[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 184_DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS
SAFE--Table of Contents
Subpart B_Listing of Specific Substances Affirmed as GRAS
Sec. 184.1298 Ferric citrate.
(a) Ferric citrate (iron (III) citrate,
C6H5FeO7, CAS Reg. No. 2338-05-8) is
prepared from reaction of citric acid with ferric hydroxide. It is a
compound of indefinite ratio of citric acid and iron.
(b) The Food and Drug Administration is developing food-grade
specifications for ferric citrate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a purity
suitable for its intended use.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as a nutrient supplement as defined in Sec. 170.3(o)(20) of this
chapter, with no limitation other than current good manufacturing
practice. The ingredient may also be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16865, May 12, 1988]
Additives that reference this regulation: