§ 350a. — Infant formulas.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC350a]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV--FOOD
Sec. 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
------------------------------------------------------------------------
Nutrient Minimum a Maximum a
------------------------------------------------------------------------
Protein (gm).................. 1.8 b ............... 4.5.
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 mg)c....... 750.0 (225
mg).c
D (IU)...................... 40.0 ............... 100.0.
K (mg)...................... 4.0 ............... .............
E (IU)...................... 0.7 (with 0.7 IU/gm .............
linoleic acid).
C (ascorbic acid) (mg)...... 8.0 ............... .............
B1 (thiamine) (mg).......... 40.0 ............... .............
B2 (riboflavin) (mg)........ 60.0 ............... .............
B6 (pyridoxine) (mg)........ 35.0 (with 15 mg/gm .............
of protein in
formula).
B12 (mg).................... 0.15 ............... .............
Niacin (mg)................. 250.0 ............... .............
Folic acid (mg)............. 4.0 ............... .............
Pantothenic acid (mg)....... 300.0 ............... .............
Biotin (mg)................. 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 (mg)................. 5.0 ............... .............
Zinc (mg)................... 0.5 ............... .............
Copper (mg)................. 60.0 ............... .............
Manganese (mg).............. 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.
(June 25, 1938, ch. 675, Sec. 412, as added Pub. L. 96-359, Sec. 2,
Sept. 26, 1980, 94 Stat. 1190; amended Pub. L. 99-570, title IV,
Sec. 4014(a), (b)(1), Oct. 27, 1986, 100 Stat. 3207-116, 3207-120; Pub.
L. 103-80, Sec. 3(l), Aug. 13, 1993, 107 Stat. 777.)
Amendments
1993--Subsec. (h)(1). Pub. L. 103-80 substituted ``(e)(1)(B) of this
section'' for ``(c)(1)(B) of this section,'' in concluding provisions.
1986--Subsecs. (a) to (d). Pub. L. 99-570, Sec. 4014(a)(7), added
subsecs. (a) to (d) and struck out former subsecs. (a) relating to
adulteration and regulatory oversight, (b) relating to notice to the
Secretary by a manufacturer and requirements and scope of that notice,
(c) relating to additional notice requirements for the manufacturer, and
(d) relating to procedures applicable to recalls by a manufacturer.
Subsecs. (e), (f). Pub. L. 99-570, Sec. 4014(a)(1), (7), added
subsecs. (e) and (f) and redesignated former subsecs. (e) and (f) as (g)
and (h), respectively.
Subsec. (g). Pub. L. 99-570, Sec. 4014(a)(1), (2), redesignated
subsec. (e) as (g) and substituted ``Such records shall be retained for
at least one year after the expiration of the shelf life of the infant
formula'' for ``No manufacturer shall be required under this subsection
to retain any record respecting the distribution of an infant formula
for a period of longer than 2 years from the date the record was made''.
Former subsec. (g) redesignated (i).
Subsec. (h). Pub. L. 99-570, Sec. 4014(a)(1), redesignated subsec.
(f) as (h).
Subsec. (h)(1). Pub. L. 99-570, Sec. 4014(a)(3), (4), substituted
``(a), (b), and (c)'' for ``(a) and (b)'' and ``(e)(1)'' for ``(c)(1)''.
Pub. L. 99-570, Sec. 4014(a)(5), which directed that ``(d)(1)(B)''
be substituted for ``(e)(1)(B)'' in second sentence could not be
executed because ``(e)(1)(B)'' did not appear. See 1993 Amendment note
above.
Subsec. (h)(2). Pub. L. 99-570, Sec. 4014(a)(6), substituted ``(a),
(b), and (c)'' for ``(a) and (b)''.
Subsec. (i). Pub. L. 99-570, Sec. 4014(a)(1), (b)(1), redesignated
subsec. (g) as (i), designated existing provisions as par. (1),
substituted ``paragraph (2)'' for ``subsection (a)(2) of this section'',
substituted a period for the colon after ``as so revised'', and added
par. (2).
Effective Date of 1980 Amendment
Section 6 of Pub. L. 96-359 provided that: ``Section 412 of the
Federal Food, Drug, and Cosmetic Act (added by section 2) [this section]
shall apply with respect to infant formulas manufactured on or after the
90th day after the date of the enactment of this Act [Sept. 26, 1980].''
Section Referred to in Other Sections
This section is referred to in sections 331, 343, 374 of this title.
