CPG Sec 555.550 Foods, Standardized; Enriched or Fortified - Adulteration Involving Misbranding - Potency

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CPG Sec. 555.550 Foods, Standardized;
Enriched or Fortified - Adulteration Involving
Misbranding - Potency
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*:
The article is an enriched or fortified food for which a standard of identity has been established,
and is more than 20% deficient in one or more of the vitamins or minerals required to be present
by the standard of identity.
SPECIMEN CHARGES:
The article is adulterated while held for sale after shipment in interstate commerce, within the
meaning of 21 U.S.C. 342(b)(1) in that a valuable constituent, namely riboflavin, has been
wholly or in part omitted, or abstracted therefrom.
The article is misbranded while held for sale after shipment in interstate commerce, within the
meaning of 21 U.S.C. 343(g)(1), in that it purports to be and is represented as enriched noodles, a
food for which a definition and standard of identity has been prescribed by regulations (21 CFR
139.155) promulgated pursuant to 21 U.S.C. 341, and it fails to conform to such definition and
standard since paragraph 139.155(a)(1) of such definition and standard prescribes, among other
things, that enriched noodles contain in each pound not less than 1.7 milligrams of riboflavin;
whereas the article contains less than 1.7 milligrams of riboflavin in each pound.
*Material between asterisks is new or revised.*
Issued: 11/21/79
Reissued: 10/1/80
Revised: 2/1/89