[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.165]

[Page 566-567]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
 
 Subpart B--Substances Generally Prohibited From Direct Addition or Use 
                              as Human Food
 
Sec. 189.165  Nordihydroguaiaretic acid (NDGA).

    (a) Nordihydroguaiaretic acid is the chemical 4,4'-(2,3-
dimethyltetramethylene) dipyrocatechol, 
C18H22O4. It occurs naturally in the 
resinous

[[Page 567]]

exudates of certain plants. The commercial product, which is 
synthesized, has been used as an antioxidant in foods.
    (b) Food containing any added NDGA is deemed to be adulterated in 
violation of the act based upon an order published in the Federal 
Register of April 11, 1968 (33 FR 5619).
    (c) The analytical method used for detecting NDGA in food is in 
section 20.008(b) of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists International,'' 13th Ed. 
(1980), which is incorporated by reference. Copies may be obtained from 
the Association of Official Analytical Chemists International, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be 
examined at the Office of the Federal Register, 800 North Capitol 
Street, NW., suite 700, Washington, DC 20408.

[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984; 
54 FR 24900, June 12, 1989]