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6/24/2005 3:37:36 PMQuestion:What is Codex? Will it impact how I buy my

supplements?Answer:The following information for this FAQ was generously

provided by Jim Roza, a delegate to the Codex Hearings for many years. He has a

unique perspective on Codex and was able to provide these insights for us:

Codex, or Codex Alimentarius (the Food Code) was created in 1963 by the World

Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the

United Nations. Its main purpose was to develop food safety practices and

standards. There are many branches to Codex, but the one that most concerns us

is the Codex Committee on Nutrition and Foods for Special Dietary Uses

(CCNSFDU). In the fall of 2004, CCNSFDU achieved consensus on a set of

guidelines for vitamin and mineral food supplements.

This FAQ will try to cover some of the most commonly asked questions about

Codex.

Q: Are Codex meetings held in secret?

A: No, they are not. The meetings are open to delegates from all over the world,

and for non-governmental organizations such as the Council for Responsible

Nutrition (CRN), the National Health Federation (NHF), and the American Holistic

Health Association (AHHA).

Q: Why was this committee given the task of adopting guidelines for supplements?

A: Unlike the United States, many countries have no laws that permit such

products and many countries regulate any tablet or capsule product as drugs.

(Remember, many supplements we can buy from the health food store here in the

States require a prescription in Europe.) The hope is that international

guidelines will promote the idea of trade in supplements as food products and

not as drugs.

Q: What is the next step in ratifying the Codex guidelines?

A: The draft guidelines that recently received consensus at the last CCNSFDU

meeting are now at step 8 (the final step in the Codex process) and must now be

approved by the Codex Commission. The commission meets the first week of July in

Rome.

Q: Will Codex override DSHEA and our rights here in the United States?

A: No, Codex does not override DSHEA or any other United States law. The

guidelines permit everything that is sold here in the U.S. Codex guidelines are

for the international trade of vitamins and minerals among those countries that

make up the Codex restrictions on what the U.S. companies can sell abroad.

Q: Could the World Trade Organization (WTO) force the US to accept Codex

guidelines?

A: It's extremely unlikely that the WTO could impose Codex dietary supplement

guidelines on the U.S. because of the provisions already in DSHEA and the Food

and Drug Administration's Modernization Act (FDAMA). It is plausible that

another member of the Codex body could bring a dispute to the WTO against the

United States, but the WTO would first have to rule in this other country's

favor, and an act of Congress would have to legitamize it. However, this is

unlikely. The most immediate threat actually comes from members of our own

Congress who would like to see DSHEA rescinded.

Q: Do the guidelines have any effect on other categories of supplements besides

vitamin and minerals?

A: No the guidelines are only for vitamin and mineral supplements and do not

affect herbs, amino acids, or other classes of dietary ingredients.

Q: Do these guidelines mandate that no supplement can be sold for preventive or

therapeutic use?

A: No the guidelines agreed upon by CCNSFDU only deal with labeling issues such

as serving size, reference values and recommended daily use.

Q: Do the guidelines state that no supplements should contain vitamins and

minerals above the Recommended Daily Allowances?

A: No, the committe decided that the maximum allowable potencies for vitamins

and minerals will be set following a risk analysis process. This allows science

to determine what (if any) limits are needed. Earlier attempts to set upper

limits using a value of the RDA have been abandoned.

Q: What are Upper Safe Limits?

A: An Upper Safe Limit is the maximum amount of vitamin or mineral that can be

taken, including the amounts you obtain from your diet, without putting your

health at risk. There are some nutrients, such as selenium, iron or vitamin A

that could be a health risk if taken in excess amounts. However, for the most

part, vitamins and minerals are extremely safe.

Q: Do the Codex guidelines require Good Manufacturing Practices in the

manufacture of supplements?

A: GMP's are not specifically mentioned in the guidelines. However, their

importance is implied throughout the document because the text refers to purity

of ingredients and the cleanliness of containers.

Q: Is Codex currently the law in any country?

A: No, the guidelines still need to be approved by the Codex Commission--it's

governing body. The Draft Standard, now at step eight of the Codex process, will

be submitted to the Commission in July, where it's expected to be adopted. Each

member country will then have to determine if and how the guidelines will be

adopted into their own current regulatory standards.

Q: Is there any reason to be concerned about Codex?

A: That depends on what safe uppper limits are set for vitamin and mineral

supplements. The guidelines specify that a science-based risk analysis will be

used in setting those limits. Currently, industry groups such as the National

Nutritional Foods Association (NNFA)and the Council for Responsible Nutrition

(CRN) are working to ensure that maximum limits are only set for appropriate

nutrients (like selenium and vitamin A).

Recent studies, however, done in the U.K. and Germany are very disturbing

because they set limits for supplements such as B6 and Niacin at or below the

RDA levels. If this is the case consumers in countries where supplement

regulations are more liberalized could see the availability of higher potency

supplements restricted. American manufacturers who sell to those markets would

have to reformulate their products for those countries.

The Codex process is very complex, and it may take a while before we see any

real impact from their meetings. We will track this as it develops.

 

 

 

 

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