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Code of Federal Regulations
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[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.3]
[Page 190]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart A--General Provisions
Sec. 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]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.10]
[Page 190-191]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart B--Labeling
Sec. 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 Unit of measurement
------------------------------------------------------------------------
Protein................................... Grams.
Fat....................................... Do.
Carbohydrate.............................. Do.
Water..................................... Do.
Linoleic acid............................. Milligrams.
Vitamins:
Vitamin A............................... International units.
Vitamin D............................... Do.
Vitamin E............................... Do.
Vitamin K............................... Micrograms.
Thiamine (Vitamin B <INF>1</INF>).................. Do.
Riboflavin (Vitamin B <INF>2</INF>................. Do.
Vitamin B <INF>6</INF>............................. Do.
Vitamin B <INF>12</INF>............................ Do.
Niacin.................................. Do.
Folic acid (Folacin).................... Do.
Pantothenic acid........................ Do.
Biotin.................................. Do.
Vitamin C (Ascorbic acid)............... Milligrams.
Choline................................. Do.
Inositol................................ Do.
Minerals:
Calcium................................. Milligrams.
Phosphorus.............................. Do.
Magnesium............................... Do.
Iron.................................... Do.
Zinc.................................... Do.
Manganese............................... Micrograms.
Copper.................................. Do.
[[Page 191]]
Iodine.................................. Do.
Sodium.................................. Milligrams.
Potassium............................... Do.
Chloride................................ Do.
------------------------------------------------------------------------
(b) In addition the following apply:
(1) Vitamin A content may also be declared on the label in units of
microgram retinol equivalents, vitamin D content in units of micrograms
cholecalciferol, vitamin E content in units of milligram alpha-
tocopherol equivalents, and sodium, potassium, and chloride content in
units of millimoles, micromoles, or milliequivalents. When these
declarations are made they shall appear in parentheses immediately
following the declarations in International Units for vitamins A, D, and
E, and immediately following the declarations in milligrams for sodium,
potassium, and chloride.
(2) Biotin, choline, and inositol content shall be declared except
when they are not added to milk-based infant formulas.
(3) Each of the listed nutrients, and the caloric density, may also
be declared on the label on other bases, such as per 100 milliliters or
per liter, as prepared for infant consumption.
(4) One of the following statements shall appear on the principal
display panel, as appropriate:
(i) The statement ``Infant Formula With Iron'', or a similar
statement, if the product contains 1 milligram or more of iron in a
quantity of product that supplies 100 kilocalories when prepared in
accordance with label directions for infant consumption.
(ii) The statement ``Additional Iron May Be Necessary'', or a
similar statement, if the product contains less than 1 milligram of iron
in a quantity of product that supplies 100 kilocalories when prepared in
accordance with label directions for infant consumption.
(5) Any additional vitamin may be declared at the bottom of the
vitamin list and any additional minerals may be declared between iodine
and sodium, provided that any additionally declared nutrient (i) has
been identified as essential by the National Academy of Sciences through
its development of a recommended dietary allowance or an estimated safe
and adequate daily dietary intake range, or has been identified as
essential by the Food and Drug Administration through a Federal Register
publication or establishment of a U.S. Recommended Daily Allowance, and
(ii) is provided at a level considered in these publications as having
biological significance, when these levels are known.
(Information Collection requirements were approved by the Office of
Management and Budget under control number 0910-0159)
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.20]
[Page 191-192]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart B--Labeling
Sec. 107.20 Directions for use.
In addition to the applicable labeling requirements in parts 101 and
105 of this chapter, the product label shall bear:
(a) Under the heading ``Directions For Preparation and Use'',
directions for:
(1) Storage of infant formula before and after the container has
been opened, including a statement indicating that prolonged storage at
excessive temperatures should be avoided;
(2) Agitating liquid infant formula before opening the container,
such as ``Shake Well Before Opening'';
(3) ``Sterilization'' of water, bottle, and nipples when necessary
for preparing infant formula for use;
(4) Dilution of infant formula, when appropriate. Directions for
powdered infant formula shall contain the weight and volume of powdered
formula to be reconstituted.
(b) In close proximity to the ``Directions for Preparation and Use''
a pictogram depicting the major steps for preparation of that infant
formula, such as (for a concentrated formula):
[[Page 192]]
[GRAPHIC] [TIFF OMITTED] TR01JA93.366
(c) A ``Use by ______'' date, the blank to be filled in with the
month and year selected by the manufacturer, packer, or distributor of
the infant formula on the basis of tests or other information showing
that the infant formula, until that date, under the conditions of
handling, storage, preparation, and use prescribed by label directions,
will: (1) when consumed, contain not less than the quantity of each
nutrient, as set forth on its label; and (2) otherwise be of an
acceptable quality (e.g., pass through an ordinary bottle nipple).
(d) The statement ``Add Water'' or ``Do Not Add Water'', as
appropriate, to appear on the principal display panel of concentrated or
ready-to-feed infant formulas. In close proximity to the statement ``Add
Water'', a symbol such as
[GRAPHIC] [TIFF OMITTED] TC01MR93.000
if the addition of water is necessary. The symbol shall be placed on a
white background encircled by a dark border.
(e) A warning statement beneath or in close proximity to the
``Directions For Preparation and Use'' that cautions against improper
preparation or use of an infant formula, such as ``THE HEALTH OF YOUR
INFANT DEPENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARATION AND
USE''.
(f) A statement indicating that parents should consult their
physicians about the use of infant formulas, such as ``USE AS DIRECTED
BY A PHYSICIAN''.
(Collection of information requirements were approved by the Office of
Management and Budget (OMB) and assigned OMB control number 0910-0159)
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.30]
[Page 192-193]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart B--Labeling
Sec. 107.30 Exemptions.
When containers of ready-to-feed infant formula, to be sold at the
retail level, are contained within a multiunit package, the labels of
the individual containers shall contain all of the label information
required by section 403 of the Federal Food, Drug, and Cosmetic Act (the
act), Secs. 107.10 and 107.20, and all appropriate sections of part 101
of this chapter, except that the labels of the individual containers
contained within the outer package shall be exempt from compliance with
the requirements of section 403 (e)(1) and (i)(2) of the act; and
Secs. 107.10 (a) and (b)(2) and 107.20 (b), (e), and (f), provided that
(a) the multiunit package meets all the requirements of this part; (b)
individual containers are securely enclosed within
[[Page 193]]
and are not intended to be separated 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.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.50]
[Page 193-195]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart C--Exempt Infant Formulas
Sec. 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
[[Page 194]]
clinically serious or life-threatening 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 Sec. 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
[[Page 195]]
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
Administration, 200 C St. SW., Washington, DC 20204.
(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 Sec. 5.215 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, 200 C St.
SW., Washington, DC 20204, and to the appropriate FDA district office
specified in Sec. 5.215.
(Information Collection requirements were approved by the Office of
Management and Budget under control number 0910-0158)
[50 FR 48187, Nov. 22, 1985, as amended at 61 FR 14479, Apr. 2, 1996; 66
FR 17358, Mar. 30, 2001]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.100]
[Page 195-196]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart D--Nutrient Requirements
Sec. 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:
------------------------------------------------------------------------
Minimum Maximum
Nutrients Unit of measurement level level
------------------------------------------------------------------------
Protein Grams 1.8 4.5
Fat do 3.3 6.0
Percent calories 30 54
Linoleic acid Milligrams 300 .......
Percent calories 2.7 .......
------------------------------------------------------------------------
[[Page 196]]
Vitamins
------------------------------------------------------------------------
Vitamin A International Units 250 750
Vitamin D do 40 100
Vitamin E do 0.7 .......
Vitamin K Micrograms 4 .......
Thiamine (vitamin B<INF>1</INF>) do 40 .......
Riboflavin (vitamin B<INF>2</INF>) do 60 .......
Vitamin B<INF>6</INF> do 35 .......
Vitamin B<INF>12</INF> do 0.15 .......
Niacin<SUP>1</SUP> do 250 .......
Folic acid (folacin) do 4 .......
Pantothenic acid do 300 .......
Biotin <SUP>2</SUP> do 1.5 .......
Vitamin C (ascorbic Milligrams 8 .......
acid)
Choline<SUP>2</SUP> do 7 .......
Inositol <SUP>2</SUP> do 4 .......
------------------------------------------------------------------------
Minerals
------------------------------------------------------------------------
Calcium do 60 .......
Phosphorus do 30 .......
Magnesium do 6 .......
Iron do 0.15 3.0
Zinc do 0.5 .......
Manganese Micrograms 5 .......
Copper Micrograms 60 .......
Iodine do 5 75
Sodium Milligrams 20 60
Potassium do 80 200
Chloride do 55 150
------------------------------------------------------------------------
\1\ The generic term ``niacin'' includes niacin (nicotinic acid) and
niacinamide (nicotinamide).
\2\ Required only for non-milk-based infant formulas.
In addition to the specifications established in the table in this
paragraph for vitamins and minerals, the following also apply:
(b) Vitamin E shall be present at a level of at least 0.7
International Unit of vitamin E per gram of linoleic acid.
(c) Any vitamin K added shall be in the form of phylloquinone.
(d) Vitamin B<INF>6</INF> shall be present at a level of at least 15
micrograms of vitamin B<INF>6</INF> for each gram of protein in excess
of 1.8 grams of protein per 100 kilocalories of infant formula in the
form prepared for consumption as directed on the container.
(e) The ratio of calcium to phosphorus in infant formula in the form
prepared for consumption as directed on the container shall be no less
than 1.1 and not more than 2.0.
(f) Protein shall be present in an amount not to exceed 4.5 grams
per 100 kilocalories regardless of quality, and not less than 1.8 grams
per 100 kilocalories of infant formula in the form prepared for
consumption as directed on the container when its biological quality is
equivalent to or better than that of casein. If the biological quality
of the protein is less than that of casein, the minimum amount of
protein shall be increased proportionately to compensate for its lower
biological quality. For example, an infant formula containing protein
with a biological quality of 75 percent of casein shall contain at least
2.4 grams of protein (1.8/0.75). No protein with a biological quality
less than 70 percent of casein shall be used.
[50 FR 45108, Oct. 30, 1985]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.200]
[Page 196]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart E--Infant Formula Recalls
Sec. 107.200 Food and Drug Administration-required recall.
Source: 54 FR 4008, Jan. 27, 1989, unless otherwise noted.
When the Food and Drug Administration determines that an adulterated
or misbranded infant formula presents a risk to human health, a
manufacturer shall immediately take all actions necessary to recall that
formula, extending to and including the retail level, consistent with
the requirements of this subpart.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.210]
[Page 196-197]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart E--Infant Formula Recalls
Sec. 107.210 Firm-initiated product removals.
(a) If a manufacturer has determined to recall voluntarily from the
market an infant formula that is not subject to Sec. 107.200 but that
otherwise violates the laws and regulations administered by the Food and
Drug Administration (FDA) and that would be subject to legal action, the
manufacturer, upon prompt notification to FDA, shall administer such
voluntary recall consistent with the requirements of this subpart.
(b) If a manufacturer has determined to withdraw voluntarily from
the market an infant formula that is adulterated or misbranded in only a
minor way and that would not be subject to legal action, such removal
from the market is deemed to be a market withdrawal, as defined in
Sec. 7.3(j) of this chapter. As required by Sec. 107.240(a), the
manufacturer shall promptly notify FDA of such violative formula and
[[Page 197]]
may, but is not required to, conduct such market withdrawal consistent
with the requirements of this subpart pertaining to product recalls.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.220]
[Page 197]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart E--Infant Formula Recalls
Sec. 107.220 Scope and effect of infant formula recalls.
(a) The requirements of this subpart apply:
(1) When the Food and Drug Administration has determined that it is
necessary to remove from the market a distributed infant formula that is
in violation of the laws and regulations administered by the Food and
Drug Administration and that poses a risk to human health; or
(2) When a manufacturer has determined that it is necessary to
remove from the market a distributed infant formula that:
(i) Is no longer subject to the manufacturer's control;
(ii) Is in violation of the laws and regulations administered by the
Food and Drug Administration and against which the agency could initiate
legal or regulatory action; and
(iii) Does not present a human risk.
(b) The Food and Drug Administration will monitor continually the
recall action and will take appropriate actions to ensure that the
violative infant formula is removed from the market.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.230]
[Page 197-198]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart E--Infant Formula Recalls
Sec. 107.230 Elements of an infant formula recall.
A recalling firm shall conduct an infant formula recall with the
following elements:
(a) The recalling firm shall evaluate in writing the hazard to human
health associated with the use of the infant formula. This health hazard
evaluation shall include consideration of any disease, injury, or other
adverse physiological effect that has been or that could be caused by
the infant formula and of the seriousness, likelihood, and consequences
of the diseases, injury, or other adverse physiological effect. The Food
and Drug Administration will conduct its own health hazard evaluation
and promptly notify the recalling firm of the results of that evaluation
if the criteria for recall under Sec. 107.200 have been met.
(b) The recalling firm shall devise a written recall strategy suited
to the individual circumstances of the particular recall. The recall
strategy shall take into account the health hazard evaluation and
specify the following: The extent of the recall; if necessary, the
public warning to be given about any hazard presented by the infant
formula; the disposition of the recalled infant formula; and the
effectiveness checks that will be made to determine that the recall is
carried out.
(c) The recalling firm shall promptly notify each of its affected
direct accounts about the recall. The format of a recall communication
shall be distinctive, and the content and extent of a recall
communication shall be commensurate with the hazard of the infant
formula being recalled and the strategy developed for the recall. The
recall communication shall instruct consignees to report back quickly to
the recalling firm about whether they are in possession of the recalled
infant formula and shall include a means of doing so. The recalled
communication shall also advise consignees how to return the recall
infant formula to the manufacturer or otherwise dispose of it. The
recalling firm shall send a followup recall communication to any
consignee that does not respond to the initial recall communication.
(d) If the infant formula presents a risk to human health, the
recalling firm shall request that each establishment, at which such
infant formula is sold or available for sale, post at the point of
purchase of such formula a notice of such recall at such establishment.
The notice shall be provided by the recalling firm after approval of the
notice by the Food and Drug Administration. The recalling firm shall
also request that each retail establishment maintain such notice on
display until such time as the Food and Drug Administration notifies the
recalling firm that the agency considers the recall completed.
(e) The recalling firm shall furnish promptly to the appropriate
Food and Drug Administration district office listed in Sec. 5.215 of
this chapter, as they are available, copies of the health hazard
evaluation, the recall strategy, and all recall communications
(including,
[[Page 198]]
for a recall under Sec. 107.200, the notice to be displayed at retail
establishments) directed to consignees, distributors, retailers, and
members of the public.
[54 FR 4008, Jan. 27, 1989, as amended at 66 FR 17358, Mar. 30, 2001]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.240]
[Page 198]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart E--Infant Formula Recalls
Sec. 107.240 Notification requirements.
(a) Notification of a violative infant formula. A manufacturer shall
promptly notify the Food and Drug Administration when the manufacturer
has knowledge (as defined in section 412(e)(2) of the Federal Food,
Drug, and Cosmetic Act (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:
(1) May not provide the nutrients required by section 412(i) of the
act and by regulations promulgated under section 412(i)(2) of the act;
or
(2) May be otherwise adulterated or misbranded.
(b) Method of notification. The notification made pursuant to
Sec. 107.240(a) shall be made, by telephone, to the Director of the
appropriate Food and Drug Administration district office specified in
Sec. 5.215 of this chapter. After normal business hours (8 a.m. to 4:30
p.m.), FDA's emergency number, 301-443-1240, shall be used. The
manufacturer shall send written confirmation of the notification to the
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, and to the
appropriate Food and Drug Administration district office specified in
Sec. 5.215 of this chapter.
(c) Reports about an infant formula recall--(1) Telephone report.
When a determination is made that an infant formula is to be recalled,
the recalling firm shall telephone within 24 hours the appropriate Food
and Drug Administration district office listed in Sec. 5.115 of this
chapter and shall provide relevant information about the infant formula
that is to be recalled.
(2) Initial written report. Within 14 days after the recall has
begun, the recalling firm shall provide a written report to the
appropriate Food and Drug Administration district office. The report
shall contain relevant information, including the following cumulative
information concerning the infant formula that is being recalled:
(i) Number of consignees notified of the recall, and date and method
of notification, including, for a recall pursuant to Sec. 107.200
information about the notice provided for retail display and the request
for its display.
(ii) Number of consignees responding to the recall communication and
quantity of recalled infant formula on hand at the time it was received.
(iii) Quantity of recalled infant formula returned or corrected by
each consignee contacted and the quantity of recalled infant formula
accounted for.
(iv) Number and results of effectiveness checks that were made.
(v) Estimated timeframes for completion of the recall.
(3) Status reports. The recalling firm shall submit to the
appropriate Food and Drug Administration district office a written
status report on the recall at least every 14 days until the recall is
terminated. The status report shall describe the steps taken by the
recalling firm to carry out the recall since the last report and the
results of these steps.
[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996; 66
FR 17359, Mar. 30, 2001]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.250]
[Page 198-199]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart E--Infant Formula Recalls
Sec. 107.250 Termination of an infant formula recall.
The recalling firm may submit a recommendation for termination of
the recall to the appropriate Food and Drug Administration district
office listed in Sec. 5.215 of this chapter for transmittal to the
Center for Food Safety and Applied Nutrition (HFS-605), for action. Any
such recommendation shall contain information supporting a conclusion
that the recall strategy has been effective. The agency will respond
within 15 days of receipt by the Center for Food Safety and Applied
Nutrition (HFS-605), of the request for termination. The recalling firm
shall continue to implement the recall strategy until it receives final
written notification from the agency that the recall has been
terminated. The agency will send such a notification unless it has
information, from
[[Page 199]]
FDA's own audits or from other sources, demonstrating that the recall
has not been effective. The agency may conclude that a recall has not
been effective if:
(a) The recalling firm's distributors have failed to retrieve the
recalled infant formula; or
(b) Stocks of the recalled infant formula remain in distribution
channels that are not in direct control of the recalling firm.
[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996; 66
FR 17359, Mar. 30, 2001]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.260]
[Page 199]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart E--Infant Formula Recalls
Sec. 107.260 Revision of an infant formula recall.
If after a review of the recalling firm's recall strategy or
periodic reports or other monitoring of the recall, the Food and Drug
Administration concludes that the actions of the recalling firm are
deficient, the agency shall notify the recalling firm of any serious
deficiency. The agency may require the firm to:
(a) Change the extent of the recall, if the agency concludes on the
basis of available data that the depth of the recall is not adequate in
light of the risk to human health presented by the infant formula.
(b) Carry out additional effectiveness checks, if the agency's
audits, or other information, demonstrate that the recall has not been
effective.
(c) Issue additional notifications to the firm's direct accounts, if
the agency's audits, or other information demonstrate that the original
notifications were not received, or were disregarded in a significant
number of cases.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.270]
[Page 199]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart E--Infant Formula Recalls
Sec. 107.270 Compliance with this subpart.
A recalling firm may satisfy the requirements of this subpart by any
means reasonable calculated to meet the obligations set forth in this
Subpart E. The recall guidance in subpart C of part 7 of this chapter
specify procedures that may be useful to a recalling firm in determining
how to comply with these regulations.
[54 FR 4008, Jan. 27, 1989, as amended at 65 FR 56479, Sept. 19, 2000]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR107.280]
[Page 199]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES--CONTINUED
PART 107--INFANT FORMULA--Table of Contents
Subpart E--Infant Formula Recalls
Sec. 107.280 Records retention.
Each manufacturer of an infant formula shall make and retain such
records respecting the distribution of the infant formula through any
establishment owned or operated by such manufacturer as may be necessary
to effect and monitor recalls of the formula. Such records shall be
retained for at least 1 year after the expiration of the shelf life of
the infant formula.
(Collection of information requirements in this section were approved by
the Office of Management and Budget under OMB control number 0910-0188)
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