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Summer
of '05
Critical Time for Dietary Supplements
by Suzan Walter
The future
of dietary supplements may be determined by what happens this summer.
Not just one, but many different yet related matters are all coming
to a head within the next the next eight months. Since everything
is interrelated, you will want to track national, regional, and
international events.
When you review
articles and e-mails dealing with supplements (and there are a number
making the rounds), it is important that you understand the impact
of each of these events individually, as well as collectively. The
following review is presented to assist you in understanding the
nuances of each issue and in recognizing when some sources blur
and confuse the distinctions.
Codex
Guidelines for Vitamin and Mineral Food Supplements
The Codex Guidelines for Vitamin and Mineral Food Supplements is
an international document drafted to be guidelines for vitamin and
mineral supplement products. It states that it is only for countries
that designate these supplements as food, exempting countries that
designate supplements as drugs. Last November, after over a decade
of wrangling over numerous supplement regulation issues, a Codex
committee completed an eight-step process that created the official
Guidelines document. Finalization of the Guidelines document is
on the agenda for the Rome July 4-9, 2005 session of the top Codex
body, the Codex Alimentarius Commission. At this time, there does
not appear to be anything that can be done to stop this final action.
Under Codex authority, these Guidelines are optional suggestions,
not a mandatory trade standard that must be followed in trade between
countries.
However, there
are agreements between Codex Alimentarius and the World Trade Organization
that allow the WTO to use Codex documents (such as the Guidelines)
as mandatory international trade standards to settle trade disputes.
The WTO can enforce dispute decisions by pressuring the losing country
through trade sanctions if they do not change their national laws
or other regulations to conform to international trade standards.
Therefore, the regulations in the Guidelines must be taken seriously.
The section
of the Guidelines expected to have the most significant impact is
the criteria by which the maximum amounts of vitamins and minerals
that will be allowed in a supplement product are determined. The
Guidelines state that "... upper safe levels of vitamins and
mineral established by scientific risk assessment based on generally
accepted scientific data...." As there is currently no generally
accepted scientific risk assessment protocol available, what these
limits will be is unknown. Some individuals are very concerned that
the upper limits will be set too low. This could mean that instead
of one convenient high-dosage capsule, the consumer might need to
take a handful of low-dosage capsules.
FAO
Risk Assessment Protocol
The Food and Agriculture Organization (FAO) of the United Nations
and the World Health Organization (WHO) announced in December, 2004,
that they were accepting applications from individuals who wish
to serve as the experts on a joint nutrient risk assessment project
to define a scientifically-based nutrient risk assessment. Work
is scheduled to begin in May, 2005. The balance of perspectives
of the experts selected will be the first sign of how this project
will progress. It is anticipated, but not guaranteed, that this
nutrient risk assessment protocol will be used to define the upper
safe limits of the Codex Guidelines.
European
Union Food Supplements Directive
The collection of countries making up the European Union (EU) will
be severely impacted by the activation of the EU Food Supplements
Directive on August 1, 2005. The Directive is purported to provide
reassurance for EU consumers that the ingredients used in food supplements
have been thoroughly assessed for safety. There is a "positive
list" that includes 28 vitamins and minerals that are deemed
safe. After August 1, EU stores can legally only sell supplement
products containing these ingredients. What is causing grave concerns,
however, is the long list of 200 vitamins and minerals that did
not make the "positive list." While a supplement would
normally need to be proved dangerous to be removed from public consumption,
the Directive works in just the opposite way. The supplement must
be proved safe to get onto the "positive list" and be
available to the EU consumer. The process of proving that a vitamin
or mineral is safe is very costly.
A number of
groups are so concerned about the negative impact of the Directive
that this matter has been taken to the regional courts in Europe.
At a January 25, 2005, hearing the Alliance for Natural Health and
Nutri-Link Ltd presented their arguments that the EU is exceeding
its powers. An opinion will be released April 5, 2005, with the
final decision expected in June, 2005. The decision will set a major
precedent for the world, particularly if the EU Directive side loses.
DSHEA
& Legislation in U.S.
The key legislative protection that gives consumers in the United
States access to dietary supplements is the Dietary Supplement Health
and Education Act of 1994 (DSHEA). A number of senators and and
members of congress in Washington are working to reverse some or
all of these protections. Last year, in the 108th session of Congress,
a number of bills were introduced that caused concern among those
who use supplements. It is expected that these bills will be reintroduced
in the current (109th) session in the mid-March to April time frame,
with serious committee hearings in the following months. While the
bill numbers will be different, the content is expected to be very
similar. A few of the bills to watch for are:
- Dietary
Supplement Safety Act (was S. 722)
This bill would amend the Federal Food, Drug, and Cosmetic Act
to require that manufacturers of dietary supplements submit to
the FDA reports on adverse experiences with dietary supplements.
Opponents question whether dietary supplements need to be held
to a higher standard than drugs. Would it be fair to have a supplement
taken off the market based on one negative reaction while a drug
can remain available even as it harms many?
- Dietary
Supplement Access and Awareness Act (was H.R. 3377)
This bill would grant the FDA authority to regulate supplements
in the same way that it regulates over-the-counter drugs. Opponents
are concerned that this is working toward the day when you would
need a doctor's prescription to get vitamin and mineral supplements.
- Safe
Food Act of 2004 (was S. 2910)
This bill would create a new federal food safety agency. Ten separate
federal agencies handling various food matters would be combined
into one. This sounds like an efficient administrative approach.
However, the bill stated that the term "food" would
not include dietary supplements. If not food, what's left? Drugs?
How
these events are connected
Some of the connections between the events described above are obvious.
However, there are some subtle relationships that are not as well
known. Here are a few examples:
- The EU has
a very strong influence on decisions made in Codex committee sessions.
In fact, the Guidelines document does not include a number of
items because the EU delegate was vehemently against them. In
one prominent example the delegate from South Africa tried on
a number of occasions to get wording into the Preamble of the
Guidelines to acknowledge that vitamins and minerals had preventive
benefits. The EU delegate successfully objected every time. At
this same Codex session the FAO/WHO publication, "Diet, Nutrition
and the Prevention of Chronic Diseases" was being promoted
on the literature table. Based on this demonstration of EU influence,
many people believe that the EU Food Supplements Directive indicates
what Codex documents might end up including in the future.
- The United
States Federal Register, October 11, 1995, FDA Policy on Standards,
states that "where a relevant international standard exists,
or completion is imminent, it will generally be used in preference
to a domestic standard...." If this is still the FDA policy,
once the Codex Guidelines are finalized this summer, will we find
the FDA working to use this against the DSHEA?
Have you noticed
the growing number of situations where dietary supplement companies
are being required to submit costly documentation to prove that
a vitamin or mineral is safe, even when there is extensive research
already demonstrating its safety and effectiveness? This is what
is currently happening in Europe and Canada. The negative economic
impact is changing the landscape of the entire industry. Are we
seeing a scenario where small companies will either have to sell
out to larger supplement companies or fold? Where many of the larger
companies are being bought out by pharmaceutical companies? Do current
events support the strength of the supplement companies or the pharmaceutical
companies?
As you consider the difference
between what is on the six o'clock news and what the health freedom
advocacy web sites proclaim, evaluate for yourself what this difference
might mean for you and those you love. Get involved with groups
that support what you believe will be most beneficial.
References:
Suzan Walter
is president of the American Holistic Health Association. She researched
and compiled information on Codex and the WTO in order to explain
these matters to the U.S. public through the web site codexinfo.org.
AHHA is careful to share only facts and encourages all readers to
review the various positions and make up their own minds about which
positions to support. Suzan attended the Codex Committee on Nutrition
and Foods for Special Dietary Uses sessions as an observer in 2002,
2003, and 2004. You can e-mail Suzan Walter and AHHA at codex@ahha.org.
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