[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.21]

[Page 16]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 201_LABELING--Table of Contents
 
                  Subpart A_General Labeling Provisions
 
Sec. 201.21  Declaration of presence of phenylalanine as a component 
of aspartame in over-the-counter and prescription drugs for human use.

    (a) Aspartame is the methylester of a dipeptide composed of two 
amino acids, phenylalanine and aspartic acid. When these two amino acids 
are so combined to form aspartame (1-methyl N-L-[alpha]-aspartyl-L-
phenylalanine), they produce an intensely sweet-tasting substance, 
approximately 180 times as sweet as sucrose. The Food and Drug 
Administration has determined that aspartame when used at a level no 
higher than reasonably required to perform its intended technical 
function is safe for use as an inactive ingredient in human drug 
products, provided persons with phenylketonuria, who must restrict 
carefully their phenylalanine intake, are alerted to the presence of 
phenylalanine in the drug product and the amount of the ingredient in 
each dosage unit.
    (b) The label and labeling of all over-the-counter human drug 
products containing aspartame as an inactive ingredient shall bear a 
statement to the following effect: Phenylketonurics: Contains 
Phenylalanine (--)mg Per (Dosage Unit).
    (c) The package labeling and other labeling providing professional 
use information concerning prescription drugs for human use containing 
aspartame as an inactive ingredient shall bear a statement to the 
following effect under the ``Precautions'' section of the labeling, as 
required in Sec. 201.57(f)(2): Phenylketonurics: Contains Phenylalanine 
(--)mg Per (Dosage Unit).
    (d) Holders of approved new drug applications who reformulate their 
drug products under the provisions of this section shall submit 
supplements under Sec. 314.70 of this chapter to provide for the new 
composition and the labeling changes.

(Approved by the Office of Management and Budget under control number 
0910-0242)

[52 FR 2111, Jan. 20, 1987; 52 FR 12152, April 15, 1987; 53 FR 4135, 
Feb. 12, 1988]