Title 21 — Food and Drugs
Chapter 9 — Federal Food, Drug, and Cosmetic Act
§ 350a. Infant formulas
Statutory text
Adulteration
An infant formula, including an infant formula powder, shall be deemed to be adulterated if—
such infant formula does not provide nutrients as required by subsection (i),
such infant formula does not meet the quality factor requirements prescribed by the Secretary under subsection (b)(1), or
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).
Requirements for quality factors, good manufacturing practices, and retention of records
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).
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) and is manufactured in a manner designed to prevent adulteration of the infant formula.
The good manufacturing practices and quality control procedures prescribed by the Secretary under subparagraph (A) shall include requirements for—
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) before the distribution of such batch,
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,
in-process controls including, where necessary, testing required by good manufacturing practices designed to prevent adulteration of each batch of infant formula, and
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.
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) relating to such vitamins.
Each nutrient premix used in the manufacture of an infant formula shall be tested for each relied upon nutrient required by subsection (i) which is contained in such premix to ensure that such premix is in compliance with its specifications or certifications by a premix supplier.
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) for which testing has not been conducted pursuant to subparagraph (A) or (B). Testing under this subparagraph shall be conducted to—
ensure that each batch of such infant formula is in compliance with the requirements of subsection (i) relating to such nutrients, and
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.
If the Secretary adds a nutrient to the list of nutrients in the table in subsection (i), 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).
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.
The Secretary shall by regulation establish requirements respecting the retention of records. Such requirements shall provide for—
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),
the retention of all certifications or guarantees of analysis by premix suppliers,
the retention by a premix supplier of all records necessary to confirm the accuracy of all premix certifications and guarantees of analysis,
the retention of—
all records pertaining to the microbiological quality and purity of raw materials used in infant formula powder and in finished infant formula, and
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,
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
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.
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.
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.
Registration of persons distributing new infant formula
No person shall introduce or deliver for introduction into interstate commerce any new infant formula unless—
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
such person has at least 90 days before marketing such new infant formula, made the submission to the Secretary required by subsection (d)(1).
For purposes of paragraph (1), the term “new infant formula” includes—
an infant formula manufactured by a person which has not previously manufactured an infant formula, and
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 ), and guidelines issued thereunder.
Submission of information about new infant formula required
A person shall, with respect to any infant formula subject to subsection (c), make a submission to the Secretary which shall include—
the quantitative formulation of the infant formula,
a description of any reformulation of the formula or change in processing of the infant formula,
assurances that the infant formula will not be marketed unless it meets the requirements of subsections (b)(1) and (i), as demonstrated by the testing required under subsection (b)(3), and
assurances that the processing of the infant formula complies with subsection (b)(2).
After the first production of an infant formula subject to subsection (c), 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).
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), the manufacturer shall, before the first processing of such formula, make the submission to the Secretary required by paragraph (1).
The Secretary shall provide a response to a submission under this subsection not later than 45 days after receiving such submission.
Additional notice requirements for manufacturer
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—
may not provide the nutrients required by subsection (i), or
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.
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.
Procedures applicable to recalls by manufacturer; regulatory oversight
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—
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
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.
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.
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.
Recordkeeping requirements for manufacturer; regulatory oversight and enforcement
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.
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.
Exemptions; regulatory oversight
Any infant formula which is represented and labeled for use by an infant—
who has an inborn error of metabolism or a low birth weight, or
who otherwise has an unusual medical or dietary problem,
is exempt from the requirements of subsections (a), (b), and (c). 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) only with respect to adulteration or misbranding described in subsection (e)(1)(B) and to comply with the regulations prescribed by the Secretary under paragraph (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). 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.
Nutrient requirements
An infant formula shall contain nutrients in accordance with the table set out in this subsection, which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table.
The Secretary may by regulation—
revise the list of nutrients in the table in this subsection, and
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 (linoleate): | |||
| percent cal | 2.7 | ||
| mg | 300.0 | ||
| Vitamins: | |||
| A (IU) | 250.0 | (75 μg)c | 750.0 (225 μg).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) (μg) | 40.0 | ||
| B2 (riboflavin) (μg) | 60.0 | ||
| B6 (pyridoxine) (μg) | 35.0 | (with 15 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. | |||
Premarket submissions to address shortages
In general
The Secretary shall waive the 90-day premarket submission requirement under subsection (c) and apply a 30-day premarket submission requirement for any person who intends to introduce or deliver for introduction into interstate commerce any new infant formula.
Effective period
The waiver authority under this subsection shall remain in effect—
for 90 days beginning on the date that the Secretary distributes information under section 350m(a)(2) of this title with respect to a shortage of infant formula; or
such longer period as the Secretary determines appropriate, to prevent or mitigate a shortage of infant formula.
Congressional notification of recall
In general
Not later than 24 hours after the initiation of a recall of infant formula as described in subsection (e), the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a notification of such recall.
Contents
A notification under paragraph (1) shall include the following:
If the recall is required by the Food and Drug Administration, a summary of the information supporting a determination that the adulterated or misbranded infant formula presents a risk to human health.
If the recall is voluntarily initiated by the manufacturer, a summary of the information provided to the Food and Drug Administration by the manufacturer regarding infant formula that has left the control of the manufacturer that may be adulterated or misbranded.
Specification of when the Food and Drug Administration was first made aware of the instance or circumstances surrounding the recall.
An initial estimate of the disruption in domestic production that may result from the recall.
Annual report to Congress
In general
Not later than March 30 of each year, the Secretary shall submit a report to Congress containing, with respect to the preceding calendar year, the following information:
The number of submissions received by the Secretary under subsection (d).
The number of such submissions that included any new ingredients that were not included in any infant formula already on the market.
The number of inspections conducted by the Food and Drug Administration or any agent thereof to evaluate compliance with the requirements for infant formulas under subsection (b).
The time between any inspection referred to in subparagraph (C) and any necessary reinspection to evaluate compliance with the requirements for infant formulas under subsection (b).
A breakdown of the information described in subparagraphs (A) through (D) between foreign and domestic manufacturers and facilities.
Confidentiality
The Secretary shall ensure that the reports under paragraph (1) do not include any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18.
Waiver of requirements for importation of specialty infant formula
In general
The Secretary may, during a shortage of specialty infant formula as determined by the Secretary, waive any requirement under this chapter applicable to facilitate the importation of specialty infant formula. Such a waiver may be applicable to—
the importation of specialty infant formula from any country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of this chapter; or
the distribution and sale of such imported specialty infant formula.
Rule of construction
Nothing in paragraph (1) shall be construed to limit the authority of the Secretary to require a recall of, or otherwise impose restrictions and requirements under this chapter with respect to, specialty infant formula that is subject to a waiver under paragraph (1).
Definition of specialty infant formula
In this subsection, the term “specialty infant formula” means infant formula described in subsection (h)(1).
Legislative history
Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.
Infant Formula Act of 1980
Pub. L. 96–359 § 2 · 94 Stat. 1190
Enacted · 21 U.S.C. § 350a
June 25, 1938, ch. 675, § 412, as added Pub. L. 96–359, § 2, Sept. 26, 1980, 94 Stat. 1190
Source evidence
Code source credit
June 25, 1938, ch. 675, § 412, as added Pub. L. 96–359, § 2, Sept. 26, 1980, 94 Stat. 1190Enacted provision · exact public law section
Sec. 2. Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding after section 411 the following new section: “Sec. 412. “requirements for infant formulas (a) (1) An infant formula shall be deemed to be adulterated if— “(A) such infant formula does not provide nutrients as required by subsection (g); “(B) such infant formula does not meet the quality factor requirements prescribed by the Secretary under this section; or “(C) the processing of such infant formula is not in compliance with the quality control requirements prescribed by the Secretary under this section. “(2) The Secretary may by regulation— “(A) revise the list of nutrients in the table in subsection (g); “(B) revise the required level for any nutrient required by subsection (g); “(C) establish requirements for quality factors for such nutrients; and “(D) establish such quality control procedures as the Secretary determines necessary to assure that an infant formula provides nutrients in accordance with this section and establish requirements respecting the retention of records of procedures required under this clause (including maintaining necessary nutrient testing records). Testing. Quality control procedures prescribed by the Secretary shall include the periodic testing of infant formulas to determine whether they are in compliance with this section. “(b) (1) On the 90th day after the date of the enactment of this section, and on each 90th day thereafter, a manufacturer of infant formula shall notify the Secretary that each infant formula manufactured by such manufacturer provides the nutrients required under subsection (g). Such notification requirement shall expire upon the effective date of regulations relating to quality control procedures prescribed by the Secretary under subsection (a)(2)(D). “(2) Not later than the 90th day before the first processing of any infant formula for commercial or charitable distribution for human consumption, the manufacturer shall notify the Secretary whether— “(A) such infant formula provides nutrients in accordance with subsection (g) and meets the quality factor requirements prescribed by the Secretary; and “(B) the processing of such infant formula meets the quality control procedure requirements prescribed by the Secretary. “(3) Before the first processing of any infant formula for commercial or charitable distribution for human consumption— “(A) after a change in its formulation, or “(B) after a change in its processing, which the manufacturer reasonably determines may affect whether the formula is adulterated as determined under subsection (a)(1), the manufacturer shall notify the Secretary of such changes and that the formula provides nutrients in accordance with subsection (g) and meets the quality factor requirements prescribed by the Secretary and that the processing of such infant formula is in compliance with the quality control procedures prescribed by the Secretary. “(c) (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 (g); or “(B) (i) may be otherwise adulterated or misbranded, and “(ii) if so adulterated or misbranded presents a risk to human health, the manufacturer shall promptly notify the Secretary of such non-compliance or risk to health. “(2) For purposes of paragraph (1), the term ‘knowledge’ as applied “Knowledge.” 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. “(d) (1) If a recall of an infant formula is begun by a manufacturer, Recall. the recall shall be carried out in accordance with such requirements as the Secretary may prescribe under paragraph (2), and— “(A) the Secretary shall, not later than the 15th day after the Review. 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 Report to Secretary. 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 Regulations. extent of recalls of infant formulas necessary and appropriate for the degree of risk to human health presented by the formula subject to the recall. “(e) (1) Each manufacturer of an infant formula shall make and Records. 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. 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. “(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. “(f) (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) and (b). 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 (c)(1) only with respect to adulteration or misbranding described in subsection (c)(1)(B), 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) and (b). 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. “(g) An infant formula shall contain nutrients in accordance with the table set out in this subsection or, if revised by the Secretary under subsection (a)(2), as so revised: “Nutrient Minimuma Maximuma Protein (gm) 1.8b 4.5. Fat: gm 3.3 6.0. percent cal 30.0 54.0. Essential fatty acids (linoleate): percent cal 2.7 mg 300.0 Vitamins: A (IU) 250.0 (75 µg)c 750.0 (225 µg).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) (µg) 40.0 B2 (riboflavin) (µg) 60.0 B3 (pyridoxine) (µg) 35.0 (with 15 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) 1.5d Choline (mg) 7.0d Inositol (mg) 4.0d Minerals: Calcium (mg) 50.0e Phosphorus (mg) 25.0e 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.”Effective date note
Pub. L. 96–359, § 6, Sept. 26, 1980, 94 Stat. 1193, 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].”Alcohol and Drug Abuse Amendments of 1986
Pub. L. 99–570 § 4014(a)(7) · 100 Stat. 3207
Added · 21 U.S.C. § 350a(a)(d)
Pub. L. 99–570, § 4014(a)(7), added subsecs. (a) to (d)
Struck · 21 U.S.C. § 350a(a)(d)
Pub. L. 99–570, § 4014(a)(7), 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
Source evidence
Code amendment note
Subsecs. (a) to (d). Pub. L. 99–570, § 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.Enacted provision · exact public law section
(7) by striking out subsections (a) through (d) and inserting in lieu thereof the following: “(a) 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), “(2) such infant formula does not meet the quality factor requirements prescribed by the Secretary under subsection (b)(1), 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). “(b) (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). “(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) 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) 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 Bl, vitamin C, and vitamin E to ensure that such infant formula is in compliance with the requirements of this subsection and subsection (i) 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) 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) 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) 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), 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)Regulations. (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 402(a)(2)(C), “(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) (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). “(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 o. Federal Regulations (as in effect on August 1, 1986), and guidelines issued thereunder. “(d) (1) A person shall, with respect to any infant formula subject to subsection (c), 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), as demonstrated by the testing required under subsection (b)(3), and “(D) assurances that the processing of the infant formula complies with subsection (b)(2). “(2) After the first production of an infant formula subject to subsection (c), 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)92)(B)(i), (b)(2)(B)(iii), (b)(3)(A), (b)(3)(C), and (i). “(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), the manufacturer shall, before the first processing of such formula, make the submission to the Secretary required by paragraph (1). “(e) (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), 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) (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) Regulations. 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.”.Alcohol and Drug Abuse Amendments of 1986
Pub. L. 99–570 § 4014(a)(1) · 100 Stat. 3207
Added · 21 U.S.C. § 350a(e); 21 U.S.C. § 350a(f)
Pub. L. 99–570, § 4014(a)(1), (7), added subsecs. (e) and (f)
Redesignated · 21 U.S.C. § 350a(e); 21 U.S.C. § 350a(f)
Pub. L. 99–570, § 4014(a)(1), (7), redesignated former subsecs. (e) and (f) as (g) and (h), respectively
Source evidence
Code amendment note
Subsecs. (e), (f). Pub. L. 99–570, § 4014(a)(1), (7), added subsecs. (e) and (f) and redesignated former subsecs. (e) and (f) as (g) and (h), respectively.Enacted provision · exact public law section
(1) by redesignating subsections (e), (f), and (g) as subsections (g), (h), and (i), respectively,Alcohol and Drug Abuse Amendments of 1986
Pub. L. 99–570 § 4014(a)(1) · 100 Stat. 3207
Redesignated · 21 U.S.C. § 350a(g)
Pub. L. 99–570, § 4014(a)(1), (2), redesignated subsec. (e) as (g)
Redesignated · 21 U.S.C. § 350a(g)
Pub. L. 99–570, § 4014(a)(1), (2), 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)
Source evidence
Code amendment note
Subsec. (g). Pub. L. 99–570, § 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).Enacted provision · exact public law section
(1) by redesignating subsections (e), (f), and (g) as subsections (g), (h), and (i), respectively,Alcohol and Drug Abuse Amendments of 1986
Pub. L. 99–570 § 4014(a)(1) · 100 Stat. 3207
Redesignated · 21 U.S.C. § 350a(h)
Pub. L. 99–570, § 4014(a)(1), redesignated subsec. (f) as (h)
Source evidence
Code amendment note
Subsec. (h). Pub. L. 99–570, § 4014(a)(1), redesignated subsec. (f) as (h).Enacted provision · exact public law section
(1) by redesignating subsections (e), (f), and (g) as subsections (g), (h), and (i), respectively,Alcohol and Drug Abuse Amendments of 1986
Pub. L. 99–570 § 4014(a)(3) · 100 Stat. 3207
Substituted · 21 U.S.C. § 350a(h)(1)
Pub. L. 99–570, § 4014(a)(3), (4), substituted “(a), (b), and (c)” for “(a) and (b)”
Substituted · 21 U.S.C. § 350a(h)(1)
Pub. L. 99–570, § 4014(a)(3), (4), substituted “(e)(1)” for “(c)(1)”
Source evidence
Code amendment note
Subsec. (h)(1). Pub. L. 99–570, § 4014(a)(3), (4), substituted “(a), (b), and (c)” for “(a) and (b)” and “(e)(1)” for “(c)(1)”.Enacted provision · exact public law section
(3) by striking out “(a) and (b)” in the first sentence of subsection (h)(1) (as so redesignated) and inserting in lieu thereof “(a), (b), and (c)”,Alcohol and Drug Abuse Amendments of 1986
Pub. L. 99–570 § 4014(a)(5) · 100 Stat. 3207
Substituted · 21 U.S.C. § 350a(h)(1)
Pub. L. 99–570, § 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
Target inherited from the preceding amendment note.
Source evidence
Code amendment note
Pub. L. 99–570, § 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.Enacted provision · exact public law section
(5) by striking out “(e)(1)(B)” in such sentence and inserting in lieu thereof “(d)(1)(B)”,Alcohol and Drug Abuse Amendments of 1986
Pub. L. 99–570 § 4014(a)(6) · 100 Stat. 3207
Substituted · 21 U.S.C. § 350a(h)(2)
Pub. L. 99–570, § 4014(a)(6), substituted “(a), (b), and (c)” for “(a) and (b)”
Source evidence
Code amendment note
Subsec. (h)(2). Pub. L. 99–570, § 4014(a)(6), substituted “(a), (b), and (c)” for “(a) and (b)”.Enacted provision · exact public law section
(6) by striking out “(a) and (b)” in subsection (h)(2) (as so redesignated) and inserting in lieu thereof “(a), (b), and (c)”, andAlcohol and Drug Abuse Amendments of 1986
Pub. L. 99–570 § 4014(a)(1) · 100 Stat. 3207
Redesignated · 21 U.S.C. § 350a(i)
Pub. L. 99–570, § 4014(a)(1), (b)(1), redesignated subsec. (g) as (i)
Amended · 21 U.S.C. § 350a(i)
Pub. L. 99–570, § 4014(a)(1), (b)(1), designated existing provisions as par. (1)
Substituted · 21 U.S.C. § 350a(i)
Pub. L. 99–570, § 4014(a)(1), (b)(1), substituted “paragraph (2)” for “subsection (a)(2) of this section”
Substituted · 21 U.S.C. § 350a(i)
Pub. L. 99–570, § 4014(a)(1), (b)(1), substituted a period for the colon after “as so revised”
Added · 21 U.S.C. § 350a(i)
Pub. L. 99–570, § 4014(a)(1), (b)(1), added par. (2)
Source evidence
Code amendment note
Subsec. (i). Pub. L. 99–570, § 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).Enacted provision · exact public law section
(1) by redesignating subsections (e), (f), and (g) as subsections (g), (h), and (i), respectively,Nutrition Labeling and Education Act Amendments of 1993
Pub. L. 103–80 § 3 · 107 Stat. 773
Substituted · 21 U.S.C. § 350a(h)(1)
Pub. L. 103–80 substituted “(e)(1)(B)” for “(c)(1)(B),” in concluding provisions
Source evidence
Code amendment note
Subsec. (h)(1). Pub. L. 103–80 substituted “(e)(1)(B)” for “(c)(1)(B),” in concluding provisions.Enacted provision · exact public law section
SEC. 3. TECHNICAL AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT. (a) Reference.— Whenever in this section an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (b) Section 201.— Paragraphs (w), (x), (y), (z), (aa), (bb), (cc), (dd), (ee), and (ff) of section 201 (21 U.S.C 321) are redesignated as paragraphs (v), (w), (x), (y), (z), (aa), (bb), (cc), (dd), and (ee) respectively. (c) Section 301.— Section 301 (21 U.S.C. 331) is amended— (1) in subsection (j), by striking out “721, or 708” and inserting in lieu thereof “708, or 721”; and (2) in subsection (s), by striking out “412(d)” and inserting in lieu thereof “412(e)”. (d) Section 302.— Section 302 (21 U.S.C. 332) is amended— (1) in subsection (a), by striking out “, and subject to” and all that follows through “381),”, and (2) in subsection (b), by striking out the second sentence. (e) Section 303.— Section 303 (21 U.S.C. 333) is amended by redesignating the second subsection (e) and subsection (f) as subsections (f) and (g), respectively. (f) Section 304.— Section 304 (21 U.S.C. 334) is amended— (1) in subsection (a)(1), by striking out “: Provided, however, That no” and inserting in lieu thereof a period and “No”, and (2) in subsection (d)(1)— (A) by striking out “: Provided, That after” and inserting in lieu thereof a period and “After”, (B) by striking out “: Provided, however, That the” and inserting in lieu thereof a period and “The”, (C) by striking out “: And provided further, That where” and inserting in lieu thereof a period and “Where”, and (D) by striking out “the foregoing proviso” and inserting in lieu thereof “the preceding sentence”. (g) Section 307.— Section 307(b)(3)(A) (21 U.S.C. 337(b)(3)(A)) is amended by striking out “Act” and inserting in lieu thereof “section”. (h) Section 401.— Section 401 (21 U.S.C. 341) is amended by striking out “and/or reasonable standards of fill of container: Provided, That no” and inserting in lieu thereof “or reasonable standards of fill of container. No”. (i) Section 402.— Section 402 (21 U.S.C. 342) is amended— (1) by striking out “; or” at the end of subparagraphs (1) and (2) of paragraph (a) and inserting in lieu thereof a period and by striking out “if it” at the beginning of subparagraph (3) of such paragraph and inserting in lieu thereof “If it”, (2) in paragraph (d)(1), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph”, and (3) in paragraph (d)(3), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph” and by striking out “: And provided further, That the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this clause” and inserting in lieu thereof “, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph”. (j) Section 403.— Section 403 (21 U.S.C. 343) is amended— (1) in paragraph (e), by striking out “: Provided, That” and inserting in lieu thereof “, except that”, (2) in paragraph (i), by striking out “, other than those sold as such” and inserting in lieu thereof “unless sold as spices, flavorings, or such colors” and by striking out “: Provided, That, to the extent” and inserting in lieu thereof a period and “To the extent”, (3) in paragraph (k), by striking out “: Provided, That” and inserting in lieu thereof “, except mat”, (4) in paragraph (l), by striking out “: Provided, however, That” and inserting in lieu thereof “, except that”, (5) in paragraph (r)(1)(B), by striking out “5(D)” and inserting in lieu thereof “(5)(D)”, and (6) in paragraph (r)(4)(B), by striking out “subsection” and inserting in lieu thereof “paragraph”. (k) Section 408.— Section 408 (21 U.S.C. 346a) is amended— (1) in subsection (a)(1), by striking out “Secretary of Health and Human Services” and inserting in lieu thereof “Administrator of the Environmental Protection Agency (hereinafter in this section referred to as the ‘Administrator’)”, (2) in subsection (d)(5), by striking out “section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))” and inserting in lieu thereof “section 556(c) of title 5, United States Code”, (3) in subsection (1), by striking out “It the event” and inserting in lieu thereof “In the events”, (4) in subsection (n), by striking out “of the Federal Food, Drug, and Cosmetic Act”, (5) in subsection (o), by striking out “Secretary of Health and Human Services” each place it occurs and inserting in lieu thereof “Administrator”, and (6) by striking out “Secretary” each place it occurs except when followed by “of Agriculture” and inserting in lieu thereof “Administrator”. (l) Section 412.— Section 412(h) (21 U.S.C. 350a(h)) is amended by striking out “(c)(1)(B),” and inserting in lieu thereof “(e)(1)(B)”. (m) Section 502.— Section 502 (21 U.S.C. 352) is amended— (1) in paragraph (e)(3), by striking out “: Provided further, That” and inserting in lieu thereof “, except that”, (2) in paragraph (f), by striking out “: Provided, That” and inserting in lieu thereof “, except that”, (3) in paragraph (g), by striking out “: Provided, That the method” and inserting in lieu thereof a period and “The method” and by striking out “: Provided further, That,” and inserting in lieu thereof “, except that”, and (4) in paragraph (n), by striking out “: Provided, That” and inserting in lieu thereof “, except that”. (n) Section 505.— Section 505 (21 U.S.C. 355) is amended— (1) in subsection (j)(6)(A)— (A) by striking out “Secretry” in clause (ii) and inserting in lieu thereof “Secretary”, and (B) by inserting a comma after “Secretary” the first time it appears in clause (iii). (2) in subsection (k)(1), by striking out “: Provided, however, That regulations” and inserting in lieu thereof a period and “Regulations”. (o) Section 506.— Section 506(a) (21 U.S.C. 356(a)) is amended by striking out “Federal Security Administrator” and “Administrator” each place it appears and inserting in lieu thereof “Secretary”. (p) Section 507.— Section 507 (21 U.S.C. 357) is amended— (1) in subsection (a), by striking out “Federal Security Administrator” and “Administrator” each place it appears and inserting in lieu thereof “Secretary”, (2) in subsection (e)— (A) by striking out “section 507” each place it occurs and inserting in lieu thereof “this section”, (B) by striking out “or 507” and inserting in lieu thereof “or this section”, and (C) by striking out “: Provided, That, for purposes” and inserting in lieu thereof a period and “For purposes”, (3) in subsection (g)(1), by striking out “: Provided, however, That regulations” and inserting in lieu thereof a period and “Regulations”, and (4) in subsection (h), by striking out “507”. (q) Section 508.— Subsections (c) and (e) of section 508 (21 U.S.C. 358) are each amended by striking out “section 4 of the Administrative Procedure Act (5 U.S.C. 1003)” and inserting in lieu thereof “section 553 of title 5, United States Code”. (r) Section 512.— Section 512 (21 U.S.C. 360b) is amended— (1) in subsection (c)(2)(A)(ii), by inserting “in” after “provided”, (2) in subsection (c)(2)(F)(i), by striking out “(C)(iii)” and inserting in lieu thereof “(D)(iii)”, (3) in subsection (c)(2)(H), by striking out “subclause” the first time it appears and inserting in lieu thereof “subclauses”, (4) in subsection (d)(1), by striking out “subparagraphs (A) through (G)” and inserting in lieu thereof “subparagraphs (A) through (I)”, and (5) in subsection (n)(1)— (A) by striking out “201(w)” in subparagraphs (B)(ii)(I). and (C)(ii)(1) and inserting in lieu thereof “201(w)”, and (B) by striking out in the last sentence “(H)” and inserting in lieu thereof “(I)”. (s) Section 513.— Section 513(b)(3) (21 U.S.C 360c(b)(3)) is amended by striking out “5703(b)” and inserting in lieu thereof “5703”. (t) Section 515.— Section 515(c)(2)(A) (21 U.S.C. 360e(c)(2)(A)) is amended by striking out “refer such application”. (u) Section 519.— Section 519(a) (21 U.S.C. 360i(a)) is amended by striking out “paragraph (4)” and inserting in lieu thereof “paragraph (7)”; (v) Section 527.— Section 527(b) (21 U.S.C. 36Occ(b)) is amended— (1) by striking out “507„” and inserting in lieu thereof “507”, and (2) in paragraph (1), by striking out “The” and inserting in lieu thereof “the”. (w) Section 534.— Section 534(f)(2) (21 U.S.C. 360kk) is amended by striking out “this Act” and inserting in lieu thereof “the Public Health Service Act”. (x) Section 601.— Section 601(a) (21 U.S.C. 361) is amended by striking out “: Provided, That this” and inserting in lieu thereof “, except that this”. (y) Section 701.— Section 701 (21 U.S.C. 371) is amended— (1) in subsection (e)(1), by striking out the period after “Regulations)” the second time it occurs, and (2) in subsection (f)(4), by striking out “sections 239 and 240 of the Judicial Code, as amended” and inserting in lieu thereof “section 1254 of title 28, United States Code”. (z) Section 703.— Section 703 (21 U.S.C. 373) is amended— (1) by striking out “: Provided, That” and inserting in lieu thereof “, except that”, and (2) by striking out “: Provided further, That” and inserting in lieu thereof “, and except that”. (aa) Section 704.— Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended— (1) by striking out the semicolon after “materials” and inserting in lieu thereof a comma, and (2) by striking out “(j)” the first time it appears and inserting in lieu thereof “(k)”. (bb) Section 721.— Section 721(b)(5)(D) (21 U.S.C. 379e(b)(5)(D)) is amended by striking out “5703(b)” and inserting in lieu thereof “5703”. (cc) Section 801.— Section 801(b) (21 U.S.C. 381(b)) is amended— (1) by striking out “Administrator” the first time it occurs and inserting in lieu thereof “Secretary of Health and Human Services”, (2) by striking out “Administrator” the second and third time it occurs and inserting in lieu thereof “Secretary”, (3) by striking out “Administrator’s” and inserting in lieu thereof “Secretary’s”, and (4) by striking out “Federal Security Agency” and inserting in lieu thereof “Department of Health and Human Services”. (dd) Agriculture.— (1) Sections 201(c), 201(d), 701(b), and 801(a) (21 U.S.C. 321(c), 321(d), 371(b), and 381(a) are each amended by striking out “Agriculture” each place it appears and inserting in lieu thereof “Health and Human Services”. (2) Sections 702(c) and 706 (21 U.S.C. 372(c) and 376) are each amended by striking out “of Agriculture” each place it appears.Food and Drug Omnibus Reform Act of 2022
Pub. L. 117–328 § 3401(g)(6) · 136 Stat. 4459
Substituted · 21 U.S.C. § 350a(c)(1)(B)
Pub. L. 117–328, § 3401(g)(6), substituted “subsection (d)(1)” for “subsection (c)(1)”
Source evidence
Code amendment note
Subsec. (c)(1)(B). Pub. L. 117–328, § 3401(g)(6), substituted “subsection (d)(1)” for “subsection (c)(1)”.Enacted provision · exact public law section
(6) Technical correction.— Section 412(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)(1)(B)) is amended by striking “subsection (c)(1)” and inserting “subsection (d)(1)”.Food and Drug Omnibus Reform Act of 2022
Pub. L. 117–328 § 3401(g)(3) · 136 Stat. 4459
Added · 21 U.S.C. § 350a(d)(4)
Pub. L. 117–328, § 3401(g)(3), added par. (4)
Source evidence
Code amendment note
Subsec. (d)(4). Pub. L. 117–328, § 3401(g)(3), added par. (4).Enacted provision · exact public law section
(3) New infant formula submissions.— Section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)) is amended by adding at the end the following: “(4) Deadline. The Secretary shall provide a response to a submission under this subsection not later than 45 days after receiving such submission.” .Food and Drug Omnibus Reform Act of 2022
Pub. L. 117–328 § 3401(g)(4) · 136 Stat. 4459
Substituted · 21 U.S.C. § 350a(i)(1)
Pub. L. 117–328, § 3401(g)(4), substituted “, which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table” for “or, if revised by the Secretary under paragraph (2), as so revised”
Source evidence
Code amendment note
Subsec. (i)(1). Pub. L. 117–328, § 3401(g)(4), substituted “, which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table” for “or, if revised by the Secretary under paragraph (2), as so revised”.Enacted provision · exact public law section
(4) List of nutrients.— Section 412(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)) is amended by striking “or, if revised by the Secretary under paragraph (2), as so revised” and inserting the following: “, which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. Revision. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table”.Food and Drug Omnibus Reform Act of 2022
Pub. L. 117–328 § 3401(c) · 136 Stat. 4459
Added · 21 U.S.C. § 350a(j)
Pub. L. 117–328, § 3401(c), added subsec. (j)
Source evidence
Code amendment note
Subsec. (j). Pub. L. 117–328, § 3401(c), added subsec. (j).Enacted provision · exact public law section
(c) Premarket Submissions of Infant Formula to Address Shortages.— Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) is amended by adding at the end the following: “(j) Premarket Submissions To Address Shortages.— “(1) In general.— The Secretary shall waive the 90-day premarket submission requirement under subsection (c) and apply a 30-day premarket submission requirement for any person who intends to introduce or deliver for introduction into interstate commerce any new infant formula. “(2) Effective period.— The waiver authority under this subsection shall remain in effect— “(A) for 90 days beginning on the date that the Secretary distributes information under section 424(a)(2) with respect to a shortage of infant formula; or “(B) such longer period as the Secretary determines appropriate, to prevent or mitigate a shortage of infant formula.” .Food and Drug Omnibus Reform Act of 2022
Pub. L. 117–328 § 3401(g)(1) · 136 Stat. 4459
Added · 21 U.S.C. § 350a(k)
Pub. L. 117–328, § 3401(g)(1), added subsec. (k)
Source evidence
Code amendment note
Subsec. (k). Pub. L. 117–328, § 3401(g)(1), added subsec. (k).Enacted provision · exact public law section
(1) Congressional notification of recall.— Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as amended by subsection (c), is further amended by adding at the end the following: “(k) Congressional Notification of Recall.— “(1) In general.— Not later than 24 hours after the initiation of a recall of infant formula as described in subsection (e), the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a notification of such recall. “(2) Contents.— A notification under paragraph (1) shall include the following: “(A) If the recall is required by the Food and Drug Administration, a summary of the information supporting a determination that the adulterated or misbranded infant formula presents a risk to human health. “(B) If the recall is voluntarily initiated by the manufacturer, a summary of the information provided to the Food and Drug Administration by the manufacturer regarding infant formula that has left the control of the manufacturer that may be adulterated or misbranded. “(C) Specification of when the Food and Drug Administration was first made aware of the instance or circumstances surrounding the recall. “(D) An initial estimate of the disruption in domestic production that may result from the recall.” .Food and Drug Omnibus Reform Act of 2022
Pub. L. 117–328 § 3401(g)(2) · 136 Stat. 4459
Added · 21 U.S.C. § 350a(l)
Pub. L. 117–328, § 3401(g)(2), added subsec. (l)
Source evidence
Code amendment note
Subsec. (l). Pub. L. 117–328, § 3401(g)(2), added subsec. (l).Enacted provision · exact public law section
(2) Annual report to congress.— Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as amended by paragraph (1), is further amended by adding at the end the following: “(l) Annual Report to Congress.— “(1) In general.— Not later than March 30 of each year, the Secretary shall submit a report to Congress containing, with respect to the preceding calendar year, the following information: “(A) The number of submissions received by the Secretary under subsection (d). “(B) The number of such submissions that included any new ingredients that were not included in any infant formula already on the market. “(C) The number of inspections conducted by the Food and Drug Administration or any agent thereof to evaluate compliance with the requirements for infant formulas under subsection (b). “(D) The time between any inspection referred to in subparagraph (C) and any necessary reinspection to evaluate compliance with the requirements for infant formulas under subsection (b). “(E) A breakdown of the information described in subparagraphs (A) through (D) between foreign and domestic manufacturers and facilities. “(2) Confidentiality.— The Secretary shall ensure that the reports under paragraph (1) do not include any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.” .Food and Drug Omnibus Reform Act of 2022
Pub. L. 117–328 § 3401 · 136 Stat. 4459
Added · 21 U.S.C. § 350a(m)
Pub. L. 117–328, § 3401(l), added subsec. (m)
Source evidence
Code amendment note
Subsec. (m). Pub. L. 117–328, § 3401(l), added subsec. (m).Enacted provision · exact public law section
SEC. 3401. PROTECTING INFANTS AND IMPROVING FORMULA SUPPLY. (a) Definitions.— (1) In general.— In this section, the term “infant formula” has the meaning given such term in section 201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)). (2) Critical food.— Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following: “(ss) The term ‘critical food’ means a food that is— “(1) an infant formula; or “(2) a medical food, as defined in section 5(b)(3) of the Orphan Drug Act.” . (b) Office of Critical Foods.— (1) In general.— The Secretary shall establish within the Center for Food Safety and Applied Nutrition an office to be known as the Office of Critical Foods. Appointment. The Secretary shall appoint a Director to lead such Office. (2) Duties.— The Office of Critical Foods shall be responsible for oversight, coordination, and facilitation of activities related to critical foods, as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)(2). (c) Premarket Submissions of Infant Formula to Address Shortages.— Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) is amended by adding at the end the following: “(j) Premarket Submissions To Address Shortages.— “(1) In general.— The Secretary shall waive the 90-day premarket submission requirement under subsection (c) and apply a 30-day premarket submission requirement for any person who intends to introduce or deliver for introduction into interstate commerce any new infant formula. “(2) Effective period.— The waiver authority under this subsection shall remain in effect— “(A) for 90 days beginning on the date that the Secretary distributes information under section 424(a)(2) with respect to a shortage of infant formula; or “(B) such longer period as the Secretary determines appropriate, to prevent or mitigate a shortage of infant formula.” . (d) Report.— Not later than one year after the date of enactment of this Act, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives that includes— (1) the number of premarket submissions for new infant formula the Secretary has received under section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)) each year since 2012; (2) how many of such submissions received requests from the Secretary for additional information; (3) how long after receiving such submissions the Secretary sent such requests for additional information; (4) what additional information the Secretary requested of the persons submitting such submissions; and (5) the date each new infant formula described in subparagraph (A) was first marketed, if available. (e) Infant Formula Flexibilities.— The Secretary shall publish a list on the website of the Department of Health and Human Services providing information on how to identify appropriate substitutes for infant formula products in shortage that are relied upon by infants and other individuals with inborn errors of metabolism or other serious health conditions. (f) International Harmonization of Infant Formula Requirements.— (1) In general.— The Secretary— (A) shall participate in meetings with representatives from other countries to discuss methods and approaches to harmonizing regulatory requirements for infant formula, including with respect to inspections, labeling, and nutritional requirements; and (B) Contracts. may enter into arrangements or agreements regarding such requirements with other countries, as appropriate, including arrangements or agreements with a foreign government or agency of a foreign government to recognize the inspection of foreign establishments that manufacture infant formula for export to the United States. (2) Study on infant formula.— (A) In general.— Not later than 60 days after the date of enactment of this Act, the Secretary shall seek to enter into an agreement with the National Academies of Sciences, Engineering, and Medicine (referred to in this paragraph as the “National Academies”) to examine and report on challenges in supply, market competition, and regulation of infant formula in the United States. (B) Contents of the report.— The report developed pursuant to the agreement under subparagraph (A) shall— (i) Assessments. Evaluations. assess and evaluate— (I) infant formula marketed in the United States; (II) any challenges in supply, or market competition with respect to such infant formula; and (III) any differences between infant formula marketed in the United States and infant formula marketed in the European Union, including with respect to nutritional content and applicable labeling and other regulatory requirements; and (ii) Recommenda- tions. include recommendations, including for infant formula manufacturers, on measures to address supply and market competition in the United States. (C) Final report.— The agreement under subparagraph (A) shall specify that the National Academies shall, not later than 1 year after the date of enactment of this Act, complete such study and submit a report on the results of such study to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. (g) Transparency and Accountability To Support Infant Formula Innovation.— (1) Congressional notification of recall.— Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as amended by subsection (c), is further amended by adding at the end the following: “(k) Congressional Notification of Recall.— “(1) In general.— Not later than 24 hours after the initiation of a recall of infant formula as described in subsection (e), the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a notification of such recall. “(2) Contents.— A notification under paragraph (1) shall include the following: “(A) If the recall is required by the Food and Drug Administration, a summary of the information supporting a determination that the adulterated or misbranded infant formula presents a risk to human health. “(B) If the recall is voluntarily initiated by the manufacturer, a summary of the information provided to the Food and Drug Administration by the manufacturer regarding infant formula that has left the control of the manufacturer that may be adulterated or misbranded. “(C) Specification of when the Food and Drug Administration was first made aware of the instance or circumstances surrounding the recall. “(D) An initial estimate of the disruption in domestic production that may result from the recall.” . (2) Annual report to congress.— Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as amended by paragraph (1), is further amended by adding at the end the following: “(l) Annual Report to Congress.— “(1) In general.— Not later than March 30 of each year, the Secretary shall submit a report to Congress containing, with respect to the preceding calendar year, the following information: “(A) The number of submissions received by the Secretary under subsection (d). “(B) The number of such submissions that included any new ingredients that were not included in any infant formula already on the market. “(C) The number of inspections conducted by the Food and Drug Administration or any agent thereof to evaluate compliance with the requirements for infant formulas under subsection (b). “(D) The time between any inspection referred to in subparagraph (C) and any necessary reinspection to evaluate compliance with the requirements for infant formulas under subsection (b). “(E) A breakdown of the information described in subparagraphs (A) through (D) between foreign and domestic manufacturers and facilities. “(2) Confidentiality.— The Secretary shall ensure that the reports under paragraph (1) do not include any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.” . (3) New infant formula submissions.— Section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)) is amended by adding at the end the following: “(4) Deadline. The Secretary shall provide a response to a submission under this subsection not later than 45 days after receiving such submission.” . (4) List of nutrients.— Section 412(i)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)) is amended by striking “or, if revised by the Secretary under paragraph (2), as so revised” and inserting the following: “, which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. Revision. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table”. (5) Guidance.— Not later than 1 year after the date of enactment of this Act, the Secretary shall issue guidance regarding information sponsors may consider including in submissions required under section 412(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(d)), including considerations for meeting each of the requirements of paragraphs (1), (2), and (3) of subsection (d). (6) Technical correction.— Section 412(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)(1)(B)) is amended by striking “subsection (c)(1)” and inserting “subsection (d)(1)”. (h) Response to Recall.— (1) Manufacturer submission.— (A) In general.— Promptly after the initiation of a recall of infant formula, the manufacturer of the recalled infant formula shall submit information to the Secretary regarding such recall. (B) Contents.— A submission under subparagraph (A) shall include the following: (i) Timeline. A plan (including an estimated timeline, as applicable) of actions the manufacturer will take, suited to the individual circumstances of the particular recall, including— (I) to identify and address any cause of, and contributing factor in, known or suspected adulteration or known or suspected misbranding; and (II) if appropriate, to restore operation of the impacted facilities. (ii) In the case that a recall of the manufacturer’s infant formula products, and subsequent actions to respond to such recall, impacts over 10 percent of the production of the infant formula intended for sale in the United States, a plan to backfill the supply of the manufacturer’s infant formula supply if the current domestic supply of such infant formula has fallen, or is expected to fall, below the expected demand for the formula. (2) Report to congress.— (A) In general.— Promptly after a submission under paragraph (1) is received, the Secretary shall provide such submission, together with the information specified in subparagraph (B), in a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. (B) Contents.— A report under subparagraph (A) shall include the following: (i) Information concerning the current domestic supply of infant formula, including— (I) a breakdown of the specific types of formula involved; and (II) Estimate. an estimate of how long current supplies will last. (ii) If a submission or submissions under paragraph (1) show that the recall and subsequent actions to respond to the recall impact over 10 percent of the domestic production of infant formula intended for sale in the United States— (I) actions to work with the impacted manufacturer or other manufacturers to increase production; and (II) specification of— (aa) any additional authorities needed regarding production or importation to fill a supply gap; and (bb) any supplemental funding necessary to address the shortage. (3) Sunset.— This subsection shall cease to have force or effect on September 30, 2026. (i) Coordination With Manufacturer.— (1) In general.— (A) Communication following inspection.— Upon completing an inspection of an infant formula manufacturing facility impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide the manufacturer involved a list of any actions necessary to— (i) address deficiencies contributing to the potential adulteration or misbranding of product at the facility; and (ii) safely restart production at the facility. (B) Response to manufacturer.— Not later than 7 days after receiving a written communication from a manufacturer of infant formula containing corrective actions to address manufacturing deficiencies identified during an inspection of a facility engaged in the manufacturing of an infant formula impacted by a recall, the Secretary, acting through the Commissioner of Food and Drugs, shall provide a substantive response to such communication concerning the sufficiency of the proposed corrective actions. (2) Inspections.— The Secretary shall ensure timely communication with a manufacturer of infant formula following an inspection of a facility engaged in the manufacturing of infant formula for consumption in the United States. If a reinspection of a manufacturer of an infant formula is required to ensure that such manufacturer completed any remediation actions or addressed any deficiencies, the Secretary shall reinspect such facility in a timely manner. The Secretary shall prioritize and expedite an inspection or reinspection of an establishment that could help mitigate or prevent a shortage of an infant formula. (3) Annual inspections.— Not later than 6 months after the date of enactment of this Act, and not less than once per calendar year thereafter, the Secretary shall conduct inspections, including unannounced inspections, of the facilities (including foreign facilities) of each manufacturer of an infant formula required to be registered under section 412(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)(1)(A)), in accordance with a risk-based approach and ensure timely and effective internal coordination and alignment among the Office of Regulatory Affairs and the Center for Food Safety and Applied Nutrition. Contracts. Memorandums. In meeting the inspection requirements under this subsection, the Secretary may rely on inspections conducted by foreign regulatory authorities, under arrangements or agreements, and conducted by State agencies under contract, memoranda of understanding, or any other obligation. (j) National Strategy on Infant Formula.— (1) In general.— The Secretary, in consultation with the Secretary of Agriculture and other heads of relevant departments and agencies, shall develop and issue, not later than 90 days after the date of enactment of this Act, a national strategy on infant formula to increase the resiliency of the infant formula supply chain, protect against future contamination and other potential causes of supply disruptions and shortages, and ensure parents and caregivers have access to infant formula and information they need. (2) Immediate national strategy.— The national strategy under paragraph (1) shall include efforts— (A) to increase the resiliency of the infant formula supply chain in the short-term by— (i) assessing causes of any supply disruption or shortage of infant formula in existence as of the date of enactment of this Act and potential causes of future supply disruptions and shortages; (ii) assessing and addressing immediate infant formula needs associated with the shortage; and (iii) developing a plan to increase infant formula supply, including through increased competition; and (B) to ensure the development and updating of education and communication materials for parents and caregivers that cover— (i) where and how to find infant formula; (ii) comparable infant formulas on the market; (iii) what to do if a specialty infant formula is unavailable; (iv) safe practices for handling infant formula; and (v) other topics, as appropriate. (3) Long-term strategy.— Not later than 90 days after the submission of the report described in subsection (f)(2), the Secretary shall update the national strategy under paragraph (1) to include efforts to improve preparedness against infant formula shortages in the long-term by— (A) outlining methods to improve information-sharing between the Federal Government and State and local governments, and other entities as appropriate, regarding shortages; (B) recommending measures for protecting the integrity of the infant formula supply and preventing contamination; (C) Outline. outlining methods to incentivize new infant formula manufacturers to increase supply and mitigate future shortages; and (D) recommending other necessary authorities to gain insight into the supply chain and risk for shortages, and to incentivize new infant formula manufacturers. (k) Meaningful Disruption in the Production of Critical Food.— Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at the end the following: “SEC. 424. REQUIREMENTS FOR CRITICAL FOOD. “(a) Notification of Meaningful Disruption for Critical Food.— “(1) In general.— A manufacturer of a critical food (as defined in section 201(ss)) shall notify the Secretary of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption. “(2) Distribution of information.— Not later than 5 calendar days after receiving a notification under paragraph (1), if the Secretary has determined that such discontinuance or interruption has resulted, or is likely to result, in a shortage of such critical food, the Secretary shall distribute, to the Secretary of Agriculture and to the maximum extent practicable to the appropriate entities, as determined by the Secretary through such means as the Secretary determines appropriate, information on such shortage. “(3) Confidentiality.— Nothing in this subsection authorizes the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code. “(4) Meaningful disruption.— In this subsection, the term ‘meaningful disruption’— “(A) means a change in production that is reasonably likely to lead to a significant reduction in the supply of a critical food by a manufacturer that affects the ability of the manufacturer to meet expected demand for its product; and “(B) does not include interruptions in manufacturing due to matters such as routine maintenance, changes or discontinuance of flavors, colors, or other insignificant formulation characteristics, or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time. “(b) Risk Management Plans.— Each manufacturer of a critical food shall develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the food, as applicable, for each establishment in which such food is manufactured. A risk management plan under this subsection— “(1) may identify and evaluate risks to the supply of more than one critical food, or critical food category, manufactured at the same establishment; “(2) may identify mechanisms by which the manufacturer would mitigate the impacts of a supply disruption through alternative production sites, alternative suppliers, stockpiling of inventory, or other means; and “(3) shall be subject to inspection and copying by the Secretary pursuant to an inspection under section 704. “(c) Failure To Meet Requirements.— “(1) In general.— If a person fails to submit information required under, and in accordance with, subsection (a)— “(A) the Secretary shall issue a letter to such person informing such person of such failure; and “(B) not later than 45 calendar days after the issuance of a letter under subparagraph (A), subject to paragraph (2), the Secretary shall make available to the public on the website of the Food and Drug Administration, with appropriate redactions made to protect the information described in subsection (a)(3)— “(i) the letter issued under subparagraph (A); and “(ii) at the request of such person, any response to such letter such person submitted to the Secretary. “(2) Exception.— If the Secretary determines that the letter under paragraph (1) was issued in error or, after review of such response, the person had a reasonable basis for not submitting a notification as required under subsection (a), the requirements of paragraph (1)(B) shall not apply.” . (l) Specialty Infant Formula for Importation.— Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as amended by subsection (f)(2), is further amended by adding at the end the following: “(m) Waiver of Requirements for Importation of Specialty Infant Formula.— “(1) In general.— The Secretary may, during a shortage of specialty infant formula as determined by the Secretary, waive any requirement under this Act applicable to facilitate the importation of specialty infant formula. Such a waiver may be applicable to— “(A) the importation of specialty infant formula from any country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of this Act; or “(B) the distribution and sale of such imported specialty infant formula. “(2) Rule of construction.— Nothing in paragraph (1) shall be construed to limit the authority of the Secretary to require a recall of, or otherwise impose restrictions and requirements under this Act with respect to, specialty infant formula that is subject to a waiver under paragraph (1). “(3) Definition of specialty infant formula.— In this subsection, the term ‘specialty infant formula’ means infant formula described in subsection (h)(1).” . (m) Importation for Personal Use.— (1) In general.— Notwithstanding any provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), during the 90-day period beginning on the date of enactment of this Act, an individual may, without prior notice to the Food and Drug Administration, import up to a 3-month supply of infant formula for personal use from— (A) Canada. Canada; (B) any country in the European Union; or (C) Determination. any other country that is determined by the Secretary to be implementing and enforcing requirements for infant formula that provide a similar assurance of safety and nutritional adequacy as the requirements of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (2) Limitations.— Infant formula may be imported pursuant to paragraph (1) only if the infant formula— (A) is exclusively for personal use and will not be commercialized or promoted; and (B) does not present an unreasonable risk to human health. (3) Reporting of adverse events.— If a health care provider becomes aware of any adverse event which the health care provider reasonably suspects to be associated with infant formula imported pursuant to paragraph (1), the health care provider shall report such adverse event to the Commissioner of Food and Drugs. (4) Public notice.— The Secretary, acting through the Commissioner of Food and Drugs, shall post on the public website of the Food and Drug Administration notice that— (A) infant formula imported pursuant to paragraph (1) may not have been manufactured in a facility that has been inspected by the Food and Drug Administration; (B) the labeling of such infant formula may not meet the standards and other requirements applicable with respect to infant formula under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and (C) the nutritional content of infant formula imported pursuant to paragraph (1) may vary from that of infant formula meeting such standards and other requirements. (5) Sense of congress.— It is the sense of Congress that persons considering the personal importation of infant formula should consult with their pediatrician about such importation.
25 of 25 references resolved to an enrolled provision
Editorial Notes
Amendments1986–2022 · 3 rounds
2022
Subsec. (c)(1)(B). Pub. L. 117–328, § 3401(g)(6), substituted “subsection (d)(1)” for “subsection (c)(1)”.
Subsec. (d)(4). Pub. L. 117–328, § 3401(g)(3), added par. (4).
Subsec. (i)(1). Pub. L. 117–328, § 3401(g)(4), substituted “, which shall be reviewed by the Secretary every 4 years as appropriate. In reviewing such table, the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards. The Secretary may revise the list of nutrients and the required level for any nutrient required by the table” for “or, if revised by the Secretary under paragraph (2), as so revised”.
Subsec. (j). Pub. L. 117–328, § 3401(c), added subsec. (j).
Subsec. (k). Pub. L. 117–328, § 3401(g)(1), added subsec. (k).
Subsec. (l). Pub. L. 117–328, § 3401(g)(2), added subsec. (l).
Subsec. (m). Pub. L. 117–328, § 3401(l), added subsec. (m).
1993
Subsec. (h)(1). Pub. L. 103–80 substituted “(e)(1)(B)” for “(c)(1)(B),” in concluding provisions.
1986
Subsecs. (a) to (d). Pub. L. 99–570, § 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, § 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, § 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, § 4014(a)(1), redesignated subsec. (f) as (h).
Subsec. (h)(1). Pub. L. 99–570, § 4014(a)(3), (4), substituted “(a), (b), and (c)” for “(a) and (b)” and “(e)(1)” for “(c)(1)”.
Pub. L. 99–570, § 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, § 4014(a)(6), substituted “(a), (b), and (c)” for “(a) and (b)”.
Subsec. (i). Pub. L. 99–570, § 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).
Statutory Notes and Related Subsidiaries
Effective Date of 1980 Amendment
Pub. L. 96–359, § 6, , 94 Stat. 1193, 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 [].”
Credits
1938–2022 · 4 acts
- 1938June 25, 1938, ch. 675, § 412, as added Pub. L. 96–359, § 2, , 94 Stat. 1190
- 1986amended Pub. L. 99–570, title IV, § 4014(a), (b)(1), , 100 Stat. 3207–116, 3207–120
- 1993Pub. L. 103–80, § 3(l), , 107 Stat. 777
- 2022Pub. L. 117–328, div. FF, title III, § 3401(c), (g)(1)–(4), (6), (l), , 136 Stat. 5838, 5840, 5841, 5845.
Show as published
(June 25, 1938, ch. 675, § 412, as added Pub. L. 96–359, § 2, , 94 Stat. 1190; amended Pub. L. 99–570, title IV, § 4014(a), (b)(1), , 100 Stat. 3207–116, 3207–120; Pub. L. 103–80, § 3(l), , 107 Stat. 777; Pub. L. 117–328, div. FF, title III, § 3401(c), (g)(1)–(4), (6), (l), , 136 Stat. 5838, 5840, 5841, 5845.)