WASHINGTON, DC, November 20, 2000—The dietary supplements sector-working group of the TransAtlantic Business Dialogue (TABD) agreed on several key elements to harmonize the regulatory framework for vitamin and mineral food supplements on both sides of the Atlantic. These major breakthroughs were forged at the Sixth TABD CEO Conference in Cincinnati, Ohio, from November 16-18.
 

The working group approved the principles and components on definition, safety, and GMPs. The working group also agreed to continue its dialogue and that its next steps would be to:
 
 

Define types of claims and appropriate labeling for food supplements and develop criteria for transatlantic acceptance of credible scientific evidence to substantiate these claims; evaluate mechanisms for authorizing/approving claims; and assess conditions for exclusivity to encourage research and development.
 
 

Encourage the scientific bodies responsible for the evaluation of the safety of total intakes of vitamins and minerals (EU Scientific Committee on Food and US Food and Nutrition Board) to cooperate closely to harmonize setting upper safe levels for vitamins and minerals.
 
 

Define and recommend methodologies for setting maximum levels for vitamin and/or mineral food supplements on the basis of upper safe levels of total intake for these nutrients and intakes from other sources. The responsible regulatory bodies are encouraged to cooperate and establish one set of figures for maximum levels for vitamins and minerals in food supplements on both sides of the Atlantic.
 
 

Seek urgently, in light of the imminent proposed US rule on GMPs, transatlantic harmony for implementing common GMPs and quality standards. The working group also agreed to develop practical procedures to support GMP details; and seek acceptance, implementation, and appropriate enforcement.
 

Progress toward transatlantic harmonization of dietary supplements was led by a team of supplement CEO’s that included: Gale Bensussen, Leiner Health Products Inc.; William Van Dyke, B&D Nutritional Ingredients, Inc.; Johannes Burges, Hermes Arzneimittel; and Sonnich Fryland, Ferrosan. They were among the more than 120 industry leaders from the U.S. and the European Union who called on their governments to adopt a list of progressive trade liberalization measures at this TABD CEO Conference. 
 

The CEO’s, meeting with senior officials form the U.S. Administration, the European Commission, the U.S. Congress, and the European Parliament, made recommendations on how best to boost transatlantic and global trade and investment. They focused on specific mechanisms for resolving trade disputes and expanding the U.S.-EU commercial marketplace, which at $1 billion per day in two-way trade, is the world’s largest trading relationship.
 

"The recommendations we have developed at this meeting will, if adopted by the governments, expand trade and investment opportunities for large, medium, and small companies by removing obstacles and inefficiencies in the U.S. and European regulatory regimes," said George David, chairman and CEO of United Technologies Corporation and US TABD chair for 2000. "Adoption of these recommendations will create jobs, raise living standards, lower costs and improve access to goods–that is, provide concrete benefits for business, for labor, and for consumers."
 

The TABD is a results-oriented forum that seeks to increase transatlantic trade and investment opportunities through the removal of costly inefficiencies from excessive regulation, duplication and differences in the EU and U.S. regulatory systems and procedures in a manner consistent with sustainable development. 
 

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The Council for Responsible Nutrition (CRN) is a science-based, trade association founded in 1973 and represents more than 100 companies in the dietary supplement industry, including ingredient suppliers and manufacturers. CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.
 

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CFH Website: "FACT: There has been some confusion between Codex Commission activities, GATT and international regulatory harmonization efforts. The three issues are connected but not synonymous.

John Hammell:  Codex activities, Gatt and international regulatory harmonization efforts are so intertwined that, in fact, they ARE virtually synonymous.

CFH Website: "The proposed Codex guidelines would be implemented only if 1) they are adopted by the full Codex Commission as presently drafted and 2) they are subsequently adopted by individual countries that have ratified GATT. GATT specifically provides that while ratifying countries must consider international health-related standards such as a final Codex guideline in connection with their own health-related laws and regulations, no ratifying country is required to adopt such a standard."

John Hammell: The US has already signed Mutual Recognition Agreements as part of GATT and NAFTA that prevent a country from refusing to harmonize its domestic laws to an international standard, except on the basis of safety.  Now government agencies are pushing to set "upper levels" on supplements.  If they prevail, America will forfeit its right to opt out on the basis of safety because our own laws will affirm our acceptance of "safe" limits.  The pattern is clear.

Furthermore, since the World Trade Organization's Dispute Settlement Body does not allow individual testimony, our government representatives, whom the pharmaceutical interests are working hard to influence, would not plead our case.  This could effectively silence those of us who claim our right to dietary supplements.

In addition, the Federal Statute which protects our domestic laws from harmonization may be a paper tiger. Despite federal statutes, Congress has already capitulated to harmonization when the World Trade Organizations Dispute Settlement Body threatened us with trade sanctions. This is why Congressman Ron Paul introduced the American Sovereignty Restoration Act to pull us out of the WTO, why 18 cosponsors backed it last congress and why it hopefully will gain momentum as people learn the truth. On the other hand, CFH and its multinational corporate member companies have not backed Paul's bill.

CFH Website: "This principle is reflected in the U.S. statute ratifying GATT, which explicitly provides that no provision of GATT is effective in this country if it is inconsistent with Federal law. Thus, any provision of Codex dietary supplement guidelines (if such guidelines are eventually adopted in any form), which conflicts with any provision of DSHEA, is null and void in the U.S. The FDA, which is required by Federal law to implement DSHEA, may not incorporate any part of any final Codex dietary supplement guideline in a regulation or policy, if to do so would contravene DSHEA."

John Hammell: Attorney Milton Bass examined this Federal Statute and did not agree with this assessment. He said that the word "inconsistent" is not defined, and the statute opens a Pandora's box as to how it would be interpreted. What if something isn't IN our law? Would it then be inconsistent? No. You can't say it would be inconsistent if its not in our law.

True, Codex cannot DIRECTLY impose a finalized standard on the USA because  harmonization works indirectly.  The US could refuse harmonization & mount a challenge before the WTO's Dispute Settlement Body, but then we would be hit with trade sanctions. In THEORY, Congress could accept the sanctions and REFUSE to harmonize, but the sanctions can be imposed across a broad spectrum of industries unrelated to supplements, so the reality is that no country can afford to accept this penalty.  This threat would put IMMENSE lobbying pressures on Congress to change our laws. These lobbying pressures are comparable to the huge pressures that forced NAFTA and GATT through to start with.

Have you noticed the current flurry of "news" articles promoting "Upper Limits" on supplements, even though the concept is scientifically questionable?  The Trans-Atlantic Business Dialogue (TABD) & TACD are exerting pressure for harmonization to the rapidly emerging European Union regulations.  The TABD's dietary supplement working group is comprised solely of multinational pharmaceutical interests who could ultimately monopolize the market. Review the press release in the archives section of CRN's website under news releases re the TABD and note that the TACD is comprised of groups like Public Citizen and CSPI, that have publicly stated their intention to repeal DSHEA, . See www.crnusa.org/shellnr112000.html, www.tabd.org and www.tacd.org ]

CFH Website: "COMMENT: The implications of harmonization over the long haul under treaties like GATT and NAFTA are not completely understood. What is clear is that at this point harmonization is each country's choice, and the United States cannot be forced to conform to an international standard that directly conflicts with existing U.S. law (e.g. DSHEA) without the consent of Congress."

John Hammell:  The implications of harmonization are becoming painfully clear to any concerned citizens who educate themselves on this issue. Review what happened in Seattle at www.louisbeam.com/seattle.htm and the "US Laws Not Safe Section" at www.iahf.com .  See also www.tradewatch.org and get the book "Who's Trade Organization?" by Ralph Nader.

It is clear that we need a groundswell of support for Congressman Ron Paul's American Sovereignty Restoration Act which would protect our domestic laws by pulling us out of the World Health Organization.

CFH Website: "4. Fiction: Examples of individual nations developing regulations, and responding to specific product concerns are being called "Codex harmonization" efforts (e.g. Norway's restricted regulations on supplements, U.K.'s attempted restrictions on vitamin B6 potency, U.S. proposed restrictions on Ma Huang potency, and Canada's recent actions to increase regulation of herbal products)."

John Hammell: This is NOT "fiction" and it IS Codex harmonization in that it is movement in the direction orchestrated by pharmaceutical interests.  In fact, IAHF and allied groups have reason to believe that a UN body called ICDRA, the International Council of Drug Regulating Authorities, coordinates the actions of the world's FDA's.

CFH Website: "FACT: The scope of the Codex's work addresses only essential nutrients and does not involve any discussion of herbs or a wide range of dietary supplements."

John Hammell:  This statement is misleading.  At a Codex meeting in Bonn in '96, Dr.Yetley of OUR FDA illegally seconded a Canadian motion to shift all deliberations on herbs completely OUT of Codex, where herbs are at least considered foods (consistent with US law), over to a secret panel at WHO, which treats herbs as DRUGS (inconsistent with US law).  Now we have lost all access to any deliberations made at WHO, in contrast to Codex where we had SOME access.  In fact, Codex typically calls substances that don't have RDA's "drugs" and shifts them to other bodies that may ultimately determine that you will need a prescription to obtain them. Look closely at what is happening with the EU Vitamin Directive.

CFH Website: "Citizens remains seriously concerned about specific incidents, both in the U.S. and abroad, that restrict consumer access to dietary supplements (eg: the UK B6 issue and the U.S. ma-haung issue). However, there is no evidence that these nations' internal actions are related in any way to efforts to force international harmonization or to influence developing Codex guidelines, especially when the examples involved fall outside the purview of issues under Codex's consideration."

John Hammell:  The first sentence makes sense, but it is followed by a misleading statement.  IAHF is aware of numerous visitations between countries by regulators to discuss vitamin regulations.  In fact, ICDRA at the UN helps to coordinate the actions of the FDA and its sister regulatory bodies world wide. This also ignores the pressures of the TABD and TACD to harmonize the laws. See "U.S. and European Leaders Agree on Principles to Harmonize Dietary Supplement Regulations" at www.crnusa.org/shellnr112000.html .

CFH Website: "It is important to remember that the proposed Codex guidelines are being hotly contested, are in the process of change and have yet to be finalized."

John Hammell:  While it is true that the guidelines are not finalized, it is also true that we are being set up for harmonization.  So why is CFH anesthetizing people on this issue by not promoting the Anti- EU Vitamin Directive Petition (www.laleva.org) and not exposing the true situation?  Their statement (above) puts people to sleep with the illusion that this is a non-issue and that there is no reason for concern.

CFH Website: "COMMENT: The right of consumers to freely access dietary supplements must be balanced against issues of safety and efficacy. While Citizens For Health sees no proof of a worldwide "conspiracy" to force harmonization, we do recognize that some government agencies continue to look for reasons to restrict access to dietary supplements, and this is our primary concern.

John Hammell:  If restriction of access to supplements is CFH's primary concern, why do they concur with disproportionate apprehensions about safety and the principles and mechanisms that would achieve precisely that end.  Here CFH is agreeing with those who want to use issues of safety and efficacy to limit our access.  So, how can they claim to represent "citizens" while promoting the position of  the multinational corporate interests who are trying to restrict our rights by raising regulatory hurdles?

CFH Website: How to take effective action: When communicating with government officials and agencies about Codex, it is important to know the facts. This educational piece gives you a strong basis with which to communicate your concerns to the U.S. Codex office, President Bush, legislators, and the FDA.

John Hammell:  "It IS important to know the facts."  It is equally as important not to be misled when crucial facts are omitted from a discussion.

CFH Website: How to take effective Action Items: 1. Become a member of Citizens For Health, and encourage others to do the same! That way you can stay abreast of new developments and support our work on this important issue."

John Hammell:  Thinking people are seeking more accurate information about "new developments" than what Citizens for Health has provided so far.

CFH Website:  "2. Distribute this informational piece to friends, family, co-workers, community organizations, religious groups, health food store owners, etc."

John Hammell:  Considering the above, this is not a good course of action.

CFH Website: "3. Write/Call/Fax/Email a brief letter to: the FDA, the US Codex Office within the USDA, President Clinton, your US Senators and Congressmen. Let them know that you "want them to support the efforts of the U.S. Codex delegation, through the FDA and the USDA to work for the protection of DSHEA and that you oppose the proposed Codex guidelines to restrict potency of and health claims on essential nutrients."

John Hammell:  Since the actions of the US Codex delegation may set us up to lose in a trade dispute, why does CFH actively support their efforts and why are they doing nothing to expose the problem?  The USDA shares royalties with a Monsanto subsidiary in the sale of questionable genetically engineered plant technologies, while the FDA has a long history of coziness with the pharmaceutical industry as well as a history of actions to limit both access to and information about dietary supplements.  Can we trust these agencies to act in the best interest of citizens?

CFH Website: "4. If you are a business person dealing with dietary supplements, contact Citizens so that we can connect you with the appropriate trade association and international network for you to help in this effort."

John Hammell:  While 95% of what CFH is doing may be good, their stance on this issue is certainly troubling.  So beware.  Judging from the positions expressed on their website, CFH may refer you to a trade association that is pharmaceutically dominated or to groups that may, by their actions or inaction, set us up for harmonization world wide.
 

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John Hammell is associated with grass roots health freedom organizations.  He urges people of good conscience to review the facts and inform others of the truth.  You can hear audio archives of Gary Null radio broadcasts with Hammell and other grassroots health freedom fighters from all over the world in the media section at www.iahf.com 

For more information or to give a much-needed donation, contact:

John Hammel
IAHF
PO Box 625
Floyd VA 24091  USA
www.iahf.com , 800-333-2553