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In October, 1996, this committee met in Bonn, Germany. The
U.S. delegation, lead by Dr. Elizabeth Yetley of the FDA, was joined by several
non-governmental organization (NGO) representatives, including several from Citizens for
Health, the grass-roots group that so effectively mobilized support for the Dietary
Supplement Health and Education Act (DSHEA) in 1992-4. In a strange turnabout, the FDA
took the role of defending consumer rights, and issued a statement which stressed that
dietary standards should be set by individual countries for their own citizens: "The United States does not support the development of guidelines for
dietary supplements of vitamins and minerals at the present time. The United States
recognizes that there are diverse opinions on the use of dietary vitamins and minerals and
what framework for regulating their safety and claims made for them would be most
appropriate. The United states believes that it is not appropriate to develop a uniform
set of standards for ingredients, formulations, and claims because of the diverse citizen
and government attitudes towards the use of dietary supplements that exists in different
countries and cultures." [Author's note: Dr. Yetley's
later actions in proposing that supplements be submitted to the
inappropriate Drug Risk Assessment model, besides being a violation of the
spirit if not the letter of the 1994 DSHEA Law, effectively shows the
above statement to be the blowing of so much smoke. Unfortunately
for supplement consumers in this country, Dr. Yetley is our
"representative" in the one nation-one vote Codex process.]
The U.S. delegation did not prevail. The support they
garnered from representatives of New Zealand, Australia, Japan, and Canada did not
outweigh the opposition from Europe, Africa, and the rest of the globe. Government
officials from countries with little history of supplement use in their populations, such
as many third-world nations, were eager to go along with the proposed guidelines.*
The proposals now forwarded to the full CODEX Commission for
consideration would, if enacted:
-
prohibit claims that are permissible in the United States under the
Dietary Supplement Health and Education Act of 1994 (DSHEA);
-
define some foods and most dietary supplements as drugs if they are used
to "modify physiological functions";
-
prevent the sale of any nutrient not already classified as a
"vitamin" or "mineral";
-
classify various nutritional ingredients as "dangerous";
-
of the few nutrients that may be sold, severely limit the maximum levels
available, to no more than 100% of the U.S. RDA per pill.
Such rules were implemented in Norway a few years ago, which at the time
had a thriving health-food store industry. These stores are now almost all gone, and it is
illegal to sell vitamin C in potencies above 200 milligrams or vitamin E above 45
i.u.
Higher potency pills can be obtained with a doctor's prescription, but they cost 5-10
times what they used to cost. Once available from the small vendors who supplied quality
nutrients to health-food stores, these formulas are now only available from drug
companies. Besides Norway, Canada and Germany also already regulate supplements as
pharmaceuticals. This is the model of supplement distribution that the CODEX Commission
wishes to establish worldwide.
High-potency supplements have been used for many years by millions of
people. The fact that risks are minor and few is borne out by the fact that no deaths
occur from them, year after year. As it stands now, a final proposal establishing a
"safe upper limit" based on RDA's will be discussed in 1997. The U.S. RDA's are
not based on scientific findings, but decades-old guesswork, and are adequate only for
preventing the most serious malnutrition diseases such as scurvy and beri
beri. This final
proposal is to complete a risk analysis and use those findings as the standard. It
is likely that at the June 1997 meeting, an RDA standard will be adopted and worked into
the CODEX standards.
Both the General Agreement on Trades and Tariffs (GATT) and the World
Trade Organization (WTO) have established CODEX as a settlement issue in trade
disagreements dealing with food. This means that although the DSHEA will remain the law of
the land, should it be challenged for "obstructing trade" or for any other
reason by an international competitor, the outcome of the case will not be measured
against the intention of the DSHEA itself, but rather against whether or not it complies
with the CODEX rules.
It is true that countries that disagree with the CODEX standard may
accept it subject to a "deviation" (exception) that then allows products to be
sold and distributed within that "deviating" country's own laws. However, this
country must declare to the CODEX Commission when it would fully accept the CODEX
standards under this "deviation" process. In other words, it would only postpone
the day when those limits would be imposed.
If supplements from established American companies were freely available
in Europe, major pharmaceutical interests in these European countries would stand to lose
large sums of money and control that they have established over the distribution of
nutritional supplements. The European-controlled CODEX Commission has effectively diverted
attention from this de facto trade barrier. Now they wish to establish, via international
government fiat, the same limitations to the free trade of safe and needed supplements in
the United States.
The full Codex Commission, parent body to the committee, will meet in
June 1997 in Rome. The next meeting is set for September 21-25, 1998, again in Bonn,
Germany.
* The CODEX preamble states that a well-balanced diet is
available to everyone in the world, and therefore supplementation is not needed. The
evidence for this assertion is lacking even in a highly-affluent society like the USA. In
many countries, such as India and China, frank vitamin A deficiency affects millions of
people and causes thousands of cases of blindness every year, and other nutritional
deficiencies are common. (Back)
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