Transcript THE COMING OF CODEX AND THE END OF CIVILIZED LIFE …

Codex: Myth, Fact, Questions
and Scientific/Public Policy
IAACN Conference
September 1, 2005
Richard Jaffe, Esq.
Rickjaffe.com
[email protected]
THE COMING OF CODEX
AND THE END OF CIVILIZED LIFE AS WE
KNOW IT
FOR THE HUMAN SPECIES
NOT
Or maybe not, but we’ll just have to
wait and see
Basic Principle (for now)
 Different Countries Have Different Laws
Regulating Supplements
 American has DSHEA
 Other Countries supplements are highly
regulated or are considered drugs
 Eg. Germany, Finland, and now the European
Union
The Trend
 Regrettably, towards increased regulation
and upper limits
HISTORICAL PRECEDENT
for regulating food and food trade
 Assyrian tablets described the method to be used in determining the
correct weights and measures for food grains,
 Egyptian scrolls prescribed the labeling to be applied to certain
foods. In ancient Athens, beer and wines were inspected for purity
and soundness,
 the Romans had a well-organized state food control system to
protect consumers from fraud or bad produce.
 In Europe during the Middle Ages, individual countries passed laws
concerning the quality and safety of eggs, sausages, cheese, beer,
wine and bread. Some of these ancient statutes still exist today.
Direct Origin of Codex
 In the Austro-Hungarian Empire between 1897
and 1911, a collection of standards and product
descriptions for a wide variety of foods was
developed as the Codex Alimentarius
Austriacus. Although lacking legal force, it was
used as a reference by the courts to determine
standards of identity for specific foods. The
present-day Codex Alimentarius draws its name
from the Austrian code.
 In the early 1960s, two United Nations
organizations, the Food and Agriculture
Organization (FAO) and the World Health
Organization (WHO), established Codex
Alimentarius (Codex).
 (Latin for "Food Code")
 The stated purpose of Codex Alimentarius
is to establish a set of international
standards for food quality and safety to
protect the health of consumers and
ensure fair practices in the international
food trade.
Structure of the Codex
Alimentarius
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Volume 1A - General requirements
Volume 1B - General requirements (food hygiene)
Volume 2A - Pesticide residues in foods (general texts)
Volume 2B - Pesticide residues in foods (maximum residue limits)
Volume 3 - Residues of veterinary drugs in foods
Volume 4 - Foods for special dietary uses (including foods for infants and children)
Volume 5A - Processed and quick-frozen fruits and vegetables
Volume 5B - Fresh fruits and vegetables
Volume 6 - Fruit juices
Volume 7 - Cereals, pulses (legumes) and derived products and vegetable proteins
Volume 8 - Fats and oils and related products
Volume 9 - Fish and fishery products
Volume 10 - Meat and meat products; soups and broths
Volume 11 - Sugars, cocoa products and chocolate and miscellaneous products
Volume 12 - Milk and milk products
Volume 13 - Methods of analysis and sampling
Collectively, the volumes contain general principles, general standards, definitions, codes,
commodity standards, methods and recommendations. The contents list of each volume is well
organized for ease of reference. For example:
General Subject Committees
 Committee on General Principles, hosted by France
 Committee on Food Labeling, hosted by Canada
 Committee on Methods of Analysis and Sampling, hosted by
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Hungary
Committee on Food Hygiene, hosted by the United States
Committee on Pesticide Residues, hosted by the Netherlands
Committee on Food Additives and Contaminants, hosted by the
Netherlands
Committee on Import/Export Inspection and Certification Systems,
hosted by Australia
Committee on Nutrition and Foods for Special Dietary Uses, hosted
by Germany (a General Committee for the purpose of Nutrition)
Committee on Residues of Veterinary Drugs in Food, hosted by the
United States
Commodity Committees
 Committee on Fats and Oils, hosted by the United Kingdom
 Committee on Fish and Fishery Products, hosted by Norway
 Committee on Milk and Milk Products (formerly the FAO/WHO Committee of
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Government Experts on the Code of Principles for Milk and Milk Products),
hosted by New Zealand
Committee on Fresh Fruits and Vegetables, hosted by Mexico
Committee on Cocoa Products and Chocolate, hosted by Switzerland
Committee on Sugars, hosted by the United Kingdom
Committee on Processed Fruits and Vegetables, hosted by the United
States
Committee on Vegetable Proteins, hosted by Canada
Committee on Cereals, Pulses and Legumes, hosted by the United States
Committee on Processed Meat and Poultry Products, hosted by Denmark
Committee on Soups and Broths, hosted by Switzerland
Committee on Meat Hygiene, hosted by New Zealand
Committee on Natural Mineral Waters, hosted by Switzerland
“Codex and the future”
 “It is difficult to imagine a world without the
Codex Alimentarius”
 “Whatever happens, it would be fair to
claim that the Codex Alimentarius'
contribution to the betterment of
humankind is one of the finer and more
extraordinary achievements of the
twentieth century.”
CODEX AND SUPPLEMENTS
 In 1988 the German-based CCNFSDU
began discussing the need to control
vitamin and mineral supplements.
 The Codex Alimentarius Commission (CAC)
decided this effort was appropriate, as dietary
supplements fall within the Codex definition of
food, which is "any substance, whether
processed, semi-processed or raw, which is
intended for human consumption, and includes
drink, chewing gum, and any substance which
has been used in the manufacture, preparation
or treatment of 'food' but does not include
cosmetics or tobacco or substances used only
as drugs."
CODEX IS APPROVED ON
INDEPENDENCE DAY!
 Finalized by the Codex Alimentarius
Commission July 4, 2005
Guidelines for Vitamin and Mineral
Food Supplements
How Potent Can Supplements Be?
 The most difficult issue to resolve was how
to set safe upper limits. The final choices
came down to recommended daily intake
or scientifically established risk
assessment. The CCNFSDU that drafted
this document finally selected the latter.
Implications? you bet
 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.
 WHERE’S THE SCIENCE?
 Studies supporting this?
 THIS IS A BELIEF OR ASSUMPTION
 Bad Science/Public Policy to Incorporate
what we’d like or hope to be the case as a
scientific basic fact.
 Maybe this should be the clarion call
instead of “freedom of choice” which after
all does not exist in most countries.
The Dangers of Codex
 Apart from being based on faulty science,
the problem is these guys really do want to
impose their standards on everyone.
Codex objectives
 Objective 1:
…While the establishment of regulatory
framework is fundamentally a national
responsibility, the CAC and its parent
bodies, the FAO and WHO, have a
strong interest in promoting national
regulatory systems that are based on
international principles and guidelines
and address all components of the food
chain. ……
Objective 6:
Promoting Maximum Application
of Codex Standards
 18. As the pre-eminent international standards
setting body for food, the CAC has a clear and
strategic interest in promoting the maximum
use of its standards both for domestic
regulation and international trade.
 International harmonization based on Codex
standards, guidelines and recommendations is
essential to promoting a global approach to
consumer health . . . .
 “This will require sustained commitment
and effort in the following key directions:
 The Statements of Principle on the Role of
Science in the Codex Decision-Making
and the Extent to which Other Factors are
Taken into Account which provide the
essential criteria for decision making in
Codex, will require strong support and
commitment by all countries if the
statements are to become operationally
effective both at international and
national levels;
 OK we know their goals:
 Can they do it? That’s the question
WTO, trade disputes and forced
regulation
 Neither the WTO nor any trade ruling can
force a change of domestic law:
 But trade sanctions can be imposed
 Scenarios bandied about: foreign
supplement manufacturers
 Will it happen?
 Possibly, but it’s complicated legally
 Depends on how far the Supreme Court is
willing to stretch, bend or use the commerce and
supremacy clauses.
 This is sui generis, so can’t really predict.
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Other factors
 FDA hostility towards DSHEA
 Democratic Initiatives to restrict DSHEA
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most recent attempt:
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: 109th CONGRESS
1st Session
H. R. 3156
To amend the Federal Food, Drug, and Cosmetic Act
with respect to dietary supplements.
 IN THE HOUSE OF REPRESENTATIVES
 June 30, 2005
 Mrs. DAVIS of California (for herself, Mr. WAXMAN, and
Mr. DINGELL) introduced the following bill; which was
referred to the Committee on Energy and Commerce
H. R. 3156
 The bill distinguishes vitamins and minerals from herbals
and other supplements
 Imposes an adverse event reporting requirement on
manufacturers of non-vitamin/mineral supplements;
 Will likely be enforcement consequences for noncompliance
 and allow FDA to remove products from marketplace
 The Bottom Line: The bill, if passed will
start to unwind DSHEA
 The good news:
 It’s being proposed and is mostly
supported by Democrats, enough said
 But that may change in time:
IN SHORT:
 Up until now, by and large, the only force
restricting or limiting supplements has been
market forces.
 In the future, expect that Codex (with the WTO)
will put pressure and perhaps dramatic and/or
overwhelming international pressure on the US
to limit or restrict the ingredients which can be
manufactured and sold in supplements.
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AND
 Expect the FDA and the Democratic
paternalists and over protectors to help out
via legislative initiatives
What can we do about it?
 Question and fight the so-called scientific premise
 Keep treating and helping patients/clients
(especially people with influence)
e.g. Harkin and Ed Gouchenauer
 science and publications
 (Time for the industry to step up to the plate)
 Legal Challenges: commerce clause, state’s rights will
have a better chance than pure freedom of choice.
(IMO).