21 U.S.C. § 350a : US Code - Section 350A: Infant formulas

Search 21 U.S.C. § 350a : US Code - Section 350A: Infant formulas

(a) Adulteration
An infant formula, including an infant formula powder, shall be
deemed to be adulterated if -
(1) such infant formula does not provide nutrients as required
by subsection (i) of this section,
(2) such infant formula does not meet the quality factor
requirements prescribed by the Secretary under subsection (b)(1)
of this section, or
(3) the processing of such infant formula is not in compliance
with the good manufacturing practices and the quality control
procedures prescribed by the Secretary under subsection (b)(2) of
this section.
(b) Requirements for quality factors, good manufacturing practices,
and retention of records
(1) The Secretary shall by regulation establish requirements for
quality factors for infant formulas to the extent possible
consistent with current scientific knowledge, including quality
factor requirements for the nutrients required by subsection (i) of
this section.
(2)(A) The Secretary shall by regulation establish good
manufacturing practices for infant formulas, including quality
control procedures that the Secretary determines are necessary to
assure that an infant formula provides nutrients in accordance with
this subsection and subsection (i) of this section and is
manufactured in a manner designed to prevent adulteration of the
infant formula.
(B) The good manufacturing practices and quality control
procedures prescribed by the Secretary under subparagraph (A) shall
include requirements for -
(i) the testing, in accordance with paragraph (3) and by the
manufacturer of an infant formula or an agent of such
manufacturer, of each batch of infant formula for each nutrient
required by subsection (i) of this section before the
distribution of such batch,
(ii) regularly scheduled testing, by the manufacturer of an
infant formula or an agent of such manufacturer, of samples of
infant formulas during the shelf life of such formulas to ensure
that such formulas are in compliance with this section,
(iii) in-process controls including, where necessary, testing
required by good manufacturing practices designed to prevent
adulteration of each batch of infant formula, and
(iv) the conduct by the manufacturer of an infant formula or an
agent of such manufacturer of regularly scheduled audits to
determine that such manufacturer has complied with the
regulations prescribed under subparagraph (A).
In prescribing requirements for audits under clause (iv), the
Secretary shall provide that such audits be conducted by
appropriately trained individuals who do not have any direct
responsibility for the manufacture or production of infant formula.
(3)(A) At the final product stage, each batch of infant formula
shall be tested for vitamin A, vitamin B1, vitamin C, and vitamin E
to ensure that such infant formula is in compliance with the
requirements of this subsection and subsection (i) of this section
relating to such vitamins.
(B) Each nutrient premix used in the manufacture of an infant
formula shall be tested for each relied upon nutrient required by
subsection (i) of this section which is contained in such premix to
ensure that such premix is in compliance with its specifications or
certifications by a premix supplier.
(C) During the manufacturing process or at the final product
stage and before distribution of an infant formula, an infant
formula shall be tested for all nutrients required to be included
in such formula by subsection (i) of this section for which testing
has not been conducted pursuant to subparagraph (A) or (B). Testing
under this subparagraph shall be conducted to -
(i) ensure that each batch of such infant formula is in
compliance with the requirements of subsection (i) of this
section relating to such nutrients, and
(ii) confirm that nutrients contained in any nutrient premix
used in such infant formula are present in each batch of such
infant formula in the proper concentration.
(D) If the Secretary adds a nutrient to the list of nutrients in
the table in subsection (i) of this section, the Secretary shall by
regulation require that the manufacturer of an infant formula test
each batch of such formula for such new nutrient in accordance with
subparagraph (A), (B), or (C).
(E) For purposes of this paragraph, the term "final product
stage" means the point in the manufacturing process, before
distribution of an infant formula, at which an infant formula is
homogenous and is not subject to further degradation.
(4)(A) The Secretary shall by regulation establish requirements
respecting the retention of records. Such requirements shall
provide for -
(i) the retention of all records necessary to demonstrate
compliance with the good manufacturing practices and quality
control procedures prescribed by the Secretary under paragraph
(2), including records containing the results of all testing
required under paragraph (2)(B),
(ii) the retention of all certifications or guarantees of
analysis by premix suppliers,
(iii) the retention by a premix supplier of all records
necessary to confirm the accuracy of all premix certifications
and guarantees of analysis,
(iv) the retention of -
(I) all records pertaining to the microbiological quality and
purity of raw materials used in infant formula powder and in
finished infant formula, and
(II) all records pertaining to food packaging materials which
show that such materials do not cause an infant formula to be
adulterated within the meaning of section 342(a)(2)(C) of this
title,
(v) the retention of all records of the results of regularly
scheduled audits conducted pursuant to the requirements
prescribed by the Secretary under paragraph (2)(B)(iv), and
(vi) the retention of all complaints and the maintenance of
files with respect to, and the review of, complaints concerning
infant formulas which may reveal the possible existence of a
hazard to health.
(B)(i) Records required under subparagraph (A) with respect to an
infant formula shall be retained for at least one year after the
expiration of the shelf life of such infant formula. Except as
provided in clause (ii), such records shall be made available to
the Secretary for review and duplication upon request of the
Secretary.
(ii) A manufacturer need only provide written assurances to the
Secretary that the regularly scheduled audits required by paragraph
(2)(B)(iv) are being conducted by the manufacturer, and need not
make available to the Secretary the actual written reports of such
audits.
(c) Registration of persons distributing new infant formula
(1) No person shall introduce or deliver for introduction into
interstate commerce any new infant formula unless -
(A) such person has, before introducing such new infant
formula, or delivering such new infant formula for introduction,
into interstate commerce, registered with the Secretary the name
of such person, the place of business of such person, and all
establishments at which such person intends to manufacture such
new infant formula, and
(B) such person has at least 90 days before marketing such new
infant formula, made the submission to the Secretary required by
subsection (c)(1) of this section.
(2) For purposes of paragraph (1), the term "new infant formula"
includes -
(A) an infant formula manufactured by a person which has not
previously manufactured an infant formula, and
(B) an infant formula manufactured by a person which has
previously manufactured infant formula and in which there is a
major change, in processing or formulation, from a current or any
previous formulation produced by such manufacturer.
For purposes of this paragraph, the term "major change" has the
meaning given to such term in section 106.30(c)(2) of title 21,
Code of Federal Regulations (as in effect on August 1, 1986), and
guidelines issued thereunder.
(d) Submission of information about new infant formula required
(1) A person shall, with respect to any infant formula subject to
subsection (c) of this section, make a submission to the Secretary
which shall include -
(A) the quantitative formulation of the infant formula,
(B) a description of any reformulation of the formula or change
in processing of the infant formula,
(C) assurances that the infant formula will not be marketed
unless it meets the requirements of subsections (b)(1) and (i) of
this section, as demonstrated by the testing required under
subsection (b)(3) of this section, and
(D) assurances that the processing of the infant formula
complies with subsection (b)(2) of this section.
(2) After the first production of an infant formula subject to
subsection (c) of this section, and before the introduction into
interstate commerce of such formula, the manufacturer of such
formula shall submit to the Secretary, in such form as may be
prescribed by the Secretary, a written verification which
summarizes test results and records demonstrating that such formula
complies with the requirements of subsections (b)(1), (b)(2)(A),
(b)(2)(B)(i), (b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i) of this
section.
(3) If the manufacturer of an infant formula for commercial or
charitable distribution for human consumption determines that a
change in the formulation of the formula or a change in the
processing of the formula may affect whether the formula is
adulterated under subsection (a) of this section, the manufacturer
shall, before the first processing of such formula, make the
submission to the Secretary required by paragraph (1).
(e) Additional notice requirements for manufacturer
(1) If the manufacturer of an infant formula has knowledge which
reasonably supports the conclusion that an infant formula which has
been processed by the manufacturer and which has left an
establishment subject to the control of the manufacturer -
(A) may not provide the nutrients required by subsection (i) of
this section, or
(B) may be otherwise adulterated or misbranded,
the manufacturer shall promptly notify the Secretary of such
knowledge. If the Secretary determines that the infant formula
presents a risk to human health, the manufacturer shall immediately
take all actions necessary to recall shipments of such infant
formula from all wholesale and retail establishments, consistent
with recall regulations and guidelines issued by the Secretary.
(2) For purposes of paragraph (1), the term "knowledge" as
applied to a manufacturer means (A) the actual knowledge that the
manufacturer had, or (B) the knowledge which a reasonable person
would have had under like circumstances or which would have been
obtained upon the exercise of due care.
(f) Procedures applicable to recalls by manufacturer; regulatory
oversight
(1) If a recall of infant formula is begun by a manufacturer, the
recall shall be carried out in accordance with such requirements as
the Secretary shall prescribe under paragraph (2) and -
(A) the Secretary shall, not later than the 15th day after the
beginning of such recall and at least once every 15 days
thereafter until the recall is terminated, review the actions
taken under the recall to determine whether the recall meets the
requirements prescribed under paragraph (2), and
(B) the manufacturer shall, not later than the 14th day after
the beginning of such recall and at least once every 14 days
thereafter until the recall is terminated, report to the
Secretary the actions taken to implement the recall.
(2) The Secretary shall by regulation prescribe the scope and
extent of recalls of infant formulas necessary and appropriate for
the degree of risks to human health presented by the formula
subject to the recall.
(3) The Secretary shall by regulation require each manufacturer
of an infant formula who begins a recall of such formula because of
a risk to human health to request each retail establishment at
which such formula is sold or available for sale to post at the
point of purchase of such formula a notice of such recall at such
establishment for such time that the Secretary determines necessary
to inform the public of such recall.
(g) Recordkeeping requirements for manufacturer; regulatory
oversight and enforcement
(1) 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 one year after the
expiration of the shelf life of the infant formula.
(2) To the extent that the Secretary determines that records are
not being made or maintained in accordance with paragraph (1), the
Secretary may by regulation prescribe the records required to be
made under paragraph (1) and requirements respecting the retention
of such records under such paragraph. Such regulations shall take
effect on such date as the Secretary prescribes but not sooner than
the 180th day after the date such regulations are promulgated. Such
regulations shall apply only with respect to distributions of
infant formulas made after such effective date.
(h) Exemptions; regulatory oversight
(1) Any infant formula which is represented and labeled for use
by an infant -
(A) who has an inborn error of metabolism or a low birth
weight, or
(B) who otherwise has an unusual medical or dietary problem,
is exempt from the requirements of subsections (a), (b), and (c) of
this section. The manufacturer of an infant formula exempt under
this paragraph shall, in the case of the exempt formula, be
required to provide the notice required by subsection (e)(1) of
this section only with respect to adulteration or misbranding
described in subsection (e)(1)(B) of this section and to comply
with the regulations prescribed by the Secretary under paragraph
(2).
(2) The Secretary may by regulation establish terms and
conditions for the exemption of an infant formula from the
requirements of subsections (a), (b), and (c) of this section. An
exemption of an infant formula under paragraph (1) may be withdrawn
by the Secretary if such formula is not in compliance with
applicable terms and conditions prescribed under this paragraph.
(i) Nutrient requirements
(1) An infant formula shall contain nutrients in accordance with
the table set out in this subsection or, if revised by the
Secretary under paragraph (2), as so revised.
(2) The Secretary may by regulation -
(A) revise the list of nutrients in the table in this
subsection, and
(B) revise the required level for any nutrient required by the
table.
NUTRIENTS
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Nutrient Minimum Maximum
a a

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Protein (gm) 1.8 4.5.
b

Fat:
gm 3.3 6.0.
percent cal 30.0 54.0.
Essential fatty acids
(linoeate):
percent cal 2.7
mg 300.0
Vitamins:
A (IU) 250.0 (75 750.0 (225
µg µ
)c ;g).c

D (IU) 40.0 100.0.
K (µg) 4.0
E (IU) 0.7 (with 0.7
IU/gm
linoleic acid)
C (ascorbic acid) (mg) 8.0
B1 (thiamine) 40.0
(µg)
B2 (riboflavin) 60.0
(µg)
B6 (pyridoxine) 35.0 (with 15
(µg) µg/gm
of protein in
formula)
B12 (µg) 0.15
Niacin (µg) 250.0
Folic acid (µg) 4.0
Pantothenic acid (µg) 300.0
Biotin (µg) 1.5
d

Choline (mg) 7.0
d

Inositol (mg) 4.0
d

Minerals:
Calcium (mg) 50.0
e

Phosphorus (mg) 25.0
e

Magnesium (mg) 6.0
Iron (mg) 0.15
Iodine (µg) 5.0
Zinc (mg) 0.5
Copper (µg) 60.0
Manganese (µg) 5.0
Sodium (mg) 20.0 60.0.
Potassium (mg) 80.0 200.0.
Chloride (mg) 55.0 150.0.
a Stated per 100 kilocalories.
b The source of protein shall be at least
nutritionally equivalent to casein.
c Retinol equivalents.
d Required to be included in this amount only in
formulas which are not milk-based.
e Calcium to phosphorus ratio must be no less than 1.1
nor more than 2.0.
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