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

CPG Sec. 515.700 Chocolate & Chocolate Liquor - Adulteration with Insect and Rodent Filth (CPG 7105.11)

REGULATORY ACTION GUIDANCE:

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

1. Insect Filth

a. The chocolate in six (6) 100 gram subsamples contains an average of 60 or more insect fragments per 100 grams.

or

b. Any one subsample contains 90 or more insect fragments, even if the overall average of all the subsamples is less than 60.

2. Rodent Filth

a. The chocolate in six (6) 100 gram subsamples contains an average of more than 1.0 rodent hair per 100 grams, regardless of the size of the hairs or hair fragments.

or

b. Any one subsample contains more than 3 rodent hairs even if the overall average is less than 1.0 rodent hair.

*NOTE: Insect and rodent filth analyses are conducted using method 965.38, Official Methods of Analysis, (2000) 17th Edition, AOAC, Gaithersburg, MD.*

SPECIMEN CHARGE:

Article adulterated (when introduced into and while in interstate commerce) (while held for sale after introduction into interstate commerce), within the meaning of 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 hairs).

NOTE: Only use direct reference citation authority when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.

*Material between asterisks is new or revised.*

Issued: 5/1/85
Revised: 3/95, 8/96, 8/2000