[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
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]
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