jeffords.Senate.gov, Tom_Harkin@Harkin.Senate.gov, Senator_Hatch@hatch.senate.gov From: John Hammell Subject: S.830 HARM-ONIZATION CONCERNS ADDRESSED DIRECTLY TO SENATORS-CHALLENGE ISSUED Cc: SEN_DODD@DODD.SENATE.GOV, SENATOR@MIKULSKI.SENATE.GOV, SENATOR_FRIST@FRIST.SENATE.GOV, Connie@mack.senate.gov, bob_graham@graham.senate.gov Americans: Please forward this to your Senators- Get their addresses from http://www.nyx.net/~anon3210/senate.html Health Freedom Fighters Outside US: Please read this anyway- the same situation unfolding here is also unfolding in your countries. If you have friends in US, please forward this to them- send them to my website. Today I had calls from a number of staffers on the Senate Labor Committee with regards to concerns expressed about S.830 the "FDA Reform Bill" (Located at: http://thomas.loc.gov/cgi-bin/query/D?c105:2:./temp/~c105k6Et:: My form letter (see very end of this message) has been flooding in to the Senate via this email distribution list, radio alerts put out by Suzanne Harris and I as well as a number of radio call in shows nationwide and via a number of other sources that shall go specifically unnamed, but which have conferred closely with Suzanne and I and have the organizational ability to flood literally thousands of faxes into Capital Hill on a moments notice. (See form letter below).(Keep pumping it in, along with your phone calls- S.830 could come to the floor today, but I don't think it will til tomorrow because they have so much other legislation to address. Suzanne Harris, of the Law Loft, has identified another section of S.830 not previously discussed in the form letter- but which presents additional cause for concern, and which consumers worldwide should examine. It is Section 807: fire up your web browser and check this detritus out at: http://thomas.loc.gov/cgi-bin/query/D?c105:2:./temp/~c105k6Et:e293962: I will provide her commentary on this section below. Many thanks to all of you out there who have been assisting me in educating our Senators (sometimes they need to hear directly from the sleeping giant: all of us, because as consumers, we have concerns that can't be represented by any vitamin trade associations, especially as they sell out to pharmaceutical interests. We made our presence known during the battle for DSHEA, and its time, once more, to awaken the sleeping giant to make sure nothing gets slipped past us in the fine print- and believe me-- they have fine print--pages and pages of it. The first Labor Committee staffer who called yesterday, will go unnamed- although I might expose him after this campaign is over- I'll have to think about it. He was highly annoyed by my education campaign and accused me of disseminating "misinformation." The individual should be fired from his job, in my opinion, as a Senate aide should have sufficient cool to listen carefully to a citizens argument and engage in an intelligent dialogue in an effort to try to understand where that person is coming from. In theory, at least, the people of America still run this country, and are still protected by its constitution. The next call came from Sean Donahue, a health policy analyst from the Senate Labor Committee, and he was quite diplomatic. I wish all people on Capital Hill could be as polite. We talked at length for close to an hour- but he does not grasp our concerns very well, being largely unfamiliar with them. He had difficulty getting onto my website, which could have been from one character mistyped, so I told him an easier way to get there was via the Life Extension Foundation's website which is linked to my site. I told him to go to www.lef.org, then on their front page scroll down to the link marked "healthcare freedom" which leads you into the political section of their website. At the top of their political section is a flashing sign reading "URGENT!" and next to it is "International Advocates for Health Freedom" Click on there and you'll go right into my site, I told him. Suzanne Harris will be speaking with him tomorrow, and I hope to speak with him again. I also received calls on my voice mail from a couple of other key Senate staffers who I will keep trying to reach tomorrow and along with the matters discussed already, Suzanne and I have a particular concern about Section 807 (see url above to get to it). Here are Suzanne's notes, (which she used on her radio show, the Law Loft Report: "Section 807 'prempts' the regulation of intrastate commerce in over the counter drugs and cosmetics from the states. Under present law, so long as manufacture, sales and marketing of an O-T-C drug or cosmetic is purely intrastate, any state can set up its own regulatory scheme to regulate such products. Not just in theory, but in actual practice, the ability of states to regulate intrastate commerce in O-T-C drugs and cosmetics has created a system that is more condusive to health freedom.The independence of each state to establish its own laws has promoted adoption of differing standards for product availability from state to state. The independence of each state has also allowed health freedom groups to fight on a state by state basis instead of having to fight all battles at the federal level where we are clearly outgunned by the pharmaceutical interests. Many political theorists prefer diversity in state standards as well on the theory that competing models eventually promote adoption of better laws by all as the better systems win out or prove their worth. Under the pre-WTO GATT system, there is a ruling which states that within a federal governmental system, the federal government is responsible for assuring that all states within that system conform to treaty standards entered into by the central government. This means, for example, that D.C. is responsible for seeing to it that the government of the state of Utah (or any other state) does not set up trade barriers or standards that are different from those to which the federal government has committed us as a nation. Thus from the point of view of those who would harmonize our laws to those of other places like the EU, it is important that the federal government gain control over the food and drug laws even as to intrastate commerce. Hence the language in Section 807. Conversely from our point of view, it is vital that the states maintain the ability to have control over intrastate commerce because it makes harmonization much more difficult. Passage into law of section 807 would make our situation much worse. Work like that done by Clinton Miller (vis a vis his efforts to protect consumer access to EPHEDRA products), on a state by state basis WOULD END (at least until a court challenge overturned the law) as to any field of law where the Federal government had pre-empted the field. In the future, if for example California citizens demanded that dietary supplements be available as foods or under lower than federal standards for over-the-counter drugs once a "harmonized" system to the EU became law in the United States, if states retained control over intrastate commerce in O-T-C drugs, then California could in theory decide to set a different standard. If however, Section 807 were law and that law were upheld by the courts, California would be powerless to set a different, more liberal standard. So, Sean Donahue, health policy analyst of the Senate Labor Committee would have us believe that the process of so called "harm-onization" is in fact........"harmless" Is it? Is it REALLY? Doesn't it deserve a much CLOSER LOOK??? I am interested in living in America, under the Constitution, and under laws that WE create. I am not at ALL interested in "harmonizing" our food and drug law with the EU-- which is clearly on the WRONG path vis a vis the regulation of dietary supplements. How do I _KNOW_ they are on the wrong path? I am in regular contact with consumers, manufacturers and distributors of dietary supplements all over Europe (and Canada, Australia, New Zealand, South Africa, Malaysia, and Japan.) I was an NGO observer on the American Codex delegation last October to the Bonn meeting of the Codex Committee on Nutrition and Foods for Special Dietary Use, and Suzanne Harris, of the Law Loft, who I work closely with, attended the meeting of the Codex Executive Committee in Geneva at the end of June where she also attended a briefing of the WHO committee on sanitary and phytosanitary measures, which was supposed to be for delegates only, but which she sneaked into as a member of the press. Harmonization sounds so beautiful. The word is mellifluous. It rolls off the tongue rather nicely, and it sounds like a tremendous thing. The Senate staff would have us believe that it is totally innocous- that section 202 is nothing more than the "sense of the labor committee" on how to streamline the process primarily to help medical device manufacturers so that they don't have to jump through too many regulatory hoops all over the world--- but this is demonstrably false. >From my website you can link in to the FDA's Office of International Relations. You can also link to the Agreement on Mutual Recognition between the United States of America and the European Community at www.mac.doc.gov/mra/mra.htm#frame Check out section 6.(Pharmaceutical Good Manufacturing Practice (GMP) As I write this, FDA is in the process of drafting new GMPs for dietary supplements. They were given this weapon via the passage of DSHEA, and judging from the ANPR in the federal register, they are going to be coming out with GMPs that favor large vitamin companies over small to mid sized companies which will have a harder time absorbing the cost of red tape imposed by HAACCP regulations. Large companies and joint ventures with pharmaceutical companies will be able to absorb these costs, and are certified by the FDA to manufacture O-T-C drugs. They will survive, but what about the small to mid sized vitamin companies? How will they be affected by harmonization? The President's Commission on Dietary Supplement Labels is pushing to expand the O-T-C drug category to include herbs and botanicals. From a standpoint of protecting American business interests is this a good idea? In comments submitted to the Commission this past month, Suzanne Harris (representing Life Extension Foundation, and the National Health Federation) has carefully analyzed this move from a standpoint of emerging international law. Her conclusion? Its not in our best interests to blur the lines between food and drugs. Why? Several reasons, but the main reason is that from a standpoint of risk/benefit analysis- American companies will have the strongest position to challenge any effort to block our exports if our products remain classified as foods... rather than drugs... due to how products are regulated under sanitary/phytosanitary measures (SPS) as opposed to technical barriers on trade (TBT). So... it says in (3) of Section 202 "the Office of International Relations of the Dept. of Health and Human Services (as established under Section 803 of the Federal Food, Drug and Cosmetic Act (21 USC 383) should have the responsibility of ensuring that the process of harmonizing international regulatory requirements is _CONTINUOUS_ ...... why should we feel that the word "harmonize" is innocous???? It doesn't seem innocous at all to me, and neither does the idea of establishing so called "Mutual Recognition Agreements" (MOUs) with the EU, when I have read the EC's current Discussion Paper on the Addition of Vitamins and Minerals to Foods and Food Supplements. The comments period on this paper ends at the end of September at the European Commission in Brussels. Not a single solitary vitamin consumer in my network in England trusts the EC process. Visit the website of MAFF (Ministry of Agriculture, Fisheries and Foods). They are pushing VERY HARD in the UK right now to regulate all vitamin B-6 above 10 mg by prescription. Alan Gaby, MD of Seattle, Washington, USA testified recently before the British Parliament regarding the safety of B-6, and the extreme arbitrariness of their efforts to limit consumer access to dosages above 10 mg. The only two countries in Europe holding out against massive restrictions on dosage levels of dietary supplements are the UK and Holland, and this attack on B-6 in the UK is part of an effort to shatter this opposition to adoption of some outrageously draconian standards in the EC. S.830 calls for (Section 202 (2) the Secretary of Health and Human Services to "regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize requirements....... and.......(3) the Office of International Relations of the Dept. of Health and Human Services (as established under section 803 of the Federal Food Drug and Cosmetic Act (21 USC 383) should have the responsibility of ensuring that the process of harmonizing international regulatory requirements is continuous"....... NO. I don't think so. There is not one single, solitary reason why even one (1) consumer of dietary supplements, ANYWHERE IN THE WORLD, should feel comfortable with this situation. As an American, I have no reason to trust this so called "harmonization" process, and I do not buy the contention that it is "innocous." I want to live under the rights and freedoms granted by our Constitution, under the laws created strictly in my own country, by Americans, where my voice still carries at least some weight... I know Canadians, Englishmen, citizens of S.Africa, and vitamin consumers in many other sovereign nations who feel similarly. Lord Acton said it best: "Power corrupts, Absolute Power Corrupts ABSOLUTELY!" I strongly urge Senators Jeffords, Hatch, and Harkin to speak directly with Suzanne Harris of the Law Loft. They should call her. Frankly, she sees a process here that they do not see. This is not their fault. They haven't studied it, and she has. Harris has written several sets of Codex comments which have been submitted to the UN's Codex Alimentarius Commission, and she is quite conversant with all aspects of this argument. She attended the Codex Executive Committee Meeting which just occurred in Geneva Switzerland at the end of June, where she attended the briefing on Sanitary/Phytosanitary Measures. She has spoken internationally on this issue, on a Swiss and Canadian radio shows, and at a Public Forum sponsored by the Health Action Network in Vancouver, Canada. In addition to being a law professor, radio commentator, investigative journalist and constitutional expert, Harris speaks several languages and is a true grassroots champion of individual liberties- the sort of person who has a strong sense of civic duty and who gives a lot to the people around her out of an innate sense of kindness. Harris is not motivated by greed. The truth is our concern. I would like to hear a debate between Senator Jeffords, and Suzanne Harris, on the air, on this issue. I feel strongly that Senators Hatch and Harkin should personally call Suzanne, because neither Senator understands this issue the way she does. Suzanne can be reached at the American Freedom Network in Colorado. I will give her number to Senators Hatch, Harkin, and Jeffords. If they should fail, for any reason, to properly discuss this matter with Suzanne, or I, my world wide email distribution list of thousands will know about it, it will be posted in my website, and I will discuss it on radio shows all over the country. In addition, I have a number of speaking engagements lined up both here and abroad. -For Freedom, John Hammell FAX ALERT FAX ALERT FAX ALERT ACT NOW FLOOR VOTE S.830 This Thurs or Fri (9/11 or 9/12) AMEND S.830 FDA REFORM BILL- NO to HARM-onization !!! Through US Capital Switchboard 800-972-3524 Call Your 2 Senators Plus (fax number are area code 202): Senator Jeffords (Sponsor S.830) via Jay Hawkins, fax 202-224-7475 Senator Hatch (who should care- sponsored DSHEA) via Tricia Knight fax 202-228-0029 Senator Harkin (who should care- is sponsoring AMTA) via Sabrina Corlett fax 202-224-9369 cosponsors: Senators: Dodd (Jeanie Ireland fax 224-7475), Coats (Vince Ventimiglia, fax unlised), Mikulski (Lynne Lawrence, 228-0404), Frist (Dave Larsen fax 228-5044), Hagel (Jim Brown fax 224-5213), Mack (Mark Smith fax 224-8022) Dear Senator Jeffords, Hatch, Harkin, Dodd, Coats, Mikulski, Frist, Hagel, Mack, and my own two if different ( ),( ): I strongly urge you to strike sections 101, (2) Special Rules- the last sentence re harmonization, and all of section 202 (Sense of the Committee Regarding Mutual Recognition Agreements and Global Harmonization Efforts. I also urge you to strike section 791, Clarification of Products. My reason for asking this is simple: this language would make our food and drug law THE SAME as the European Union, where dietary supplements are regulated as DRUGS, and overly restrictive laws place SEVERE restrictions on POTENCY LEVELS of dietary supplements. It would also allow any manufacturer to arbitrarily get dietary supplements classified as DRUGS, contrary to existing law. A Discussion Paper on the Addition of Vitamins and Minerals to Foods and Food Supplements is undergoing a comments period before the European Commission in Brussels until the end of September. The only countries holding out against restricting potency levels to only slight multiples above the RDA are the UK and Holland. It should be clear to you that so called “HARMONIZATION” is not what we should be striving for in this case as it threatens the health of all Americans, and goes diametrically against the FOOD definition for dietary supplements established under the Dietary Supplement Health and Education Act of 1994. For more information on the Codex International Threat to Health Freedom, (including Codex harmonization efforts in individual countries such as S.830, please see the website of International Advocates for Health Freedom at http://www.pnc.com.au/~cafmr/hammell/index.html Although the word “harmonization” sounds rather innocous, and sounds like something we should be for, it would clearly cause HARM to “harmonize”. Do NOT restrict my dietary supplements as DRUGS! Do NOT harmonize our food and drug law to that of the European Union! Name: Date: Address: City: State: Zip: For Health Freedom, John C. Hammell ****************************************** Donations Needed- Am One Person Working Alone 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