future Codex regulations
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.
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
to provide safety standards for less developed countries that
don't have any, and
to ensure artificial trade barriers are not set up ("harmonization").
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.
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.
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.
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.
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.
Conduct a hazard analysis. Prepare a list of steps in the process
where significant hazards can occur and describe the preventive
Identify the Critical Control Points (CCPs) in the process.
Establish critical limits for preventive measures associated with
each identified CCP.
Establish CCP monitoring requirements. Establish procedures for
using the results of monitoring to adjust the process and maintain
Establish corrective actions to be taken when monitoring indicates
that there is a deviation from an established critical limit.
Establish effective record-keeping procedures that document the
Establish procedures for verification that the HACCP system is
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.
outstanding safety record of dietary supplements and the lack of
benefit that HACCP would provide strongly suggest that such regulations
are not needed.
overview of HACCP.