[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.345]

[Page 49-50]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION--Table of Contents
 
           Subpart D_Special Dietary and Nutritional Additives
 
Sec. 172.345  Folic acid (folacin).

    Folic acid (CAS Reg. No. 59-30-3), also known as folacin or folate, 
may be safely used in food as a nutrient in accordance with the 
following prescribed conditions:
    (a) Folic acid is the chemical N-[4-[[(2-amino-1,4-dihydro-4-oxo-6-
pteridinyl)methyl]amino]benzoyl]-L-glutamic acid.
    (b) Folic acid meets the specifications of the ``Food Chemicals 
Codex,'' 4th ed. (1996), pp. 157-158, which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are 
available from the National Academy Press, Box 285, 2101 Constitution 
Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or 
may be examined at the Center for Food Safety and Applied Nutrition's 
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal--register/
code--of--federal--regulations/ibr--locations.html.
    (c) Folic acid may be added to foods subject to a standard of 
identity established under section 401 of the Federal Food, Drug, and 
Cosmetic Act (the act) when the standard of identity specifically 
provides for the addition of folic acid.
    (d) Folic acid may be added, at levels not to exceed 400 micrograms 
([micro]g) per serving, to breakfast cereals, as defined under Sec. 
170.3(n)(4) of this chapter, and to corn grits at a level such that each 
pound of corn grits contains not more than 1.0 milligram of folic acid.
    (e) Folic acid may be added to infant formula in accordance with 
section 412(i)(1) of the act or with regulations issued under section 
412(i)(2) of the act which are codified in Sec. 107.100 of this 
chapter.
    (f) Folic acid may be added to a medical food, as defined in section 
5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), at levels not to 
exceed the amount necessary to meet the distinctive nutritional 
requirements of the disease or condition for which the food is 
formulated.
    (g) Folic acid may be added to food for special dietary use at 
levels not to exceed the amount necessary to meet the special dietary 
needs for which the food is formulated.
    (h) Folic acid may be added to foods represented as meal-replacement 
products, in amounts not to exceed:
    (1) Four hundred [micro]g per serving if the food is a meal-
replacement that is represented for use once per day; or

[[Page 50]]

    (2) Two hundred [micro]g per serving if the food is a meal-
replacement that is represented for use more than once per day.

[61 FR 8807, Mar. 5, 1996, as amended at 61 FR 27779, June 3, 1996; 64 
FR 1758, Jan. 12, 1999]