December 5, 1997
Dr. Robert Moore
Food and Drug Administration
Office of Special Nutritionals
200 C Street, S.W.
Washington, D.C. 20204
Re: Request for comments on draft Codex guidelines for vitamin and mineral supplements
The Center for Science in the Public Interest (CSPI) submits these comments regarding the
United States' position on the Codex Alimentarius Commission's proposed draft guidelines for
vitamin and mineral supplements. We are concerned that the decision to return the guidelines to
Step 3 for further comment and consideration will delay the issuance of guidelines to ensure the
safe use of vitamin and mineral supplements. We believe that the adoption of these guidelines is
essential to ensure that consumers do not consume excessive levels of substances that could lead
to tragic adverse health consequences.
As the Food and Drug Administration (FDA) is well aware, the regulation of vitamins and
minerals in this country has had a very controversial history. Under current law, the FDA cannot
set maximum levels of potency for vitamins and minerals, or consider vitamins and minerals to be
drugs, solely because their potency is greater than that which FDA determines to be nutritionally
rational. Moreover, since 1994, Congress has placed the burden of proof on the FDA to establish
that a dietary supplement is unsafe before removing it from the marketplace.
Despite the fact that the U.S. Congress has made it exceedingly difficult for the FDA to regulate
the sale of vitamins and minerals, the FDA can still prohibit the sale of any vitamin and mineral
supplement in dosages that pose "a significant or unreasonable risk." The FDA should, thus,
support efforts by Codex to ensure that vitamins and minerals are marketed in safe dosages.
It is clear that some vitamin and mineral supplements can pose risks at excessive doses. For
example, excessive consumption of:
- Vitamin A has been linked to miscarriages and birth defects, including malformations of the
cranium, face, heart, thymus, and central nervous system. Large doses of Vitamin A have
also been associated with headache, vomiting, double-vision, baldness, bone abnormalities and
- Vitamin D can lead to calcium deposits in soft tissues and result in irreversible renal and
cardiovascular damage. Young children are most at risk.
- Vitamin B6 can cause the failure of muscular coordination and functional disturbances and/or
pathological changes in the sensory system.
In addition, even small doses of some vitamins and minerals may produce toxic effects. For
example, adverse reactions from selenium have been reported at daily dosages as low as l mg,
which have been linked to fingernail changes and hair loss. At dosages as high as 27.3 mg per
tablet, symptoms include: nausea, abdominal pain, nail and hair changes, functional disturbances
and/or pathological changes in the peripheral nervous system, fatigue and irritability.
Therefore, it is essential that the FDA support international efforts to ensure that supplements are
available only in safe doses. Neither section 411 of the FDCA nor DSHEA prohibit the FDA
from taking regulatory action against a dietary supplement that "presents a significant or
unreasonable risk of illness or injury" or poses "an imminent hazard to public health or safety."
The portions of the Codex proposal that we urge the FDA to support do not conflict with the
agency's Congressional mandates. Therefore, the FDA should urge Codex to approve the
following sections of the Proposed Draft Guidelines with the modifications we suggest.
3.2.1. Supplements may contain vitamins and minerals up to a level that is
considered safe on the basis of risk assessment considerations, as determined by
appropriate risk assessment methodology, taking into account all sources of
nutrients in the diet.
In addition, CSPI supports the labeling provisions contained in section 8.5 of the draft guidelines.
In particular, we urge the adoption of a requirement for warning statements "if the product
contains a significant amount of a nutrient with respect to the toxicity level." Such a provision is
consistent with the warning label provisions in the Dietary Supplement Health and Education Act
3.2.2. The maximum level of each nutrient contained in a vitamin and mineral
supplement should not exceed the estimated safe intake per daily dose.
For the foregoing reasons, we urge the FDA to support the proposed Codex provisions on safe
vitamin and mineral supplement dosages.
Director of Legal Affairs
Ilene Ringel Heller
Senior Staff Attorney