Updated: 2005-11-29
BACKGROUND:
The status of color additives cannot always be definitely determined by reference to
color additive regulations. Thus, a color additive may not appear on either
the permanent or provisional lists and yet be legal because the order terminating the
listing of the color additive allowed a grace period in which the color additive could
continue to be used. In addition, although a color additive may no longer be
permitted for a particular use, there may be extenuating circumstances which, when
taken into consideration, would not warrant our taking regulatory action against a
firm found to be using a non-permitted color additive.
REGULATORY ACTION GUIDANCE:
Before recommending regulatory action, where it appears that a color additive is
being used illegally, the district should check with either CFSAN/Office of
*Compliance*/Division of Enforcement (HFS-605) as to the status of the color
additive and of the products in which it has been used. The district should not advise
or suggest recall of any product containing what appears to be a non-permitted
color additive without consulting CFSAN/Office of *Compliance*/Division of
Enforcement (HFS-605).
When violations in the color additive area are confirmed, the District may forward to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) a recommendation, accompanied by all the facts, for recall or other appropriate regulatory action.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 8/31/89, 3/95, 5/2005