Return-Path: jham@concentric.net Errors-To: X-Sender: jham@pop3.concentric.net Date: Tue, 30 Sep 1997 16:24:22 +0600 To: ewuertz@spidome.net From: John Hammell Subject: ALERT! HELP FIND A CONGRESSMAN TO AMEND FDA REFORM BILL! So called "harmonization" language in the FDA Reform Bill threatens to make American food and drug law the same as the European Union's where dietary supplements are regulated as drugs and where restrictions are tightening. I need assistance in finding someone in the house to introduce an amendment on the floor. (S.830- House Bill # hasn't been given yet) Many of you assisted me by faxing and emailing a form letter to the Senate regarding the need to strike the harmonization language from S.830. Although we flooded them with faxes, it was just before they moved to the floor on their fast track. I did get calls back from some key Senate staff, but unfortunately the bill had a huge head of steam behind it (passing 98-2), and our objections to the harmonization language went largely ignored. So right now I am urgently attempting to find someone in the House who might be willing to introduce an amendment to the House companion bill to S.830 (which doesn't yet have a number- to find out if its been given a number, keep checking the Legis office at 202-225-1772) What follows is a letter that I faxed to Congressman Burr's office today. (He is the sponsor of HR 1411, The Drug and Biological Products Modernization Act of 1997, which is one of 3 house bills currently being combined to form the companion bill to S.830 (It hasn't been given a number yet.) Please help me find someone in the house to introduce a bill which will amend the harmonization language in order to allow more time for citizen input, as well as to stipulate that Congress must review any proposed harmonization. I would be more aggressive and try to get the harmonization removed, or try to get the EU's laws harmonized to ours (instead of ours to theirs) but doubt that this is politically possible given that the Senate Bill went through by 98-2. We must also ask this question to Congressman Congressman Barton, (sponsor of HR 1710- the Medical Device Modernization Act) because his bill also contains harmonization language. If we can succeed in getting an amendment introduced when this bill goes to the house floor (could happen this coming week), then there would be a CHANCE to get the harmonization language amended in the conference committee when the house and senate bills are joined into one legislative package (which gets sent to the President for passage.) Please refer to the following letter when trying to get your Congressman to introduce the same amendment discussed below: John C. Hammell, legislative advocate 9/30/97 International Advocates for Health Freedom 2411 Monroe St. Hollywood, FL 33020 800-333-2553 The Honorable Richard M. Burr, Sponsor of HR 1411 c/o Alison Newman, Health Issues L.A. Fax 202-225-2995 Re: Please Amend FDA Reform Bill: Language Proposed for H.R. 1411- Amendment Enclosed Dear Congressman Burr: Although I am advocating an amendment to change the harmonization language in HR 1411's Section 18 (Harmonization), I will discuss our concerns in a broader context, including S.830, in hopes of having a dialogue with you about this today. A large number of citizens in all 50 states are very concerned with the harmonization language in S.830, which we attempted to have stricken as you can see from the enclosed form letter which was pumped in to the Senate Labor Committee in high volume. I received calls back regarding this from Bruce Artim on Senator Hatch's staff (Senate Judiciary Committee), as well as from Sean Donahue, Health Policy Analyst on the Senate Labor Committee and there is a need for an ongoing dialogue regarding these concerns so I am ccing this to them. I'd like to emphasize to you that I did not become aware of the harmonization language in S.830 until just before the August recess. I generated my form letter at that time, but there was no opportunity for any real dialogue until after Congress came back in September, and by then S.830 was being fast tracked, giving me no time to try to get the bill amended in committe. By the time I had the ear of Sean and Bruce, the bill was almost to the Senate floor, with a huge head of steam behind it---- but thousands of citizens remain very concerned. Although this legislation is being driven by the medical device manufacturers, language contained within it also effects the regulation of drugs, biological products, foods, (including dietary supplements) food additives and color additives. Our concerns specifically entail the harmonization of our food and drug law between the European Union, and the United States. To be more specific, we are especially concerned with the threat posed to consumer access to dietary supplements, which are regulated as foods in the United States, where consumers enjoy broad access to a wide range of products, including vitamins and minerals at high potencies. Suzanne Harris, JD, of the Law Loft, an interdisciplinary Think Tank in Colorado is in the process of completing comments which must be submitted today, September 30th to the European Commission in Brussels regarding a discussion paper entitled "Addition of Vitamins and Minerals to Foods and Food Supplements." The EU is drafting proposals next month to harmonize their regulations on vitamins and minerals between all EU member states, and the only two countries holding out against severe restrictions on potency limits are the UK and Holland. Since the European Commission is the primary entity which generates proposals for new legislation for the European Union (the Council of Ministers being the body that actually creates new legislation in the form of European Union directives), the Law Loft and International Advocates for Health Freedom views the circulation of this document (after having read its text) as a first step towards tightening European Union regulations against dietary supplements and fortified foods even more than it has in the past. Ms. Harris will be completing her comments to the EC later today, and I will fax them to you as soon as I have them. Our concern stems from the fact that in the EU, dietary supplements are regulated as drugs, not as foods as they are in the United States, potencies of vitamins are heavily restricted in many EU countries, and we have evidence to show that the EU is moving in the direction of much tighter regulations. Given these concerns, we would like to see the language of S.1411 changed in the following way, and we'd also like this change to be made in the companion bill to S.830 when the bill number is announced. We'd like the conference committee to include this amendment when the final language for the FDA Reform Bill is written. (Suggested Changes are enclosed within parentheses.) SEC. 18. HARMONIZATION. Section 803 (21 U.S.C. 383) is amended by adding at the end the following: (C ) The secretary shall participate in meetings with representatives of other countries to discuss methods and approaches to reduce the burden of regulation and harmonize regulatory requirements if the secretary determines that such harmonization continues consumer protections consistent with the purposes of this Act. The Secretary shall report to the Committee on Commerce of the House of Representatives of the Senate at least (120) days before executing any bilateral or multilateral agreement under this paragraph, (and all harmonization agreements entered into must be reviewed by Congress.) These changes are necessary to insure sufficient time for public input, and Congress must review all harmonization language in order to insure that American consumer access to dietary supplements is not impaired due to harmonization with EU laws which are far more restrictive than our own. 60 days is not a sufficiently long period of time for Congress to review such matters as it doesn't allow enough time for citizen input, or for a proper Congressional review. Sincerely, John C. Hammell cc: Senator Orrin Hatch c/o Bruce Artem, fax 202-224-6331 Sean Donahue (Senate Labor Committee Health Policy Analyst) fax 202224-6510 Congressman Barton c/o Beth Hall fax 202- 225-3052 Congressman Whitfield c/o Tim Taylor fax 202-225-3547 , ****************************************** 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