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  1. CODEX NHFA 2005

  2. CODEX Vitamin & Mineral GuidelinesPASSED! International Guidelines for Trade Vitamins and Minerals NHFA 2005

  3. CODEX ALIMENTARIUS 1. Ancient “to protect consumers from dishonest practices in the sale of food” Codex Website 2005 NHFA 2005

  4. CODEX ALIMENTARIUS 3. Codex Alimentarius Austriacus Austro-Hungarian 1911 “to determine standards of identity for specific foods.” Codex Website 2005 NHFA 2005

  5. CODEX ALIMENTARIUS 5. 1940’s - Consumer Concerns “…protect consumers from poor quality and hazardous foods.” NHFA 2005

  6. FAO 6. 1961 – World Concerns FAO steps in for world food safety NHFA 2005

  7. FAO United Nations Food and Agricultural Organization NHFA 2005

  8. FAO Desire for international agreement “on minimum food standards…” NHFA 2005

  9. 1961 FAO Establishment of Codex Alimentarius Commission • Protecting the consumer’s health - Ensuring quality - Reducing trade barriers NHFA 2005

  10. CODEX ALIMENTARIUS Historically -Visible Underweight contents Size variations Misleading labeling Poor quality NHFA 2005

  11. CODEX ALIMENTARIUS Science based - Invisible Alarm micro-organisms pesticide residues environmental contaminants food additives NHFA 2005

  12. WHO United Nations World Health Organization NHFA 2005

  13. WHO “… with the goal of developing sustainable, integrated food safety systems for the reduction of health risk along the entire food chain, from the primary producer to the consumer”. [1] WHA Resolution 53.15, 2000. [1] Weekly Epidemiological Record, 2004, 79, 173-180, No. 18, April 30. NHFA 2005

  14. 1963 Established Joint Program FAO and WHO Codex Alimentarius Commission NHFA 2005

  15. FAO/WHO Dual Goals Broad Jurisdiction . Protecting the health of consumers . Ensuring fair practices in food trade NHFA 2005

  16. CODEX ALIMENTARIUS 172 Countries Desire to Harmonize Voluntarily NHFA 2005

  17. HARMONIZATION CONCEPT “The harmonization of food standards is generally viewed as a prerequisite to the protection of consumer health as well as allowing the fullest possible facilitation of international trade.” Codex website 2005 NHFA 2005

  18. HARMONIZATION PROMOTED “…the Uruguay Round Agreements on the Application of Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT) both encourage the international harmonization of food standards.” Codex Website 2005 NHFA 2005

  19. CODEX COMMENTSWHY THE PROGRESS OFHARMONIZATION IS IMPEDED -Different legal and administrative systems -Varying political power systems -National attitudes and concepts of sovereign rights Codex Website 2005 NHFA 2005

  20. Uruguay Round Agreements 1994 WTO WORLD TRADE ORGANIZATION SPS & TBT Agreements NHFA 2005

  21. WTO - 1994 Independent Trade Organization - Member Countries Join by Contract - Enforceable by Dispute Resolution Body NHFA 2005

  22. WTO  Codex WTO Agreements refer to Codexas the international standard to be used by WTO members for trading goods. NHFA 2005

  23. WTO Majority of WTO members are Codex Alimentarius members NHFA 2005

  24. WTO Will WTO be a vehicle for the enforcement of Codex? NHFA 2005

  25. Regional Trade Agreements Will other regional trade agreements such as CAFTA andNAFTA point to Codex and affirm the enforcement of Codex standards or guidelines? NHFA 2005

  26. EU Food SupplementsDirective Will Codex adopt a positive list approach and ban everything else like the EU FSD tried to do? NHFA 2005

  27. HEALTH FREEDOM PRINCIPLES Freedom of access for health-seekers Freedom to practice all healing methods Regulate by the least restrictive means NHFA 2005

  28. SAMPLES OFHealth Freedom Responses -Ask WTO for a formal opinion re enforcement -Work to strengthen national US laws -Challenge UN/FAO/WHO jurisdiction NHFA 2005

  29. Codex GuidelinesPassed Final Codex Guidelines Approved by Commission Italy July 4, 2005 NHFA 2005

  30. Freedom Infringements Core Problem Disregard for Over-breadth NHFA 2005

  31. Freedom Alert Conceptual Merger FAO + WHO NHFA 2005


  33. WHO PEOPLE LAW WHO People Health NHFA 2005

  34. MERGER Regulation Food+People ( how they use food ) NHFA 2005

  35. DIFFERENT BURDENS OF PROOF Regulating Nutritious Food  Regulating Toxic Substances  Regulating People NHFA 2005

  36. Burdens of Proof Government must show there is imminent risk of significant public harm before regulating vs. People must show that it is safe or has benefit before acting NHFA 2005

  37. Nutrients and Food Government must show that there is an imminent risk of significant harm before prohibiting Example: DSHEA NHFA 2005

  38. Toxins/Drugs Manufacturers must show that it is safe to distribute or has benefit that outweighs the risk before distributing Example: Ampicillin NHFA 2005

  39. People Government must show that a person will cause an imminent risk of public harm Example: Contagious Disease Except…..!!!!!!!! NHFA 2005

  40. BEFORE REGULATING PEOPLE Government MUST consider: Fundamental rights Freedom of self-determination National sovereignty Human rights Cultural diversity Right to fairness and due process Least restrictive means of regulation NHFA 2005

  41. PEOPLE HEALTH FREEDOMS Educate Freedom of Speech Pray Freedom of Religion Sell Commerce Law Recommend Freedom of Speech Use Self-determination Refuse Self-determination NHFA 2005

  42. LEAST RESTRICTIVE MEANS Examples: Voluntary vs. Mandatory Treatment vs. Isolation Exemptions with conditions NHFA 2005

  43. Mixing “food law” and “people law” Freedom Alert! Watching for merger power NHFA 2005

  44. “ These Guidelines apply in those jurisdictions where products defined in 2.1 are regulated as foods.” Draft Guidelines for Vitamin and Mineral Food Supplements People: Some countries consider vitamins and minerals to be food, others don’t. CODEX GUIDELINESSee merger power NHFA 2005

  45. “ Most people who have access to a balanced diet can usually obtain all the nutrients they require from their normal diet.” (underline added) Draft Guidelines for Vitamin and Mineral Food Supplements People DOGMA: There is a proper “balanced” way to get nutrients which is considered “normal” CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE NHFA 2005

  46. “ Because foods contain many substances that promote health, people should therefore be encouraged to select a balanced diet from food before considering any vitamin and mineral supplement.” (underline added) Draft Guidelines for Vitamin and Mineral Food Supplements People DOGMA Does this mean Vitamins and Minerals are not really food? CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE NHFA 2005

  47. “Vitamin and mineral food supplements should contain vitamins/ provitamins and minerals whose nutritional value for human beings has been proven by scientific data and whose status as vitamins and minerals is recognized by FAO and WHO.” (underline added) Draft Guidelines for Vitamin and Mineral Food Supplements People Violation Burden of proof shifting with “should” No preliminary and mandatory showing of imminent risk of significant harm. CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE NHFA 2005

  48. “Maximum amounts of vitamins and minerals in vitamin and mineral food supplements per daily portion of consumption as recommended by the manufactures shall be set, taking the following criteria into account: (underline added) Draft Guidelines for Vitamin and Mineral Food Supplements People Violation Burden of proof shifted from government to manufacturers No preliminary and mandatory showing of imminent risk of harm. CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE NHFA 2005

  49. “(a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into consideration, as appropriate, the varying degrees of sensitivity f different consumer groups:” (underline added) Draft Guidelines for Vitamin and Mineral Food Supplements People Violation Conventional science above people’s choice, Government has not first proven risk of significant harm. CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE NHFA 2005

  50. FREEDOM ALERT! Maximum Amounts of Vitamins and MineralsShall Be Set ! Upper safe levels… established by scientific risk assessment! NHFA 2005