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 (µg) per serving, to breakfast cereals, as defined under § 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 § 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 µg per serving if the food is a meal-replacement that is represented for use once per day; or
(2)
Two hundred µg per serving if the food is a meal-replacement that is represented for use more than once per day.