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 program field office 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 program field office 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 Updated: 11/29/05
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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