|
The following
are the AHHA comments submitted to the FDA representative,
Dr. Barbara Schneeman, to be considered when drafting the
United States' position related to the Proposed Draft
Guidelines for Vitamin and Mineral Food Supplements
that will be discussed at the 26th Session of the Codex
Committee on Nutrition and Foods for Special Dietary Uses
(CCNFSDU) to be held in Bonn, Germany, November 1-5, 2004.
September 9, 2004
Comments for
U.S. Head Delegate, Dr. Barbara Schneeman, to be
considered when finalizing the United States' position
related to the Proposed Draft Guidelines for Vitamin
and Mineral Food Supplements that will be discussed at
the 26th Session of the Codex Committee on Nutrition and
Foods for Special Dietary Uses (CCNFSDU) to be held in
Bonn, Germany, November 1-5, 2004.
As a consumer
education organization, the American Holistic Health
Association (AHHA) has been working to increase the
American public's awareness of the Codex Alimentarius.
The highest consumer interest has been in the Guidelines
for Vitamin and Mineral Food Supplements being
developed by the CCNFSDU.
It is our
understanding that the WTO expects the Codex Alimentarius
to draft food standards for international trade
regulations and for food safety. In order to resolve
international trade disputes these standards need to be
applicable in all situations and for all countries. In the
case of vitamin and mineral supplements there are so many
variables and exceptions that it is not possible to
present the WTO with one trade standard that could be
applied to every nation.
* If you survey all of the countries around the globe, you
will find that they designate vitamin and mineral
supplements in one of the following three ways:
as food
as drugs
as food at a lower level; as drugs at a higher level
* Another variable is that vitamin and mineral supplement
products can have natural and/or synthetic ingredients as
the source of the nutrients.
* To complicate the situation even further, the same
vitamin and mineral products can be used for different
purposes:
Prevent nutritional deficiencies
Health enhancement
Disease prevention
Treatment
The key
concern expressed by the American public is that there are
conflicting indications for how the Guidelines for
Vitamin and Mineral Food Supplements document will be
used after it has been finalized. AHHA urges the U.S.
Delegation to spearhead an effort to verify how the WTO
will use these Guidelines. Currently, it appears
that those drafting this important document are
misinformed as to how it will actually be used.
Firsthand
experience talking with delegates at CCNFSDU sessions in
Germany and members of the German Codex staff indicates
strong convictions that the Guidelines is a
document with optional suggestions to be used by those
countries needing this type of data. Delegates seem to
believe that because the document is entitled "Guidelines"
it is only guidelines, or suggestions. However, in 1998
the WTO informed Codex that it does not differentiate
between standards and guidelines. Both will
be used as mandatory standards.
Reference:
EXECUTIVE COMMITTEE OF THE CODEX ALIMENTARIUS
COMMISSION, Rome, 3-5 June 1998, REPORT ON MATTERS
RELATING TO THE IMPLEMENTATION OF THE WTO AGREEMENT ON THE
APPLICATION OF SANITARY AND PHYTOSANITARY MEASURES AND THE
AGREEMENT ON TECHNICAL BARRIERS TO TRADE
Text of report with letter from WTO can be accessed by
doing search at
http://docsonline.wto.org/gen_search.asp?searchmode=simple
Search for documents numbered 98-0462 and 98-1071.
A. STATUS OF CODEX STANDARDS, GUIDELINES AND OTHER
RECOMMENDATIONS CX/EXEC 98/45/9 April 98
The 22nd CAC Session had requested the WTO Committee on
Sanitary and Phytosanitary Measures (the SPS Committee) to
clarify how the Committee would differentiate "standards,
guidelines and other recommendations" in relation to the
SPS Agreement by WTO Members. The WTO letter of response
dated March 1998 included "The definition makes no
distinction between standards, guidelines and
recommendations. The SPS Agreement does not provide
specific definitions for the terms 'standards',
'guidelines' or 'recommendations'."
"In no case do these provisions differentiate between
the three terms 'standards', 'guidelines' or
'recommendations'"
"...how a Codex text was applied depended on its
substantive content rather than the category of that text
(eg., commodity standards, MRLs, codes of practice,
guidelines)."
The content
of the Codex Guidelines for Vitamin and Mineral Food
Supplement specifically excludes the roles of
prevention and treatment. It also limits application to
only countries designating vitamin and mineral supplements
as food. The wording of the Guidelines has been changed to
have should, not shall. References have been made in 25th
CCNFSDU session report to CAC that "as the text was not a
standard". However, under SCOPE 1.2 the text states "These
Guidelines do apply..." To clear up any future confusion,
if the CCNFSDU does intend for the Guidelines to
not be a mandatory standard, this needs to be stated
within the document, most appropriately under the SCOPE
section. This would be in keeping with the WTO
clarifications to Codex "...how a Codex text was
applied depended on its substantive content rather than
the category of that text."
Otherwise,
once the Guidelines are finalized, the WTO might
decide that, since there is no international standard, it
will use the Guidelines for Vitamin and Mineral Food
Supplements as a mandatory standard and apply to all
countries, perhaps even those designating these
supplements as drugs. The WTO might even decide to use the
Guidelines to apply to all uses of vitamins and
minerals, even those used for therapeutic purposes.
Increasing
numbers of American consumers are becoming aware of what a
valuable privilege they have to be able to purchase the
vitamin and mineral supplements of their choice. They see
the looming restrictions going into effect in the European
Union countries and are genuinely concerned that this
might happen in the U.S.
While most
industry sources are confident there is no reason to be
concerned, there are a number of individuals with legal
training who are concerned after studying how the WTO
handles international trade disputes.
AHHA urges
the U.S. Delegation to
* Have legal experts study the following WTO procedures
with respect to identifying the circumstances under which
these might have the power to force the U.S. to change
it's laws, particularly using trade sanctions:
Technical Barriers to Trade
Most-Favoured Nations
Dispute Settlement Body
* Find a source within WTO who can answer these questions:
If the WTO received the Guidelines for Vitamin and
Mineral Food Supplements in its current form, how
could this document be used by WTO?
If the CCNFSDU wanted to guarantee that the
Guidelines for Vitamin and Mineral Food Supplements is
not to be used as a mandatory standard, what does the WTO
officially need to have included within the text of the
document to ensure this, and where within the document?
AHHA urges
the U.S. Delegation to make certain that the CCNFSDU
delegates are accurately informed as to the answers to
these two questions. How the Guidelines document will be
used by the WTO needs to be on record in the CCNFSDU
session report - from the WTO, not from a Codex source.
AHHA also
urges the U.S. Delegation to take the leadership role
supporting the addition of appropriate wording to the
Guidelines document, stating that this document is not
to be a mandatory standard, but only optional suggestions.
AHHA will be present to support you in this. Our
president, Suzan Walter, will be attending the CCNFSDU
session as an observer.
Please make
sure the Guidelines for Vitamin and Mineral Food
Supplements document is not finalized until these
matters have been resolved.
In reviewing
the preliminary U.S. Positions on the Guidelines for
Vitamin and Mineral Food Supplements we offer the
following comments:
1)
3.1.2 Synthetic sources not food
We are concerned that this reference to synthetic sources
for a vitamin or mineral supplement is inconsistent with
the scope of Codex in general and this document in
particular. The WTO is expecting Codex to provide
standards related to foods. Synthetic ingredients
are not food. Also, in 2003 there was a significant issue
made at the CCNFSDU session that the word 'food' must be
added to the title of the Guidelines document. We
urge you to carefully consider all of the ramifications of
including synthetic sources in the scope this document.
This is one of those variables that make an
all-encompassing food standard impossible for dietary
supplements. (Reference our comments above on this matter)
2)
Work on your rationale for 3.2.2 section deletion
We agree that the statement in square brackets should be
deleted. You are encouraged to have stronger arguments to
rebut those committed to keeping upper limits on vitamins
and minerals as low as possible. They will find numerous
reasons to take a safe upper limit and keep lowering it
due to possible other sources. This process could easily
be abused.
3)
Concern about wording of 3.2.2
It is reasonable that a ceiling be established for a
nutrient, where more than that amount would be toxic and
dangerous for human consumption. This research needs to be
done by a fair, qualified scientific process and this
information should be made available in the public domain.
However, the wording in the Guidelines is "Daily
portion of consumption as recommended by the manufacturer"
We are concerned that implementation is wide open for
misinterpretation. As this section is not in square
brackets, we are realistic that the CCNFSDU session Chair
would most likely refuse to have it addressed. We do urge
the U.S. Delegation to be alert and vigilant to matters
related to this section. The goal is helpful information
related to safety, not setting restrictive international
standards.
4) 5.5
should be in square brackets
If you look at the November 2003 CCNFSDU session appendix,
which includes the Guidelines, you will note that 5.5 is
in square brackets. The initial bracket has been
accidentally omitted in the most recent online Codex
version, but the end bracket stands. The U.S. Delegation
will want to review 5.5 and determine their position on
this matter.
These
comments submitted by
American Holistic Health Association
PO Box 17400
Anaheim, CA 92817 USA
(714) 779-6152
mail@ahha.org
www.ahha.org
www.codexinfo.org
|
