Codex: Fact or Fiction?

[Guest guest]

This is from the director of NOW foods. In my opinion, he isn't as

concerned as he should be, but this helps one understand the issue.

The CODEX guidelines are being finalized THIS WEEK, and many heath

advocates like myself are very concerned. My reason is that the Drug

companies seem to have more of a stranglehold on supposedly more

liberal Europe, than they do in the USA. What could possibly stop the

drug companies from using CODEX to remove the biggest threat to their

business? Think about it. Money talks, does it not? I think the

answer is YOU.

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02.25.05--Codex: Fact or Fiction?

 

By Jim Roza, NOW Director of External Affairs and Codex Delegate,

February 23, 2005

 

What is Codex? Will it take away my freedom to purchase dietary

supplements? These are some of the questions that I am asked on a

daily basis. Currently, there is a lot of misinformation on the

internet that would have you believe that Codex will soon replace

DSHEA and take away our rights to buy supplements. As Director of

External Affairs for NOW and a Codex delegate, I am in a unique

position to answer any questions you may have and to clear up any

misinformation you have heard or read about Codex.

 

WHAT IS CODEX?

 

Codex is an international body that meets to establish guidelines for

food safety and the free trade of goods. There are many different

Codex Committees, but the one that is most specific to dietary

supplements is the Codex Committee on Nutrition and Foods for Special

Dietary Uses (CCNSFDU). Last fall, CCNSFDU achieved consensus on a

set of guidelines for vitamin and mineral food supplements.

 

ARE CODEX COMMITTEE MEETINGS SUCH AS CCNSFDU HELD IN SECRET?

 

No, they are not. The meetings are open to delegations from all over

the world as well as non-governmental organizations such as the

Council for Responsible Nutrition (CRN), the National Health

Federation (NHF) and the American Holistic Health Association (AHHA).

 

WHY WAS THIS COMMITTEE GIVEN THE TASK OF ADOPTING GUIDELINES

SUPPLEMENTS?

 

Many countries have no laws that permit such products and many

countries regulate any tablet or capsule product as drugs.

International guidelines will help facilitate trade in supplements as

food products and not as drugs.

 

WHAT IS THE NEXT STEP IN RATIFYING THE CODEX GUIDELINES?

 

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.

 

WILL CODEX OVERRIDE DSHEA AND OUR RIGHTS HERE IN THE UNITED STATES?

 

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 vitamin and minerals

among those countries that make up the Codex body. Therefore, it will

impose restrictions on what U.S. companies can sell abroad.

 

COULD THE WORLD TRADE ORGANIZATION (WTO) FORCE THE US TO ACCEPT CODEX

GUIDELINES?

 

It is extremely unlikely that the WTO could impose Codex dietary

supplement guidelines on the U.S. because of the statutory provisions

inherent in DSHEA and the Food and Drug Administration's Modernization

Act (FDAMA). It is possible that another member of the Codex body

could bring a dispute to the WTO against the U.S. WTO would have to

rule in their favor and then it would require an act of Congress

before any changes could occur. A more imminent threat exists from

some of our own members of congress who would like to see DSHEA rescinded.

 

DO THE GUIDELINES AFFECT OTHER CATEGORIES OF SUPPLEMENTS BESIDES

VITAMINS AND MINERALS?

 

No, the guidelines only apply to vitamin and mineral supplements and

do not affect herbs, amino acids or other classes of dietary ingredients

 

DO THESE GUIDELINES MANDATE THAT NO SUPPLEMENT CAN BE SOLD FOR

PREVENTIVE OR THERAPEUTIC USE?

 

No, the guidelines agreed upon by CCNSFDU deal only with labeling

issues such as serving size, reference values and recommended daily use.

 

DO THE GUIDELINES SPECIFY THAT SUPPLEMENTS CONTAIN NO VITAMINS AND

MINERALS ABOVE RECOMMENDED DAILY ALLOWANCES?

 

No, the committee decided that the maximum allowable potencies for

vitamins and minerals will be set using a risk analysis process. This

allows science to determine what (if any) limits are needed. Earlier

attempts to set upper set limits using a value of the RDA have been

discontinued.

 

WHAT ARE UPPER SAFE LIMITS?

 

An Upper Safe Limit is the maximum amount of a vitamin or mineral that

can be taken, including the amounts you obtain from your diet, without

putting health at risk. There are some nutrients such as selenium,

iron or Vitamin A that could be problematic if taken in excess

amounts. For the most part, however, vitamins and minerals are

extremely safe.

 

DO THE CODEX GUIDELINES REQUIRE GOOD MANUFACTURING PRACTICES (GMPs) IN

THE MANUFACTURE OF SUPPLEMENTS?

 

GMPs are not specifically mentioned in the guidelines. Their

importance, however, is evident throughout the document because the

text refers to the purity of ingredients and the cleanliness of

containers.

 

IS CODEX THE LAW NOW IN ANY COUNTRY?

 

No, the guidelines still need to be approved by the Codex Commission,

its 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.

 

IS THERE ANY REASON TO BE CONCERNED ABOUT CODEX?

 

That depends on what safe upper 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, groups such

as NNFA and CRN are working to ensure that maximum limits are only set

for those nutrients e.g., selenium, Vitamin A, where it is

appropriate. Recent studies in the U.K. and Germany, however, 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

foreign 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 to gain entry into those markets.