0256 21cfr107

§ 107.50

21 CFR Ch. I (4–1–06 Edition)

from the retail package under conditions of retail sale; and (c) the label on
each individual container includes the
statement ‘‘This Unit Not Intended For
Individual Sale’’ in type size not less
than one-sixteenth inch in height. The
word ‘‘Retail’’ may be used in lieu of or
immediately following the word ‘‘Individual’’ in the statement.

Subpart C—Exempt Infant
Formulas
§ 107.50 Terms and conditions.
(a) Terms and conditions. Section
412(f)(1) of the act exempts from the requirements of section 412(a), (b), and
(c)(1)(A) of the act infant formulas that
are represented and labeled for use by
an infant who has an inborn error of
metabolism or low brith weight or who
otherwise has an unusual medical or
dietary problem, if such formulas comply with regulations prescribed by the
Secretary. The regulations in this subpart establish the terms and conditions
that a manufacturer must meet with
respect to such infant formulas.
(b) Infant formulas generally available
at the retail level. (1) These exempt infant formulas can generally be purchased from retail store shelves that
are readily available to the public.
Such formulas are also typically represented and labeled for use to provide
dietary management for diseases or
conditions that are not clinically serious or life-threatening, even though
such formulas may also be represented
and labeled for use in clinically serious
or life-threatening disorders.
(2) Except as provided in paragraphs
(b)(4) and (5) of this section, an infant
formula manufacturer shall, with respect to each formula covered by this
paragraph, comply with the nutrient
requirements of section 412(g) of the
act or of regulations promulgated
under section 412(a)(2) of the act, the
quality control procedure requirements
of part 106, and the labeling requirements of subpart B of this part.
(3) To retain the exempt status of an
infant formula covered by this paragraph, the manufacturer shall submit
to the Food and Drug Administration
(FDA), at the address specified in paragraph (e)(1) of this section, on or before
May 21, 1986, or on or before the 90th

day before the first processing of the
infant formula for commercial or charitable distribution, whichever occurs
later, the label and other labeling of
the infant formula, a complete quantitative formulation for the infant formula, and a detailed description of the
medical conditions for which the infant
formula is represented. FDA will review the information under paragraph
(d) of this section.
(4) To retain the exempt status of an
infant formula covered by this paragraph, when any change in ingredients
or processes that may result in an adverse impact on levels of nutrients or
availability of nutrients is instituted,
the manufacturer shall submit to FDA
at the address specified in paragraph
(e)(1) of this section, before the first
processing of the infant formula, the
label and other labeling of the infant
formula, a complete quantitative formulation for the infant formula, a detailed description of the reformulation
and the rationale for the reformulation, a complete description of the
change in processing, and a detailed description of the medical conditions for
which the infant formula is represented. FDA will review that information under paragraph (d) of this section.
(5) A manufacturer may deviate from
the requirements of paragraph (b)(2) of
this section only with respect to those
specific requirements for which it submits to FDA, at the address specified
in paragraph (e)(1) of this section, the
medical, nutritional, scientific, or
technological rationale (including any
appropriate animal or human clinical
studies). FDA will review that information under paragraph (d) of this section.
(c) Infant formulas not generally available at the retail level. (1) These exempt
infant formulas are not generally found
on retail shelves for general consumer
purchase. Such formulas typically are
prescribed by a physician, and must be
requested from a pharmacist or are distributed directly to institutions such
as hospitals, clinics, and State or Federal agencies. Such formulas are also
generally represented and labeled solely to provide dietary management for
specific diseases or conditions that are
clinically serious or life-threatening

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Food and Drug Administration, HHS

§ 107.50

and generally are required for prolonged periods of time. Exempt infant
formulas distributed directly to institutions such as hospitals, clinics, and
State or Federal agencies that are of
the same formulation as those generally available at the retail level are
subject to the requirements of paragraph (b) of this section rather than to
the requirements of this paragraph.
(2) Except as provided for in paragraph (c)(5) of this section, an infant
formula manufacturer shall, with respect to each formula covered by this
paragraph, comply with the nutrient
requirements of section 412(g) of the
act or of regulations promulgated
under section 412(a)(2) of the act, and
the labeling requirements of subpart B
of this part.
(3) Each manufacturer of an infant
formula covered by this paragraph
shall establish quality control procedures designed to ensure that the infant formula meets applicable nutrient
requirements of this section, including
any special nutritional characteristics
for the specific disorders or conditions
for which the formula is represented
for use. Each manufacturer shall maintain records of such quality control
procedures sufficient to permit a public
health evaluation of each manufactured batch of infant formula and shall
permit any authorized FDA employee
at all reasonable times to have access
to and to copy and verify the records
referred to in this paragraph.
(4) To retain the exempt status of an
infant formula covered by this paragraph, the manufacturer shall submit
the information required by paragraphs
(b)(3) and (4) of this section.
(5) A manufacturer may deviate from
the requirements of paragraph (c)(2) of
this section only with respect to those
specific requirements for which it submits to FDA, at the address specified
in paragraph (e)(1) of this section, the
medical, nutritional, scientific, or
technological rationale (including any
appropriate animal or human clinical
studies). FDA will review that information under paragaraph (d) of this section.
(6) The requirements of this section
do not apply to an infant formula specially and individually prepared for one

or more specific infants on a physician’s request.
(d) FDA review of exempt status. (1)
FDA’s Center for Food Safety and Applied Nutrition will review information
submitted by infant formula manufacturers under paragraph (b) (3), (b) (4),
or (c)(4) of this section. On the basis of
such review and other information
available to the agency, the Center for
Food Safety and Applied Nutrition
may impose additional conditions on,
or modify requirements for, the quality
control procedures, nutrient specifications, or labeling of an infant formula,
or withdraw a product’s exempt status.
Such determinations will be made by
the Director of the Center for Food
Safety and Applied Nutrition.
(2)(i) If after completing its review of
all information submitted, the Center
for Food Safety and Applied Nutrition
concludes that additional or modified
quality control, nutrient, or labeling
requirements are needed, or that a
product’s exempt status is withdrawn,
the Center for Food Safety and Applied
Nutrition will so notify the manufacturer and this notification will specify
the reasons therefor. Upon receipt of
this notification, the manufacturer has
10 working days to have the decision
reviewed under § 10.75 by the office of
the Commissioner of Food and Drugs.
A determination by the Director of the
Center for Food Safety and Applied Nutrition that is not appealed becomes a
final agency decision.
(ii) After a final decision by the Director or by the office of the Commissioner that a product’s exempt status
is withdrawn, the manufacturer shall
comply with the nutrient requirements
of section 412(g) of the act or of regulations
promulgated
under
section
412(a)(2) of the act, the quality control
requirements of part 106, and the labeling requirements of subpart B of this
part.
(iii) The compliance date for the
withdrawal of a product’s exempt status or the imposition of additional or
modified quality control, nutrient, or
labeling requirements is 60 calendar
days after issuance of the final decision
except as otherwise provided for reasons stated in the decision. If the agency determines that a health hazard

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§ 107.100

21 CFR Ch. I (4–1–06 Edition)

may exist and so notifies the manufacturer, withdrawal of a product’s exempt status shall be effective on the
date of receipt of notification from the
Director of the Center for Food Safety
and Applied Nutrition. Additional or
modified requirements, or the withdrawal of an exemption, apply only to
those formulas that are manufactured
after the compliance date. A postponement of the compliance date may be
granted for good cause.
(3) FDA may decide that withdrawal
of an exemption is necessary when, on
the basis of its review under paragraph
(d)(1) of this section, it concludes that
quality control procedures are not adequate to ensure that the formula contains all required nutrients, that deviations in nutrient levels are not supported by generally accepted scientific,
nutritional, or medical rationale, or
that deviations from subpart B of this
part are not necessary to provide appropriate directions for preparation
and use of the infant formula, or that
additional labeling information is necessary.
(4) FDA will use the following criteria in determining whether deviations from the requirements of this
subpart are necessary and will adequately protect the public health:
(i) A deviation from the nutrient requirements of section 412(g) of the act
or of regulations promulgated under
section 412(a)(2) of the act is necessary
to provide an infant formula that is appropriate for the dietary management
of a specific disease, disorder, or medical condition;
(ii) For exempt infant formulas subject to paragraph (b) of this section, a
deviation from the quality control procedures requirements of part 106 is necessary because of unusal or difficult
technological problems in manufacturing the infant formula; and
(iii) A deviation from the labeling requirements of subpart B of this part is
necessary because label information,
including pictograms and symbols required by those regulations, could lead
to inappropriate use of the product.
(e) Notification requirements. (1) Information required by paragraphs (b) and
(c) of this section shall be submitted to
Center for Food Safety and Applied Nutrition (HFS–830), Food and Drug Ad-

ministration, 5100 Paint Branch Pkwy.,
College Park, MD 20740.
(2) The manufacturer shall promptly
notify FDA when the manufacturer has
knowledge (as defined in section
412(c)(2) of the act) that reasonably
supports the conclusion that an exempt
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 paragraph (b)
or (c) of this section, or when there is
an exempt infant formula that may be
otherwise adulterated or misbranded
and if so adulterated or misbranded
presents a risk of human health. This
notification shall be made, by telephone, to the Director of the appropriate FDA 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 FDA district office specified in part 5, subpart
M of this chapter.
[50 FR 48187, Nov. 22, 1985, as amended at 61
FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30,
2001; 66 FR 56035, Nov. 6, 2001; 67 FR 9585,
Mar. 4, 2002; 69 FR 17291, Apr. 2, 2004]

Subpart D—Nutrient Requirements
§ 107.100 Nutrient specifications.
(a) An infant formula shall contain
the following nutrients at a level not
less than the minimum level specified
and not more than the maximum level
specified for each 100 kilocalories of
the infant formula in the form prepared for consumption as directed on
the container:
Nutrients
Protein
Fat
Linoleic acid

Unit of measurement
Grams
do
Percent calories
Milligrams
Percent calories

Minimum
level

Maximum
level

1.8
3.3
30
300
2.7

4.5
6.0
54
..........
..........

250

750

Vitamins
Vitamin A

International Units

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