0256 21cfr106

§ 106.120

21 CFR Ch. I (4–1–06 Edition)

(5) The manufacturer shall include in
a complaint file the following information concerning the complaint:
(i) The name of the infant formula;
(ii) The batch number;
(iii) The name of complainant;
(iv) A copy of the complaint or a
memo of the telephone conversation or
meeting and all correspondence with
the complainant;
(v) By reference or copy, all the associated manufacturing records and complaint investigation records needed to
evaluate the complaint. When copies of
such records are not maintained in the
complaint file, they must be available
within 24 hours when requested by an
FDA official.
(vi) All actions taken to follow up on
the complaint; and
(vii) All findings and evaluations of
the complaint.
(6) The manufacturer should maintain the files regarding infant formula
complaints at the establishment where
the infant formula was manufactured,
processed, or packed. When the manufacturer wishes to maintain all consumer complaints for the entire firm at
one location other than at the facility
where an infant formula was manufactured, processed, or packed, the manufacturer may do so as long as all
records required by this section are
available within 24 hours of request for
inspection at that facility. However,
all records of consumer complaints, including summaries, any reports, and
any files, maintained at the manufacturing facility or at any other facility
shall be made available to investigators for review and copying upon request.
(l) The manufacturer shall make
readily available for authorized inspection all records required under this
part or copies of such records. Records
shall be available at any reasonable
time at the establishment where the
activities described in such records occurred. (Infant formula complaint files
may be maintained at one facility, as
provided in § 106.100(k)(6), if all required
records are readily available at that facility.) These records or copies thereof
shall be subject to photocopying or
other means of reproduction as part of
such inspection. Records that can be
immediately retrieved from another lo-

cation by electronic means shall be
considered as meeting the requirements of this paragraph.
(m) Records required under this part
may be retained either as original
records or as true copies such as photocopies, microfilm, microfiche, or other
accurate reproductions of the original
records. Where reduction techniques,
such as microfilming are used, suitable
reader and photocopying equipment
shall be readily available.
(n) Production control, product testing, testing results, complaints, and
distribution records necessary to verify
compliance with parts 106, 107, 109, 110,
and 113 of this chapter, or with other
appropriate regulations, shall be retained for 1 year after the expiration of
the shelf life of the infant formula or 3
years from the date of manufacture,
whichever is greater.
(o) The manufacturer shall maintain
quality control records that contain
sufficient information to permit a public health evaluation of any batch of
infant formula.
[56 FR 66571, Dec. 24, 1991; 57 FR 7435, Mar. 2,
1992]

Subpart D—Notification
Requirements
§ 106.120 New formulations and reformulations.
(a) Information required by section
412(b)(2) and (3) of the act shall be submitted to Center for Food Safety and
Applied Nutrition (HFS–830), Food and
Drug
Administration,
5100
Paint
Branch Pkwy., College Park, MD 20740.
(b) The manufacturer shall promptly
notify the Food and Drug Administration when the manufacturer has knowledge (as defined in section 412(c)(2) of
the act) that reasonably supports the
conclusion that an infant formula that
has been processed by the manufacturer and that has left an establishment subject to the control of the manufacturer may not provide the nutrients required by section 412(g) of the
act and by regulations promulgated
under section 412(a)(2) of the act, or
when there is an infant formula that is
otherwise adulterated or misbranded
and that may present risk to human
health. This notification shall be made,

188

VerDate Aug<31>2005

01:16 Apr 21, 2006

Jkt 208066

PO 00000

Frm 00198

Fmt 8010

Sfmt 8010

Y:\SGML\208066.XXX

208066

Food and Drug Administration, HHS

§ 107.10

by telephone, to the Director of the appropriate Food and Drug Administration district office specified in part 5,
subpart M of this chapter. After normal business hours (8 a.m. to 4:30 p.m.)
the FDA emergency number, 301–443–
1240, shall be used. The manufacturer
shall send a followup written confirmation to the Center for Food Safety and
Applied Nutrition (HFS–605), Food and
Drug
Administration,
5100
Paint
Branch Pkwy., College Park, MD 20740,
and to the appropriate Food and Drug
Administration district office specified
in part 5, subpart M of this chapter.
[47 FR 17025, Apr. 20, 1982, as amended at 54
FR 24891, June 12, 1989; 61 FR 14479, Apr. 2,
1996; 66 FR 17358, Mar. 30, 2001; 66 FR 56035,
Nov. 6, 2001; 69 FR 17291, Apr. 2, 2004]

PART 107—INFANT FORMULA
Subpart A—General Provisions
Sec.
107.3

Subpart A—General Provisions
§ 107.3 Definitions.
The following definitions shall apply,
in addition to the definitions contained
in section 201 of the Federal Food,
Drug, and Cosmetic Act (the act):
Exempt formula. An exempt infant formula is an infant formula intended for
commercial or charitable distribution
that is represented and labeled for use
by infants who have inborn errors of
metabolism or low birth weight, or who
otherwise have unusual medical or dietary problems.
Manufacturer. A manufacturer is a
person who prepares, reconstitutes, or
otherwise changes the physical or
chemical characteristics of an infant
formula or packages the infant formula
in containers for distribution.
References. References in this part to
regulatory sections of the Code of Federal Regulations are to chapter I of
title 21, unless otherwise noted.
[50 FR 48186, Nov. 22, 1985]

Definitions.

Subpart B—Labeling

Subpart B—Labeling
107.10
107.20
107.30

Nutrient information.
Directions for use.
Exemptions.

Subpart C—Exempt Infant Formulas
107.50

Terms and conditions.

Subpart D—Nutrient Requirements
107.100

Nutrient specifications.

Subpart E—Infant Formula Recalls
107.200 Food and Drug Administration-required recall.
107.210 Firm-initiated product removals.
107.220 Scope and effect of infant formula
recalls.
107.230 Elements of an infant formula recall.
107.240 Notification requirements.
107.250 Termination of an infant formula recall.
107.260 Revision of an infant formula recall.
107.270 Compliance with this subpart.
107.280 Records retention.
AUTHORITY: 21 U.S.C. 321, 343, 350a, 371.
SOURCE: 50 FR 1840, Jan. 14, 1985, unless
otherwise noted.

§ 107.10 Nutrient information.
(a) The labeling of infant formulas,
as defined in section 201(aa) of the Federal Food, Drug, and Cosmetic Act,
shall bear in the order given, in the
units specified, and in tabular format,
the following information regarding
the product as prepared in accordance
with label directions for infant consumption:
(1) A statement of the number of
fluid ounces supplying 100 kilocalories
(in case of food label statements, a
kilocalorie is represented by the word
‘‘Calorie’’); and
(2) A statement of the amount of
each of the following nutrients supplied by 100 kilocalories:
Nutrients
Protein .............................................
Fat ...................................................
Carbohydrate ...................................
Water ...............................................
Linoleic acid ....................................
Vitamins:
Vitamin A ..................................
Vitamin D .................................
Vitamin E ..................................
Vitamin K ..................................
Thiamine (Vitamin B 1) .............
Riboflavin (Vitamin B 2 .............

Unit of measurement
Grams.
Do.
Do.
Do.
Milligrams.
International units.
Do.
Do.
Micrograms.
Do.
Do.

189

VerDate Aug<31>2005

01:16 Apr 21, 2006

Jkt 208066

PO 00000

Frm 00199

Fmt 8010

Sfmt 8010

Y:\SGML\208066.XXX

208066