To: Dr. Barbara Schneeman
Director, Office of Nutritional Products Labeling and Dietary Supplements
Food and Drug Administration
5600 Fishers Lane
Rockville MD 20857-0001
To: Dr. Edward Scarborough
U.S. CODEX Manager - U.S. CODEX Office
United States Department of Agriculture
South Building, Room 4861
1400 Independence Ave, SW
Washington, DC 20250
To: Receiver of Dockets
Dockets Management Branch
Department of Health and Human
Services
Food and Drug Administration
Room 1061, 5630 Fishers Lane
Rockville, MD 20852
Second Amendment to
for Furtherance of Dietary Supplement Harmonization
Policy
by the U.S. CODEX Delegation and Food and Drug
Administration,
in Harmony with DSHEA and 19 USC 3512
This Second Amendment is submitted with regard to the Citizen Petition of June 1, 2005, (Amended June 14, 2005) urging the US Codex Office to further, as its policy, harmonization with the CODEX Vitamin and Mineral Guideline (VMG) only in conformity with existing US Law and includes the issues raised therein by reference and to refrain from harmonization via either legislative or regulatory means with any standard, guideline or regulation which conflicts with or violates US current Law. Attached hereto and made a part hereof is a copy of the VMG, marked for amendment to conform to existing United States laws and regulations.
This Petition is further addressed to the Food and Drug Administration, as the agency responsible for US Policy on food and nutrient safety at the International Food Safety Agency, including herein, by reference the original Petition and the First Amendment thereto, copies of which are appended hereto.
Further the Petitioner states:
1. (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 discernable 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 ALIMETNARIUS 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 Tena Campbell stated in the Ephedra Decision, 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 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.
(f) We have appended hereto,
and make part hereof, the Alliance for Natural Health (ANH) and Citizens for
Health (CFH) comments on the failure of toxic Risk Assessment to conform to
standards of science.
2. (a) The US Codex Office, the FDA and all other involved agencies have legal authority to further international harmonization only in conformity with US law:
Title 19, Section 3512, forbids the US from harmonizing with standards which violate US law;
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.
(b) FDA has adopted a policy of harmonization with International Standards, even where those standards are not finalized. “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 .
(c) 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.
(d) The Natural Solutions Foundation, in cooperation with Citizens for Health, has caused its attorneys to prepare a Revised Version of the Vitamin and Mineral Guideline more in conformity with the requirements of Law. A copy of the Revised Version is attached hereto and made a part hereof (together with a comparison copy, showing the specific changes requested).
3. (a) Environmental Impact information is generally required only if the petition requests approval of food or color additives, drugs, biological products, animal drugs, or certain medical devices, or for a food to be categorized as GRAS (generally recognized as safe) under the Procedures for preparing environmental impact statements found in Title 21, Part 25 of the Code of Federal Regulations. An environmental impact statement is therefore not required.
4. The Petitioner requests the following Actions by the agencies, with regard to CODEX and the International Food Safety Agency:
(a) The opening of an appropriate Docket for this Petition and for consideration of the Revised Version of the Vitamin and Mineral Guideline.
(b) The holding of 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. Petitioners assert 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.
(c) (1) The adoption of the Revised Version of the Vitamin and Mineral Guideline (attached hereinafter) to promote harmonization in conformity with United States Law, and (2) support for such harmonization at future CODEX and International Food Safety Agency meetings.
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitions that are unfavorable to the petition.
Dated: October 14, 2005
Natural
Solutions Foundation
Cc: Barack Obama, President
Joseph Biden, Vice President
Secretary of HHS ___________________________________________
Secretary of Commerce Maj.
Gen. Albert N. Stubblebine III (US Army, Ret.)
Secretary of Agriculture President
Secretary of Transportation Natural
Solutions Foundation
Commissioner of EPA
Barbara Schneeman, FDA
Sen. William Frist, MD ___________________________________________
Rep. Dennis Hastert Rima
Laibow, MD
Sen. Harry Reid Medical
Director
Rep. Nancy Pelosi Natural
Solutions Foundation
Prepared by: Natural Solutions Foundation
Ralph Fucetola, JD P.O. Box 722
Maryville, MO 64468
Procedural Advisor:
Jim Turner, JD
Revised
Version
Text
of final Codex Vitamin and Mineral Guideline.
Marked for Amendment
Deletions struck through;
additions underlined.
Finalized by the Codex Alimentarius Commission July 4, 2005
Guidelines for Vitamin and Mineral Food Supplements
PREAMBLE
Most people who have access to a balanced diet can usually obtain all the
nutrients they require from their normal diet. Because foods contain many
substances that promote health, people should therefore by encouraged to select
a balanced diet from food before considering any vitamin and mineral supplement.
In cases where the intake from the diet is insufficient or where consumers
consider their diet requires supplementation, vitamin and mineral food
supplements serve to supplement the daily diet.
The Food and Agriculture Organization (FAO) Expert
Consultation on Food Safety: Science and Ethics, held in Rome, Italy, in
September 2002, set out the following food, nutrition and health rights:
“The human right to adequate food is recognized in
several instruments under international law. […] The right of every human being
to be free from hunger is fundamental and uncontested. The most important
implication of the right to adequate food is that states and peoples must be
supported to enable them to address situations of food insecurity themselves. The
right to culturally acceptable food should not be regarded primarily as a right
to receive a specific type of food aid, but as a right to be supported so as to
create one's own food security. Support to address sustainable food security
must therefore also include ensuring the capacity in recipient countries for
food that is both safe and nutritious.”[1]
In today’s world, billions of people in wealthy and
less wealthy countries lack access to a balanced diet capable of providing
optimal nutrition, are beset by challenges of food scarcity and nutritional
inadequacy, and therefore fail to obtain all the nutrients they require from
their available diet. Although foods contain many substances that promote
health, and people should be encouraged to select a balanced diet from food,
because of the widespread lack of balanced diets, and the absence of nutrient
density or balance in many widely consumed foods, people should also be
encouraged to consider using vitamin and mineral supplements; national and
global food-relief programs should separately ensure this.
Since,
in a vast number of cases, the nutrient intake from the diet is either
insufficient or insufficiently nutrient-dense to provide optimal health, and
recognizing that consumers and health professionals often determine that their
diet requires supplementation, it is appropriate to ensure that ample amounts
of vitamin and mineral food supplements of sufficient quality, variety, and
potency are available to effectively supplement the daily diet as required and
desired by citizen-consumers of all nation states.
1. SCOPE
1.1 These This framework and its guidelines apply to vitamin and
mineral food supplements intended for use in supplementing the daily diet with
vitamins and/or minerals.
1.2 They also apply to food supplements containing vitamins and/or
minerals as well as that additionally include other ingredients should
also be in conformity with the specific rules on vitamins and minerals laid
down in these Guidelines found to be safe (i.e. lack proof of harm at
commonly employed dosages presented by appropriate regulatory authorities) and
effective for their intended use in accordance with clinically, scientifically
and legally sound international standards.
1.3. These Guidelines only apply in those jurisdictions where products
defined in 2.1 are regulated as foods. This framework and its guidelines apply in all
jurisdictions where products defined in 2.1 are marketed, whether as foods,
drugs, natural substances or under any other category name.
1.4. Vitamin and mineral food supplements, when used in or as foods for
special dietary uses as defined in the General Standard for the Labeling of and
Claims for Prepackaged Foods for Special Dietary Uses (CODEX STAN 146-1985) are
not covered by this framework and its guidelines these
Guidelines.
2. DEFINITIONS
2.1 Vitamin and mineral food supplements for the purpose of these this
framework and its guidelines derive their nutritional relevance primarily
from the minerals and/or vitamins they contain. Vitamin and mineral food
supplements are sources of concentrated forms of those nutrients, alone
or in combinations, marketed in forms such as capsules, tablets, powders, tinctures,
solutions, etc., that are designed to be taken in measured small-unit (“small”
as in physical size not “low” as in potency or strength) quantities but
at amounts from low to high potency that are not in a conventional food
form and whose purpose is to supplement the intake of vitamins and/or minerals
from the normal diet.
3. COMPOSITION
3.1 Selection of vitamins and minerals
3.1.1. Vitamin and mineral food supplements are food products (whatever else
they may be called) that should contain vitamins/provitamins and/or
minerals whose nutritional value for human beings has been proven established
by clinical and scientific data and whose status as vitamins and
minerals is recognized by FAO, and WHO and/or other appropriate
scientific or legal authority applying sound clinical, scientific and legal
principles, and whose form is that set out in section 2.1 of this framework and
guidelines.
3.1.2.
The sources of vitamins and minerals may be either natural or synthetic and
their selection should be based on considerations such as safety, efficacy
and bioavailability. In addition, purity criteria should take into account
FAO/WHO standards, or if FAO/WHO standards are not available, international
Pharmacopoeias or recognized international standards. In the absence of
criteria from these sources, national legislation may be used determinations,
international pharmacopoeias and other scientifically and/or legally sound
international standards.
3.1.3 Vitamin and mineral food supplements may contain all vitamins and
minerals that comply with the criteria in 3.1.1. a single and/or mineral form
or an appropriate combination of vitamins and/or minerals.
3.2 Contents of vitamins and minerals
3.2.1 The minimum level of each vitamin and/or mineral contained in a
vitamin and mineral food supplement per daily portion of consumption as
suggested by the manufacturer should be 15% of the recommended daily intake as
determined by FAO/WHO.
An
acceptable range of oral intake (AROI),[2]
between known deficiency and established toxicity, each based on clinical
observation and/or laboratory assessment, that can be considered a range of
optimal intakes for each vitamin and/or mineral contained in a vitamin and
mineral food supplement per daily portion of consumption as suggested by the
manufacturer should be set, taking the following criteria into account:
(a) Consumers should not be led to believe, by the
amounts of or information about vitamins and minerals in supplement products,
or by officially recommended nutrient intakes (e.g. Population Reference Intake
or Recommended Daily Allowance values) that there is exact quantitative
knowledge of what individuals should eat in order to attain and maintain
optimal health.
(b) Biochemical individuality, stage of life and
gender are among the factors considered in establishing reference intake values
of vitamins and minerals for populations that require the setting of a broad
range (rather than specific upper and/or lower limits) of nutrient intake
except to convey an understanding of the quantity of nutrients contained in the
product.
(c) the AROI for vitamins and minerals shall be
established by appropriate scientific risk analysis consisting of risk assessment, risk management and
risk communication based on generally accepted scientific procedures, taking
into consideration, as appropriate, the varying degrees of sensitivity of
different individual consumers and consumer population groups;
(d)
The AROI includes the daily intake of vitamins and minerals from other dietary
sources as established by aggregated clinical observations rather than abstract
handbooks or other sources of imputed nutrient content of foods.
3.2.2 Maximum amounts of vitamins and minerals in vitamin and mineral food
supplements per daily portion of consumption as recommended by the manufacturer
shall be set taking the following criteria into account:
(a) upper safe levels of vitamins and mineral established by scientific risk
assessment based on generally accepted scientific data, taking into
consideration, as appropriate, the varying degrees of sensitivity of different
consumer groups;
(b) the daily intake of vitamins and minerals from other dietary sources.
When the maximum levels are set, due account may be taken of the reference
intake values of vitamins and minerals for the population. This provision
should not lead to setting of maximum levels that are solely based on
recommended nutrient intakes (e.g. Population Reference Intake or Recommended
Daily Allowance values).
4. PACKAGING
4.1 The product shall be packed in containers which will safeguard the hygienic
and other qualities of the food.
4.2. The containers, including packaging material, shall be made only of
substances which are safe and suitable for their intended use. Where the Codex
Alimentarius Commission has established a standard for any substance used as
packaging material, that standard shall apply.
5. LABELING
5.1 Vitamin and mineral food supplements should be labeled according to the
Codex Standard for the Labeling of Prepackaged Foods (Codex-Stan 1-1985 Rev.
1-1991) as well as according to the General Guidelines on Claims (CAC/GL
1-1979) with the exception that claims that a balanced diet of ordinary
foods cannot supply adequate amounts of all nutrients and that identified
amounts of vitamins and minerals may be used in the prevention, alleviation,
treatment or cure of disease, disorder or particular physiological condition
can be made if substantiated by clinical and scientific evidence.
5.2 The name of the product shall be "food supplement" with an
indication of the category(ies) of nutrients or of the individual vitamin(s)
and/or mineral(s) contained in the product as the case may be.
5.3 The amount of the vitamins and minerals present in the product should be
declared in the labeling in numerical form. The units to be used should be
units of weight consistent with the Codex Guidelines on Nutrition Labeling with
the caveat that all references to the recommended daily intake, Dietary
Reference Intakes (DRIs), or other reference intake values, in all sections of
this framework and its guidelines are for the purpose of providing consumers
with a suitable profile of nutrients contained in the food and considered to be
of nutritional importance. The information should not lead consumers to believe
that there is exact quantitative knowledge of what individuals should eat in
order to maintain health, but rather to convey an understanding of the quantity
of nutrients contained in the product. A more exact quantitative delineation
for individuals is not valid because there is no meaningful way in which
knowledge about individual requirements can be used in labeling, labels or
other direct to consumer information.[3]
5.4 To convey an understanding of the quantity of nutrients contained in the
product the amounts of the vitamins and minerals declared should be those per
portion of the product as recommended for daily consumption and if different,
the amount per unit for and average single use may also be given.
5.5 Information on vitamins and minerals should also be expressed as a
percentage of the nutrient reference values mentioned (in the form of
Dietary Reference Intakes for example), as the case may be, in the Codex
Guidelines on Nutrition Labeling.
5.6 The label should indicate how the product should be used (quantity,
frequency, special conditions) under average expectable circumstances
recognizing that biochemical individuality may significantly alter these
parameters.
5.7 The label shall contain advice to the consumer to obtain a personal
optimum daily vitamin and mineral intake level and not to unintentionally
exceed that not to exceed the maximum one-day amount.
5.8 The label should not state or imply that supplements can be used for the
replacement of meals or a varied diet.
5.9 The label shall contain a statement that the product should be stored out
of the reach of young children to assist in preventing choking injuries.
----------------------------------
1 This refers to the physical forms of the vitamin and mineral food supplements
not to the potency of the supplements.
2
Principles And Methods For The Assessment Of Risk From Essential Trace Elements
http://www.inchem.org/
documents/ehc/ehc/ehc228.htm#1.0 and Problems Peculiar to the Setting of
Limits for Essential Food Elements G.C. Becking Kingston, Ontario, Canada http://www.nnia.co.za/CPD/articles/risk_assessment.pdf
In Risk Assessment in the Food Chain of Children, Edited by Peter J. Aggett and
Harry A Kuiper. Nestlč Nutrition Workshop Series, Pediatric Program, Vol. 44,
Nestec Ltd., Vevey/Lippincott Williams & Wilkins, Philadelphia © 2000 each
discuss AROI. Becking says “The
proposed methodology is discussed with regard to its applicability to essential
trace elements. However, it should be applicable to all essential food
components subject to homeostatic control by the human body.”
3 The
text of the caveat, line 3 to the end, is from the Codex Guidelines on
Nutrition Labeling http://www.fao.org/documents/show_cdr.asp?url_file=/DOCREP/005/Y2770E/y2770e06.htm
Text prepared by James
Turner, JD, Rima Laibow, MD and Ralph Fucetola, JD
10/14/05
Revised
Version - Text of final Codex Vitamin and Mineral Guideline.
Offered for Amendment on behalf of
Natural
Solutions Foundation and Citizens Working Group on Codex
Finalized by the Codex Alimentarius Commission July 4, 2005
Guidelines for Vitamin and Mineral Food Supplements
PREAMBLE
The Food and Agriculture Organization (FAO) Expert
Consultation on Food Safety: Science and Ethics, held in Rome, Italy, in
September 2002, set out the following food, nutrition and health rights:
“The human right to adequate food is recognized in
several instruments under international law. […] The right of every human being
to be free from hunger is fundamental and uncontested. The most important
implication of the right to adequate food is that states and peoples must be
supported to enable them to address situations of food insecurity themselves.
The right to culturally acceptable food should not be regarded primarily as a
right to receive a specific type of food aid, but as a right to be supported so
as to create one's own food security. Support to address sustainable food
security must therefore also include ensuring the capacity in recipient
countries for food that is both safe and nutritious.”[4]
In today’s world, billions of people in wealthy and
less wealthy countries lack access to a balanced diet capable of providing
optimal nutrition, are beset by challenges of food scarcity and nutritional
inadequacy, and therefore fail to obtain all the nutrients they require from
their available diet. Although foods contain many substances that promote
health, and people should be encouraged to select a balanced diet from food,
because of the widespread lack of balanced diets, and the absence of nutrient
density or balance in many widely consumed foods, people should also be encouraged
to consider using vitamin and mineral supplements; national and global
food-relief programs should separately ensure this.
Since,
in a vast number of cases, the nutrient intake from the diet is either
insufficient or insufficiently nutrient-dense to provide optimal health, and
recognizing that consumers and health professionals often determine that their
diet requires supplementation, it is appropriate to ensure that ample amounts
of vitamin and mineral food supplements of sufficient quality, variety, and
potency are available to effectively supplement the daily diet as required and
desired by citizen-consumers of all nation states.
1. SCOPE
1.1 This framework and its guidelines apply to vitamin and mineral food
supplements intended for use in supplementing the daily diet with vitamins
and/or minerals.
1.2 They also apply to food supplements containing vitamins and/or minerals
that additionally include other ingredients found to be safe (i.e. lack proof
of harm at commonly employed dosages presented by appropriate regulatory
authorities) and effective for their intended use in accordance with
clinically, scientifically and legally sound international standards.
1.3. This framework and its guidelines apply in all jurisdictions where
products defined in 2.1 are marketed, whether as foods, drugs, natural
substances or under any other category name.
1.4. Vitamin and mineral food supplements, when used in or as foods for special
dietary uses as defined in the General Standard for the Labeling of and Claims
for Prepackaged Foods for Special Dietary Uses (CODEX STAN 146-1985) are
covered by this framework and its guidelines.
2. DEFINITIONS
2.1 Vitamin and mineral food supplements for the purpose of this framework and
its guidelines derive their nutritional relevance primarily from the minerals
and/or vitamins they contain. Vitamin and mineral food supplements are sources
of concentrated forms of nutrients, alone or in combinations, marketed in forms
such as capsules, tablets, powders, tinctures, solutions, etc., that are
designed to be taken in measured small-unit (“small” as in physical size not
“low” as in potency or strength) quantities at amounts from low to high potency
that are not in a conventional food form and whose purpose is to supplement the
intake of vitamins and/or minerals from the normal diet.
3. COMPOSITION
3.1 Selection of vitamins and minerals
3.1.1. Vitamin and mineral food supplements are food products (whatever else
they may be called) that contain vitamins/provitamins and/or minerals whose
nutritional value for human beings has been established by clinical and
scientific data and whose status as vitamins and minerals is recognized by FAO,
WHO and/or other appropriate scientific or legal authority applying sound
clinical, scientific and legal principles, and whose form is that set out in
section 2.1 of this framework and guidelines.
3.1.2.
The sources of vitamins and minerals may be either natural or synthetic and
their selection should be based on considerations such as safety, efficacy and
bioavailability. In addition, purity criteria should take into account FAO/WHO
determinations, international pharmacopoeias and other scientifically and/or
legally sound international standards.
3.1.3 Vitamin and mineral food supplements may contain all vitamins and
minerals that comply with the criteria in 3.1.1. a single and/or mineral form
or an appropriate combination of vitamins and/or minerals.
3.2 Contents of vitamins and minerals
3.2.1 An acceptable range of oral intake (AROI),[5]
between known deficiency and established toxicity, each based on clinical
observation and/or laboratory assessment, that can be considered a range of
optimal intakes for each vitamin and/or mineral contained in a vitamin and
mineral food supplement per daily portion of consumption as suggested by the
manufacturer should be set, taking the following criteria into account:
(a) Consumers should not be led to believe, by the
amounts of or information about vitamins and minerals in supplement products,
or by officially recommended nutrient intakes (e.g. Population Reference Intake
or Recommended Daily Allowance values) that there is exact quantitative
knowledge of what individuals should eat in order to attain and maintain
optimal health.
(b) Biochemical individuality, stage of life and
gender are among the factors considered in establishing reference intake values
of vitamins and minerals for populations that require the setting of a broad
range (rather than specific upper and/or lower limits) of nutrient intake
except to convey an understanding of the quantity of nutrients contained in the
product.
(c) the AROI for vitamins and minerals shall be
established by appropriate scientific risk analysis consisting of risk assessment, risk management and
risk communication based on generally accepted scientific procedures, taking
into consideration, as appropriate, the varying degrees of sensitivity of
different individual consumers and consumer population groups;
(d)
The AROI includes the daily intake of vitamins and minerals from other dietary
sources as established by aggregated clinical observations rather than abstract
handbooks or other sources of imputed nutrient content of foods.
4. PACKAGING
4.1 The product shall be packed in containers which will safeguard the hygienic
and other qualities of the food.
4.2. The containers, including packaging material, shall be made only of
substances which are safe and suitable for their intended use. Where the Codex
Alimentarius Commission has established a standard for any substance used as
packaging material, that standard shall apply.
5. LABELING
5.1 Vitamin and mineral food supplements should be labeled according to the
Codex Standard for the Labeling of Prepackaged Foods (Codex-Stan 1-1985 Rev.
1-1991) as well as according to the General Guidelines on Claims (CAC/GL
1-1979) with the exception that claims that a balanced diet of ordinary foods
cannot supply adequate amounts of all nutrients and that identified amounts of
vitamins and minerals may be used in the prevention, alleviation, treatment or
cure of disease, disorder or particular physiological condition can be made if
substantiated by clinical and scientific evidence.
5.2 The name of the product shall be "food supplement" with an
indication of the category(ies) of nutrients or of the individual vitamin(s)
and/or mineral(s) contained in the product as the case may be.
5.3 The amount of the vitamins and minerals present in the product should be
declared in the labeling in numerical form. The units to be used should be
units of weight consistent with the Codex Guidelines on Nutrition Labeling with
the caveat that all references to the recommended daily intake, Dietary
Reference Intakes (DRIs), or other reference intake values, in all sections of
this framework and its guidelines are for the purpose of providing consumers
with a suitable profile of nutrients contained in the food and considered to be
of nutritional importance. The information should not lead consumers to believe
that there is exact quantitative knowledge of what individuals should eat in
order to maintain health, but rather to convey an understanding of the quantity
of nutrients contained in the product. A more exact quantitative delineation
for individuals is not valid because there is no meaningful way in which
knowledge about individual requirements can be used in labeling, labels or
other direct to consumer information.[6]
5.4 To convey an understanding of the quantity of nutrients contained in the
product the amounts of the vitamins and minerals declared should be those per
portion of the product as recommended for daily consumption and if different,
the amount per unit for and average single use may also be given.
5.5 Information on vitamins and minerals should also be expressed as a percentage
of the nutrient reference values mentioned (in the form of Dietary Reference
Intakes for example), as the case may be, in the Codex Guidelines on Nutrition
Labeling.
5.6 The label should indicate how the product should be used (quantity, frequency,
special conditions) under average expectable circumstances recognizing that
biochemical individuality may significantly alter these parameters.
5.7 The label shall contain advice to the consumer to obtain a personal optimum
daily vitamin and mineral intake level and not to unintentionally exceed that
one-day amount.
5.8 The label should not state or imply that supplements can be used for the
replacement of meals or a varied diet.
5.9 The label shall contain a statement that the product should be stored out
of the reach of young children to assist in preventing choking injuries.
----------------------------------
1 This
refers to the physical forms of the vitamin and mineral food supplements not to
the potency of the supplements.
2
Principles And Methods For The Assessment Of Risk From Essential Trace Elements
http://www.inchem.org/
documents/ehc/ehc/ehc228.htm#1.0 and Problems Peculiar to the Setting of
Limits for Essential Food Elements G.C. Becking Kingston, Ontario, Canada http://www.nnia.co.za/CPD/articles/risk_assessment.pdf
In Risk Assessment in the Food Chain of Children, Edited by Peter J. Aggett and
Harry A Kuiper. Nestlč Nutrition Workshop Series, Pediatric Program, Vol. 44,
Nestec Ltd., Vevey/Lippincott Williams & Wilkins, Philadelphia © 2000 each
discuss AROI. Becking says “The
proposed methodology is discussed with regard to its applicability to essential
trace elements. However, it should be applicable to all essential food
components subject to homeostatic control by the human body.”
3 The
text of the caveat, line 3 to the end, is from the Codex Guidelines on
Nutrition Labeling http://www.fao.org/documents/show_cdr.asp?url_file=/DOCREP/005/Y2770E/y2770e06.htm
Text prepared by James
Turner, JD, Rima Laibow, MD and Ralph Fucetola, JD
10/14/05
June
14, 2005
To: Dr. Edward Scarborough
U.S.
CODEX Manager
U.S.
CODEX Office
United
States Department of Agriculture
South
Building, Room 4861
1400 Independence Ave, SW
Washington, DC 20250
AMENDMENT
to CITIZEN PETITION
to U.S. CODEX Office for
Adoption
of Dietary Supplement Harmonization Policy
by
the U.S. CODEX Delegation
in Harmony with DSHEA and 19 USC 3512
This AMENDMENT is submitted with regard to the Citizen Petition of June 1, 2005, urging the US Codex Office to adopt, as its policy, harmonization with international standards only in conformity with existing US Law, further now stating:
1. The CODEX Vitamin and Mineral Standard uses inappropriate science (Risk Assessment procedures [toxicology] rather than nutritional science [biochemistry] to mandate maximum permissible levels of nutrients so low that they are, by intention, without impact on any human being; a Fact Hearing must be held to determine the scientifically factual basis for the use of Risk Analysis in decisions pertaining to nutrition.
The US Codex Office has accepted the use of Risk Assessment procedures for nutrients although Risk Assessment is a methodology relevant to toxicology and both irrelevant and antithetical to nutritional science and biochemistry. Over the past many years, the United States has failed to oppose the use of Risk Assessment techniques in the CODEX Committee on Nutrition and Foods for Special Dietary Purposes and, since 1994, has failed to make its opposition to the use of Risk Analysis or any other attempt to limit access to nutrients clear in order to prevent the restrictive, and, because of US law, the illegal Vitamin and Mineral Standard from moving forward via consensus to Step 8 in preparation for ratification.
The 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 which are required for life. Risk Assessment procedures were modified without scientific validation or clinical testing. Has the United States held a public fact finding hearing to determine if this jerry-rigged statistical system has any applicability to nutritional science? 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? Why has the US adopted this scientifically factually indefensible policy which should not be abandoned in favor of a policy which supports and promotes DSHEA as the international standard?
2. The US Codex Office and all other involved agencies are without legal authority to set, as was announced at the Public Hearing of June 9, 2005, as its Policy for the United States Government, and its Delegates to the 28th CAC meeting next month, a Policy which explicitly and specifically violates US law as set forth in the Natural Solutions Foundation’s Citizen’s Petition presented to the US Codex Office on June 1, 2005:
Title 19, Section 3512, forbids the US from harmonizing with standards which violate US law;
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.
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.
Dated: June _____, 2005
Natural
Solutions Foundation
Cc:
CODEX Office via facsimile and email
Barack Obama, President
Secretary HHS ___________________________________________
Secretary of Commerce Maj.
Gen. Albert N. Stubblebine III (US Army, Ret.)
Secretary of Agriculture President
Secretary of Transportation
Commissioner of EPA
Commissioner of FDA
___________________________________________
Rima
Laibow, MD
Medical
Director
Prepared by:
Ralph Fucetola, JD Natural Solutions Foundation
POB 722
Procedural Advisor: Jim Turner, JD Maryville MO 64468
June 1, 2005
To: Dr. Edward Scarborough
USDA
U.S. CODEX Manager
U.S. CODEX Office
United States Department of Agriculture
South Building, Room 4861
1400 Independence Ave, SW
Washington, DC 20250
CITIZEN
PETITION to U.S. CODEX Office for
Adoption
of Dietary Supplement Harmonization Policy
by the
U.S. CODEX Delegation in Harmony with DSHEA and 19 USC 3512
I. Introduction
The Natural Solutions Foundation of POB 722, Maryville MO 64468 hereby PETITIONS the U.S. CODEX Office to adopt as the
policy of the U.S. CODEX Delegation support for international harmonization
only as it conforms to United States law and practice. This policy should be
adopted on an emergent basis, prior to the 28th General Sessions of the CODEX
Commission scheduled for July 4-9, 2005 in Rome, Italy. This Petition is posted
on the Internet at www.HealthFreedomUSA.org/petition
.
The Dietary Supplement industry has responded with growth
and expansion to substantial consumer demand since the adoption of the Dietary
Health and Education Act of 1994 (DSHEA). Much of this growth may be attributed
to the Free Market in Dietary Supplements that was established by DSHEA. As
U.S. District Court Judge Tena Campbell stated in the Ephedra Decision last
month (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...”
At this point, many people in the industry, Health Freedom
Advocates and consumers, fear that the CODEX ALIMENTARIUS process may, over
time, reverse these positive developments. There is public perception and
concern that international agencies are seeking to harmonize Dietary Supplement
regulations with restrictive rules and practices prevalent in certain countries
outside the United States, rather than with the Freedom of Access guaranteed by
DSHEA. Since most of the world’s Dietary Supplement consumption and demand
takes place in the United States, our law should be the basis for international
harmonization.
The CODEX Commission is scheduled to adopt standards
regarding Dietary Supplements at the July meeting that will lead to violations
of United States law and practice and therefore the U.S. CODEX Delegation
should be instructed to vigorously oppose the adoption of such standards by
using every legal means at their disposal to oppose such adoption.
II. Action Requested
The Petitioners urge the U.S. CODEX Office and all other
Agencies and government instrumentalities to adopt as the policy of the U.S.
CODEX Delegation and Agencies support only for international harmonization that
conforms to United States law and practice, at the 28th General Session of the CODEX
ALIMENTARIUS Commission, and in all further deliberations, considerations,
CODEX Committee and CODEX Commission policy positions, dealings and meetings
going forward from this time and specifically to:
1. Reject any international standard that is inconstant
with DSHEA or with 19 USC 3512,
2. Support the Congressional determination that vitamins
and minerals are foods, not drugs or toxic chemicals, and, therefore,
3. Support the use of nutritional science, a branch of
biochemistry, not risk assessment science, a branch of toxicology, to determine
optimal levels, since toxicity is virtually unknown in nutrients but is part of
the definition of a “toxin.” Since optimal levels vary based on complex and
interweaving factors such as age, diet, nutrient absorption, the presence or
absence of co-factors, genetic makeup, underlying nutritional status, disease
state, toxic burden and biochemical individuality, no maximum intake levels are
meaningful for nutrients although they are highly significant for toxins.
4. Support the biochemical reality embodied in DSHEA’s
protection of all supplements and categories of nutrients which the CODEX
Vitamin and Mineral Standard violates when it states that the principal
nutritional value of foods comes from its vitamins and minerals. 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, essential to
health, in food. These compounds are protected under DSHEA but ignored or
prevented from being part of the supplemental feeding list if a “Positive List”
is enacted by the CODEX ALIMENTARIUS Commission when it seeks to ratify the
vitamin and mineral standard this July in Rome.
5. “Take Care that the Laws be faithfully executed” (Article II, Section 3, United States Constitution) as established by DSHEA that, as foods, nutritional supplements 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.
III.
Statement of Grounds
A. Factual Grounds
The
28th meeting of The CODEX ALIMENTARIUS Commission in Rome July 4-9, 2005, will
consider adopting vitamin and mineral guidelines based on regulatory principles
that may, over time limit access to dietary supplements of consumers in the
United States, and that could significantly restrict access to vitamin and
mineral supplements worldwide.
Based
on 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 has prepared the Vitamin and Mineral
Standard for ratification by the CODEX ALIMENTARIUS Commission in July, 20)
that, despite the limited title of the proposed Standard, 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.
Ratification
by the CODEX ALIMENTARIUS Commission of the Vitamin and Mineral Standard as
proposed by CCNFSDU will amount to approving a blank check since the actual
limits and specific items which it will restrict have not been specified or
proposed. The positions of decision makers on the CCNFSDU, which would have the
authorization to select nutrients and levels without oversight or review once
the Vitamin and Mineral Standard has been ratified, are antithetical to the use
of nutrients for the “prevention, treatment or cure of any disease or
conditions” and include the publicly stated position that “Nutrition has no
place in medicine”. These positions and trends are both antithetical to the
will of the American people as expressed in their buying habits (i.e.,
approximately $20 billion in after-tax, unreimbursable dollars for supplements
in 2004) and in DSHEA.
This
summer the Commission will meet to approve vitamin and mineral guidelines that
were finalized by the CODEX Committee on Nutrition and Foods for Special
Dietary Uses (CCNFSDU) in Bonn, Germany last November. These standards, as
noted above, have neither specificity nor precision: the vitamin and mineral
standard has no content and, if ratified, would not be subject to further
review by a governing body and cannot be modified by countries like the United
States whose laws it violates. If the Commission moves forward and approves
these guidelines, CODEX will restrict access to vitamins and minerals in
several ways:
1. Setting 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” 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 violates the legislative intent and provisions of DSHEA that Dietary
Supplements are Foods, not Drugs.
3. Marginalizing the nutrient supplement possibilities 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. In addition, the population-based CODEX standards under-appreciate the
nutritional status of the world’s remaining 4.6 billion people, a majority of
whom lack the recommended amount of one or more essential nutrient.
4. Creating, through setting maximum 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.
5. Narrowing substantially 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 Right of
Free Speech guaranteed by the First Amendment.
6. Fostering the worldwide health assumption that
sufficient levels of nutrients can be found in a regular diet; this is
unsupported by 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.
Natural
health consumers are becoming active and organized to protect and expand their
health rights. Worldwide health could be significantly undermined by the
CODEX-created limits to nutrients available in many countries according to
official documents prepared jointly by the World Health Organization and the
Food and Agriculture Organization. Codex, by itself, may change U.S. laws.
Codex's upper potency limits, established for vitamins and minerals, may
restrict U.S. consumer access to high-potency vitamins and minerals to which
they are accustomed. U.S. companies may choose to “dumb down” their potencies
to mirror their international formulations.
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,
including an opinion created by the Congressional Research Service for two
members of Congress, that because of the Sanitary and Phytosanitary Agreement,
Article 3, it shall be 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 a hidden barrier to international trade. This
would be in clear violation of both DSHEA and with 19 USC 3512. CODEX
misapplies an inappropriate toxic chemicals risk assessment model to regulate
helpful nutrients which have virtually no established toxicity and therefore,
present virtually no consumer danger. Although any assessment of vitamin and
mineral usage should evaluate nutrients using nutritional science rather than
with the toxicological science 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 and should be
opposed by the United States with vigor both in CODEX meetings and otherwise.
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
Standard 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 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. The procedures employed to accomplish that modification
are untested through scientific or clinical evaluations and are entirely
theoretical. Their impact upon the earth’s population, however, will be
practical and devastating. CODEX also fails in this fundamental requirement 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 new and untested procedures whose
accuracy and utility have not been evaluated through appropriate studies and
trials.
3. 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. 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_risks2.pdf
, 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 Saul’s presentation to the Canadian Parliament, “Where
Are The Bodies?”, http://www.doctoryourself.com/testimony.htm.
CODEX
reinforces, in its vitamin and mineral guidelines, its existing prohibition on
preventing truthful information about the ability of foods and nutrients to
treat, diagnose, prevent, mitigate and cure disease. CODEX prohibits
supplemental nutritional feeding world wide, 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 joint publications of the World Health Organization and the Food
and Agriculture Organization which detail the 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 $1 of development aid), a fact CODEX vitamin and mineral
guidelines ignore without scientific support for their position.
CODEX
ignores, in its vitamin and mineral guidelines, the high costs in loss of life,
degraded quality of life and economic loss created by the chronic diseases of
nutrient-deficiency although they are abundantly documented in clinical,
biochemistry and epidemiological literature. The human and economic impact and
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 only
through adequate nutrition. They further document that nutrition cannot always
be provided by diet. Clinically necessary nutrient intake is, however,
prohibited under the proposed CODEX vitamin and mineral standard.
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, where Justice O’Connor 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).
We
submit that the standards proposed for adoption at the 28th General Session
cannot withstand legal scrutiny under the Supreme Court Test.
B. Legal Authority
1.
The Legal Basis for this Petition is the First Amendment to the Constitution of
the United States: “Congress shall make no law . . . abridging the . . . the
right of the people . . .to petition the Government for a redress of
grievances.”
2.
The 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.
(2) Construction:
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 Department contain general provisions
that support the actions requested in this petition. Federal Law includes
provisions that grant the Secretary broad authority to promulgate rules and regulations
“necessary to carry out the Act[s].”
4.
The Office Should Promulgate the Requested Policy as an Interim Final Rule
Without First Completing Notice
and Comment, Risk Assessment, and Cost-Benefit Analysis
Under
ordinary circumstances, the agency must comply with procedural requirements
under both the Administrative Procedures Act (APA) and the USDA Reorganization
Act of 1994, including the use of notice-and-comment rulemaking and the
completion of a risk assessment and cost-benefit analysis before issuance of a
new rule. However, both acts provide for exceptions to those requirements for
circumstances such as those present here, where the new international
regulations would constitute an imminent threat to public safety and any delay
in policy making would be contrary to the public interest.
The
Office should avail itself of those statutory exceptions and promulgate the
requested policies without first providing the public with notice and an
opportunity for comment and before completing a full risk assessment and
cost-benefit analysis. The agency should first adopt the policy as an
"interim-final rule," which would become binding upon publication (or
shortly thereafter), and subsequently provide for public comment and complete
its risk assessment and cost-benefit analysis. As explained below, the Office
is authorized to take such an approach under the USDA Reorganization Act of
1994.
a. The Requested Regulations Satisfy the "Good
Cause" Exception to the Administrative Procedure Act's Requirement for
Notice and Comment.
The APA provides that full notice-and-comment rulemaking
is not required when an agency "for good cause finds (and incorporates the
finding and a brief statement of the reasons therefore in the rules issued)
that notice and public procedure thereon are impracticable, unnecessary, or
contrary to the public interest." 5 U.S.C. §553(b)(B). The good cause
exception "is an important safety valve to be used where delay would do
real harm." United States Steel v. EPA, 595 F.2d 207, 214 (5th Cir. 1979).
According to the legislative history of the provision, "'impracticable'
means a situation in which the due and required execution of the agency
functions would be unavoidably prevented by its undertaking public rule-making
proceedings." S. Rep. No. 752, 79th Cong., 1st Sess., at 16 (1945). As one
court has held, determining "impracticality" requires "analysis
in practical terms of the particular statutory-agency setting and the reasons
why agency action could not await notice and comment." American Transfer
& Storage Company v. ICC, 719 F.2d 1283, 1295 (5th Cir. 1983).
There are numerous instances in which courts have upheld
an agency's decision to invoke the "good cause" exception and issue a
rule without providing for notice and comment where a delay would threaten
public safety or the environment. See, e.g., Hawaii Helicopter Operators Ass'n
v. FAA, 51 F.3d 212, 214 (9th Cir. 1995) (good cause exception satisfied in
view of "the threat to public safety reflected in an increasing number of
helicopter accidents"); Northern Arapahoe Tribe v. Hodel, 808 F.2d 741,
750-52 (10th Cir. 1987) (good cause exception satisfied in view of urgent need
for hunting regulations where herds were threatened with extinction); Northwest
Airlines-v. Goldschmidt, 645 F.2d 1309, 1321 (8th Cir. 1981) (good cause
exception satisfied in view of urgent need to allocate landing slots at major
airport).
The rationale underlying those decisions, that compliance
with time-consuming procedural requirements would “do real harm” by delaying
implementation of urgently needed policies to safeguard public health, is
equally applicable here, where international regulations in derogation of
United States Law and practice will have a negative impact on U.S. consumers.
Clearly, the exigent circumstances necessary to satisfy the APA's good cause
exception are present.
b. The Requested Regulations Present a Situation In Which
Regulatory Analysis is "Not Practicable Because of Compelling
Circumstances" Under the U.S. Department of Agriculture Reorganization Act
of 1994.
Under § 2204e of the USDA Reorganization Act of 1994, USDA
must complete a risk assessment and cost-benefit analysis for each proposed
major regulation that relates to human health, safety, or the environment. 7 U.S.C.
§ 2204e. That section does provide an exception, however: when a risk
assessment and cost-benefit analysis is "not practicable because of
compelling circumstances," an explanation can be provided in lieu of a
full analysis. Id. at § 2204e (b)(1). The compelling circumstances here are the
imminent adoption of international standards in derogation of United States Law
and practice.
III.
Conclusion
Codex's
restrictive vitamin and mineral guideline should be replaced by the U.S.
Dietary Supplement Health Education Act (DSHEA) food-based standard as the
international standard for vitamin, minerals and all other dietary supplements.
The 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. Any attempt to
restrict or limit dosages, potency, information or access to 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 Citizen’s comments regarding
harmonization: http://www.citizen.org/trade/harmonization/comments/articles.cfm?ID=4394 and the National Health Federation,
“CODEX Breaks its own Rules” http://www.thenhf.com/codex_may_2005_nhf_press_release.htm
Also see the European Alliance for Natural Health
Submission on Risk Assessment at:
http://www.alliance-natural-health.org/_docs/ANHwebsiteDoc_120.pdf
The
Petitioners urge the U.S. CODEX Office to adopt as the policy of the U.S. CODEX
Delegation support only for international harmonization that conforms to United
States law and practice, 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.”
Dated:
June _____, 2005
Natural Solutions Foundation
Cc:
CODEX
Office via facsimile and email
Barack Obama, President
Secretary
HHS ____________________________________
Secretary of Agriculture Maj. Gen. Albert N. Stubblebine III
Secretary of Commerce (US Army, Ret.)
Secretary of Health and Human Services President
Commissioner of EPA
Commissioner
of FDA ____________________________________
Rima
Laibow, MD
Prepared
by: Medical
Director
Ralph
Fucetola, JD
Natural Solutions Foundation
Procedural Advisor: Jim Turner, JD POB 722
Maryville MO 64468
nsfmarketplace@gmail.com
[1] http://www.fao.org/documents/show_cdr.asp?url_file=/docrep/006/j0776e/j0776e01.htm FAO Expert Consultation on Food Safety: Science and Ethics... paragraphs 8 and 10
[2]Principles And Methods
For The Assessment Of Risk From Essential Trace Elements http://www.inchem.org/
documents/ehc/ehc/ehc228.htm#1.0 and Problems Peculiar to the Setting of Limits
for Essential Food Elements G.C. Becking Kingston, Ontario, Canada http://www.nnia.co.za/CPD/articles/risk_assessment.pdf
In Risk Assessment in the Food Chain of Children, Edited by Peter J. Aggett and
Harry A Kuiper. Nestlč Nutrition Workshop Series, Pediatric Program, Vol. 44,
Nestec Ltd., Vevey/Lippincott Williams & Wilkins, Philadelphia © 2000 each
discuss AROI. Becking says “The
proposed methodology is discussed with regard to its applicability to essential
trace elements. However, it should be applicable to all essential food
components subject to homeostatic control by the human body.”
[3] The text of the caveat, line 3 to the end, is from the Codex Guidelines on Nutrition Labeling http://www.fao.org/documents/show_cdr.asp?url_file=/DOCREP/005/Y2770E/y2770e06.htm
[4] http://www.fao.org/documents/show_cdr.asp?url_file=/docrep/006/j0776e/j0776e01.htm FAO Expert Consultation on Food Safety: Science and Ethics... paragraphs 8 and 10
[5]Principles And Methods
For The Assessment Of Risk From Essential Trace Elements http://www.inchem.org/
documents/ehc/ehc/ehc228.htm#1.0 and Problems Peculiar to the Setting of Limits
for Essential Food Elements G.C. Becking Kingston, Ontario, Canada http://www.nnia.co.za/CPD/articles/risk_assessment.pdf
In Risk Assessment in the Food Chain of Children, Edited by Peter J. Aggett and
Harry A Kuiper. Nestlč Nutrition Workshop Series, Pediatric Program, Vol. 44,
Nestec Ltd., Vevey/Lippincott Williams & Wilkins, Philadelphia © 2000 each
discuss AROI. Becking says “The
proposed methodology is discussed with regard to its applicability to essential
trace elements. However, it should be applicable to all essential food
components subject to homeostatic control by the human body.”
[6] The text of the caveat, line 3 to the end, is from the Codex Guidelines on Nutrition Labeling http://www.fao.org/documents/show_cdr.asp?url_file=/DOCREP/005/Y2770E/y2770e06.htm
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