American Holistic Health Association (AHHA) - Food vs. Drug Concern
Guidelines
Food vs. Drug Concern

1. SCOPE
1.3. These Guidelines apply in those jurisdictions where products defined in 2.1 are regulated as foods.

This exempts countries that designate vitamin and mineral supplements as drugs.

Early on, when the CCNFSDU was drafting the Codex Draft Guidelines for Vitamin and Mineral Food Supplements, an important issue had to be resolved. Some countries designate dietary supplements as food, while others designate them as pharmaceutical drugs. There are even other countries that designate low dosages of supplements as food and higher dosages as drugs. The final resolution of this issue was to have the Guidelines only apply to situations where vitamins and mineral supplements are designated by a country as food. This exempted all other countries.

This exemption of many countries is not a problem under Codex regulations, as a guideline type of document is optional as to whether or not a country uses some or all of the suggestions.

A concern is that the World Trade Organization (WTO) relies on Codex to provide trade standards to be used to resolve international trade disputes brought to the WTO Dispute Settlement Process. Codex has been formally notified that the WTO does not differentiate between the different types of Codex documents (standards, guidelines, and recommendations). That means that while, Codex guidelines are optional under Codex, they can be used by the WTO as mandatory trade standards. In the case of the Guidelines, it is not known whether or not the WTO will honor the exemptions.

The WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) has a segment that appears to require all countries to change (harmonize) their regulations to match international standards.
"Article 3: Harmonization
1. 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..."

Will this require ALL countries to conform to the Guidelines, even those designating dietary supplements as drugs?


Dietary supplements in drug countries

Australia is one of the countries designating dietary supplements as a drug. A recent article by Eve Hillary "Codex - The Sickness Indu$try's Last Stand" outlines what is happening "down under."


In Canada a Natural Health Products Regulations, introduced in January of 2004, in essense reclassified dietary supplements as a drug (rather than a food). Now natural health products (NHPs) are required to be licensed. The article Canada and the United States: Crossborder Issues Relevant to the Dietary Supplements Industry explains the phase-in schedule for these products to achieve the expensive required license.


Denmark is nov viewed by many as one of the most restrictive countries as far as regulation of dietary supplements. Denmark To Eliminate Concept Of Supplements: 'They're All Medicines' presents a EU rationale that anything "presented for preventing disease as well as substances which may be administered to human beings with a view to restoring, correcting or modifying physiological functions to be a medicinal product."


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