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. 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. Large doses of Vitamin A have also been associated with headache, vomiting, double-vision, baldness, bone abnormalities and liver damage. Vitamin D can lead to calcium deposits in soft tissues and result in irreversible renal and cardiovascular damage.
Young children are most at risk.
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. Therefore, it is essential that the FDA support international efforts to ensure that supplements are available only in safe doses. 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.