CODEX

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CODEX

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CODEX Vitamin Mineral GuidelinesPASSED!

• International Guidelines for Trade
• Vitamins and Minerals

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CODEX ALIMENTARIUS

• 1. Ancient
• to protect consumers from dishonest practices in
  the sale of food
• Codex Website 2005

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CODEX ALIMENTARIUS

• 3. Codex Alimentarius Austriacus
• Austro-Hungarian 1911
• to determine standards of identity for specific
  foods.
• Codex Website 2005

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CODEX ALIMENTARIUS

• 5. 1940s - Consumer Concerns
• protect consumers from poor quality and
  hazardous foods.

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FAO

• 6. 1961 World Concerns
• FAO steps in for
• world food safety

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FAO

• United Nations
• Food and Agricultural Organization

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FAO

• Desire for international agreement
• on minimum food standards

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1961

• FAO Establishment of Codex Alimentarius
  Commission
• Protecting the consumers health
• - Ensuring quality
• - Reducing trade barriers

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CODEX ALIMENTARIUS

• Historically -Visible
• Underweight contents
• Size variations
• Misleading labeling
• Poor quality

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CODEX ALIMENTARIUS

• Science based - Invisible Alarm
• micro-organisms
• pesticide residues
• environmental contaminants
• food additives

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WHO

• United Nations
• World Health Organization

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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. http//www.who.int/wer.

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1963

• Established
• Joint Program
• FAO and WHO
• Codex Alimentarius Commission

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FAO/WHO

• Dual Goals
• Broad Jurisdiction
• . Protecting the health of consumers
• . Ensuring fair practices in food trade

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CODEX ALIMENTARIUS

• 172 Countries
• Desire to Harmonize
• Voluntarily

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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

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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

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CODEX COMMENTS WHY THE PROGRESS
OFHARMONIZATION IS IMPEDED

• -Different legal and administrative systems
• -Varying political power systems
• -National attitudes and concepts of sovereign
  rights
• Codex Website 2005

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Uruguay Round Agreements

• 1994 WTO
• WORLD TRADE ORGANIZATION
• SPS TBT Agreements

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WTO - 1994

• Independent Trade Organization
• -
• Member Countries Join by Contract
• -
• Enforceable by Dispute Resolution Body

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WTO ? Codex

• WTO Agreements refer to Codex as the
  international standard to be used by WTO members
  for trading goods.

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WTO

• Majority of WTO members
• are
• Codex Alimentarius members

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WTO

• Will WTO be a vehicle for the enforcement of
  Codex?

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Regional Trade Agreements

• Will other regional trade agreements such as
  CAFTA and NAFTA point to Codex and affirm the
  enforcement of Codex standards or guidelines?

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EU Food SupplementsDirective

• Will Codex adopt a positive list approach and
  ban everything else like the EU FSD tried to do?

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HEALTH FREEDOM PRINCIPLES

• Freedom of access for health-seekers
• Freedom to practice all healing methods
• Regulate by the least restrictive means

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SAMPLES OFHealth Freedom Responses

• -Ask WTO for a formal opinion re enforcement
• -Work to strengthen national US laws
• -Challenge UN/FAO/WHO jurisdiction

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Codex GuidelinesPassed

• Final Codex Guidelines
• Approved by Commission
• Italy July 4, 2005

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Freedom Infringements

• Core Problem
• Disregard for Over-breadth

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Freedom Alert

• Conceptual Merger
• FAO WHO

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FAO COMMODITIES LAW

• FAO Food Safety

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WHO PEOPLE LAW

• WHO People Health

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MERGER

• Regulation
• Food People ( how they use food )

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DIFFERENT BURDENS OF PROOF

• Regulating Nutritious Food
• ?
• Regulating Toxic Substances
• ?
• Regulating People

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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

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Nutrients and Food

• Government must show that there is an imminent
  risk of significant harm before prohibiting
• Example DSHEA

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Toxins/Drugs

• Manufacturers must show that it is safe to
  distribute or has benefit that outweighs the risk
  before distributing
• Example Ampicillin

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People

• Government must show that a person will cause an
  imminent risk of public harm
• Example Contagious Disease
• Except..!!!!!!!!

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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

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PEOPLE HEALTH FREEDOMS

• Educate Freedom of Speech
• Pray Freedom of Religion
• Sell Commerce Law
• Recommend Freedom of Speech
• Use Self-determination
• Refuse Self-determination

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LEAST RESTRICTIVE MEANS

• Examples
• Voluntary vs. Mandatory
• Treatment vs. Isolation
• Exemptions with conditions

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Watching for merger power

• Mixing
• food law
• and
• people law

• Freedom Alert!

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CODEX GUIDELINESSee merger power

• 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 dont.

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CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE

• 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

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CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE

• 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?

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CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE

• 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.

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CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE

• 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.

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CODEX GUIDELINESFREEDOM INFRINGING LANGUAGE

• (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
• peoples choice,
• Government has not first proven risk of
  significant harm.

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FREEDOM ALERT!

• Maximum Amounts of Vitamins and MineralsShall Be
  Set !
• Upper safe levels
• established by scientific risk assessment!

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Rational for Risk Assessment

• EXPORTS
• Countries cannot block imports coming in that
  are equal to or less than Codex limits. They
  also cannot set maximum limits for importation of
  lower than Codex amounts such as the lower RDA
  values.
• FREEDOM ALERT! WHAT ABOUT NO UPPER LIMITS ?

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Rational for Risk Assessment

• IMPORTS
• RDA can no longer be used to set maximum limit a
  country will allow to be imported.
• A product cannot be blocked from importation if
  it contains equal to or less than the Codex
  limits.
• FREEDOM ALERT! WHAT ABOUT NO UPPER LIMITS ?

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FREEDOM ALERT!

• No rational for upper limits on food!
• Low RDA
• Mandatory Risk Assessment
• No Upper Limits
• Burden of Proof shifting
• AT THE PRICE OF FREEDOM

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FREEDOM DEMAND!

• Freedom Demand On behalf of the people, no
  upper limits shall be placed on amounts of food
  content in products being traded where a food has
  not been shown by a government by clear and
  convincing evidence to cause imminent and
  significant harm to the public.
• Burden of Proof remains with the government
• FREEDOM OF ACCESS!

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Alliance for Natural HealthDr. Robert Verkerk
BSc MSc DIC PhD

• 11.2 There is no evidence that they food
  supplements pose more risk than foods, in fact,
  existing evidence suggests they pose
  significantly less risk to humans than foods.As
  such, from a risk management viewpoint, it is
  rational to treat food supplements in a more
  similar manner to conventional foods, rather than
  as synthetic food additives, environmental
  chemicals, or medicinal products.
• FAO/WHO nutrient risk assessment project. ANH
  submission. December 2004

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Alliance for Natural HealthDr. Robert Verkerk
BSc MSc DIC PhD

• 3.1.3 Science-based risk assessment cannot be
  justified for a large number of nutrient forms
  where a) nutrients are known to be safe even
  when consumed in high dosages, and b) there is
  no evidence that the nutrient form has caused any
  significant adverse effects in a population
  despite the fact that they are consumed by
  hundreds of millions of people around the world
  on a daily basis.
• FAO/WHO nutrient risk assessment project. ANH
  submission. December 2004

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Burden of Proof

• Food burden on government
• People burden on government
• Toxins/Drugs burden on manufacturers

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CODEX BURDEN

• Should Be
• Food burden on government
• People burden on government

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Consumers Want

• Purity No Adulteration
• Quality No spoilage or diminished value

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Consumers Want

• NO TOXINS
• Toxic chemicals and chemical residues
• Toxic food additives
• Toxic Pesticides and Fertilizers
• Toxic Pathogens
• Toxic ingredients and preservatives

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Consumers Want

• Content Verification

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Consumers Want

• Safe Packaging
• Safe Shipping Environment

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Consumers Want

• Truthful Labeling
• Significant Facts that Impact Choice
• Non-misleading labeling

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Consumers Want

• Warnings
• When probable cause shows need.

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Consumers Want

• Maximized Options

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Consumers Dont Want

• Consumers do not want their access to foods that
  they desire or foods that they need limited or
  blocked.

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ITALY 2005

• Which countries stood up during the floor
  debates at Codex and spoke to health freedom?

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China at CodexITALY 2005

• China stated that every government in making
  decisions about vitamins and minerals should take
  into account the dietary limitations of their own
  countries, that governments can select vitamins
  and minerals according to the customs and habits
  of their country. China also pointed out that
  there should be definitions of the sources of
  vitamins.

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ITALY 2005

• Which NGO stood up during the floor debates at
  Codex and spoke to health freedom?

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NHF at CodexITALY 2005

• NHF - National Health Federation requested the
  guidelines not be adopted but rather be sent back
  to committee for 3 important reasons. First,
  according to Codex rules a "purpose" statement
  must be part of all guidelines adopted and the
  Vitamin and Mineral guidelines did not contain a
  purpose. Secondly, the guidelines did not define
  vitamin and mineral and therefore it is unclear
  as to what is being regulated. And lastly, that
  the Chinese comments were substantive and
  according to Codex rules on page 27 of the
  procedural manual, a substantive amendment
  request should be addressed at the committee
  level

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After Italy

• WHO - World Health Organization presented Lim 6
  Implementation of the WHO Global Strategy on
  Diet, Physical Activity and Health Action that
  Could be Taken by Codex (CAC/28 LIM/6)

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Leaders Representing YOU!

• We need to be at the table long term if we
  plan to make a difference and protect health
  freedom.

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Congressmen/women Hoodwinked!

• They say dont worry about Codex because it is
  just international!
• BUT
• Then they say they are going to vote for H.R.
  3156 because Dietary Supplements are dangerous!

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You Can Make a Difference!

• Send A Clinton Miller One Page Fax to your
  Congressman!

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HR 3156

• The Dietary Supplement Act (DSHEA)
• Is Under Attack!

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HR 3156 - Section 1.

• It has a misleading clever title.
• Dietary Supplement Access and Awareness Act.

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HR 3156 Section 2.

• It calls for new laws
• - product listing
• - reporting
• - post market surveillance
• - and changing safety responsibilities

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H.R. 3156 Section 2.

• It treats herbs and amino acids as
• RISKY DRUGS instead of NUTRIENT FOODS
• that are generally regarded as safe!

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HR 3156 Section 2.

• It could ban a product when there is even a
  relatively small risk

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HR 3156 Section 2.

• Instead of the U.S. government needing to prove
  harm
• ----
• Manufacturers would have to prove it is not
  harmful

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HR 3156 Section 3.

• Calls for 10 million dollars
• 5 million targeting health care professionals
• 5 million targeting consumers

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HR 3156 Section 3.

• 5 million targeting health care professionals
• on the importance of reporting adverse health
  experiences to the FDA

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HR 3156 Section 3.

• 5 million targeting consumers
• - educating consumers on the importance of
  informing their health professionals of the
  dietary supplements and drugs they are taking.

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HR 3156

• Sign and Send Your One Page Fax!

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Fundamental Right

• Health freedom is a fundamental natural right of
  survival and personal sovereignty. Such a
  profound gift must be forever protected and
  maintained by all peoples in relationship with
  each other and together, honoring our
  interdependence, while holding sacred our
  individual cultures, spirits, and intentions.
• Diane M. Miller JD

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NATIONAL HEALTH FREEDOM COALITION A 501(c) 3
Educational Nonprofit Organization

• NATIONAL HEALTH FREEDOM ACTION
• A 501 (c ) 4 Lobbying Organization
• PMB 218, 2136 Ford Parkway, St. Paul, MN
  55116-1863
• www.nationalhealthfreedom.org, E-mail
  similars_at_aol.com
• 651-690-0732

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National Health Freedom Coalition

• We promote access to all health care
  information, services, treatments and products
  that the people deem beneficial for their own
  health and survival we promote an understanding
  of the laws and factors impacting the right to
  access and we promote the health of the people
  of this nation.
• PMB 218, 2136 Ford Parkway, St. Paul, MN
  55116-1863
• Phone [phone] Fax [phone]
  www.nationalhealthfreedom.org ,

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