FYI CODEX UPDATE

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From: " Bill Sanda: Weston A. Price Foundation " <info@...>

Date: Thu, 28 Jul 2005 03:03:44 -0700 (PDT)

Subject: INFORMATION ALERT: CODEX UPDATE

WESTON A. PRICE FOUNDATION

INFORMATION ALERT

July 27, 2005

The Rome 2005 Codex Supplement Guidelines Aftermath: Risk and Opportunity

The international CODEX delegates adopted adopted global guidelines for

vitamin and mineral food supplements as one of its first decisions. The

guidelines recommend labeling that contains information on maximum

consumption levels of vitamin and mineral food supplements, assisting

countries to increase consumer information, which will theoretically help

consumers use them in a safe and effective way, according to the World

Health Organization (WHO).

" According to WHO, the guidelines ensure that consumers receive

beneficial health effects from vitamins and minerals.

" The guidelines say that people should be encouraged to select a balanced

diet to get the sufficient amount of vitamins and minerals. Only in cases

where food does not provide sufficient vitamins and minerals should

supplements be used. "

The vitamin and mineral guidelines, while not overriding national

legislation, provide national governments with a blueprint for domestic

vitamin and mineral regulation, which is much more restrictive than

American dietary supplement law. The restrictions in the guidelines

create a risk for supplement consumers worldwide. As nations begin

adopting laws consistent with the guidelines to avoid losing

international trade disputes, there is a risk that the world market in

supplements will sink to a lowest common denominator of a relatively few

low potency products. As the market contracts around such limitations,

pressure will mount on the U.S. to adjust its law to the international

standard. The American supplement industry advocates of the

international Codex guidelines say they will resist such pressures but,

critics fear, they have little commercial incentive to do so.

The industry Codex advocates assert that consumers and manufacturers

worldwide will benefit from adoption of the guidelines, because they

require acceptance of science as a rational approach to setting upper

intake limits, create freedom of trade for the industry, and increase

freedom of choice for the public. This might turn out to be true for

countries such as Greece, Norway, Spain, or France, which currently

significantly restrict dietary supplement products. However, countries

just beginning to establish dietary supplement regulations will be

inclined to adopt the Codex standard rather than laws similar to the much

less restrictive U.S. Dietary Supplement Health and Education Act

(DSHEA).

In response to this concern, industry guidelines advocates argue that it

could have been much worse. They site maximum levels of nutrients set on

the basis of safety evaluation through risk assessment as far superior to

maximum levels set the basis of Recommended Dietary Allowances (RDA), as

called for in the original proposed Codex guidelines. The population

reference intakes (PRI) and RDA, they point out, are based on nutritional

need, and are not scientifically valid for assessing safety and setting

maximum levels of intake. The current guidelines also treat supplements

as food and minimize the impact of the precautionary principle, which

blocks products from marketing until proven safe even if there is no

suggestion of harm. These are significant accomplishments. However, the

cost for these successes is enormous.

Under the Codex guidelines, vitamins and minerals will be evaluated for

safety as if they were toxic chemicals. Nothing prevents the unbridled

use of this approach from discovering very low safe upper limits (it is

technically possible, though unlikely, that they could even, in some

instances, be lower than the RDA). Fifty years of U.S. legislative and

judicial determinations, culminating in the passage of DSHEA, oppose this

concept. The opposition often had to overcome the repeated and shrill

objections of the U.S. Food and Drug Administration. It appears to

critics of the Codex guidelines that, having failed domestically, the

U.S. FDA now hopes to get the international community to treat nutrients

as poisons. The critics point out that a senior FDA official supportive

of treating nutrients as toxins has taken FDA leave in order to run the

Codex-supported toxicological review of vitamins and minerals. The

critics find this fact troubling. Industry supporters of the guidelines

say they will stand firm against unfair treatment of nutrients as toxins.

A battle looms.

In addition to the battle over safety standards, supplement guidelines

critics support the FAO/WHO observation that Codex must do more to

include nutrition standards in its commercial trade guidelines. In this

context, supplement advocates, while opposing the use of improper

standards for the safety evaluation of supplements, support the role of

dietary supplements in the campaign to end world hunger and promote world

health. They point out that researchers have shown that $1 of vitamin A

supplementation equals $30 of development aid. They argue that similar

results are likely for all essential vitamin and mineral supplements but

that the Codex guideline could make it more difficult to achieve these

benefits. This position is one they believe is not antithetical to

supplement industry interests. The dietary supplement community of

consumers, producers, researchers, sellers and others could play a

leading role in the FAO/WHO contribution to the global effort to end

world hunger. This appears to be a position that the manufacturers who

support the current guidelines could embrace.

During the first day of the Codex meeting's five minute supplement

guidelines discussion, China, while not objecting, gave a glimpse of the

unfolding discourse. It stated that every government, in making

decisions about vitamins and minerals, should be allowed to take into

account the dietary limitations of their own countries, that governments

be allowed to select vitamins and minerals according to the customs and

habits of their country, and that definitions of the sources of vitamins

be permitted and publicized. This is not the way the Codex guidelines

envision the international supplement trade unfolding. International

trade rules permit a country to diverge from an international standard if

it has a sound scientific basis to do so. It is possible that some

countries-possibly China?-might diverge from the guidelines in way more

supportive of dietary supplements than is Codex.

The road out of Rome runs between the Palatine, the hill from which

Romulus and Remus launched the Roman adventure, and Claudius' palace,

overlooking the Circus Maximus. Authorities removed the final remains of

2005's Live8 Roma from Circus Maximus on Wednesday. FAO world

headquarters sits at the bottom of the hill, cattycorner from Claudius'

palace and the Roman Forum. This was the center of the Roman Republic.

A banner on the side of the FAO headquarters invites each individual to

become a partner with FAO in ending world hunger.

by Jim , general counsel to the Weston A. Price Foundation and

attendee at the Rome CODEX meeting.

********************************************************

Bill Sanda

Executive Director

Weston A. Price Foundation

bsanda@...

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