At 05:02 PM 10/7/98 -0700, you wrote:
>>>>
John Hammell:

Elizabeth A. Yetley, Ph.D., Director, Office of Special Nutritionals, U.S. Food and Drug Administration, says you and others are mischaracterizing the FDA's role in, and the ultimate legal result of, the CODEX possibly due to the following:
A misunderstanding of the requirements which the United States is obligated to abide by as a signatory to the Final Act of the Uruguay Round, which includes the GATT and other agreements having bearing on these concerns. Nothing in the trade agreements or process will restrict either the sale of dietary supplements in the United States or the type of information that manufacturers may provide to consumers about their products.
Since Dr. Yetley's statement below outline some of the probable arguments which she and others would pose to any Congressional committee, I thought you might be interested in the opportunity to read her statement and respond directly to Dr. Yetley and disseminate her statement and your response to your email list.

Perhaps Suzanne Harris, JD, the Law Loft, would assist in explaining potential legal consequences of both the CODEX and the FDA's role in the CODEX which Dr. Yetley did not address or has misinterpreted.

Sincerely,

Thomas H. Usher
Editor: NewHoo: Health: Life_Extension
<http://www.newhoo.com/Health/Life_Extension/>http://www.newhoo.com/Health/Life_Extension/

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Tom- Thanks for calling this to my attention. I responded to Yetley's propaganda piece of Sept.'97 in October of '97, and my response has been posted in the IAHF website for the past year. In the article that I just wrote and emailed out yesterday, I included the following statement which mentions both Yetley's propaganda piece, and my response. Interestingly, Yetley's statement was originally generated as her rebuttal to a form letter of mine which was published in Life Extension Magazine, but she has had nothing to say about my rebuttal to her rebuttal, so the ball is in her court. Here is what I already sent out to you but which I guess you didn't notice:

"The FDA announced their intention to "harmonize" their regulations to emerging Codex standards in an Advance Notice of Proposed Rulemaking (ANPR) that was published in the Federal Register on July 7, 1997, Vol. 62, #129 pp.36243-36248. This can be viewed on the web at http://www.fda.gov/search.html and entering the search phrase "Consideration of Codex Alimentarius Standards". (It can also be viewed at http://iahf.com/codx-fda.txt) (This ANPR by the FDA contradicts a propaganda piece which the FDA generated in response to an anti Codex form letter published in Life Extension Magazine. The FDA's propaganda piece asserts falsely that our domestic law isn't being undermined, and can be viewed at http://www.fda.gov/search.html and entering the search phrase "codex alimentarius commission,vitamins." I have rebutted their propaganda at http://iahf.com/cdx-fda.html"

So- If you'd like to read my response to Yetley's pack of lies, go to http://iahf.com/cdx-fda.html
My rebuttal to her garbage assisted us to get dietary supplements specifically exempted from the harmonization language of the FDA reform bill, and I wrote it specifically to silence the head staffer of the Senate labor commitee who challenged me to respond to it, and they have not had anything to say about it since except to do what I asked them to do: they exempted dietary supplements from the harmonization section of the FDA Reform Bill.
 

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PS  Here is the URL for Dr. Yetley's statement:  <http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=http%3A%2F%2Fvm%2Ecfsan%2Efda%2Egov%2F%7Edms%2Fcodex%2Ehtml&DocOffset=5&DocsFound=148&QueryZip=CODEX&Collection=all&SearchUrl=http%3A%2F%2Fwww%2Everity%2Efda%2Egov%2Fsearch97cgi%2Fs97>http://www.verity.fda.gov/search97cgi/s97_cgi.exe?action=View&VdkVgwKey=http%3A%2F%2Fvm%2Ecfsan%2Efda%2Egov%2F%7Edms%2Fcodex%2Ehtml&DocOffset=5&DocsFound=148&QueryZip=CODEX&Collection=all&SearchUrl=http%3A%2F%2Fwww%2Everity%2Efda%2Egov%2Fsearch97cgi%2Fs97%5Fcgi%2Eexe%3Faction%3DSearch%26QueryZip%3DCODEX%26ResultTemplate%3Dstndrslp%252Ehts%26QueryText%3DCODEX%26Collection%3Dall%26ResultStart%3D1%26ResultCount%3D10&hlnavigate=ALL
 

U.S. Food and Drug Administration
September 8, 1997
 
 
 
 

                              Information Paper
 
 
 

Codex Alimentarius Commission Committee on Nutrition and Foods for Special
  Dietary Uses Proposed Guidelines for Dietary Vitamin and Mineral Dietary
                                Supplements
 

At the October, 1995 meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses, the German delegation proposed, and was supported by other member nations, that the Committee consider the development of guidelines for dietary supplements of vitamins and minerals. The proposed guidelines, among other things, would make recommendations for minimum and maximum quantities of vitamins and minerals in these types of supplements, establish lists of aceeptable or unacceptable ingredients, and address certain labeling issues, including claims. While the United States opposed the Committee undertaking this work, the Committee decided to consider the proposed guidelines.

Recently, consumers and other interested parties have expressed concerns that the proposed guidelines, if adopted, would have unwanted effects on the access of American consumers to vitamin and mineral supplements. In particular, letters state that the proposed guidelines are "a threat to health freedom," will "end access to dietary supplements in the United States," will prevent manufacturers from being "able to advertise the numerous health benefits of taking dietary supplements," and will lead to a greater role of international organizations (such as the World Health Organization and Food and Agricultural Organization of the United Nations) in domestic regulation of dietary supplements due to the U.S. ratification of the General Agreement on Tariffs and Trade (GATT).

The public concerns that the proposed Codex Alimentarius Commission (Codex) guidelines may restrict the availability of supplements in the United States or limit the amount and type of information that may be legally disseminated by manufacturers may arise from, in part, a misunderstanding of the requirements which the United States is obligated to abide by as a signatory to the Final Act of the Uruguay Round, which includes the GATT and other agreements having bearing on these concerns. Nothing in the trade agreements or process will restrict either the sale of dietary supplements in the United States or the type of information that manufacturers may provide to consumers about their products.

The Codex is an international intergovernmental body responsible for the implementation of the Joint Food and Agriculture Organization/World Health Organization (FAO/WHO) Food Standards Program, which aims to simplify and integrate food standards by developing recommended standards for food which will enhance consumer protection and fair practices in the food trade. Subordinate committees of the commission meet on a regular basis, generally every one to three years, to discuss and work on standards and guidelines to meet the objectives for various issues that affect food trade (e.g., contaminants, food labeling, commodity standards, etc.). One of the Codex committees is the  Codex Committee on Nutrition and Food for Special Dietary Uses (the committee), which is responsible for addressing the need for standards and guidelines on nutritional quality for foods and guidelines and standards for commodities such as infant formula, cereal-based supplemental foods for infants and children, dietary supplements, and foods for special dietary uses (e.g., gluten-free foods for persons with celiac disease or very-low calorie diets for physician-supervised weight reduction).

In the October 11, 1995 Federal Register (60 FR 53078 at 53084), FDA announced the agency's general policy on the development and use of standards with respect to international harmonization of regulatory requirements and guidelines and addressed, in detail, the conditions under which FDA plans to participate with standards-setting-bodies outside of FDA in the development of standards for products regulated by the agency. Three key aspects of this policy that bear directly on the commonly expressed concerns about the United States' participation in the development and use of international standards are that the standards must: (1) ensure product safety, (2) be based on sound scientific and technical information, and (3) not be in conflict with any statute, regulation, or policy under which FDA operates. These policies ensure that the United States position is consistent with applicable U.S. laws.

The United States, by participating in the process, does not surrender to an international organization any of its sovereign authority to protect the health and safety of Americans. The provisions of the trade agreements that address food safety issues are contained in the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). This Agreement contains a number of conditions that food safety measures must meet, such as reasonable requirements that a measure be based on scientific principles and that it not arbitrarily or unjustifiably discriminate against imports. However, under this Agreement, the United States retains all rights to take actions to protect the health and safety of the American public. In meeting its obligations under the SPS Agreement, the United States does not relinquish its rights to enact and enforce laws to ensure the health and safety of its citizens.

While the SPS Agreement contains a general obligation to use international standards, it protects the ability of governments to use different standards if they determine that the relevant international standard does not adequately meet their nation's food safety needs. The Codex is one organization that will work to develop standards that can be used by the WTO member countries, including the United States.

Finally, the proposed guidelines for dietary supplements of vitamins and minerals were considered at the meeting of the committee held October 7-11, 1996 in Bonn, Germany. After considerable discussion, the committee amended a number of sections of the proposed guidelines. However, the committee did not reach consensus on many issues, including dosage levels, the need for warning statements, and the types or sources of nutrients to be included in vitamin and mineral supplements. Nonetheless, the Committee forwarded the proposed guidelines to the Codex Alimentarius Commission with a recommendation to advance the proposal to the next step (step 5) of the approval process and to circulate to member governments, the proposal for further consideration of those issues for which there was not a consensus.

The Commission considered the recommendation of the Committee at its meeting in Geneva, Switzerland from June 23-28, 1997. At that meeting, the United States, along with the governments of Canada, Australia, and Japan, objected to the development of the proposed guidelines within the framework of Codex because of the belief that national authorities are in a better position to regulate these products based on individual national needs. These countries also objected to advancing the proposed guidelines to the next higher level of consideration because of the lack of consensus on many key aspects of the proposal. While the Commission agreed not to advance the proposed guidelines to the next level of consideration, it did not agree to terminate consideration of the proposed guidelines; instead, the Commission remanded them back to the committee for further discussion and consideration. In its decision to return the proposed guidelines to the committee, the Commission advised the Committee that it should also reconsider whether a need really exists to proceed with the development of the guidelines.

Thus, although the proposed guidelines will remain under consideration by the committee, four points are relevant at this stage: 1) the proposed guidelines will again be circulated to member governments for comment and will be considered at the next meeting of the committee in October, 1998; 2) the proposed guidelines are at a very early stage in their development, and all of the issues are subject to further debate and changes at future meetings; 3) the committee will address the need to continue this work at its next meeting; and 4) the proposed guidelines only apply to vitamin and minerals supplements and not to other dietary supplements containing herbs, botanicals, or other substances.

The Commission also addressed the issue of standards for potentially harmful herbs and botanical preparations sold as foods, including as dietary supplements. At the October, 1996 committee meeting, a discussion paper prepared by the Canadian government was considered. This paper basically proposed that the committee consider developing a list of botanicals and herbs that would not be permitted to be used as food because that use may be unsafe. The United States, along with several other countries, argued that this activity was not within the committee's scope of work and that there was no consensus on the scientific risk assessment procedures that are available to develop such a list of potentially harmful herbs. The committee generally agreed with this position and agreed to ask the Commission to consider deleting this topic from further consideration. The committee also recommended that the Commission consider recommending that FAO/WHO establish a technical working group to study whether there is adequate scientific evidence to develop a science-based risk assessment procedure to evaluate the safety of botanicals and herbs. At its June, 1997 meeting, the Commission agreed to delete this matter from the committee's work program. Additionally, the Commission did not forward any recommendation to FAO/WHO on herbs and botanical supplements.

In the fall and winter of 1997, the FDA will be collecting scientific input from industry and interested parties on the proposed vitamin and mineral dietary supplement guidelines. The comments and other information will be used by the United States delegate to the committee to develop a U.S. position on the proposed guidelines for dietary supplements of vitamins and minerals. For all subjects discussed by the committee, including the proposed guidelines for dietary supplements, the positions taken by the U.S. government are based on sound science and also are developed in accordance with applicable U.S. law and regulations promulgated under the authority of the Federal Food, Drug, and Cosmetic Act and related statutes.
 
 

                             --------------------------------------------------
For additional information, go to Codex Alimentarius Commission<>
 

  * Report of 22nd Session of Codex Alimentarius Commission (June 23-28, 1997)

  * Summary Report--<Codex Alimentarius: Vitamins, mineral supplements, herbs and spices (August 1997)
 
 
 
 

                           Sincerely,
                           Elizabeth A. Yetley, Ph.D.
                           Director, Office of Special Nutritionals
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