NHFA 20051 CODEX. 2 CODEX Vitamin & Mineral Guidelines PASSED! International Guidelines for Trade...

NHFA 2005 1

CODEXCODEX

NHFA 2005 2

CODEX CODEX Vitamin & Mineral GuidelinesVitamin & Mineral Guidelines

PASSED!PASSED!

International Guidelines for TradeInternational Guidelines for Trade

Vitamins and MineralsVitamins and Minerals

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CODEX ALIMENTARIUSCODEX ALIMENTARIUS

1. Ancient1. Ancient

““to protect consumers from to protect consumers from dishonest dishonest practices in the salepractices in the sale of food” of food”

Codex Website 2005Codex Website 2005

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3. Codex Alimentarius Austriacus3. Codex Alimentarius AustriacusAustro-Hungarian 1911Austro-Hungarian 1911

““to determine to determine standards of identitystandards of identity for for specific foods.”specific foods.”


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5. 1940’s - Consumer Concerns5. 1940’s - Consumer Concerns

“…“…protect consumers from protect consumers from poor quality poor quality and hazardousand hazardous foods.” foods.”

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FAOFAO

6. 1961 – World Concerns6. 1961 – World Concerns

FAO steps in for FAO steps in for

world food safety

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FAOFAO

United NationsUnited Nations

Food and Agricultural OrganizationFood and Agricultural Organization

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FAOFAO

Desire for international agreement Desire for international agreement

““on minimum food standardson minimum food standards…”…”

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19611961

FAO Establishment of FAO Establishment of Codex Alimentarius CommissionCodex Alimentarius Commission

- Protecting the consumer’s healthProtecting the consumer’s health

- Ensuring quality- Ensuring quality

- Reducing trade barriers- Reducing trade barriers

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Historically -Historically -VisibleVisible

Underweight contentsUnderweight contentsSize variationsSize variationsMisleading labelingMisleading labelingPoor qualityPoor quality

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Science based - Science based - Invisible AlarmInvisible Alarm

micro-organismsmicro-organismspesticide residuespesticide residuesenvironmental contaminantsenvironmental contaminantsfood additivesfood additives

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WHOWHO

United NationsUnited Nations

World Health OrganizationWorld Health Organization

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WHOWHO

“… “… with the goal of developing with the goal of developing sustainable, integrated food safety sustainable, integrated food safety systems for the reduction of health systems for the reduction of health

risk along the entire food chain, risk along the entire food chain, from the primary producer to the from the primary producer to the

consumerconsumer”.”.

[1] WHA Resolution 53.15, 2000. WHA Resolution 53.15, 2000. [1] Weekly Epidemiological Record, 2004, 79, 173-180, No. 18, Weekly Epidemiological Record, 2004, 79, 173-180, No. 18, April 30. http://www.who.int/wer.April 30. http://www.who.int/wer.

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19631963

EstablishedEstablished

Joint ProgramJoint Program

FAO and WHOFAO and WHO

Codex Alimentarius CommissionCodex Alimentarius Commission

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FAO/WHOFAO/WHO

Dual GoalsDual GoalsBroad JurisdictionBroad Jurisdiction

. Protecting the health of consumers. Protecting the health of consumers

. Ensuring fair practices in food trade. Ensuring fair practices in food trade

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172 Countries172 Countries

Desire to HarmonizeDesire to Harmonize

VoluntarilyVoluntarily

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HARMONIZATION HARMONIZATION CONCEPTCONCEPT

““The harmonization of food standards The harmonization of food standards is generally viewed as a prerequisite is generally viewed as a prerequisite to the protection of consumer health to the protection of consumer health as well as allowing the fullest as well as allowing the fullest possible facilitation of international possible facilitation of international trade.” trade.”

Codex website 2005Codex website 2005

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HARMONIZATION HARMONIZATION PROMOTEDPROMOTED

“…“…the Uruguay Round Agreements on the the Uruguay Round Agreements on the Application of Sanitary and Application of Sanitary and Phytosanitary Measures (SPS) and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT) both Technical Barriers to Trade (TBT) both encourage the international encourage the international harmonizationharmonization of food standards.” of food standards.”


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CODEX COMMENTSCODEX COMMENTS

WHY THE PROGRESS OFWHY THE PROGRESS OFHARMONIZATION IS IMPEDEDHARMONIZATION IS IMPEDED

-Different legal and administrative systems-Different legal and administrative systems

-Varying political power systems-Varying political power systems

-National attitudes and concepts of -National attitudes and concepts of sovereign rightssovereign rights


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Uruguay Round Uruguay Round AgreementsAgreements

1994 WTO1994 WTO

WORLD TRADE ORGANIZATIONWORLD TRADE ORGANIZATIONSPS & TBT AgreementsSPS & TBT Agreements

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WTO - 1994WTO - 1994

Independent Trade OrganizationIndependent Trade Organization

--

Member Countries Join by ContractMember Countries Join by Contract

--

Enforceable by Dispute Resolution BodyEnforceable by Dispute Resolution Body

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WTO WTO Codex Codex

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

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WTOWTO

Majority of WTO members Majority of WTO members

are are

Codex Alimentarius membersCodex Alimentarius members

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WTO WTO

Will WTO be a Will WTO be a vehiclevehicle for the for the enforcement of Codex?enforcement of Codex?

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Regional Trade Regional Trade AgreementsAgreements

Will other regional trade agreements Will other regional trade agreements such as such as CAFTA andCAFTA and NAFTANAFTA point point

to Codex and affirm the enforcement to Codex and affirm the enforcement of Codex standards or guidelines?of Codex standards or guidelines?

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EU EU Food Food

SupplementsSupplementsDirectiveDirective

Will Codex adopt a positive list Will Codex adopt a positive list approach and ban everything else approach and ban everything else

like the like the EU FSD tried to doEU FSD tried to do??

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HEALTH FREEDOM HEALTH FREEDOM PRINCIPLESPRINCIPLES

Freedom of access for health-seekersFreedom of access for health-seekers

Freedom to practice all healing methodsFreedom to practice all healing methods

Regulate by the least restrictive meansRegulate by the least restrictive means

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SAMPLES OFSAMPLES OFHealth Freedom Health Freedom

ResponsesResponses

-Ask WTO for a formal opinion re enforcement-Ask WTO for a formal opinion re enforcement

-Work to strengthen national US laws-Work to strengthen national US laws

-Challenge UN/FAO/WHO jurisdiction -Challenge UN/FAO/WHO jurisdiction

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Codex GuidelinesCodex GuidelinesPassedPassed

Final Codex GuidelinesFinal Codex Guidelines

Approved by CommissionApproved by Commission

Italy July 4, 2005Italy July 4, 2005

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Freedom Freedom InfringementsInfringements

Core ProblemCore Problem

Disregard for Disregard for Over-breadthOver-breadth

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Freedom AlertFreedom Alert

Conceptual MergerConceptual Merger

FAO FAO ++ WHO WHO

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FAO FAO COMMODITIES LAWCOMMODITIES LAW

FAO Food SafetyFAO Food Safety

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WHO WHO PEOPLE LAWPEOPLE LAW

WHO People HealthWHO People Health

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MERGERMERGER

RegulationRegulation

FoodFood ++ PeoplePeople ( how they use food ) ( how they use food )

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DIFFERENT DIFFERENT BURDENS OF PROOFBURDENS OF PROOF

Regulating Nutritious FoodRegulating Nutritious Food

Regulating Toxic SubstancesRegulating Toxic Substances

Regulating PeopleRegulating People

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Burdens of ProofBurdens of Proof

Government must show there is imminent risk of Government must show there is imminent risk of significant public harm before regulatingsignificant public harm before regulating

vs.vs.

People must show that it is safe or has benefit People must show that it is safe or has benefit before actingbefore acting

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Nutrients and FoodNutrients and Food

Government must show that there is Government must show that there is an imminent risk of significant harm an imminent risk of significant harm

before prohibitingbefore prohibiting

Example: DSHEAExample: DSHEA

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Toxins/DrugsToxins/Drugs

Manufacturers must show that it is Manufacturers must show that it is safe to distribute or has benefit that safe to distribute or has benefit that

outweighs the risk before outweighs the risk before distributingdistributing

Example: AmpicillinExample: Ampicillin

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PeoplePeople

Government must show that a person will Government must show that a person will cause an imminent risk of public harm cause an imminent risk of public harm

Example: Contagious DiseaseExample: Contagious Disease

Except…..!!!!!!!!Except…..!!!!!!!!

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BEFORE REGULATING BEFORE REGULATING PEOPLEPEOPLE

Government MUST consider:Government MUST consider:Fundamental rightsFundamental rightsFreedom of self-determinationFreedom of self-determinationNational sovereigntyNational sovereigntyHuman rightsHuman rightsCultural diversityCultural diversityRight to fairness and due processRight to fairness and due processLeast restrictive meansLeast restrictive means of regulation of regulation

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PEOPLE HEALTH FREEDOMSPEOPLE HEALTH FREEDOMS

EducateEducate Freedom of SpeechFreedom of Speech

PrayPray Freedom of ReligionFreedom of Religion

SellSell Commerce LawCommerce Law

RecommendRecommend Freedom of SpeechFreedom of Speech

UseUse Self-determinationSelf-determination

RefuseRefuse Self-determinationSelf-determination

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LEAST LEAST RESTRICTIVE MEANSRESTRICTIVE MEANS

Examples:Examples:

Voluntary Voluntary vs.vs. Mandatory Mandatory

Treatment Treatment vs.vs. Isolation Isolation

Exemptions Exemptions withwith conditions conditions

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Watching for merger Watching for merger powerpower

MixingMixing

““food law”food law”

and and

““people law”people law”

Freedom Freedom Alert!Alert!

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CODEX GUIDELINESCODEX GUIDELINESSee merger powerSee merger power

“ “ These Guidelines apply in These Guidelines apply in those jurisdictions where those jurisdictions where products defined in 2.1 are products defined in 2.1 are regulated as foods.”regulated as foods.”

Draft Guidelines for Vitamin and Mineral Food SupplementsDraft Guidelines for Vitamin and Mineral Food Supplements

People:People:

Some countries consider Some countries consider vitamins and vitamins and

minerals to be food, minerals to be food, others don’t.others don’t.

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CODEX GUIDELINESCODEX GUIDELINESFREEDOM INFRINGING LANGUAGEFREEDOM INFRINGING LANGUAGE

“ “ MostMost people who have people who have access to a access to a balancedbalanced diet diet can can usuallyusually obtain obtain allall the the nutrients nutrients they require they require from from their their normalnormal diet.” diet.”

(underline added)(underline added)

Draft Guidelines for Vitamin and Mineral Food Supplements Draft Guidelines for Vitamin and Mineral Food Supplements

People DOGMA:People DOGMA:

There is a proper There is a proper “balanced” way to get “balanced” way to get

nutrients which is nutrients which is considered “normal”considered “normal”

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“ “ Because foods contain many Because foods contain many substances that promote health, substances that promote health, people people should should therefore be therefore be encouraged to select a encouraged to select a balanced diet from food before balanced diet from food before considering any vitamin and considering any vitamin and mineral supplement.” mineral supplement.” (underline (underline added)added)


People DOGMAPeople DOGMA

Does this mean Vitamins Does this mean Vitamins

and Minerals are not and Minerals are not really food?really food?

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““Vitamin and mineral food Vitamin and mineral food supplements supplements should containshould contain vitamins/ provitamins and vitamins/ provitamins and minerals whose nutritional value minerals whose nutritional value for human beings for human beings has been has been provenproven by scientific data and by scientific data and whose status as vitamins and whose status as vitamins and minerals minerals is recognizedis recognized by FAO by FAO and WHO.” and WHO.” (underline added)(underline added)


People People Violation Violation

Burden of proof Burden of proof shifting with shifting with

“should”“should”

No preliminary and No preliminary and mandatory mandatory showing of showing of

imminent risk of imminent risk of significant harm.significant harm.

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““Maximum amounts of vitamins and Maximum amounts of vitamins and minerals in vitamin and mineral minerals in vitamin and mineral food supplements per daily portion food supplements per daily portion of consumption as recommended of consumption as recommended by the manufactures by the manufactures shall be setshall be set, , taking the following criteria into taking the following criteria into account: account: (underline added)(underline added)


People People ViolationViolation

Burden of proof Burden of proof shifted shifted from government to from government to

manufacturersmanufacturers

No preliminary and No preliminary and mandatory showing mandatory showing of imminent risk of of imminent risk of

harm.harm.

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““(a) upper safe levels of vitamins and (a) upper safe levels of vitamins and minerals established by scientific minerals established by scientific risk assessment based on risk assessment based on generally generally accepted scientific dataaccepted scientific data, taking , taking into consideration, as appropriate, into consideration, as appropriate, the varying degrees of sensitivity f the varying degrees of sensitivity f different consumer groups:” different consumer groups:” (underline added)(underline added)


People People ViolationViolation

Conventional scienceConventional science aboveabove

people’s choice, people’s choice,

Government has not Government has not first proven risk of first proven risk of

significant harm.significant harm.

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FREEDOM ALERT!FREEDOM ALERT!

Maximum Amounts of Vitamins and Maximum Amounts of Vitamins and MineralsMinerals

Shall Be SetShall Be Set ! !

Upper safe levels…Upper safe levels…

established by scientific risk assessment!established by scientific risk assessment!

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Rational for Risk AssessmentRational for Risk Assessment

EXPORTSEXPORTSCountries cannot block imports coming Countries cannot block imports coming in that are equal to or less than Codex in that are equal to or less than Codex limits. They also cannot set maximum limits. They also cannot set maximum limits for importation of lower than limits for importation of lower than Codex amounts such as the lower RDA Codex amounts such as the lower RDA values.values.

FREEDOM ALERT! FREEDOM ALERT! WHAT ABOUT NO UPPER LIMITS ?WHAT ABOUT NO UPPER LIMITS ?

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Rational for Risk AssessmentRational for Risk Assessment

IMPORTSIMPORTS

RDA can no longer be used to set RDA can no longer be used to set maximum limit a country will allow to maximum limit a country will allow to be imported.be imported.

A product cannot be blocked from A product cannot be blocked from importation if it contains equal to or importation if it contains equal to or less than the Codex limits.less than the Codex limits.

FREEDOM ALERT! FREEDOM ALERT! WHAT ABOUT NO UPPER LIMITS ?WHAT ABOUT NO UPPER LIMITS ?

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FREEDOM ALERT!FREEDOM ALERT!

No rational for upper limits on food!No rational for upper limits on food!

1.1. Low RDALow RDA

2.2. Mandatory Risk AssessmentMandatory Risk Assessment

3.3. No Upper LimitsNo Upper Limits

Burden of Proof shifting Burden of Proof shifting

AT THE PRICE OF FREEDOMAT THE PRICE OF FREEDOM

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FREEDOM DEMAND!FREEDOM DEMAND!

Freedom Demand:Freedom Demand: On behalf of the people, no On behalf of the people, no upper limits shall be placed on amounts of food upper limits shall be placed on amounts of food content in products being traded where a food content in products being traded where a food has not been shown by a government by clear has not been shown by a government by clear

and convincing evidence to cause imminent and and convincing evidence to cause imminent and significant harm to the public.significant harm to the public.

Burden of Proof remains with the governmentBurden of Proof remains with the governmentFREEDOM OF ACCESS!FREEDOM OF ACCESS!

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Alliance for Natural Alliance for Natural HealthHealth

Dr. Robert Verkerk BSc MSc DIC PhDDr. Robert Verkerk BSc MSc DIC PhD

““11.2 There is no evidence that they [food 11.2 There is no evidence that they [food supplements] pose more risk than foods, in fact, supplements] pose more risk than foods, in fact, existing evidence suggests they pose significantly existing evidence suggests they pose significantly less risk to humans than foods….As such, from a less risk to humans than foods….As such, from a risk management viewpoint, it is rational to treat risk management viewpoint, it is rational to treat food supplements in a more similar manner to food supplements in a more similar manner to conventional foods, rather than as synthetic food conventional foods, rather than as synthetic food additives, environmental chemicals, or medicinal additives, environmental chemicals, or medicinal products.”products.”

FAO/WHO nutrient risk assessment project. ANH submission. December 2004FAO/WHO nutrient risk assessment project. ANH submission. December 2004

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Alliance for Natural Alliance for Natural HealthHealth

Dr. Robert Verkerk BSc MSc DIC PhDDr. Robert Verkerk BSc MSc DIC PhD

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

FAO/WHO nutrient risk assessment project. ANH submission. December 2004FAO/WHO nutrient risk assessment project. ANH submission. December 2004

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Burden of Proof Burden of Proof

Food Food – burden on– burden on governmentgovernment

PeoplePeople – burden on – burden on governmentgovernment

Toxins/Drugs Toxins/Drugs – burden on– burden on manufacturersmanufacturers

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CODEX BURDENCODEX BURDEN

Should Be:Should Be:

Food Food – burden on– burden on governmentgovernment

PeoplePeople – burden on – burden on governmentgovernment

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Consumers WantConsumers Want

PurityPurity – No Adulteration – No Adulteration

QualityQuality – No spoilage or diminished value – No spoilage or diminished value

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NO TOXINSNO TOXINS

Toxic chemicals and chemical residuesToxic chemicals and chemical residues

Toxic food additivesToxic food additives

Toxic Pesticides and FertilizersToxic Pesticides and Fertilizers

Toxic Pathogens Toxic Pathogens

Toxic ingredients and preservativesToxic ingredients and preservatives

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Content VerificationContent Verification

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Safe Safe Packaging Packaging

Safe Safe ShippingShipping Environment Environment

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Truthful LabelingTruthful Labeling

Significant Facts that Impact ChoiceSignificant Facts that Impact Choice

Non-misleading labelingNon-misleading labeling

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Warnings Warnings

When probable cause shows need.When probable cause shows need.

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Maximized OptionsMaximized Options

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Consumers Don’t Consumers Don’t WantWant

Consumers do not want their access to Consumers do not want their access to foods that they desire or foods that foods that they desire or foods that

they need they need limited or blockedlimited or blocked..

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ITALY 2005ITALY 2005

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

NHFA 2005 68

China at CodexChina at CodexITALY 2005ITALY 2005

ChinaChina 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 2005ITALY 2005

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

NHFA 2005 70

NHF at CodexNHF at CodexITALY 2005ITALY 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 ItalyAfter 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 Leaders Representing YOU!YOU!

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

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Congressmen/womenCongressmen/women Hoodwinked! Hoodwinked!

They say don’t worry about Codex because it is They say don’t worry about Codex because it is just international!just international!

BUTBUTThen they say they are going to vote for H.R. Then they say they are going to vote for H.R.

3156 because Dietary Supplements are 3156 because Dietary Supplements are dangerous!dangerous!

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You Can Make a You Can Make a Difference!Difference!

Send A Clinton Miller One Page Send A Clinton Miller One Page FaxFax to your Congressman! to your Congressman!

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HR 3156HR 3156

The Dietary Supplement Act The Dietary Supplement Act (DSHEA)(DSHEA)

Is Under Attack!Is Under Attack!

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HR 3156 - Section 1.HR 3156 - Section 1.

It has a misleading clever title.It has a misleading clever title.

Dietary Supplement Access and Awareness Act.Dietary Supplement Access and Awareness Act.

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HR 3156 – Section 2.HR 3156 – Section 2.

It calls for new laws It calls for new laws - product listing- product listing

- reporting - reporting

- post market surveillance - post market surveillance

- and changing safety - and changing safety responsibilitiesresponsibilities

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H.R. 3156 – Section 2.H.R. 3156 – Section 2.

It treats herbs and amino acids asIt treats herbs and amino acids as RISKY DRUGSRISKY DRUGS instead ofinstead of NUTRIENT FOODS NUTRIENT FOODS

that are generally regarded as safethat are generally regarded as safe!!

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It could ban a product when there It could ban a product when there is “even a relatively small risk…”is “even a relatively small risk…”

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Instead of the U.S. government Instead of the U.S. government needing to prove harmneeding to prove harm

--------Manufacturers would have to prove Manufacturers would have to prove

it is not harmfulit is not harmful

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HR 3156 – Section 3. $HR 3156 – Section 3. $$$$$

Calls for 10 million dollarsCalls for 10 million dollars

5 million targeting health care professionals

5 million targeting consumers

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HR 3156 Section 3. $HR 3156 Section 3. $$$

5 million targeting health care professionals5 million targeting health care professionals

“on the importance of reporting adverse health experiences to the FDA”

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HR 3156 –Section 3. $HR 3156 –Section 3. $$$

5 million targeting consumers5 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 3156HR 3156

Sign and Send Your One Page Fax!Sign and Send Your One Page Fax!

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Fundamental RightFundamental 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 NATIONAL HEALTH FREEDOM

COALITIONCOALITION A 501(c) 3 Educational Nonprofit OrganizationA 501(c) 3 Educational Nonprofit Organization

NATIONAL HEALTH FREEDOM NATIONAL HEALTH FREEDOM ACTIONACTION

A 501 (c ) 4 Lobbying OrganizationA 501 (c ) 4 Lobbying Organization

PMB 218, 2136 Ford Parkway, St. Paul, MN 55116-1863PMB 218, 2136 Ford Parkway, St. Paul, MN 55116-1863www.nationalhealthfreedom.org, E-mail: [email protected]

651-690-0732651-690-0732

http://www.nationalhealthfreedom.org/

mailto:[email protected]

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National Health Freedom CoalitionNational Health Freedom Coalition

We promote access to all health care information, We promote access to all health care information, services, treatments and products that the people deem services, treatments and products that the people deem beneficial for their own health and survival; we beneficial for their own health and survival; we promote an understanding of the laws and factors promote an understanding of the laws and factors impacting the right to access; and we promote the impacting the right to access; and we promote the health of the people of this nation.health of the people of this nation.

PMB 218, 2136 Ford Parkway, St. Paul, MN 55116-1863

Phone: 651-690-0732 Fax: 651-699-8306 www.nationalhealthfreedom.org ,

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NHFA 20051 CODEX. 2 CODEX Vitamin & Mineral Guidelines PASSED! International Guidelines for Trade...

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