21 U.S.C. § 350a — Infant formulas

Page 125 TITLE 21—FOOD AND DRUGS § 350a former subpar. (B), which read as follows: ‘‘Notwith- standing the provisions of subparagraph (A), the label- ing and advertising for any food to which this section applies may not give prominence to or emphasize ingre- dients which are not— ‘‘(i) vitamins, ‘‘(ii) minerals, or ‘‘(iii) represented as a source of vitamins or min- erals.’’ Subsec. (c)(1)(B)(i). Pub. L. 103–417, § 3(c)(1), inserted ‘‘powder, softgel, gelcap,’’ after ‘‘capsule,’’. Subsec. (c)(1)(B)(ii). Pub. L. 103–417, § 3(c)(2), struck out ‘‘does not simulate and’’ after ‘‘in such a form,’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1994 AMENDMENT For provision that dietary supplements may be la- beled after Oct. 25, 1994, in accordance with amend- ments made by section 7(d) of Pub. L. 103–417, and shall be so labeled after Dec. 31, 1996, see section 7(e) of Pub. L. 103–417, set out as a note under section 343 of this title. AMENDMENT OF INCONSISTENT REGULATIONS BY SECRETARY Pub. L. 94–278, title V, § 501(b), Apr. 22, 1976, 90 Stat. 411, as amended by Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695, provided that: ‘‘The Secretary of Health and Human Services shall amend any regulation promulgated under the Federal Food, Drug, and Cos- metic Act [this chapter] which is inconsistent with sec- tion 411 of such Act [section 350 of this title] (as added by subsection (a)) and such amendments shall be pro- mulgated in accordance with section 553 of title 5, United States Code.’’ § 350a. Infant formulas (a) Adulteration An infant formula, including an infant for- mula powder, shall be deemed to be adulterated if— (1) such infant formula does not provide nu- trients 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 manufac- turing practices and the quality control proce- dures prescribed by the Secretary under sub- section (b)(2). (b) Requirements for quality factors, good manu- facturing practices, and retention of records (1) The Secretary shall by regulation establish requirements for quality factors for infant for- mulas 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 estab- lish good manufacturing practices for infant for- mulas, including quality control procedures that the Secretary determines are necessary to as- sure that an infant formula provides nutrients in accordance with this subsection and sub- section (i) and is manufactured in a manner de- signed to prevent adulteration of the infant for- mula. (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 for- mula or an agent of such manufacturer, of each batch of infant formula for each nutrient required by subsection (i) before the distribu- tion of such batch, (ii) regularly scheduled testing, by the man- ufacturer of an infant formula or an agent of such manufacturer, of samples of infant for- mulas 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 manufac- turing practices designed to prevent adultera- tion of each batch of infant formula, and (iv) the conduct by the manufacturer of an infant formula or an agent of such manufac- turer of regularly scheduled audits to deter- mine that such manufacturer has complied with the regulations prescribed under subpara- graph (A). In prescribing requirements for audits under clause (iv), the Secretary shall provide that such audits be conducted by appropriately trained in- dividuals who do not have any direct responsi- bility for the manufacture or production of in- fant formula. (3)(A) At the final product stage, each batch of infant formula shall be tested for vitamin A, vi- tamin B1, vitamin C, and vitamin E to ensure that such infant formula is in compliance with the requirements of this subsection and sub- section (i) relating to such vitamins. (B) Each nutrient premix used in the manufac- ture 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 specifica- tions 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 test- ing has not been conducted pursuant to subpara- graph (A) or (B). Testing under this subpara- graph shall be conducted to— (i) ensure that each batch of such infant for- mula 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 for- mula 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 deg- radation. (4)(A) The Secretary shall by regulation estab- lish requirements respecting the retention of records. Such requirements shall provide for— Page 126 TITLE 21—FOOD AND DRUGS § 350a (i) the retention of all records necessary to demonstrate compliance with the good manu- facturing practices and quality control proce- dures prescribed by the Secretary under para- graph (2), including records containing the re- sults 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 micro- biological quality and purity of raw mate- rials used in infant formula powder and in finished infant formula, and (II) all records pertaining to food pack- aging materials which show that such mate- rials do not cause an infant formula to be adulterated within the meaning of section 342(a)(2)(C) of this title, (v) the retention of all records of the results of regularly scheduled audits conducted pursu- ant to the requirements prescribed by the Sec- retary 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 for- mulas 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 re- tained for at least one year after the expiration of the shelf life of such infant formula. Except as provided in clause (ii), such records shall be made available to the Secretary for review and duplication upon request of the Secretary. (ii) A manufacturer need only provide written assurances to the Secretary that the regularly scheduled audits required by paragraph (2)(B)(iv) are being conducted by the manufacturer, and need not make available to the Secretary the actual written reports of such audits. (c) Registration of persons distributing new in- fant formula (1) No person shall introduce or deliver for in- troduction into interstate commerce any new infant formula unless— (A) such person has, before introducing such new infant formula, or delivering such new in- fant 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 sub- section (d)(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 in- fant formula and in which there is a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer. For purposes of this paragraph, the term ‘‘major change’’ has the meaning given to such term in section 106.30(c)(2) of title 21, Code of Federal Regulations (as in effect on August 1, 1986), and guidelines issued thereunder. (d) Submission of information about new infant formula required (1) A person shall, with respect to any infant formula subject to subsection (c), make a sub- mission to the Secretary which shall include— (A) the quantitative formulation of the in- fant 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 require- ments of subsections (b)(1) and (i), as dem- onstrated by the testing required under sub- section (b)(3), and (D) assurances that the processing of the in- fant formula complies with subsection (b)(2). (2) After the first production of an infant for- mula subject to subsection (c), and before the in- troduction into interstate commerce of such for- mula, 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 com- plies 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). (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 wheth- er the formula is adulterated under subsection (a), the manufacturer shall, before the first processing of such formula, make the submis- sion to the Secretary required by paragraph (1). (4) The Secretary shall provide a response to a submission under this subsection not later than 45 days after receiving such submission. (e) Additional notice requirements for manufac- turer (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 mis- branded, the manufacturer shall promptly notify the Sec- retary of such knowledge. If the Secretary de- termines that the infant formula presents a risk to human health, the manufacturer shall imme- diately take all actions necessary to recall ship- ments of such infant formula from all wholesale and retail establishments, consistent with recall Page 127 TITLE 21—FOOD AND DRUGS § 350a regulations and guidelines issued by the Sec- retary. (2) For purposes of paragraph (1), the term ‘‘knowledge’’ as applied to a manufacturer means (A) the actual knowledge that the manu- facturer had, or (B) the knowledge which a rea- sonable person would have had under like cir- cumstances or which would have been obtained upon the exercise of due care. (f) Procedures applicable to recalls by manufac- turer; regulatory oversight (1) If a recall of infant formula is begun by a manufacturer, the recall shall be carried out in accordance with such requirements as the Sec- retary 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 re- call meets the requirements prescribed under paragraph (2), and (B) the manufacturer shall, not later than the 14th day after the beginning of such recall and at least once every 14 days thereafter until the recall is terminated, report to the Secretary the actions taken to implement the recall. (2) The Secretary shall by regulation prescribe the scope and extent of recalls of infant for- mulas necessary and appropriate for the degree of risks to human health presented by the for- mula subject to the recall. (3) The Secretary shall by regulation require each manufacturer of an infant formula who be- gins a recall of such formula because of a risk to human health to request each retail establish- ment 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 establish- ment for such time that the Secretary deter- mines necessary to inform the public of such re- call. (g) Recordkeeping requirements for manufac- turer; regulatory oversight and enforcement (1) Each manufacturer of an infant formula shall make and retain such records respecting the distribution of the infant formula through any establishment owned or operated by such manufacturer as may be necessary to effect and monitor recalls of the formula. Such records shall be retained for at least one year after the expiration of the shelf life of the infant formula. (2) To the extent that the Secretary deter- mines that records are not being made or main- tained in accordance with paragraph (1), the Secretary may by regulation prescribe the rec- ords required to be made under paragraph (1) and requirements respecting the retention of such records under such paragraph. Such regula- tions shall take effect on such date as the Sec- retary prescribes but not sooner than the 180th day after the date such regulations are promul- gated. Such regulations shall apply only with respect to distributions of infant formulas made after such effective date. (h) Exemptions; regulatory oversight (1) Any infant formula which is represented and labeled for use by an infant— (A) who has an inborn error of metabolism or a low birth weight, or (B) who otherwise has an unusual medical or dietary problem, is exempt from the requirements of subsections (a), (b), and (c). 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 mis- branding described in subsection (e)(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 in- fant formula from the requirements of sub- sections (a), (b), and (c). An exemption of an in- fant formula under paragraph (1) may be with- drawn by the Secretary if such formula is not in compliance with applicable terms and condi- tions prescribed under this paragraph. (i) Nutrient requirements (1) An infant formula shall contain nutrients in accordance with the table set out in this sub- section, which shall be reviewed by the Sec- retary 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 in- fant formula standards. The Secretary may re- vise the list of nutrients and the required level for any nutrient required by the table. (2) The Secretary may by regulation— (A) revise the list of nutrients in the table in this subsection, and (B) revise the required level for any nutrient required by the table. NUTRIENTS Nutrient Minimum a Maximum a Protein (gm) ............ 1.8 b .................. 4.5. Fat: gm ......................... 3.3 .................. 6.0. percent cal ............ 30.0 .................. 54.0. Essential fatty acids (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 for- mula). B12 (µg) .................. 0.15 .................. Niacin (µg) ............ 250.0 .................. Folic acid (µg) ....... 4.0 .................. Pantothenic acid (µg). 300.0 .................. Biotin (µg) ............. 1.5 d .................. Page 128 TITLE 21—FOOD AND DRUGS § 350a NUTRIENTS—Continued Nutrient Minimum a Maximum a 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 equiva- lent 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. (j) Premarket submissions to address shortages (1) In general The Secretary shall waive the 90-day pre- market submission requirement under sub- section (c) and apply a 30-day premarket sub- mission requirement for any person who in- tends to introduce or deliver for introduction into interstate commerce any new infant for- mula. (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 350m(a)(2) of this title with respect to a shortage of infant formula; or (B) such longer period as the Secretary de- termines appropriate, to prevent or mitigate a shortage of infant formula. (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 Rep- resentatives a notification of such recall. (2) Contents A notification under paragraph (1) shall in- clude 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 infor- mation provided to the Food and Drug Ad- ministration 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 sur- rounding the recall. (D) An initial estimate of the disruption in domestic production that may result from the recall. (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 cal- endar 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 re- ferred to in subparagraph (C) and any nec- essary reinspection to evaluate compliance with the requirements for infant formulas under subsection (b). (E) A breakdown of the information de- scribed in subparagraphs (A) through (D) be- tween foreign and domestic manufacturers and facilities. (2) Confidentiality The Secretary shall ensure that the reports under paragraph (1) do not include any infor- mation that is a trade secret or confidential information subject to section 552(b)(4) of title 5 or section 1905 of title 18. (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 chapter applicable to facilitate the importa- tion of specialty infant formula. Such a waiver may be applicable to— (A) the importation of specialty infant for- mula from any country that is determined by the Secretary to be implementing and en- forcing requirements for infant formula that provide a similar assurance of safety and nu- tritional adequacy as the requirements of this chapter; or (B) the distribution and sale of such im- ported specialty infant formula. (2) Rule of construction Nothing in paragraph (1) shall be construed to limit the authority of the Secretary to re- quire a recall of, or otherwise impose restric- tions and requirements under this chapter 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 in- fant formula’’ means infant formula described in subsection (h)(1). (June 25, 1938, ch. 675, § 412, as added Pub. L. 96–359, § 2, Sept. 26, 1980, 94 Stat. 1190; amended Pub. L. 99–570, title IV, § 4014(a), (b)(1), Oct. 27, Page 129 TITLE 21—FOOD AND DRUGS § 350a–1 1 So in original. There is no subparagraph (A). 1986, 100 Stat. 3207–116, 3207–120; Pub. L. 103–80, § 3(l), Aug. 13, 1993, 107 Stat. 777; Pub. L. 117–328, div. FF, title III, § 3401(c), (g)(1)–(4), (6), (l), Dec. 29, 2022, 136 Stat. 5838, 5840, 5841, 5845.) Editorial Notes AMENDMENTS 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 Sec- retary shall consider any new scientific data or infor- mation 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 re- vised by the Secretary under paragraph (2), as so re- vised’’. 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 manufac- turer and requirements and scope of that notice, (c) re- lating to additional notice requirements for the manu- facturer, 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), redesig- nated subsec. (e) as (g) and substituted ‘‘Such records shall be retained for at least one year after the expira- tion 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 in- fant formula for a period of longer than 2 years from the date the record was made’’. Former subsec. (g) re- designated (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), sub- stituted ‘‘(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 sen- tence 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), redesig- nated 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, Sept. 26, 1980, 94 Stat. 1193, provided that: ‘‘Section 412 of the Federal Food, Drug, and Cos- metic 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].’’ § 350a–1. Protecting infants and improving for- mula 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) Omitted (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. The Secretary shall appoint a Director to lead such Office. (2) Duties The Office of Critical Foods shall be respon- sible for oversight, coordination, and facilita- tion of activities related to critical foods, as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(ss)], as added by subsection (a)(2). (c) Omitted (d) Report Not later than one year after December 29, 2022, 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 Rep- resentatives 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 in- formation; (3) how long after receiving such submis- sions the Secretary sent such requests for ad- ditional information; (4) what additional information the Sec- retary requested of the persons submitting such submissions; and (5) the date each new infant formula de- scribed in subparagraph (A) 1 was first mar- keted, 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 iden- tify appropriate substitutes for infant formula products in shortage that are relied upon by in- fants 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 rep- resentatives from other countries to discuss methods and approaches to harmonizing reg-