What is the status of FD&C Red No.3?
A. In 1990, FDA discontinued the provisional listing of all lake forms of FD&C Red No.3 and its dye form used in external drugs and cosmetics. The uses were terminated because one study of the color additive in male rats showed an association with thyroid tumors. In announcing the decision, FDA that any human risk posed by FD&C Red No.3 was extremely small and was based less on safety concerns than the legal mandate of the Delaney Clause. FD&C Red No.3 remains permanently listed for use in food and ingested drugs, although FDA has announced its intent to propose rescinding those listings.
