Supplement issue Information - FYI

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From www.consumerhealthreviews.com

Critical Time for Dietary Supplements Summer of '05

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.

1. 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.

2. 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.

3. 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. The final decision expected in June, 2005. The

decision will set a major precedent for the world, particularly if

the EU Directive side loses.

4. 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:

5. 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?

6. 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.