[Fwd: CODEX Overview : Be Informed]

[Guest guest]

Here is the information that is being sent to me regarding COdex.

*Thanks to Dick Mc, Ken , and Marcia for getting

this information out.*

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*CODEX OVERVIEW

What is the current status on Codex*? Has it passed congress?

*This document from the US FDA, seems to put all the concerns about

CODEX behind us, as just a bad dream. *It is VERY well worth reading,

as it seems to claim that there is no way that CODEX can override DSHEA.

*FDA US Food and Drug Administration

CFSAN/Office of Nutritional Products, Labeling and Dietary

Supplements March 2005

Responses to Questions about Codex and Dietary Supplements*

*

*

Many U.S. consumers have expressed concerns about the development of

the Codex Draft Guidelines for Vitamin and Mineral Food Supplements.

Some are concerned that these Guidelines, if adopted by Codex, will restrict

consumers' access to the wide range of vitamin and mineral supplements of

varying potencies legally sold in the United States.

Others are concerned that the Guidelines will limit the amount and type of

information on the labels of dietary supplements sold in the United States.

Still others believe that the Guidelines will require dietary supplements to

be sold as drugs in the United States.

We hope the responses below help you understand why the adoption of

Draft Guidelines for Vitamin and Mineral Food Supplements by Codex will

not restrict U.S. consumers' access to vitamin and mineral supplements or

impose any restrictions that go beyond those established by U.S. law. We

also hope the responses help explain why the U.S. participates in the Codex

process and how you can keep abreast of Codex activities.

*What is Codex?

*The Codex Alimentarius Commission, or Codex, was created in 1963 by

two U.N. organizations, the Food and Agriculture Organization and the

World Health Organization. Its main purpose is to protect the health of

consumers and to ensure fair practices in international trade in food

through

the development of food standards, codes of practice, guidelines and other

recommendations. Codex standards and guidelines are developed by

committees, which are open to all member countries. Member countries

review and provide comments on Codex standards and related texts at

several stages in the development process. In the United States, public

meetings are held to receive comments on Codex drafts and comments are

invited from all interested parties (See U.S. Codex Office web site). Codex

standards and related texts are voluntary; member countries are not bound

by or required to adopt them. You can obtain more information about

Codex at the Rome Codex web site. You can also obtain information about

U.S. Codex activities at the U.S. Codex Office web site.

*What work has Codex undertaken on vitamin and mineral

supplements?

*In the early 1990's, the Codex Committee on Nutrition and Foods for

Special Dietary Uses (CCNFSDU) began discussions on guidelines for

vitamin and mineral supplements. This Committee is responsible for

studying nutritional issues referred by the Codex Alimentarius Commission;

drafting provisions, as appropriate, on the nutritional aspects of all

foods;

and developing standards, guidelines, or related texts for foods for special

dietary uses. Germany is the host government for the Committee, which has

met either every year or every other year since 1966. At its most recent

session (Bonn, November 1-5, 2004), the Committee completed work on

Draft Guidelines for Vitamin and Mineral Food Supplements and submitted

them for adoption by the Codex Alimentarius Commission at the Commission's

July 2005 meeting.

*What is the scope and content of these Guidelines?

*The Guidelines apply only to supplements that contain vitamins and/or

minerals, where these products are regulated as foods. The Guidelines

address the composition of vitamin and mineral supplements, including the

safety, purity, and bioavailability of the sources of vitamins and minerals.

The Guidelines do not specify upper limits for vitamins and minerals in

supplements. Instead, they provide criteria for establishing maximum

amounts of vitamins and minerals per daily portion of supplement consumed,

as recommended by the manufacturer. The criteria specify that

maximum amounts should be established by scientific risk assessment based

on generally accepted scientific data and taking into consideration, as

appropriate,

the varying degrees of sensitivity of different consumer groups.

The Guidelines also address the packaging and labeling of vitamin and

mineral supplements. We encourage you to read the complete text of the

Guidelines, which is found in Appendix II of the report of the most recent

session of the CCNFSDU. See ALINORM 05/28/26 on the page of Full

Reports of Recent Sessions .

*What has been the U.S. position on these Guidelines?

*The U.S. supports consumer choice and access to dietary supplements that

are safe and labeled in a truthful and non-misleading manner. The Dietary

Supplement Health and Education Act of 1994 (DSHEA) ensures that a

broad array of dietary supplements are available to U.S. consumers. The

Codex Guidelines for Vitamin and Mineral Food Supplements will not, in

any way, affect the availability of supplement products to U.S. consumers.

On the contrary, the absence of science-based Codex guidelines could

adversely affect the ability of U.S. manufacturers to compete in the

international marketplace.

*Why won't these Guidelines restrict U.S. consumers' access to vitamin

and mineral supplements?

*Some consumers mistakenly believe that if Codex should adopt guidelines

on vitamin and mineral food supplements that are more restrictive than

DSHEA, the U.S. would be required to automatically change its laws and

regulations to comply with the international standard. Some consumers have

expressed concerns that the World Trade Organization (WTO) and its trade

dispute settlement panels may place pressure on the U.S. to change its laws

because of international trade agreements such as the Agreement on the

Application of Sanitary and Phytosanitary Measures (SPS Agreement),

which references Codex as the international organization for food safety

standards. We see no basis for these concerns. First, the DSHEA covers a

much broader range of dietary supplements than the vitamin and mineral

supplements that are the subject of the Codex Guidelines. Moreover, for

supplements covered by these Guidelines, we note the following:

· *The SPS Agreement does not require a country to adopt any

international standard.

*Rather, the SPS Agreement provides that members may base their Sanitary

and Phytosanitary measures either on international standards, guidelines or

recommendations, where they exist, or may establish measures that result in

a higher level of protection if there is a scientific justification, or if a

country determines it to be appropriate in accord with provisions of the SPS

Agreement (SPS Agreement, Article 3(1) and (3)).

· *WTO and WTO dispute panels do not have the power to change

U.S. law.

*If a WTO decision in response to a dispute settlement panel is adverse

to the

U.S., only Congress and the Administration can decide whether to

implement the panel recommendation, and, if so, how to implement it.

· For dietary supplements, it is unlikely that another country will accuse

the U.S. of imposing a trade barrier for the importation of supplement

products into the U.S. marketplace because the U.S. laws and regulations

are generally broader in scope and less restrictive than the international

standard.

· However, other countries with more restrictive laws and regulations for

dietary supplement products than the U.S. may create trade barriers to the

importation of products manufactured by the U.S. dietary supplement

industry. Thus, the U.S. government's involvement in the setting of

international

standards can help minimize the potential of trade barriers to U.S

products in international trade. Further, there is no basis for the concern

that the Codex Guidelines on Vitamin and Mineral Food Supplements

would require dietary supplements be sold as prescription drugs in the

United States. First, there is nothing in the Guidelines that suggests that

supplements be sold as drugs requiring a prescription. Second, U.S.

regulatory agencies are bound by the laws established by Congress, not by

Codex standards. Third, because of our generally less restrictive standards,

it is unlikely that the trade dispute would be brought against the U.S.

*In summary, *U.S. consumers' access to a broad array of dietary supplements

under DSHEA would not be changed in any way by Codex's

adoption of guidelines on vitamin and mineral food supplements. The

Guidelines also include packaging and labeling provisions for vitamin and

mineral food supplement products. Would vitamin and mineral supplements

sold in the U.S. be required to comply with these? All Codex standards and

related texts are voluntary, and vitamin and mineral food supplement

products sold in the U.S. would not be required to comply with provisions

that are more restrictive than U.S. law (i.e., DSHEA).

*If the U.S. is not trying to harmonize its regulatory framework for

dietary supplements with Codex, what are the benefits of our country

participating in the process of developing these Codex Guidelines?

*Our participation in the Codex process is important to encourage the

development of guidelines on vitamin and mineral supplements that are

based on sound science and not on arbitrary criteria. For example,

encouraging the use of science-based risk assessment for determining the

maximum levels of vitamins and minerals in supplements reduces the

chance that arbitrary standards will be used for determining maximum

levels.

*How can I keep abreast of the work of Codex?

*To keep abreast of U.S. Codex activities, you may want to periodically

access the U.S. Codex Office website. You can also obtain the agenda and

reference documents for Commission and committee meetings and final

reports from these meetings from the Rome Codex website. The appendices

to the committee reports provide the latest draft versions following a

committee meeting of some of the Codex standards that are being developed

or revised by the Committee.

You might want to check this link on Codex and dietary Supplements from

FDA

http://www.cfsan.fda.gov/~dms/dscodex.html

*

To Your Vibrant Health and Blessings in Abundance!**

a Vetter RN, MSN, FNP, CDE *

*/Holistic Family Nurse Practitioner, Certified Diabetes Educator,

Certified Herbalist, Reiki Master/Teacher, Global Wellness Consultant/**/

(330) 725-0441 (EST) USA

_a@... ___

/

*

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