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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec 525.250 Cloves - Adulteration with Stems November 2005

Final
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Center for Food Safety and Applied Nutrition

REGULATORY ACTION GUIDANCE:

The following represents criteria for direct reference seizure *requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the Human and Animal Food Program*:

The cloves contain an average of 5% or more stems by weight.

REMARKS:

Since the majority of spices are imported, determine that the lot in question has not been previously examined and released by FDA as an import. If the lot has been examined and released previously, submit all available facts to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) for seizure consideration in the usual manner.

SPECIMEN CHARGE:

Article adulterated while held for sale after shipment in interstate commerce, within meaning of 21 U.S.C. 342(b)(2), in that clove stems have been substituted wholly or in part for cloves.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 3/95, 5/05
Updated: 11/29/05


Submit Comments

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)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.