European Union Food Supplements Directive
The collection of countries making up the European Union (EU) will be severely impacted by the activation of the EU Food Supplements Directive on August 1, 2005. The Directive is purported to provide reassurance for EU consumers that the ingredients used in food supplements have been thoroughly assessed for safety. There is a "positive list" that includes 28 vitamins and minerals that are deemed safe. After August 1, EU stores can legally only sell supplement products containing these ingredients. What is causing grave concerns, however, is the long list of 200 vitamins and minerals that did not make the "positive list." While a supplement would normally need to be proved dangerous to be removed from public consumption, the Directive works in just the opposite way. The supplement must be proved safe to get onto the "positive list" and be available to the EU consumer. The process of proving that a vitamin or mineral is safe is very costly.

A number of groups are so concerned about the negative impact of the Directive that this matter has been taken to the regional courts in Europe. At a January 25, 2005, hearing the Alliance for Natural Health and Nutri-Link Ltd presented their arguments that the EU is exceeding its powers. An opinion will be released April 5, 2005, with the final decision expected in June, 2005. The decision will set a major precedent for the world, particularly if the EU Directive side loses.

DSHEA & Legislation in U.S.
The key legislative protection that gives consumers in the United States access to dietary supplements is the Dietary Supplement Health and Education Act of 1994 (DSHEA). A number of senators and and members of congress in Washington are working to reverse some or all of these protections. Last year, in the 108th session of Congress, a number of bills were introduced that caused concern among those who use supplements. It is expected that these bills will be reintroduced in the current (109th) session in the April-May time frame, with serious committee hearings in the following months. While the bill numbers will be different, the content is expected to be very similar. A few of the bills to watch for are:

• Dietary Supplement Safety Act (was S. 722)
  This bill would amend the Federal Food, Drug, and Cosmetic Act to require that manufacturers of dietary supplements submit to the FDA reports on adverse experiences with dietary supplements. Opponents question whether dietary supplements need to be held to a higher standard than drugs. Would it be fair to have a supplement taken off the market based on one negative reaction while a drug can remain available even as it harms many?
• Dietary Supplement Access and Awareness Act (was H.R. 3377)
  This bill would grant the FDA authority to regulate supplements in the same way that it regulates over-the-counter drugs. Opponents are concerned that this is working toward the day when you would need a doctor's prescription to get vitamin and mineral supplements.
• Safe Food Act of 2004 (was S. 2910)
  This bill would create a new federal food safety agency. Ten separate federal agencies handling various food matters would be combined into one. This sounds like an efficient administrative approach. However, the bill stated that the term "food" would not include dietary supplements. If not food, what's left? Drugs?

How these events are connected
Some of the connections between the events described above are obvious. However, there are some subtle relationships that are not as well known. Here are a few examples: