Dissecting the Truths and Myths about Codex and U.S. Dietary Supplement Law

March 22, 2005

 

Justin J. Prochnow, Esq.

 

What is the truth about Codex?  Are the Codex Draft Guidelines on Vitamin and Mineral Food Supplements (“Codex Draft Guidelines”) going to replace the Dietary Supplement Health and Education Act of 1994 (“DSHEA”) in July of 2005?  Or are the Codex Draft Guidelines simply “voluntary” international standards that have no binding effect on the U.S. and are little cause for concern?  As is generally the case, the answer lies somewhere between these two divergent viewpoints at opposite ends of the Codex “spectrum.”  The information, or misinformation, surrounding the Codex Draft Guidelines and other Codex standards has been swirling around the internet like a tornado.  Some emails have foretold of the eradication of DSHEA and the end of U.S. dietary supplement law upon passage of the Codex Draft Guidelines in July 2005 at the Codex Alimentarius Commission’s biannual meeting in Rome, Italy.  Although these “alarmist” emails are simply factually incorrect and DSHEA will still be the operating U.S. law in July, the passage of the Codex Draft Guidelines should not be ignored.  Unfortunately, the incorrect views espoused in these “alarmist” emails only serve to obfuscate the valid issues surrounding Codex.  Following are the straight facts about the Codex Alimentarius Commission, the adoption of Codex standards by the World Trade Organization, and the possible ramifications on U.S. dietary supplement law, so that you will have the information necessary to weigh the credibility of various opinions and reach an informed conclusion regarding the Draft Guidelines on Vitamin and Mineral Food Supplement and Codex.

 

The Codex Alimentarius Commission

 

The Codex Alimentarius Commission (“Codex Commission”) was established in 1963 following resolutions passed at the 11th Session of the Conference of the Food and Agriculture Organization ("FAO") in 1961, and the 16th World Health Assembly for the World Heath Organization ("WHO") in 1963.  The Codex Commission is a body organized under the Joint FAO/WHO Food Standards Programme.  The Codex Commission’s self-proclaimed “mission” is to have all countries join the international community in formulating and harmonizing food standards and ensuring their global implementation.  These standards are voluntary from the standpoint of the Codex Commission.

 

The Codex Commission meets every two years, alternately at the FAO headquarters in Rome, where it will meet in July of 2005, and at the WHO headquarters in Geneva.  The Codex Commission is open to all Member Nations and Associate Members of the FAO and the WHO, which includes over 160 countries, one of which is the United States.  The Codex Commission is comprised of two types of subsidiary bodies: Codex Committees and Coordinating Committees.  Each committee is hosted by a member country that is in charge of the maintenance and administration of the committee.  Codex Committees are then divided up and classified as either Commodity Committees or General Subject Committees.  The Commodity Committees have responsibility for developing standards for specific foods or classes of foods, such as milk, sugar, or fresh fruit.  General Subject Committees develop standards that have relevance to all Commodity Committees.  There are nine of the General Subject Committees; of particular interest and importance to the dietary supplement community is the Committee on Nutrition and Foods for Special Dietary Uses.

 

The Committee on Nutrition and Foods for Special Dietary Uses is hosted by Germany, and most recently met in November of 2004.  At the November 2004 meeting in Bonn, Germany, the Codex Draft Guidelines that have provoked so much discussion were finalized for final approval at the July 2005 meeting of the Codex Commission in Rome.  These Codex Draft Guidelines seek to establish international standards for mineral and vitamin supplements, including identifying the specific minerals and vitamins allowed to be included in supplements, and determining the minimum and maximum levels of the specified minerals and vitamins.  A major concern for people in the dietary supplement community is that the Codex Draft Guidelines are vague and unclear about who will be making the determinations as to the approved minerals and vitamins or how the appropriate minimum and maximum levels will be set.  Attempts to find out more information about these issues have gone largely unanswered.

 

So, what is the big deal?  If Codex standards are basically voluntary, why are we even concerned?  Although Codex standards are voluntary on their face, provisions in several agreements of the World Trade Organization (“WTO”) adopt Codex standards and make them mandatory for countries that are Member Nations of the WTO. 

 

World Trade Organization

Prior to the establishment of the WTO,  the General Agreement on Tariffs and Trade, or GATT, provided rules for an international trading system.  An international organization, also known informally as GATT, grew out of the General Agreement.  Over the years, GATT evolved through several rounds of negotiations.  The last and largest GATT round was the Uruguay Round which lasted from 1986 to 1994, and led to the creation of the WTO.  The WTO was established on January 1, 1995, replacing GATT, and is the only global international organization dealing with the rules of trade between nations.  There are over 140 Member Nations in the WTO, of which the United States is one.

At the heart of the WTO are the WTO agreements, which are negotiated and signed by the bulk of the world’s trading nations and are ratified in their parliaments.  These agreements are often called the WTO’s “trade rules,” but they are actually agreements that the member countries negotiate.  There are two specific WTO agreements that address food safety, animal health and safety, plant health and safety, and product standards.  These agreements are the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement). 

Of particular relevance to this discussion is Article 3 of the SPS Agreement regarding harmonization, which provides the following:

To harmonize sanitary and phytosanitary measures on as wide a basis as possible, Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations, where they exist, except as otherwise provided for in this Agreement, and in particular paragraph 3.

International standards or guidelines for food safety are further defined in the SPS Agreement as those that are established by the Codex Alimentarius Commission.  A similar provision is set forth in the Substantive Provisions section of Annex 3 to the TBT Agreement.  These provisions, with the use of the term “shall,” effectively make the “voluntary” Codex guidelines mandatory for Member Nations of the WTO.

Legal Effect on DSHEA and U.S. Law

So, if the Codex Draft Guidelines will become mandatory for Member Nations of the WTO, what effect does this have on the U.S.?  Contrary to some of the “alarmist” emails referenced above, the Codex Draft Guidelines will have no binding legal effect on U.S. law.  The Codex Draft Guidelines cannot and will not overrule federal law, most notably DSHEA.  Accordingly, U.S. law will not change in July 2005 as a result of the probable passage of the Codex Draft Guidelines.  So, if that is the case, why should anybody be concerned?  Although Codex guidelines do not have a binding effect on U.S. law, they may provides the model and/or impetus for future attacks on U.S. law, whether that future is more immediate or further down the road.  The growing concern is that the Codex Draft Guidelines will be used to pressure the U.S. to conform to international law or will be used by opponents of DSHEA and the dietary supplement community to further restrict the manufacturing, sale, and dissemination of dietary supplements in the United States. 

            WTO Dispute Settlement Body

As stated above, the WTO, through WTO agreements, has adopted Codex standards as mandatory for WTO Member Nations.  How do these WTO agreements get enforced?  Action in the WTO is through the WTO Dispute Settlement Body.  The WTO Dispute Settlement Body is unique in that there is compulsory jurisdiction for all Member Nations of the WTO.  Additionally, in contrast to most other international organizations, the WTO Dispute Settlement Body can impose sanctions against Member Nations for violations of WTO agreements. 

An important distinction to make is that individual companies cannot be sued in WTO Dispute Settlement court.  WTO Dispute Settlement Body action entails one individual Member Nation bringing action against another individual Member Nation.  The process generally entails the following:

Consultation.            (Up to 60 days).  Before taking any other actions, the countries in dispute must talk to each other to see if they can settle their differences.

Appointment of Panel. (Up to 45 days to be appointed, 6 months for the panel to conclude).  If consultations fail, the complaining country can ask to have a panel appointed.  The panel investigates the complaints, conducts a hearing, and then issues a report.  The panel’s report can only be rejected by consensus in the Dispute Settlement Body, so the panel’s conclusions are difficult to overturn.

Final Report.  (3 weeks).  The panel submits a Final Report to the two sides and three weeks later, it gets circulated to all WTO Member Nations.

Final Ruling.   (60 days).  The Final Report becomes the Dispute Settlement Body’s ruling within 60 days unless a consensus of the Dispute Settlement Body rejects it or it is appealed.

Appeals.   (60-90 days).  Appeals last 60-90 days with a Final Report being issued from a three member panel.  The Dispute Settlement Body accepts or rejects the appeals report within 30 days.

After a case has been decided, the losing country must appear in front of the Dispute Settlement Body within 30 days and state whether it intends to comply with the recommendations in the Final Report.  If the losing country fails to act, it has to enter into negotiations with the complaining country to determine compensation.  If after 20 days, no satisfactory compensation is agreed upon, the complaining side can ask for permission to impose limited trade sanctions.  The Dispute Settlement Body must grant this authorization within 30 days unless there is a consensus against the request. 

In principle, the sanctions should be imposed in the same area of trade as the dispute.  However, if this proves to be impractical or would not be effective, sanctions can be imposed in a different area covered by the same agreement.  If this proves to be impractical as well, sanctions can be imposed under a different WTO agreement.

Even if the WTO Dispute Settlement Body imposes sanctions, it does not mean that the U.S. will automatically change its laws to comply.  The U.S. would have to determine whether it could absorb the sanctions or whether the sanctions were onerous enough to force a change in the law to conform to the Codex guidelines.  In order to adopt new legislation, Congress would usually have to proceed with the formal legislative process.

FDA Regulations

Contrary to some other emails and opinions, the FDA cannot not simply adopt the Codex Draft Guidelines as new FDA regulation upon their passage in July 2005.  First of all, the FDA has given no indication that it intends to issue regulations similar to the Codex Draft Guidelines.  Although some people have pointed to statements made in the Federal Register almost ten years ago, these statements are not akin to mandated FDA policy.  If the FDA does decide that it wants to take on this type of battle and face the type of opposition that would most certainly appear from the dietary supplement community, it could only do so by attempting to issue new regulations which do not run afoul of DSHEA.  The FDA would have to proceed by initiating the formal rule making process, issuing a Notice of Proposed Rulemaking and complying with the other necessary requirements to pass new regulations.

            Conclusion

            What will be the ultimate ramifications of the Codex Draft Guidelines on U.S. dietary supplement law?  No one can predict with certainty what the actual impact will be.  The legal reality is that the passage of the Codex Draft Guidelines in July 2005 will not immediately change U.S. law, regardless of what some of the “alarmist” emails proclaim.  Your right to purchase and sell supplements will not be taken away by the Codex guidelines come July 2005.  Notwithstanding these immediate legal realities, the Codex Draft Guidelines still warrant your close attention.  Whether the FDA attempts to issue regulations similar to Codex standards, whether certain members of Congress use the Codex guidelines as rallying points in an attempt to harmonize U.S. law with international standards and diminish DSHEA, or whether action takes place in the WTO to impose sanctions on the United States, remains unknown.  Unfortunately, the “alarmist” emails declaring the end of DSHEA have a negative effect for those fighting against Codex standards.  Instead of rallying support for opposition to the Codex Draft Guidelines, these emails diminish the credibility of the people who have raised rational and valid concerns about the possible threats to the U.S. dietary supplement community.  It is important that the U.S. dietary supplement community be aware of the facts surrounding the Codex Draft Guidelines and rally in an informed, rational manner so that members of Congress, the FDA, and other influential groups are aware that the changes suggested by the Codex Draft Guidelines are not justified, warranted or wanted by the majority of the U.S. dietary supplement community.  The ramifications of the Codex Draft Guidelines will continue to be one of the “hot” topics and an issue that requires reasoned discussion and action.

If you have questions regarding Codex guidelines or any other areas of Food and Drug law involving dietary supplements, cosmetics, medical devices or conventional foods, please feel free to contact me by email at prochnowjj@gtlaw.com or by telephone at 303-572-6562.

Justin J. Prochnow, Esq.

Greenberg Traurig, LLP

1200 17th Street, Suite 2400

Denver, Colorado  80202

 

Justin Prochnow

 

Justin Prochnow is a Governmental Affairs Associate in the law firm of Greenberg Traurig LLP’s Denver office, concentrating primarily on regulatory affairs.  His practice focuses on Food and Drug law, Advertising Law and Business Litigation. Justin has significant experience in litigation as a former prosecutor and has both prosecuted and defended significant business litigation, including class action cases involving securities violations, RICO violations, and mortgage foreclosure scams.