Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

Updated: 2005-11-29

Sec. 550.700 Dried Prunes, Dehydrated Low Moisture Prunes, and Pitted Prunes - Adulteration Involving Insects; Decomposition; Dirt; Pits, and Pit Fragments (CPG 7110.27)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

NOTE: Examine a minimum of ten subsamples.

  1. Dried and Dehydrated Low Moisture Prunes - The average of the subsamples is 5 percent or more by count insect infested, moldy or decomposed, dirty and/or otherwise unfit prunes.
  2. Pitted Prunes - Examination of a minimum of 50 prunes from each of 10 subs from each code, or from the lot if no codes are present, by microanalytical manual method M13K3 shows the following:

    An average of 2% or more by count of prunes with whole pits and/or pit fragments 2mm or longer;

    and
    Four or more of the 10 subs examined contain 2% or more prunes by count with whole pits and/or pit fragments 2 mm or longer.

REMARKS:

Seizures of these products must be discussed with U.S.D.A. *E-mail* or FAX the following information to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding:

Sample Number Date of Shipment
Article Involved Dealer
Amount of Lot Shipper
Codes Analytical Conclusions

SPECIMEN CHARGE:

  1. Filth adulteration - Article adulterated when introduced into and while in interstate commerce, within the meaning of U.S.C. 342(a)(3) in that it consists wholly or in part of a filthy substance by reason of presence therein of insects, insect webbing, insect excreta, insect damaged prunes and dirt; and of a decomposed substance by reason of presence therein of moldy, decomposed prunes.
  2. Pitted Prunes - Article adulterated when introduced into and while in interstate commerce, within the meaning of U.S.C. 342(b)(2) in that prunes with pits and/or pit fragments have been substituted wholly or in part for pitted prunes.

Article misbranded when introduced into and while in interstate commerce, within meaning of *21 U.S.C. 343(a)(1)* in that label statement "Pitted Prunes" is false and misleading as applied to a product containing prunes with pit fragments.

Issued: 10/1/80
Revised: 3/95, 5/2005