INFLUENCES
There are two opposing factions for the use and control of dietary supplements. One restricts supplement access by the public to low doses to prevent a deficiency condition, with higher doses to be under medical supervision. Pharmaceutical drugs are the preferred option for treatment. The other faction views dietary supplements as safe and appropriate for individuals to have free access to, and effective in prevention and treatment of many diseases. A review of the history of the development of the Codex Guidelines appears to support the idea that this trade regulation restricting free access to dietary supplements was initiated by the anti-supplements faction. These countries are the ones that have prevailed each time opposition attempted to stop the development of the Guidelines or to minimize the restrictions. more...

Who will benefit the most from the implementation of the Guidelines? There are many who feel the pharmaceutical industry will be the strongest beneficiary. They feel that when vitamins and minerals are no longer available in dosages sufficient for use to prevent disease, more drugs will be needed to treat the resulting illnesses. more...

DSHEA & LEGISLATION IN U.S.
The United States is one of the few countries with specific legislation to protect consumer access to dietary supplements. The key legislative protection is the Dietary Supplement Health and Education Act of 1994 (DSHEA). A number of senators and and members of Congress in Washington, DC introduce bills each year to reverse some or all of these protections. Will these elected officials use the Guidelines to strengthen their arguments that DSHEA needs to be changed?

As of July 2005 there are two pieces of legislation. These would require reporting of adverse reactions to dietary supplements. They would also give the FDA the power to declare a dietary supplement unsafe and remove it from the market based on these reports. Some point out that these safety criteria are stricter than those required by over-the-counter medications.

U.S. House of Representatives Bill 3156 -- Dietary Supplement Access and Awareness Act
This bill proposes to revise the "unreasonable risk" clause of DSHEA by significantly strengthening the FDA's ability to judge a supplement unsafe.

U.S. Senate Amendment 1379 -- attached to to U.S. Senate Department of Defense Authorization Bill 1042
This amendment requires certain dietary supplement manufacturers to report serious adverse events. It also prohibits supplements with stimulants to be available in military installation stores.

USDA & FDA
The U.S. Codex Office is under the Food Safety and Inspection Service (FSIS) of US Department of Agriculture (USDA) which is part of the U.S. Department of Health and Human Services (HHS). Dr. Frank E. Scarborough is U.S. Manager for Codex, U.S. Codex Office.

Regulation of dietary supplements is under the Center for Food Safety and Applied Nutrition of the U.S. Food and Drug Administration (FDA), which is part of the U.S. Department of Health and Human Services (HHS). A significant number of the head delegates of U.S. delegations to Codex committees are employees of the FDA, including the delegation to the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) which drafted the Guidelines.

Some see the FDA as having to serve two opposing agendas - pharmaceutical drugs and dietary supplements. Can they be loyal to both? Will the FDA activate a policy to harmonize DSHEA to international standards -- the Guidelines?

TRADE AGREEMENTS
The United States has signed a number of trade agreements and is in the process of negotiating more. Many view these trade agreements as threats to health freedoms within the U.S. due to the segments that give up regulatory control to others and require harmonizing national laws to match international trade standards.

Countries becoming members of the World Trade Organization (WTO) grant that organization the authority to enforce the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and Agreement on Technical Barriers to Trade (TBT). The WTO can force a member country (including the U.S.) to change a national law or pay large trade sanctions, if the country loses a trade dispute brought to the WTO Dispute Settlement Procedure.

The (CAFTA) Central America Free Trade Agreement (CAFTA) was negotiated by the U.S. President. By law it then has to be ratified by the House and Senate. The Senate approved on June 30 and the House July 28.

CAFTA is viewed by many to be a precursor to the signing of the Free Trade Agreement of the Americas (FTAA). While the purpose of these trade agreements is to promote free trade among Western Hemisphere countries, many point out special interest influences that could have serious negative impact on many populations and on personal rights. Also, there are countries in Central and South American that could use the SPS and TBT provisions in these agreements to pressure or force the U.S. to harmonize with the Codex Guidelines. more...

EUROPEAN UNION FOOD SUPPLEMENTS DIRECTIVE
The European Union Food Supplements Directive became law in all EU countries in June 2002. This controversial Directive is set to ban thousands of popular vitamin and mineral supplement products in EU countries. An important step in the incremental implementation of this law is the activation of the "positive list" on August 1, 2005. On that date all supplement products not on this list will become illegal to be sold in stores in EU countries.

There was a law suit to overturn the prohibitive provisions of the Directive that reached the EU Court of Justice. The final decision was announced July 12, 2005 upholding the terms of the EU Food Supplements Directive.

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This website was restructured in June 2005. This specific page was last updated July, 2005.