REGULATORY ACTION GUIDANCE:
The following represents the 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*:
a. The peanut butter contains an average of 30 or more insect fragments per 100 grams;
b. The peanut butter contains an average of 1 or more rodent hairs per 100 grams.
The peanut butter is gritty to the taste and the Water-Insoluble Inorganic Residue (W.I.I.R.) is more than 25 milligrams per 100 grams.
If there is reason to believe that a lot was packed under the supervision of or certified by the U. S. Department of Agriculture, *e-mail* or FAX the following information to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding:
Date of Shipment
Amount of Lot
The article was adulterated when introduced into, while in, and is adulterated while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence therein of insect fragments (rodent hair), or that it is unfit for food because it contains grit and is gritty to the taste.
NOTE: Use direct citation authority only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a procedures issuances.
*Material between asterisks is new or revised.*
Issued: 10/7/79 12/2/88, 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)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.