Sec. 555.550 Foods, Standardized; Enriched or Fortified - Adulteration Involving
Misbranding - Potency (CPG 7120.22)
REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure to the *Division of
Compliance Management and Operations (HFC-210) and for direct citation by the District
Offices*:
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