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Possible future Codex regulations
January 1999

Codex Alimentarius

It is possible that the sale of dietary supplements in the United States could be additionally governed by international regulations. The GATT Treaty ratified by the U.S. specifies Codex regulations as a guideline for the U.S. dietary supplement regulation.

Codex Alimentarius formed in 1961 as an outgrowth of the World Health Organization and the United Nations. Its stated purpose is to improve world health by establishing guidelines for food safety for two purposes:

  1. to provide safety standards for less developed countries that don't have any, and
  2. to ensure artificial trade barriers are not set up ("harmonization").

All guidelines are to be based on valid science using principles of risk analysis. Codex policy is that consumer opinions and health should be overriding concerns. Some consumer groups believe, however, that pharmaceutical interests represented at Codex could encourage over-regulation that would run counter to consumer interests.

Codex guidelines take many years to formulate and thus have been slow to have any impact in the United States. Furthermore, the FDA Modernization Act passed in 1997 forbids U.S. adoption of any Codex regulations that undo the freedoms established by the 1994 Dietary Supplements Health Education Act (DSHEA). Nonetheless, it is important to watch Codex regulations since there are various ways in which they could get adopted into US law.


A standard, Hazard Analysis Critical Control Points (HACCP), was developed in reaction to various outbreaks of food contamination. HACCP involves manufacturing quality procedures aimed specifically at preventing the introduction of contaminants.

HACCP was adopted by Codex as a requirement for food processing. The USDA and FDA are working to integrate those guidelines into regulation of U.S. food. HACCP could eventually be required by Codex for dietary supplements. This means that the FDA would attempt to make it law in the U.S., possibly in place of GMPs.

The National Advisory Committee on Microbial Criteria laid out the latest version of HACCP in the International Journal of Food Microbiology, in 1992. The Committee set out 7 Principles defining the HACCP process. They are:

  1. Conduct a hazard analysis. Prepare a list of steps in the process where significant hazards can occur and describe the preventive measures.
  2. Identify the Critical Control Points (CCPs) in the process.
  3. Establish critical limits for preventive measures associated with each identified CCP.
  4. Establish CCP monitoring requirements. Establish procedures for using the results of monitoring to adjust the process and maintain control.
  5. Establish corrective actions to be taken when monitoring indicates that there is a deviation from an established critical limit.
  6. Establish effective record-keeping procedures that document the HACCP system.
  7. Establish procedures for verification that the HACCP system is working correctly.

Though on the surface HACCP may seem like a good idea, requiring HACCP for dietary supplements runs the risk of imposing costly procedures on the manufacturing process that are not necessary and not even helpful. The only serious outbreak of contamination ever found in a dietary supplement - trypophan in 1989 -- would not have been caught by HACCP.

The outstanding safety record of dietary supplements and the lack of benefit that HACCP would provide strongly suggest that such regulations are not needed.

See the FDA's overview of HACCP.



More about standards & regulations:

Industry standards

Creating a quality model for dietary supplements

Different types of standards

Pros and cons of standards

Competing standards

Testing products for quality

Dosage recommendations

Good manufacturing practices (GMPs)

Self-regulatory quality standards

Government regulations

FDA safety monitoring

Federal Trade Commision (FTC)

State laws

Health benefit claims

RDA, DV, and other recommended intake values

Funding of research at the National Institutes of Health (NIH)

Possible future FDA regulations

Possible future Codex regulations


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(c) Copyright 1999-2003 Dietary Supplement Quality Initiative. For permission to reprint, please contact our editor.