Mandating No HARMonization with CODEX,
Food Safety and Food Regulation
A Natural Solutions Foundation White Paper
Regarding U.S. Codex Office and Food Safety and Inspection Service (FSIS) for
Adoption of Codex Committee Policies by the U.S. Codex Delegation and FSIS
in Harmony with the Dietary Substances Health and Education Act (DSHEA),
19 USC 3512 (the Anti-Harmonization Statute) and other Statutory and Case Law
Introduction - The Foundation
Introduction - Purpose
Requests for Congressional Action
Statement of Grounds - Facts
Statement of Grounds - Legal
Recommended Findings of Fact
Sharing this White Paper
I. Introduction-A Who Are We?
The Natural Solutions Foundation, founded in 2004, is an international NGO (Non Governmental Organization) focused on health freedom. We are active and registered in several countries and are a not for profit 501(c)(3) tax-exempt organization in the United States.
The Mission of the Foundation is to discover, develop, demonstrate and disseminate natural solutions to the problems facing us and threatening our health and freedom, achieving and maintaining a healthy self, community and world. Since its founding, the Natural Solutions Foundation has pursued a vigorous program on many fronts, including educating Congress and decision makers about natural solutions to significant social problems involving health and wellness.
We consider health freedom to be an essential part of those solutions and have, for example, spearheaded a powerful citizens initiative to have Health Freedom is Our First Freedom recognized as one of the Top Ten Social Issues on http://www.Change.org. Once this was accomplished, Health Freedom is Our First Freedom was then accepted into President Obamas official Briefing Book on http://www.Change.gov.
We have also developed an international presence, in part by attending Codex Alimentarius meetings around the world, helping to ban the use of fluoride in infant formulas intended for healthy infants by providing powerful scientific information to Codex delegates who were eager for ways to help their infants at the Codex Committee for Nutrition and Foods for Special Dietary Uses (CCNFSDU, Chaing Mai, 2006), shared vitally needed health-focused information with Codex member states and provided leadership to Codex member states on how to protect their countrys food supplies without running afoul of the World Trade Organizations draconian trade sanctions.
The Natural Solutions Foundation understands that threats to health and freedom are both domestic and international, as are the solutions. We have well over two hundred thousand people on our Action eAlert supporter list. Individuals and other organizations are welcome to participate in our many programs and action options so that netroots and decision makers share the same information and conclusions about the solutions to problems touching us all.
Among the innovative solutions we are pursuing are Mouse Warrior Campaigns which allow everyone with Internet access to communicate their opinions and need for Health Freedom as Our First Freedom to members of Congress, executives, health and food quality/safety officials around the globe and other people making decisions about health freedom and health freedom policy. We urge everyone to join our free, secure Health Freedom Action eAlerts by visiting our home page, www.HealthFreedomUSA.org or our international page, http://www.GlobalHealthFreedom.org and signing up there. Our efforts include the International Decade of Nutrition Program and an alliance among Health Conscious Nations expressed through international cooperation at Codex (the World Food Code) and the creation of Valley of the Moon Eco Demonstration Project (VotM) with its Beyond Organic, BioDynamic, Zero Emissions (BO-BD-ZE), ecologically sound communities and schools for farmers and non-farmers alike. VotM exists to share high impact, low technology, natural solutions to permit economically and environmentally sustainable, chemical free farming and other sustainable techniques for health and economic stability. Among these solutions, we consider Fr. Godfrey Nzamajos UN Center of Excellent-recognized Songhai Community in Benin to provide an outstanding example. VotM has formed a strategic alliance with the Songhai Community, sponsoring and teaching BioDynamic methods testing in several countries including the Republic of Panama.
II. Introduction-B: What Does This White Paper Accomplish?
This White Paper addresses the urgent need for Congress to adopt further assurances that American access to clean, biologically effective, health promoting and wholesome nutrition will not be compromised by HARMonization with new Federal food safety laws (including HR 875, 759, S. 425, etc.) or domestic or international rules, regulations or standards such as the Guidelines and Standards ratified and promulgated by the Codex Alimentarius Commission (the World Food Code). Such assurances already exist in US law but are flagrantly ignored by those attending Codex Alimentarius. Reigning in that disregard is essential to the food safety and security of the United States. And, since nutrients and nutrition are essential to health, halting such disregard of the law will improve the national health and the national bottom line at the same time by reducing expenditures for health care and diet, related illnesses, currently accounting for at a minimum of 1 out of every three dollars spent on health care. Diabetes, a disease of under nutrition, and its heartbreaking (and often lethal) consequences accounts for 1 out of every seven dollars spent in the health care sector in the US.
US participation in Codex Alimentarius and similar international activities drives food toward the unsustainable, the toxic, the non-nutritive and the undisclosed. The assurances that this will change and that we recommend build on the basis of the protections enacted in the Dietary Supplement Health and Education Act (DSHEA), the Anti-Harmonization Act, 19 USC 3512 and the DSHEA savings clause 1011 of the 2007 FDA Reorganization Act, as well as the First Amendment since full disclosure and free dissemination of information about the relationship between health benefits and food components is illegally suppressed by the FDA through its claims policies and other regulatory measures.
The FDA was documented to be a failed agency by the November 2007 Report of the Subcommittee on Science and Technology, FDA Science and Mission at Risk.
That report concluded that FDA a failed agency because:
1) The FDA cannot fulfill its mission because its scientific base has eroded
and its scientific organizational structure is weak.
2) The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
3) The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
4) FDA does not have the capacity to ensure the safety of food for the nation.
5) The development of medical products based on new science cannot be adequately regulated by the FDA.
6) There is insufficient capacity in modeling risk assessment and analysis.
7) The FDA science agenda lacks a coherent structure and vision, as well as effective coordination and prioritization.
8) The FDA has substantial recruitment and retention challenges.
9) The FDA has an inadequate and ineffective program for scientist performance.
10) The FDA has not taken sufficient advantage of external and internal collaborations.
11) The FDA lacks the information science capability and information infrastructure to fulfill is regulatory mandate.
12) The FDA cannot provide the information infrastructure support to regulate products based on new science.
We would add:
13. The FDA does little or nothing to control or prevent conflicts of interest leading to decision which impact the public health which are based, in whole or in part, on the financial and professional advancement and advantage of the decision-makers who are thus unable to act impartially.
In 1994 Congress unanimously adopted DSHEA, signaling a new approach to allowing Americans the freedom to develop the most advanced and dynamic nutritional marketplace in the world. Memorializing the essential concept that nutrients are to be treated as foods, and, as such, cannot be limited or controlled in their dose or combination any more than eating, for example, lamb flavored ice cream could or should be regulated, DSHEA created a legal climate which allows natural remedies, therapies that may benefit and medical treatment to flourish through the active participation of over 90% of the US population.
However, that expression of the Peoples will has been continually undercut by a clear Federal agency [FDA, IOM, EPA, USDA] prejudice against natural, wholesome, non-industrialized food and nutrition. The Food and Drug Administration (FDA), EPA, IOM, NIH and the United States Department of Agriculture (USDA) all fail the Public trust in this regard.
Nonetheless, the Dietary Supplement industry has responded with growth and expansion to massive consumer demand since the adoption of DSHEA. Much of this growth may be attributed to the thriving free market in Dietary Supplements established by DSHEA. As U.S. District Court Judge Tena Campbell stated in Nutraceutical Corporation and Solaray, Inc. v. Lester Crawford, Acting Commissioner, U.S. Food and Drug Administration, Case No. 2:04CV409 TC, USDC, Utah Central Division, the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection
Many people in the health and wellness industries, Health Freedom Advocates like the Natural Solutions Foundation and consumers fear that the Federal agencies avowed adherence to HARMonizing our laws and regulations to the Codex Alimentarius process (starting October 11, 1995, Federal Register and continuing unabated since then) is, over time, reversing these positive, and widely supported developments. There is great public consternation and well-earned concern that these agencies are seeking to HARMonize United States Standards, Guidelines and Codes of Practice with the restrictive rules and practices prevalent in certain countries outside the United States. These restrictive, anti-high-potency nutrient standards are consonant with Codex standards and guidelines such as the Vitamin and Mineral Guideline (VMG - ratified by Codex Alimentarius Commission July 4, 2005, Rome, Italy to the public jubilation of the US Delegate, despite the fact that this Guideline violates US law in both principle and fact), rather than with the freedom of access to nutrients and other wellness products protected and guaranteed by DSHEA.
Because of DSHEA, most of the worlds Dietary Supplement consumption and demand takes place in the United States, meaning that US law should be the basis for international HARMonization rather than the other way around. The United States has far more experience with the strong positive [and virtually absent negative ] consequences of free consumer access to nearly unlimited health supports than any other country and understands fully the importance both to health and to freedom of health choice embedded in this access pattern. The United States also has developed a wide clinical experience with diverse nutrients and substances which supports the conclusion that nutrients at levels chosen by consumers and the practitioners who use them for their patients are enviably safe and free of toxic effects and dangers. In fact, deaths from these products are virtually unknown, while their competitors, pharmaceutical drugs, are noted by the American Medical Association and others as constituting a major cause of death, even when used according to professional guidelines and recommendations.
Congress must reject the position stated by FDA in the US Federal Register (October 11, 1994) that it would HARMonize [emphasis added] our laws and regulations to international standards, even when those international standards were not yet completed. Further, Congress must mandate that delegates and participants in international standard setting bodies, of which Codex is only one, may ONLY support and ratify those standards, guideline or regulations which are directly supported by US law
In addition to the highly restrictive VMG, the Codex Committee on General Principles has prepared, among other things, Proposed Draft Working Principles for Risk Analysis for Food Safety (Guidance to National Governments) [and] Proposed Amendments to the General Principles of the Codex Alimentarius [and] New definition of risk analysis terms related to food safety. These principles include the definition developed by a World Health Organization Workshop on Application of Risk Analysis to Nutrients of an adverse event caused by nutrients as any change in a bio marker [emphasis added] regardless of the beneficial impact of those nutrients - http://www.who.int/ipcs/highlights/nutrientraproject/en/. The Codex Committee on Methods of Analysis and Sampling should consider the proper science and methods to apply to Dietary Supplements and nutritional products. Risk Assessment without regard to benefit is advised by the aforementioned Codex Vitamin and Mineral Guideline. National Nutrient Risk Managers are advised to use population data when it is available to set limits that prevent this bizarre class of events called adverse events which translate to any change in a bio marker regardless of the beneficial impact of those nutrients. When such population data are not available, this class of bureaucrats is advised to pool data from desperate populations and literally guess what those limits would be. If no data exist to be pooled, then they are advised to follow the same non-science-based process to set limits.
These principles and practices leave the health of whole populations literally subject to collapse. No such limit setting for nutrients is permitted under US law.
The same document also refers to safe upper limits for nutrients despite the fact that under DSHEA specifically exempts nutrients from upper limiits of any type. Science makes it clear that biology concurs with US law in this case and the dangers of taking any type of supplement are virtually non-existent while the dangers of taking pharmaceutical drugs, whose sales are significantly impacted when people are free to use nutrients, are so great that the American Medical Association and other organizations have listed the unintended effects of properly used drugs as a major cause of death in the developed world.
Laibow, RE, et. al., Codex Book, Natural Solutions Foundation, 2005
III. Congressional Mandate and Protective Clause Request
We urge Congress (1) to mandate to the U.S. Codex Office. FSIS (or its successor) and all other agencies and government instrumentalities, all delegates to Codex or other national or international standard setting bodies that they shall adopt as the policy of the U.S. Codex [or other agency] Delegation and Agencies support only for harmonization of Codex Standards, Guidelines and Codes of Practice, or other international standards and regulations, that conforms to United States law and practice, and (2) to adopt DSHEA (and family/organic/small enterprise, church, school, club, garden, farm, ranch, seed saving and similar food-related enterprise) protective language in any food safety bill or other bill relating in any way to food (closely patterned after the Rule of Interpretation protecting DSHEA products added to the 2007 Kennedy FDA enabling act, Section 1011).
First, with respect to the agencies and delegates representing American interests internationally, they must be instructed specifically to:
1. Reject any international standard that is inconstant with the First Amendment to the United States Constitution or any other part of the US Constitution, DSHEA or with 19 USC 3512 or any other US law, statute or regulation,
2. Support the Congressional determination that vitamins and minerals are foods, not drugs or toxic chemicals, and, therefore,
3. Support the rejection of any regulation, standard or agreement which imposes upper limits on nutrients. Since optimal intake levels of nutrients is the result of biochemical individuality and may vary (based on complex, shifting, interdependent and interweaving factors such as age, diet, nutrient absorption capacity, the presence or absence of co-factors, genetic makeup, underlying nutritional status, disease state, toxic body burden), no maximum intake levels or upper limits for nutrients have biological significance and must not be determined or fixed by government policy, regulation or agreement. Nutrients are not toxins and must not be regulated as if they were. Nutrient combinations and doses have been demonstrated, through 14 years of US consumer and practitioner experience, to be remarkably safe at any desired level. In the same way that liver ice cream should not be prohibited by government legislators or regulators, so nutrients must not be the subject of such regulations since they pose no risk to consumers, although their hazards to the expensive illness care industry, which is widely acknowledged to be playing a significant role in helping to bankrupt the US economy, are significant.
Risk Assessment is a wholly unnecessary and a totally inappropriate mechanism for determining safety and dosage of nutrients although it is highly significant as a tool for limiting exposure to toxins. In their documents dealing with the use of Risk Assessment for nutrients, both WHO and Codex make note of the fact that Risk Assessment is a tool of toxicology and that its use for substances which are essential for survival is both untested, unproven and has never been subjected to either professional scrutiny or peer review. Given that Codex is supposed to operate strictly on a Science Based principle, this makes the use of Risk Assessment for determination of any aspect of nutrient policy totally inappropriate.
4. Support the biochemical reality embodied in DSHEAs protection of all supplements and categories of nutrients which Codex, through the Codex Vitamin and Mineral Guideline and other texts, violates when it states that the principal nutritional value of foods comes from its vitamins and minerals. Food world wide is demineralized and diminished in nutrients, including the vitamins and other co-factors, including helpful and essential factors, many of which have yet to be identified in a laboratory but whose absence can be detected through the clinical problems and diseases which result.
Exemplary and abundant scientific and clinical evidence supports the importance of essential fatty acids, oils, complex plant residues with physiological impact in foods, flavinoids, antioxidants, amino acids and other vital factors, sisosterols, and many other compounds which are essential to health and which are found in food. All of these compounds are protected under DSHEA, but ignored or limited by the Codex Alimentarius Commission. Further, World Health Organization guidance in the above referenced Workshop document makes it clear that nutrients are treated as toxins and any effective biological activity is to be considered an adverse event.
In other documents, the World Health Organization identifies under-nutrition as the cause of the epidemic, preventable, non-communicable diseases which are the principle killers of the developed world:
Cardiovascular Disease and Stroke
DSHEA allows nutrients to be used to protect against, mitigate, treat, or cure these conditions of under nutrition. Codex makes this impossible for any country following its guidelines, thus assuring massive under-nutrition. US delegates and agencies must be prevented from supporting anything which defies US law and supports massive under-nutrition. These guidelines, standards and other agreements stand in stark contradistinction to both the principles and intent of DSHEA.
5. The agencies must Take Care that the Laws be faithfully executed (Article II, Section 3, United States Constitution) as established by DSHEA that, as foods, nutritional supplements of any type do not require safe upper limits, maximum potencies, maximum permissible upper limits or similar constraints on their use and that any such limits are antithetical to the legislative intent and guarantees of DSHEA.
6. Furthermore, the Natural Solutions Foundation urges support for the position, already enshrined in US law, that:
(a) Nutients are foods and should be regarded as such.
(b) Toxic burdens (industrial chemicals, pesticides, heavy metals, fungicides, food additives, artificial colors, preservatives and flavors, etc.) are well known to increase nutrient requirements to levels which cannot be met by food alone.
(c) High nutrient density dietary supplements may be required to counteract the deleterious effects on health of toxic burdens.
(d) Natural source dietary supplements present no significant health hazard, based on sound scientific analysis and a 14 year history of a self-imposed experiment by the American people who have taken massive amount of supplements and nutrients with no harm or negative consequences to their health although it can be argued that there has been harm done to the bottom lines of the industries that profit from their ill health.
(e) Synthetic/GMO source synthetic nutrients provide the only hazards associated with nutrient ingestion at any level which people select for themselves. Appendix 3 to the Final Report of the Ad Hoc Working Group on Foods Derived from Biotechnology, approved by the Codex Alimentarius Commission in 2008 makes it clear that neither the safety nor bio-availability of nutrients derived from Biotechnology (GMO)s) is known and that such compounds may actually function as anti-nutrients, interfereing with metabolism, absorption and enzyme function. The Final Report recommends testing their impact on large human populations, although involuntary testing, such as already being carried out through unlabeled GMOs in the food chain, violates both US and International law.
(f) Compounds which are, in fact, toxic, like pesticides, herbicides, fungicides, GMOs, industrial toxins and veterinary drug residues should be reduced via the principles of Risk Analysis and the Precautionary Principle, to levels which have no discernible impact on any human or animal system. Toxicology supports this principle for toxins while biochemistry refutes it for nutrients.
(g) Compounds which fail to pass the Ames or similar cancer protective tests should be banned from the human food chain as already required under US law.
(h) Optimal health should be the stated public policy goal of the worlds food standard setting bodies, including Codex Alimentarius, and of the United States. Delegates and representatives to all such bodies must be clearly instructed to support and endorse only those items which further this goal.
(i) Preservative techniques which increase free radical concentrations and/or which result in the degradation of food components to toxic or carcinogenic compounds [e.g., irradiation] should be globally banned.
(j) All known or suspected toxins which are applied to food or created through its farming, growth, processing, packaging, shipment or treatment should be clearly labeled to allow consumers optimal choice in their food supply.
(k) No US delegation shall permit persons with any type of financial, professional or personal ties to the industries involved in the deliberations. Any other type of conflict of interest shall bar persons from participating as delegates. No private consultations with industry representatives or others who stand to gain from the particular outcome of any deliberation or action shall be permitted. All such contacts shall be open to the public and matters of clear public record.
(l) No US regulator or bureaucrat shall be permitted to take employment, remuneration, subsidy or support of any type from the industry with which that regulator or bureaucrat has been involved while on the public payroll for a period of 5 years following termination of their employment by the US or State governments, agencies, foundations, organizations or other bodies. Financial, professional or other conflicts of interest between government employees and industries which they are involved in regulation shall result in immediate dismissal and the possibility of civil or criminal charges.
Second, regarding all pending food safety bills, the Natural Solutions Foundation strongly recommends that public health and personal liberty require protective language, such as the following, be enacted in any such bill, whether the bill divests the FDA of food safety authority (as HR 875 would do, creating a new Food Safety Agency) or would further empower FDA (as HR 759 would do):
Rule of Interpretation
No provision of this act shall be deemed to apply (a) to any home, home-business, homestead, small farm (including organic or natural) agricultural activity, social club, association, church, school or other local organization, (b) to any family farm or ranch, or (c) to any natural or organic food product, including dietary supplements regulated under the Dietary Supplement Health and Education Act of 1994.
For well researched details about the potential threat posed by the Food (sic) Safety bills pending in Congress, see independent investigative reporter Linn Cohen Coles writings on this subject, which have been widely reprinted, including by the Foundation, for example, A Solemn Walk Through HR 875 by Sue Diederich and Linn Cohen-Cole: http://www.healthfreedomusa.org/?p=2287
These two sets of recommendations are predicated upon the clear expression from hundreds of thousands of Americans, representing the views of millions, that Health Freedom is Our First Freedom.
IV. Statement of Grounds
A. Factual Grounds
The Codex Alimentarius Commission has adopted Standards, Guidelines and Codes of Practice are based on regulatory principles that will, if the United States Harmonizes with them as announced, but despite US law, over time, limit access to nutrients, complementary therapies and dietary supplements of consumers in the United States, and that will significantly restrict access to clinically effective vitamin and mineral supplements worldwide. This will have a markedly deleterious impact on liberty and an equally significant one health, if the definition of the major killers of our time as preventable diseases of under-nutrition by the World Health Organization is be believed.
Based on evaluation of its contents and the public statements of the Chairman of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), Bonn, 2004, it is the intent and understanding of that Committee (which promulgated the Vitamin and Mineral Guideline, which was then ratified by the Codex Commission in full (July 4, 2005, Rome, Italy) that, despite the limited title of the Guideline, it will, because of the legal structure under which the Codex Alimentarius Commission operates, restrict all classes of nutrients, not just those classed as Vitamins and Minerals. While Codex texts, including this one, are voluntary, countries which deviate from them without following very specific steps, are liable to enormous WTO trade sanctions.
Furthermore, since the guidance offered by the aforementioned WHO Workshop makes it clear that high potency nutrients are to be considered as producing adverse events when their ingestion results in any change of a biomarker in any direction leading to change, no matter how beneficial, this guidance means that high potency nutrients will be unavailable in any HARMonized country, enhancing under-nutrition and the burden of suffering and death caused by preventable sub-optimal nutrition. High potency nutrients, absence of anti-nutrients and foods free from toxins are the antidote.
The US must not support restrictive and, under our laws, illegal, measures such as those ratified by Codex, with the US delegations vigorous approval and leadership.
If the Codex Alimentarius Commission continues to support restrictive measures, such as the Vitamin and Mineral Guidelines, Codex will restrict access to wholesome nutrition in several ways:
1. Setting so called upper safe limits (maximum potencies, maximum permissible upper limits or similar limitations) for each vitamin and mineral based on inappropriate scientific risk assessment from the science of toxicology, not the science of nutrition; this violates scientific sense and clinical experience. Optimum levels which carry no legal weight and are not used to restrict access to nutrients are a much more reasonable, clinically and scientifically supported standard and must be individually determined for each individual.
2. Setting any upper limits on supplements and nutrients; this directly violates US law by violating the legislative intent and provisions of DSHEA which hold that Dietary Supplements are Foods, not Drugs.
3. Marginalizing and eliminating nutrient supplement access for the nearly 1 billion people worldwide, who, by international standards and the assessments of the World Health Organization and the Food and Agriculture Organization, now experience devastating widespread under nutrition and go hungry on a regular basis. Declines in IQs for the worlds hungry and under-nourished children are but one of the devastating results. Why would the US, which spends so much money in foreign aid, adopt or support positions which put the worlds most vulnerable into an even more vulnerable, but completely preventable, compromised position? In addition, the population-based Codex standard, which represent no strong science whatsoever, as made clear by the directions to National Nutrient Risk Managers under-appreciate the nutritional status of the worlds hungry 4.6 billion people, most of whom lack the recommended amount of one or more essential nutrient every day of their lives.
4. Creating, through setting maximum permitted vitamin and mineral consumption limits, an approach to regulating dietary supplements which is consistent with and leading the way toward, if not itself directly establishing, prior restraint, illegal under the US Constitution.
5. Substantially restricting the amount of nutrition and health information about vitamins and minerals consumers will be allowed to receive, asserting that only drugs can contain label claims for products that are suitable for the prevention, alleviation, treatment or cure of disease, disorder or particular physiological conditions; this violates the US Right of Free Speech guaranteed by the First Amendment.
6. Fostering the incorrect worldwide health assumption that adequate levels of nutrients can be found in a regular diet since the ideas of nutritional sufficiency and average expectable daily diet are totally unsupported by nutritional science while an abundant body of scientific literature and clinical experience as well as the repeated findings of international organizations like the World Health Organization, UNESCO and the Food and Agriculture Organization confounds these assumptions. Were either idea true, there would be no widespread malnutrition or under-nutrition in the world.
7. Continuing to fail to implement the WHO/FAO Global Strategy on Diet, Physical Activity and Health which explicitly supports better health through better nutrition, including dietary supplementation, to address the epidemic of preventable diseases of under-nutrition including major killers like Cancer, Heart Disease and Stroke, Diabetes and Obesity.
American health consumers (otherwise know as people) are becoming active and organized to protect and expand their health rights. The threat to dietary supplements which DSHEA corrected in 1994 mobilized more letters to a pre-internet Congress than any other issue in the history of the United States, including the Viet Nam War.
Worldwide health is being significantly undermined by the Codex-created limits to nutrients available in many countries and regions when they make their regulations and laws Codex Compliant, according to official documents prepared jointly by the World Health Organization and the Food and Agriculture Organization. Codex, by itself, cannot change U.S. law unless U.S. agencies adopt its regulations. To do so, US regulatory agencies would need to supersede US law. Indeed, FDA has done so on several occasions, most Codexs upper potency limits, established for vitamins and minerals, will restrict U.S. consumer access to high-potency vitamins and minerals to which they are accustomed since US policy, legal or not, has been to HARMonize with international standards in preference to US ones as articulated in the FDA statement on harmonization in the US Federal Register (October 11, 1995). In a notice published in the Federal Register of October 11, 1995 (60 FR 53078), FDA articulated its policy regarding the development and use of standards with respect to the harmonization of various national and international regulatory requirements and guidelines - http://www.cfsan.fda.gov/~lrd/fr970707.html . Some U.S. companies are already choosing to dumb down their potencies to mirror their international formulations.
FDAs highly restrictive and by their own analysis, crushingly expensive for small companies, unnecessary imposition of Current Good Manufacturing Procedures on the industry, more akin to drug industry rules than food industry in a sector which is filled with small Mom-and-Pop business providing innovation and leadership at low financial return, furthers this process. These cGMPs will become fully effective over the next year. FDA has admitted that about 2/3 of small nutrient companies will go out of business because of the cost and burdens of this imposition.
Codex Alimentarius standards and guidelines are enforced at the international level via trade sanctions imposed by the World Trade Organization (WTO) through its dispute resolution process. However, there is grave concern in many quarters that statements such as this, from the WTO web site, the SPS Agreement explicitly permits governments to choose not to use the international standards. However, if the national requirement results in a greater restriction of trade, a country may be asked to provide scientific justification, - http://www.wto.org/english/tratop_e/sps_e/spsund_e.htm - make it incumbent upon each member nation of the WTO to bring its domestic standards into conformity with Codex standards and guidelines in order to avoid the creation of hidden barriers to international trade. This would violate both DSHEA and with 19 USC 3512. Codex misapplies an inappropriate toxic chemicals risk assessment model to regulate helpful nutrients which have virtually no known toxicity and therefore, present virtually no consumer or environmental danger. Any assessment of vitamin and mineral usage should evaluate nutrients using nutritional science rather than with toxicological science which is properly used to evaluate toxin and dangerous industrial chemicals. Since supplements, including vitamins and minerals, are defined as foods under DSHEA, upper limits of any type are inappropriate, unnecessary and violate US law. They should therefore be opposed by the United States with vigor both in Codex meetings and otherwise rather than enthusiastically endorsed in violation of US law.
The Natural Solutions Foundation has publicized what we refer to as The Codex Two Step Process showing how any country can lawfully opt out of Codex restrictions to protect its national nutrition and food traditions, without WTO sanction. See our short video on the subject at: http://www.youtube.com/watch?v=6QNg3MD6BxM
A fully developed template of just how this would work, called the Codex Book, is available from the Natural Solutions Foundation at http://www.healthfreedomusa.org/?page_id=220.
An essential principle to remember here is that, despite propagandistic junk science to the contrary, nutrients have no meaningful toxicity. The human body is able to rid itself of excess doses of nutrients or store them for future use in times of shortfall, whereas it is not able to rid itself adequately of toxic and dangerous chemicals. This difference, coupled with differential impact of nutrients and detrimental impact of toxins, is precisely the distinction upon which the determination that the latter are, in fact, toxic while the former are clearly non-toxic. The Codex Vitamin and Mineral Guideline (VMG) disregards the unique biological individuality which determines the basic nutritional needs of each individual. Biological requirements can vary widely (by orders of magnitude) during the life span since nutritional requirements are affected by climate, dietary supply, genetics, energy output, toxic load, emotional, organ and immune health, electromagnetic and geopathic stress as well as normal and pathological aging processes and enzymatic decline with aging. Codex disregards this and all other short and long term biological individuality. Codex fails in this fundamental requirement by erroneously disregarding biological, physiological and pathophysiologic variation in nutrient needs.
Codex was founded upon the initiative of pharmaceutical executives who stand to profit from under nutrition because it leads to diseases they make treatments for. It was not founded by nutritionists or humanitarians.
The US delegation to Codex is packed with representatives of, and people representing the interests of, corporate concerns who manufacture and market drugs for humans and animals, agricultural chemicals, industrialized food supply companies whose and other industrial sectors whose interests run counter to health and consumer protection. Consumers and health professionals are scant on Codex delegations and their positions are given virtually no weight either in the Codex deliberations or the preparation of US Codex positions.
Codex documents make it clear that the process of risk assessment does not properly apply to nutrients and that the process must be modified to account for the differences between nutrients and toxins. But whether or not Codex continued with its wrong-headed approach, the US is violating its own law when it presses for these strategies, approves them, does not oppose them and seeks to implement them at home.
The procedures employed to accomplish that modification are untested through scientific or clinical evaluations and are entirely theoretical. Their devastating impact upon the earths population, however, is easily predicted and devastating.
Briefly, Codex fails in its fundamental requirement of protecting consumers, as stated in its Mandate, by erroneously applying toxic chemical risk assessment principles to nutrients which are foods, not toxins, erroneously asserting that
1. Nutrients should be treated and evaluated as toxins.
2. Such evaluation requires and relies upon novel, non peer-reviewed and untested procedures whose accuracy and utility have not been evaluated through appropriate studies and trials.
3. Dietary Supplements, including vitamins and minerals are toxins, not foods, and therefore require upper limits on ingestion
4. Foods and nutrients are not useful in treating disease.
5. Dietary supplements have little value because people can get the limited amounts they need from food.
6. The nutritional quality of foods is due primarily to the vitamin and mineral content of those foods.
7. Rigid, low limits should be set for vitamins and nutrients because nutritional requirements do not change with biochemical, age-related, genetic and other assaults and do not vary from person to person, despite abundantly documented genetic and environmental variations within and between populations.
8. Theoretical reference values are more important than unique individual nutrient needs and clinical requirements.
9. Toxicology science is preferred to individual choice as the best control on access to foods such as Dietary Supplements.
10. Dietary Supplements require control on access despite the fact that they are foods under DSHEA.
The well documented safety of Dietary Supplements, as foods, is documented by La Leva di Archimede at http://www.laleva.cc/petizione/english/ronlaw_eng.html, with particular reference to http://www.laleva.cc/petizione/ron_law_tables/tabella.html, http://www.laleva.cc/petizione/ronlaw/australia_societal_vs_individual_r..., http://www.laleva.cc/supplements/medical_injury_law.pdf, http://www.laleva.cc/petizione/ronlaw/leape_relative%20risks1.pdf, http://www.laleva.cc/petizione/ronlaw/relative_risk_boeing72.pdf , http://www.laleva.cc/petizione/ronlaw/relative_risks_bubbles3.pdf) and Dr. Andrew Sauls presentation to the Canadian Parliament, Where Are The Bodies?, http://www.doctoryourself.com/testimony.htm .
Codex reinforces, in its Vitamin and Mineral Guidelines, related documents and positions, and numerous other texts, its already existing prohibition on preventing truthful information about the ability of foods and nutrients to treat, diagnose, prevent, mitigate and cure disease and prohibiting the truthful association of health benefits and food components. Codex prohibits supplemental nutritional feeding world wide with disastrous potential results and the dissemination of information on the positive impact of nutritional supplementation and support on chronic, degenerative disease. Codex rejects without scientific basis or support the position supporting access to nutrients strongly documented and endorsed by a vast scientific literature and numerous joint publications of the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) which detail the essential contribution of nutrition to the prevention and treatment of chronic diseases in both the developing and developed world. World hunger experts recognize that nutrient supplementation can be extraordinarily useful in improving world health and eliminating disease (vitamin A supplements in developing countries can offer 30 times as much social improvement as millions of dollars of development aid), a fact the Codex Vitamin and Mineral Guideline (VMG) and related texts ignore without scientific support or validation for their position. Shockingly, the US is clearly the driving force behind this position, despite the fact that it violates US law.
Codex ignores the WHO-documented high costs of under nutrition in loss of life, degraded quality of life and economic loss created by the chronic diseases of nutrient-deficiency which are so abundantly documented in clinical, biochemistry and epidemiological literature. The human and economic impact/costs of under nutrition are recognized by the World Health Organization and the Food and the Food and Agriculture Organization who document that chronic disease (e.g., heart disease and stroke, diabetes, obesity, cancer, etc.) is a non-contagious epidemic problem which can be prevented, treated and cured through adequate nutrition. These sources further document that nutrition often cannot be provided by diet. Clinically necessary nutrient intake is, however, prohibited under the proposed Codex Vitamin and Mineral Guideline.
At loggerheads with the US positions at Codex and similar bodies, The United States Supreme Court has spoken forcefully, enforcing consumers right to truthful information about health care issues. See: Thompson v Western States Medical Centers - 535 U.S. 357, where Justice OConnor wrote,
If the First Amendment means anything, it means that regulating speech must be a last - not first - resort. . . We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information. . . Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring . . . a warning that . . . its risks were unknown.
The basic rule, announced by the case, to determine constitutionally permitted government restrictions on Commercial Speech (speech that makes or is about an offer for a transaction, such as the sale of Dietary Supplements) is a Two Prong Test: the first prong is to ask two questions: (1) is the speech in question about unlawful activity and (2) is the speech misleading. If no to both, the speech is entitled to protection unless the Government can carry its burden and prove (1) the governmental interest involved is substantial, (2) the regulation must directly advance the governmental interest and (3) the regulation of Commercial Speech cannot be more extensive than is necessary to serve that interest (quoting Central Hudson v Public Service, 447 US 557, at 566).
B. Statement of Grounds - Legal Authority
1. The primary Legal Basis for the actions Congress should take to mandate a policy that Health Freedom is Our First Freedom is the First Amendment to the Constitution of the United States: Congress shall make no law . . . abridging the . . . the right of the people . . .to the Freedom of Speech.. and of Association.
2. A further Legal Basis for the Proposed Policy is Section 3512 of Title 19 and specifically, 19 USC 3512(a)(1) and (a)(2) as applied to the protection of human life through DSHEA.
Section 3512. Relationship of agreements to United States law and State law
(a) Relationship of agreements to United States law
(1) United States law to prevail in conflict
No provision of any of the Uruguay Round Agreements, nor the application of any such provision to any person or circumstance, that is inconsistent with any law of the United States shall have effect.
Nothing in this Act shall be construed -
(A) to amend or modify any law of the United States, including any law relating to -
(i) the protection of human, animal, or plant life or health,
(ii) the protection of the environment, or
(iii) worker safety, or
(B) to limit any authority conferred under any law of the United States, including section 2411 of this title, unless specifically provided for in this Act.
3. Additionally, the Statutes authorizing the various agencies involved contain general provisions that support the actions needed. Federal Law includes provisions that grant the relevant Secretary broad authority to promulgate rules and regulations necessary to carry out the Act[s].
4. Codex Alimentarius (Codex) is the World Food Code, an international agency under the joint sponsorship of WHO (World Health Organization) and FAO (Food and Agriculture Organization), two primary organs of the United Nations.
According to its Statute, the purposes of Codex are protecting the health of the consumers and ensuring fair practices in the food trade. (Codex Statute, Article 1(a)) Codex does this by promulgating standards, codes of practice and guidelines. Codex General Principles, 1 reads:
The Codex Alimentarius is a collection of internationally adopted food standards presented in a uniform manner. These food standards aim at protecting consumers health and ensuring fair practices in the food trade. The Codex Alimentarius also includes provisions of an advisory nature in the form of codes of practice, guidelines and other recommended measures intended to assist in achieving the purposes of the Codex Alimentarius. The publication of the Codex Alimentarius is intended to guide and promote the elaboration and establishment of definitions and requirements for foods to assist in their harmonization and in doing so to facilitate international trade.
Finalized standards, after acceptance by governments are published by Codex. (Codex Statute, Article 1(d)) It is clear from this language that Codex guidelines, being only advisory, do not impose any requirements on marketers unless and until they are adopted by individual national governments.
V The Findings of Fact that Congress Should Adopt
In acting to protect the Public from HARMonization to further protect Health Freedom as Our First Freedom, we urge Congress to find:
(a) The Vitamin and Mineral Guideline adopted by CODEX on July 4 2005 uses inappropriate science (i.e., Risk Assessment procedures [Toxicology]) rather than appropriate science (i.e., Nutritional Science [Biochemistry]) which is very likely to inappropriately mandate maximum permissible levels of nutrients so low that they are, by intention, without impact on any human being, the intended outcome of Risk Assessment procedures; a Fact Hearing must be, and petitioner hereby requests that a fact hearing be, held to determine the scientifically factual and appropriate basis for the use of Risk Analysis [Toxicology] rather than more appropriate nutritional [Biochemistry] scientific standards in all decisions pertaining to nutrition.
(b) Codex has accepted the use of Risk Assessment procedures for nutrients. However, Risk Assessment is a methodology relevant only to toxicology and both irrelevant and antithetical to Nutritional Science and biochemistry. The Risk Assessment methodology employed by CODEX has been arbitrarily modified without scientific validation or professional consensus to restrict permissible dosages of nutrients essential to life to levels which can, by intent, have no impact on any human being, no matter how sensitive. This misapplication, distortion and misconstruction of Risk Assessment is in clear contradiction to the principles of toxicology and scientific Risk Assessment procedures which have been developed to determine the highest dosages of dangerous industrial and natural toxins to which humans can be exposed to without discernible effect. For this reason, instead of evaluating vitamin and mineral upper limits using inappropriately modified and unscientific Risk Analysis, US Policy must further the use of Nutritional Science to support the liberal access to nutrients enjoyed under legislative protection in the US. Under the Dietary Supplements Health and Education Act, passed by unanimous Congressional consent in 1994, while a nutrient may be dealt with by the FDA if it is shown to pose a significant risk to health and safety, nutrients are treated as foods which, as such, may have no upper limits set upon their use.
(c) The United States has failed to oppose the use of these scientifically unsupported and unverified Risk Assessment techniques in the CODEX Committee on Nutrition and Foods for Special Dietary Uses. It has failed to note or oppose these procedures on the basis of the substantial Conflict of Interest represented by the publicly acknowledged personal, professional and financial involvement in commercial Risk Assessment by the Chairman of the Codex Committee on Nutrition and Foods for Special Dietary Uses as the head of the BfR, a commercial Risk Assessment company. The United States has failed to oppose the classification of nutrients as toxins in 1994, by that same committee despite the clear violation of US law which that classification represents. And, since 1994, the United States has failed to present any opposition to the use of Risk Analysis and other attempts to limit access to nutrients in order to prevent the restrictive (and illegal under US law) Vitamin and Mineral Guideline from reaching Step 8 and from being ratified on July 4, 2005 at the 28th Codex Alimentarius Commission meeting in Rome, Italy, contrary to DSHEA (Dietary Supplement health and Education Act of 1994) and the unanimous determination of Congress that Dietary Supplements are Foods, not toxic substances and, as foods, can have no upper limit set upon their intake or use.
(d) U.S. District Court Judge Campbell stated in April 2005 (Nutraceutical Corporation and Solaray, Inc. v. Lester Crawford, Acting Commissioner, U.S. Food and Drug Administration, Case No. 2:04CV409 TC, USDC, Utah Central Division),
the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection
(e) The CODEX Technical Report discussing the application of Risk Assessment to nutrients makes it clear that this procedure does not apply to nutrients because, unlike drugs, they have minimum intake limits that are required for life and health. Risk Assessment procedures were modified for application to vitamin and mineral supplements without scientific validation, peer review or clinical testing.
There is a considerable body of established scientific literature supporting the nutritional harm caused by low-level intake of essential and vital nutrients. Has the United States held a public fact finding hearing to determine if this jerry-rigged statistical system has any applicability to Nutritional Science and what the risks to the US and global population are when Risk Assessment is applied to nutrients? If not, why has the US supported the use of this technique in the nutritional determinations made by the CCNFSDU when so many lives are at stake in this issue, estimated by public health scientists to exceed 3 Billion consequential deaths world-wide? Why has the US supported and adopted this scientifically, biologically and factually indefensible Policy which should be abandoned in favor of a Policy which supports and promotes nutrients as foods, as DSHEA mandates, as the domestic and international standard which are so strongly supported by both science and US Law? A fact Hearing must be, and petitioner hereby request that a fact hearing be, held to determine the impact on public health in the United States from the use of Risk Analysis [Toxicology] rather than more appropriate nutritional [Biochemistry] scientific standards.
The Natural Solutions Foundation entered a Citizens Petition and Comments to the USDA and FDA on this topic in 2005 and 2006. The Media Release of June 9,2006 stated:
Gen. Albert N. Stubblebine III (US Army, Ret.) announced today that the Natural Solutions Foundation is Petitioning the U.S. Codex Office and the Food Safety and Inspection Service (FSIS) Docket No. FSIS-2006-0004 (both agencies of the U.S. Department of Agriculture) to adopt support for international nutrient regulations (and any other international harmonization) only as it conforms to United States law and practice as the policy of the U.S. Codex Delegation.
Neither USDA nor FDA responded to the Petition of the Citizens concerned with this issue, although several hundred thousand messages were sent to the agencies in support thereof.
(f) The Dietary Supplement Health Education Act (DSHEA), 1994 classifies supplements as foods which therefore may have no Safe Upper Limits, Maximum Permissible Upper Limits or other restrictions upon their use.
(g) FDA has improperly adopted a policy of harmonization with International Standards, even where those standards are not finalized when those standards are in violation of US law or regulatory practice. In a notice published in the Federal Register of October 11, 1995 (60 FR 53078), FDA articulated its policy regarding the development and use of standards with respect to the harmonization of various national and international regulatory requirements and guidelines - http://www.cfsan.fda.gov/~lrd/fr970707.html .
(h) The adoption of the Risk Assessment Model and the anti-DSHEA harmonization Policy are ultra vires and premature; have occurred without sufficient Public Hearings and in direct contravention of the Public Policy of the United States as enacted by Congress. The appropriate US agencies must therefore assert a Nutritional Standard as the only lawful alternative to the inappropriate and unscientific use of toxicological Risk Assessment with regard to Dietary Substances. It is incumbent upon the United States therefore to ensure that the proper science is presented and considered in the process of attempting to set upper limits for nutrient supplements and to vigorously support the reopening of the Vitamin and Mineral Guideline to correct its scientific deficiencies since the science upon which it is based, relying on toxicology while ignoring the appropriate science, biochemistry, is flawed, creating a position that is contrary to US legal requirements and domestic (as well as global) health and well being of every man, woman and child on the planet.
Because the US delegations to Codex have consistently acted against the interest of US law and the public interest, and because on the issue of the Codex Vitamin and Mineral Guideline the science used to support it is deeply flawed, and because the science which supports the use of high potency nutrients is abundant, Congress should direct the US delegation at Codex to call for the Vitamin and Mineral Guideline to be reopened and further direct it to press for adoption of a DSHEA-like standard to allow the world to harmonize to a health-promoting standard of nutritional sufficiency.
The Natural Solutions Foundation urges Congress to take urgent action with regard to CODEX and the International Food Safety Agency:
Specifically, Congress should hold Public Hearings on following Questions of Fact:
1. Whether or not the use of Toxic Risk Assessment to determine the allowable forms and dosages of Vitamins and Minerals will promote public health. We believe it will not, as the use of Risk Assessment is inappropriate science with reference to Foods, including Vitamins and Minerals
2. Whether forms and dosages of Vitamins and Minerals determined through Toxic Risk Assessment will adversely impact on the health and well-being of the residents and Citizens of the United States.
3. Whether Codex delegations acted against US legislative and regulatory policy and, if so, upon whose authority, whether Codex delegations should be free of industry personnel and include health, consumer and health freedom personnel and whether standards, including the Vitamin and Mineral Guideline and related texts, should be reopened upon application by the US to bring these standards into line with both science and US law.
Thereafter, Congress should adopt appropriate legislation further protecting the inalienable right of the People to Health Freedom as Our First Freedom.
The policy of FDA and the USDA in the various Codex Committees (and in other multinational arenas, such as the (sic) North American Union) should be a policy of strict support for the Dietary Supplement Health Education Act (DSHEA) food-based standard as the international standard for vitamin, minerals and all other dietary supplements as well as all other US laws. Additionally, all standards and regulations promulgated by the US should facilitate consumer choice and protection.
DSHEA, passed unanimously by the U.S. Congress in 1994, recognizes and protects the value of individuals making personal nutritional and health choices in a way that is rejected by the Codex guidelines. It also protects all speech concerning health benefits associated with nutrients or food. Any attempt to restrict or limit dosages, potency, information or access to supplements or information about nutrition, food and supplements denigrates their classification under DSHEA as foods and, hence, without need for access restriction.
The culmination of 50 years of U.S. legislation and litigation has refined the supplement policy of the United States ensuring that individual choice and desire play a key role in ensuring private and public health. The Codex guideline subordinates individual choice to scientifically inaccurate and unsupported, supposed professional expertise. The DSHEA balances professionals, science and people.
Members of the public have continually warned United States policy makers that pending international regulations fail to meet both the standards of United States law and the requirements of the international law.
See for example, Public Citizens comments regarding harmonization:
And the National Health Federation, Codex Breaks its own Rules http://www.thenhf.com/codex_may_2005_nhf_press_release.htm
Also, the European Alliance for Natural Health Submission on Risk Assessment
See also these Media Releases from the Foundation:
June 3, 2005
Natural Solutions Foundation files Emergency Citizen Petition to Support DSHEA in CODEX Crisis
July 5, 2006
Codex Chairman Seeks to Thwart Natural Solutions Foundation Pro Health Codex Initiative
October 10, 2006:
US Urged by Natural Solutions Foundation to Alter Codex Course, Support WHO Global Strategy to End World Hunger, Promote World Health
We therefore urge Congress to mandate that the U.S. Codex Office, FSIS and all other Federal agencies adopt as Public Policy support only for regional, multinational and international Standards, Guidelines and Codes of Practice that conform to United States law and practice, which support consumer choice and natural well-being and specifically the provisions of DSHEA through 19 USC 3512, United States law to prevail in conflict - No provision of any of the Uruguay Round Agreements, nor the application of any such provision to any person or circumstance, that is inconsistent with any law of the United States shall have effect.
We further urge Congress to direct the US Codex Office and all future delegations to call for a reopening of any Codex standard, guideline or other text which violates US law.
Finally, Congress must include clear and unambiguous protection for homes, farms, ranches, small businesses and natural products from enhanced food safety laws (such as H.R. 875 and 759) and regulations that may be applied to industrialized agriculture but which would have a chilling effect on local and natural food and nutrition.
Health Freedom is Our First Freedom and the People must be free to engage in farm and food activities that enhance their health and prosperity.
Dated: April 2, 2009
Natural Solutions Foundation
This White Paper has been published at: http://www.healthfreedomusa.org/?p=2394
Maj. Gen. Albert N. Stubblebine III (US Army, Ret.)
President & Trustee
Rima Laibow, MD
Medical Director & Trustee
Ralph Fucetola JD
Vice President - Legal & Trustee
Sharing this information
You may repost this White Paper freely, so long as full credit is given and
the link to this page is included:
Please forward this link to our Action eAlert about this White Paper widely:
To tell your members of Congress about this White Paper, click here: