Infant food formula (quality control procedures) (21 CFR 107.3-107.280)

191 Food and Drug Administration, HHS § 107.10 by telephone, to the Director of the ap propriate Food and Drug Administra tion district office specified in part 5, subpart M of this chapter. After nor mal business hours (8 a.m. to 4:30 p.m.), contact the FDA Emergency Call Cen ter at 866–300–4374. The manufacturer shall send a followup written confirma tion to the Center for Food Safety and Applied Nutrition (HFS–605), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to the appropriate Food and Drug Administration district office specified in part 5, subpart M of this chapter. [47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989; 61 FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001; 75 FR 32658, June 9, 2010] PART 107—INFANT FORMULA Subpart A—General Provisions Sec. 107.3 Definitions. Subpart B—Labeling 107.10 Nutrient information. 107.20 Directions for use. 107.30 Exemptions. Subpart C—Exempt Infant Formulas 107.50 Terms and conditions. Subpart D—Nutrient Requirements 107.100 Nutrient specifications. Subpart E—Infant Formula Recalls 107.200 Food and Drug Administration-re quired recall. 107.210 Firm-initiated product removals. 107.220 Scope and effect of infant formula recalls. 107.230 Elements of an infant formula re call. 107.240 Notification requirements. 107.250 Termination of an infant formula re call. 107.260 Revision of an infant formula recall. 107.270 Compliance with this subpart. 107.280 Records retention. AUTHORITY: 21 U.S.C. 321, 343, 350a, 371. SOURCE: 50 FR 1840, Jan. 14, 1985, unless otherwise noted. Subpart A—General Provisions § 107.3 Definitions. The following definitions shall apply, in addition to the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act): Exempt formula. An exempt infant for mula is an infant formula intended for commercial or charitable distribution that is represented and labeled for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or die tary problems. Manufacturer. A manufacturer is a person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula or packages the infant formula in containers for distribution. References. References in this part to regulatory sections of the Code of Fed eral Regulations are to chapter I of title 21, unless otherwise noted. [50 FR 48186, Nov. 22, 1985] Subpart B—Labeling § 107.10 Nutrient information. (a) The labeling of infant formulas, as defined in section 201(aa) of the Fed eral Food, Drug, and Cosmetic Act, shall bear in the order given, in the units specified, and in tabular format, the following information regarding the product as prepared in accordance with label directions for infant con sumption: (1) A statement of the number of fluid ounces supplying 100 kilocalories (in case of food label statements, a kilocalorie is represented by the word ‘‘Calorie’’); and (2) A statement of the amount of each of the following nutrients sup plied by 100 kilocalories: Nutrients Unit of measurement Protein ............................................. Grams. Fat ................................................... Do. Carbohydrate ................................... Do. Water ............................................... Do. Linoleic acid .................................... Milligrams. Vitamins: Vitamin A .................................. International units. Vitamin D ................................. Do. Vitamin E .................................. Do. Vitamin K .................................. Micrograms. Thiamine (Vitamin B 1) ............. Do. Riboflavin (Vitamin B 2 ............. Do. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00201 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R ei er A vi le s on D S K G B LS 3C 1P R O D w ith C F R 192 21 CFR Ch. I (4–1–11 Edition) § 107.20 Nutrients Unit of measurement Vitamin B 6 ................................ Do. Vitamin B 12 .............................. Do. Niacin ....................................... Do. Folic acid (Folacin) ................... Do. Pantothenic acid ...................... Do. Biotin ........................................ Do. Vitamin C (Ascorbic acid) ........ Milligrams. Choline ..................................... Do. Inositol ...................................... Do. Minerals: Calcium .................................... Milligrams. Phosphorus .............................. Do. Magnesium ............................... Do. Iron ........................................... Do. Zinc .......................................... Do. Manganese .............................. Micrograms. Copper ..................................... Do. Iodine ....................................... Do. Sodium ..................................... Milligrams. Potassium ................................ Do. Chloride .................................... Do. (b) In addition the following apply: (1) Vitamin A content may also be declared on the label in units of microgram retinol equivalents, vita min D content in units of micrograms cholecalciferol, vitamin E content in units of milligram alpha-tocopherol equivalents, and sodium, potassium, and chloride content in units of millimoles, micromoles, or milli equivalents. When these declarations are made they shall appear in paren theses immediately following the dec larations in International Units for vi tamins A, D, and E, and immediately following the declarations in milli grams for sodium, potassium, and chlo ride. (2) Biotin, choline, and inositol con tent shall be declared except when they are not added to milk-based infant for mulas. (3) Each of the listed nutrients, and the caloric density, may also be de clared on the label on other bases, such as per 100 milliliters or per liter, as prepared for infant consumption. (4) One of the following statements shall appear on the principal display panel, as appropriate: (i) The statement ‘‘Infant Formula With Iron’’, or a similar statement, if the product contains 1 milligram or more of iron in a quantity of product that supplies 100 kilocalories when pre pared in accordance with label direc tions for infant consumption. (ii) The statement ‘‘Additional Iron May Be Necessary’’, or a similar state ment, if the product contains less than 1 milligram of iron in a quantity of product that supplies 100 kilocalories when prepared in accordance with label directions for infant consumption. (5) Any additional vitamin may be declared at the bottom of the vitamin list and any additional minerals may be declared between iodine and sodium, provided that any additionally de clared nutrient (i) has been identified as essential by the National Academy of Sciences through its development of a recommended dietary allowance or an estimated safe and adequate daily dietary intake range, or has been iden tified as essential by the Food and Drug Administration through a FED ERAL REGISTER publication or estab lishment of a U.S. Recommended Daily Allowance, and (ii) is provided at a level considered in these publications as having biological significance, when these levels are known. [50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002] § 107.20 Directions for use. In addition to the applicable labeling requirements in parts 101 and 105 of this chapter, the product label shall bear: (a) Under the heading ‘‘Directions For Preparation and Use’’, directions for: (1) Storage of infant formula before and after the container has been opened, including a statement indi cating that prolonged storage at exces sive temperatures should be avoided; (2) Agitating liquid infant formula before opening the container, such as ‘‘Shake Well Before Opening’’; (3) ‘‘Sterilization’’ of water, bottle, and nipples when necessary for pre paring infant formula for use; (4) Dilution of infant formula, when appropriate. Directions for powdered infant formula shall contain the weight and volume of powdered formula to be reconstituted. (b) In close proximity to the ‘‘Direc tions for Preparation and Use’’ a picto gram depicting the major steps for preparation of that infant formula, such as (for a concentrated formula): VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00202 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R ei er A vi le s on D S K G B LS 3C 1P R O D w ith C F R 193 Food and Drug Administration, HHS § 107.30 (c) A ‘‘Use by lll’’ date, the blank to be filled in with the month and year selected by the manufacturer, packer, or distributor of the infant formula on the basis of tests or other information showing that the infant formula, until that date, under the conditions of han dling, storage, preparation, and use prescribed by label directions, will: (1) when consumed, contain not less than the quantity of each nutrient, as set forth on its label; and (2) otherwise be of an acceptable quality (e.g., pass through an ordinary bottle nipple). (d) The statement ‘‘Add Water’’ or ‘‘Do Not Add Water’’, as appropriate, to appear on the principal display panel of concentrated or ready-to-feed infant formulas. In close proximity to the statement ‘‘Add Water’’, a symbol such as if the addition of water is necessary. The symbol shall be placed on a white background encircled by a dark border. (e) A warning statement beneath or in close proximity to the ‘‘Directions For Preparation and Use’’ that cau tions against improper preparation or use of an infant formula, such as ‘‘THE HEALTH OF YOUR INFANT DE PENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARA TION AND USE’’. (f) A statement indicating that par ents should consult their physicians about the use of infant formulas, such as ‘‘USE AS DIRECTED BY A PHYSI CIAN’’. [50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002] § 107.30 Exemptions. When containers of ready-to-feed in fant formula, to be sold at the retail level, are contained within a multiunit package, the labels of the individual containers shall contain all of the label information required by section 403 of the Federal Food, Drug, and Cosmetic Act (the act), §§ 107.10 and 107.20, and all appropriate sections of part 101 of this chapter, except that the labels of the individual containers contained within the outer package shall be exempt from compliance with the require ments of section 403 (e)(1) and (i)(2) of the act; and §§ 107.10 (a) and (b)(2) and 107.20 (b), (e), and (f), provided that (a) the multiunit package meets all the re quirements of this part; (b) individual containers are securely enclosed within and are not intended to be separated VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00203 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066 E R 01 JA 93 .3 66 < /G P H > E C 01 M R 93 .0 00 < /G P H > W R ei er A vi le s on D S K G B LS 3C 1P R O D w ith C F R 194 21 CFR Ch. I (4–1–11 Edition) § 107.50 from the retail package under condi tions of retail sale; and (c) the label on each individual container includes the statement ‘‘This Unit Not Intended For Individual Sale’’ in type size not less than one-sixteenth inch in height. The word ‘‘Retail’’ may be used in lieu of or immediately following the word ‘‘Indi vidual’’ in the statement. Subpart C—Exempt Infant Formulas § 107.50 Terms and conditions. (a) Terms and conditions. Section 412(f)(1) of the act exempts from the re quirements of section 412(a), (b), and (c)(1)(A) of the act infant formulas that are represented and labeled for use by an infant who has an inborn error of metabolism or low brith weight or who otherwise has an unusual medical or dietary problem, if such formulas com ply with regulations prescribed by the Secretary. The regulations in this sub part establish the terms and conditions that a manufacturer must meet with respect to such infant formulas. (b) Infant formulas generally available at the retail level. (1) These exempt in fant formulas can generally be pur chased from retail store shelves that are readily available to the public. Such formulas are also typically rep resented and labeled for use to provide dietary management for diseases or conditions that are not clinically seri ous or life-threatening, even though such formulas may also be represented and labeled for use in clinically serious or life-threatening disorders. (2) Except as provided in paragraphs (b)(4) and (5) of this section, an infant formula manufacturer shall, with re spect to each formula covered by this paragraph, comply with the nutrient requirements of section 412(g) of the act or of regulations promulgated under section 412(a)(2) of the act, the quality control procedure requirements of part 106, and the labeling require ments of subpart B of this part. (3) To retain the exempt status of an infant formula covered by this para graph, the manufacturer shall submit to the Food and Drug Administration (FDA), at the address specified in para graph (e)(1) of this section, on or before May 21, 1986, or on or before the 90th day before the first processing of the infant formula for commercial or char itable distribution, whichever occurs later, the label and other labeling of the infant formula, a complete quan titative formulation for the infant for mula, and a detailed description of the medical conditions for which the infant formula is represented. FDA will re view the information under paragraph (d) of this section. (4) To retain the exempt status of an infant formula covered by this para graph, when any change in ingredients or processes that may result in an ad verse impact on levels of nutrients or availability of nutrients is instituted, the manufacturer shall submit to FDA at the address specified in paragraph (e)(1) of this section, before the first processing of the infant formula, the label and other labeling of the infant formula, a complete quantitative for mulation for the infant formula, a de tailed description of the reformulation and the rationale for the reformula tion, a complete description of the change in processing, and a detailed de scription of the medical conditions for which the infant formula is rep resented. FDA will review that infor mation under paragraph (d) of this sec tion. (5) A manufacturer may deviate from the requirements of paragraph (b)(2) of this section only with respect to those specific requirements for which it sub mits to FDA, at the address specified in paragraph (e)(1) of this section, the medical, nutritional, scientific, or technological rationale (including any appropriate animal or human clinical studies). FDA will review that informa tion under paragraph (d) of this sec tion. (c) Infant formulas not generally avail able at the retail level. (1) These exempt infant formulas are not generally found on retail shelves for general consumer purchase. Such formulas typically are prescribed by a physician, and must be requested from a pharmacist or are dis tributed directly to institutions such as hospitals, clinics, and State or Fed eral agencies. Such formulas are also generally represented and labeled sole ly to provide dietary management for specific diseases or conditions that are clinically serious or life-threatening VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00204 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R ei er A vi le s on D S K G B LS 3C 1P R O D w ith C F R 195 Food and Drug Administration, HHS § 107.50 and generally are required for pro longed periods of time. Exempt infant formulas distributed directly to insti tutions such as hospitals, clinics, and State or Federal agencies that are of the same formulation as those gen erally available at the retail level are subject to the requirements of para graph (b) of this section rather than to the requirements of this paragraph. (2) Except as provided for in para graph (c)(5) of this section, an infant formula manufacturer shall, with re spect to each formula covered by this paragraph, comply with the nutrient requirements of section 412(g) of the act or of regulations promulgated under section 412(a)(2) of the act, and the labeling requirements of subpart B of this part. (3) Each manufacturer of an infant formula covered by this paragraph shall establish quality control proce dures designed to ensure that the in fant formula meets applicable nutrient requirements of this section, including any special nutritional characteristics for the specific disorders or conditions for which the formula is represented for use. Each manufacturer shall main tain records of such quality control procedures sufficient to permit a public health evaluation of each manufac tured batch of infant formula and shall permit any authorized FDA employee at all reasonable times to have access to and to copy and verify the records referred to in this paragraph. (4) To retain the exempt status of an infant formula covered by this para graph, the manufacturer shall submit the information required by paragraphs (b)(3) and (4) of this section. (5) A manufacturer may deviate from the requirements of paragraph (c)(2) of this section only with respect to those specific requirements for which it sub mits to FDA, at the address specified in paragraph (e)(1) of this section, the medical, nutritional, scientific, or technological rationale (including any appropriate animal or human clinical studies). FDA will review that informa tion under paragaraph (d) of this sec tion. (6) The requirements of this section do not apply to an infant formula spe cially and individually prepared for one or more specific infants on a physi cian’s request. (d) FDA review of exempt status. (1) FDA’s Center for Food Safety and Ap plied Nutrition will review information submitted by infant formula manufac turers under paragraph (b) (3), (b) (4), or (c)(4) of this section. On the basis of such review and other information available to the agency, the Center for Food Safety and Applied Nutrition may impose additional conditions on, or modify requirements for, the quality control procedures, nutrient specifica tions, or labeling of an infant formula, or withdraw a product’s exempt status. Such determinations will be made by the Director of the Center for Food Safety and Applied Nutrition. (2)(i) If after completing its review of all information submitted, the Center for Food Safety and Applied Nutrition concludes that additional or modified quality control, nutrient, or labeling requirements are needed, or that a product’s exempt status is withdrawn, the Center for Food Safety and Applied Nutrition will so notify the manufac turer and this notification will specify the reasons therefor. Upon receipt of this notification, the manufacturer has 10 working days to have the decision reviewed under § 10.75 by the office of the Commissioner of Food and Drugs. A determination by the Director of the Center for Food Safety and Applied Nu trition that is not appealed becomes a final agency decision. (ii) After a final decision by the Di rector or by the office of the Commis sioner that a product’s exempt status is withdrawn, the manufacturer shall comply with the nutrient requirements of section 412(g) of the act or of regula tions promulgated under section 412(a)(2) of the act, the quality control requirements of part 106, and the label ing requirements of subpart B of this part. (iii) The compliance date for the withdrawal of a product’s exempt sta tus or the imposition of additional or modified quality control, nutrient, or labeling requirements is 60 calendar days after issuance of the final decision except as otherwise provided for rea sons stated in the decision. If the agen cy determines that a health hazard VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00205 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R ei er A vi le s on D S K G B LS 3C 1P R O D w ith C F R 196 21 CFR Ch. I (4–1–11 Edition) § 107.100 may exist and so notifies the manufac turer, withdrawal of a product’s ex empt status shall be effective on the date of receipt of notification from the Director of the Center for Food Safety and Applied Nutrition. Additional or modified requirements, or the with drawal of an exemption, apply only to those formulas that are manufactured after the compliance date. A postpone ment of the compliance date may be granted for good cause. (3) FDA may decide that withdrawal of an exemption is necessary when, on the basis of its review under paragraph (d)(1) of this section, it concludes that quality control procedures are not ade quate to ensure that the formula con tains all required nutrients, that devi ations in nutrient levels are not sup ported by generally accepted scientific, nutritional, or medical rationale, or that deviations from subpart B of this part are not necessary to provide ap propriate directions for preparation and use of the infant formula, or that additional labeling information is nec essary. (4) FDA will use the following cri teria in determining whether devi ations from the requirements of this subpart are necessary and will ade quately protect the public health: (i) A deviation from the nutrient re quirements of section 412(g) of the act or of regulations promulgated under section 412(a)(2) of the act is necessary to provide an infant formula that is ap propriate for the dietary management of a specific disease, disorder, or med ical condition; (ii) For exempt infant formulas sub ject to paragraph (b) of this section, a deviation from the quality control pro cedures requirements of part 106 is nec essary because of unusal or difficult technological problems in manufac turing the infant formula; and (iii) A deviation from the labeling re quirements of subpart B of this part is necessary because label information, including pictograms and symbols re quired by those regulations, could lead to inappropriate use of the product. (e) Notification requirements. (1) Infor mation required by paragraphs (b) and (c) of this section shall be submitted to Center for Food Safety and Applied Nu trition (HFS–830), Food and Drug Ad ministration, 5100 Paint Branch Pkwy., College Park, MD 20740. (2) The manufacturer shall promptly notify FDA when the manufacturer has knowledge (as defined in section 412(c)(2) of the act) that reasonably supports the conclusion that an exempt infant formula that has been processed by the manufacturer and that has left an establishment subject to the control of the manufacturer may not provide the nutrients required by paragraph (b) or (c) of this section, or when there is an exempt infant formula that may be otherwise adulterated or misbranded and if so adulterated or misbranded presents a risk of human health. This notification shall be made, by tele phone, to the Director of the appro priate FDA district office specified in part 5, subpart M of this chapter. After normal business hours (8 a.m. to 4:30 p.m.), contact the FDA Emergency Call Center at 866–300–4374. The manufac turer shall send a followup written con firmation to the Center for Food Safe ty and Applied Nutrition (HFS–605), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to the appropriate FDA dis trict office specified in part 5, subpart M of this chapter. [50 FR 48187, Nov. 22, 1985, as amended at 61 FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001; 67 FR 9585, Mar. 4, 2002; 75 FR 32659, June 9, 2010] Subpart D—Nutrient Requirements § 107.100 Nutrient specifications. (a) An infant formula shall contain the following nutrients at a level not less than the minimum level specified and not more than the maximum level specified for each 100 kilocalories of the infant formula in the form pre pared for consumption as directed on the container: Nutrients Unit of measure ment Min imum level Max imum level Protein Grams 1 .8 4 .5 Fat do 3 .3 6 .0 Percent calories 30 54 Linoleic acid Milligrams 300 .......... Percent calories 2 .7 .......... Vitamins Vitamin A International Units 250 750 VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00206 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R ei er A vi le s on D S K G B LS 3C 1P R O D w ith C F R 197 Food and Drug Administration, HHS § 107.210 Nutrients Unit of measure ment Min imum level Max imum level Vitamin D do 40 100 Vitamin E do 0 .7 .......... Vitamin K Micrograms 4 .......... Thiamine (vitamin B1) do 40 .......... Riboflavin (vitamin B2) do 60 .......... Vitamin B6 do 35 .......... Vitamin B12 do 0 .15 .......... Niacin 1 do 250 .......... Folic acid (folacin) do 4 .......... Pantothenic acid do 300 .......... Biotin 2 do 1 .5 .......... Vitamin C (ascorbic acid) Milligrams 8 .......... Choline 2 do 7 .......... Inositol 2 do 4 .......... Minerals Calcium do 60 .......... Phosphorus do 30 .......... Magnesium do 6 .......... Iron do 0 .15 3 .0 Zinc do 0 .5 .......... Manganese Micrograms 5 .......... Copper Micrograms 60 .......... Iodine do 5 75 Sodium Milligrams 20 60 Potassium do 80 200 Chloride do 55 150 1 The generic term ‘‘niacin’’ includes niacin (nicotinic acid) and niacinamide (nicotinamide). 2 Required only for non-milk-based infant formulas. In addition to the specifications estab lished in the table in this paragraph for vitamins and minerals, the following also apply: (b) Vitamin E shall be present at a level of at least 0.7 International Unit of vitamin E per gram of linoleic acid. (c) Any vitamin K added shall be in the form of phylloquinone. (d) Vitamin B6 shall be present at a level of at least 15 micrograms of vita min B6 for each gram of protein in ex cess of 1.8 grams of protein per 100 kilocalories of infant formula in the form prepared for consumption as di rected on the container. (e) The ratio of calcium to phos phorus in infant formula in the form prepared for consumption as directed on the container shall be no less than 1.1 and not more than 2.0. (f) Protein shall be present in an amount not to exceed 4.5 grams per 100 kilocalories regardless of quality, and not less than 1.8 grams per 100 kilocalories of infant formula in the form prepared for consumption as di rected on the container when its bio logical quality is equivalent to or bet ter than that of casein. If the biologi cal quality of the protein is less than that of casein, the minimum amount of protein shall be increased proportion ately to compensate for its lower bio logical quality. For example, an infant formula containing protein with a bio logical quality of 75 percent of casein shall contain at least 2.4 grams of pro tein (1.8/0.75). No protein with a bio logical quality less than 70 percent of casein shall be used. [50 FR 45108, Oct. 30, 1985] Subpart E—Infant Formula Recalls SOURCE: 54 FR 4008, Jan. 27, 1989, unless otherwise noted. § 107.200 Food and Drug Administra tion-required recall. When the Food and Drug Administra tion determines that an adulterated or misbranded infant formula presents a risk to human health, a manufacturer shall immediately take all actions nec essary to recall that formula, extend ing to and including the retail level, consistent with the requirements of this subpart. § 107.210 Firm-initiated product re movals. (a) If a manufacturer has determined to recall voluntarily from the market an infant formula that is not subject to § 107.200 but that otherwise violates the laws and regulations administered by the Food and Drug Administration (FDA) and that would be subject to legal action, the manufacturer, upon prompt notification to FDA, shall ad minister such voluntary recall con sistent with the requirements of this subpart. (b) If a manufacturer has determined to withdraw voluntarily from the mar ket an infant formula that is adulter ated or misbranded in only a minor way and that would not be subject to legal action, such removal from the market is deemed to be a market with drawal, as defined in § 7.3(j) of this chapter. As required by § 107.240(a), the manufacturer shall promptly notify FDA of such violative formula and may, but is not required to, conduct such market withdrawal consistent with the requirements of this subpart pertaining to product recalls. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00207 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R ei er A vi le s on D S K G B LS 3C 1P R O D w ith C F R 198 21 CFR Ch. I (4–1–11 Edition) § 107.220 § 107.220 Scope and effect of infant formula recalls. (a) The requirements of this subpart apply: (1) When the Food and Drug Adminis tration has determined that it is nec essary to remove from the market a distributed infant formula that is in violation of the laws and regulations administered by the Food and Drug Ad ministration and that poses a risk to human health; or (2) When a manufacturer has deter mined that it is necessary to remove from the market a distributed infant formula that: (i) Is no longer subject to the manu facturer’s control; (ii) Is in violation of the laws and regulations administered by the Food and Drug Administration and against which the agency could initiate legal or regulatory action; and (iii) Does not present a human risk. (b) The Food and Drug Administra tion will monitor continually the re call action and will take appropriate actions to ensure that the violative in fant formula is removed from the mar ket. § 107.230 Elements of an infant for mula recall. A recalling firm shall conduct an in fant formula recall with the following elements: (a) The recalling firm shall evaluate in writing the hazard to human health associated with the use of the infant formula. This health hazard evaluation shall include consideration of any dis ease, injury, or other adverse physio logical effect that has been or that could be caused by the infant formula and of the seriousness, likelihood, and consequences of the diseases, injury, or other adverse physiological effect. The Food and Drug Administration will conduct its own health hazard evalua tion and promptly notify the recalling firm of the results of that evaluation if the criteria for recall under § 107.200 have been met. (b) The recalling firm shall devise a written recall strategy suited to the in dividual circumstances of the par ticular recall. The recall strategy shall take into account the health hazard evaluation and specify the following: The extent of the recall; if necessary, the public warning to be given about any hazard presented by the infant for mula; the disposition of the recalled in fant formula; and the effectiveness checks that will be made to determine that the recall is carried out. (c) The recalling firm shall promptly notify each of its affected direct ac counts about the recall. The format of a recall communication shall be dis tinctive, and the content and extent of a recall communication shall be com mensurate with the hazard of the in fant formula being recalled and the strategy developed for the recall. The recall communication shall instruct consignees to report back quickly to the recalling firm about whether they are in possession of the recalled infant formula and shall include a means of doing so. The recalled communication shall also advise consignees how to re turn the recall infant formula to the manufacturer or otherwise dispose of it. The recalling firm shall send a fol lowup recall communication to any consignee that does not respond to the initial recall communication. (d) If the infant formula presents a risk to human health, the recalling firm shall request that each establish ment, at which such infant formula is sold or available for sale, post at the point of purchase of such formula a no tice of such recall at such establish ment. The notice shall be provided by the recalling firm after approval of the notice by the Food and Drug Adminis tration. The recalling firm shall also request that each retail establishment maintain such notice on display until such time as the Food and Drug Ad ministration notifies the recalling firm that the agency considers the recall completed. (e) The recalling firm shall furnish promptly to the appropriate Food and Drug Administration district office listed in part 5, subpart M of this chap ter, as they are available, copies of the health hazard evaluation, the recall strategy, and all recall communica tions (including, for a recall under § 107.200, the notice to be displayed at VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00208 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R ei er A vi le s on D S K G B LS 3C 1P R O D w ith C F R 199 Food and Drug Administration, HHS § 107.250 retail establishments) directed to con signees, distributors, retailers, and members of the public. [54 FR 4008, Jan. 27, 1989, as amended at 66 FR 17358, Mar. 30, 2001; 69 FR 17291, Apr. 2, 2004] § 107.240 Notification requirements. (a) Notification of a violative infant for mula. A manufacturer shall promptly notify the Food and Drug Administra tion when the manufacturer has knowl edge (as defined in section 412(e)(2) of the Federal Food, Drug, and Cosmetic Act (the act)) that reasonably supports the conclusion that an infant formula that has been processed by the manu facturer and that has left an establish ment subject to the control of the man ufacturer: (1) May not provide the nutrients re quired by section 412(i) of the act and by regulations promulgated under sec tion 412(i)(2) of the act; or (2) May be otherwise adulterated or misbranded. (b) Method of notification. The notifi cation made pursuant to § 107.240(a) shall be made, by telephone, to the Di rector of the appropriate Food and Drug Administration district office listed in part 5, subpart M of this chap ter. After normal business hours (8 a.m. to 4:30 p.m.), contact the FDA Emergency Call Center at 866–300–4374. The manufacturer shall send written confirmation of the notification to the Center for Food Safety and Applied Nu trition (HFS–605), Food and Drug Ad ministration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to the ap propriate Food and Drug Administra tion district office listed in part 5, sub part M of this chapter. (c) Reports about an infant formula re call—(1) Telephone report. When a deter mination is made that an infant for mula is to be recalled, the recalling firm shall telephone within 24 hours the appropriate Food and Drug Admin istration district office listed in part 5, subpart M of this chapter and shall provide relevant information about the infant formula that is to be recalled. (2) Initial written report. Within 14 days after the recall has begun, the re calling firm shall provide a written re port to the appropriate Food and Drug Administration district office. The re port shall contain relevant informa tion, including the following cumu lative information concerning the in fant formula that is being recalled: (i) Number of consignees notified of the recall, and date and method of no tification, including, for a recall pursu ant to § 107.200 information about the notice provided for retail display and the request for its display. (ii) Number of consignees responding to the recall communication and quan tity of recalled infant formula on hand at the time it was received. (iii) Quantity of recalled infant for mula returned or corrected by each consignee contacted and the quantity of recalled infant formula accounted for. (iv) Number and results of effective ness checks that were made. (v) Estimated timeframes for comple tion of the recall. (3) Status reports. The recalling firm shall submit to the appropriate Food and Drug Administration district office a written status report on the recall at least every 14 days until the recall is terminated. The status report shall de scribe the steps taken by the recalling firm to carry out the recall since the last report and the results of these steps. [54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996; 66 FR 17359, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001; 75 FR 32659, June 9, 2010] § 107.250 Termination of an infant for mula recall. The recalling firm may submit a rec ommendation for termination of the recall to the appropriate Food and Drug Administration district office listed in part 5, subpart M of this chap ter for transmittal to the Center for Food Safety and Applied Nutrition (HFS–605), for action. Any such rec ommendation shall contain informa tion supporting a conclusion that the recall strategy has been effective. The agency will respond within 15 days of receipt by the Center for Food Safety and Applied Nutrition (HFS–605), of the request for termination. The recalling firm shall continue to implement the recall strategy until it receives final written notification from the agency that the recall has been terminated. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00209 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R ei er A vi le s on D S K G B LS 3C 1P R O D w ith C F R 200 21 CFR Ch. I (4–1–11 Edition) § 107.260 The agency will send such a notifica tion unless it has information, from FDA’s own audits or from other sources, demonstrating that the recall has not been effective. The agency may conclude that a recall has not been ef fective if: (a) The recalling firm’s distributors have failed to retrieve the recalled in fant formula; or (b) Stocks of the recalled infant for mula remain in distribution channels that are not in direct control of the re calling firm. [54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996; 66 FR 17359, Mar. 30, 2001; 69 FR 17291, Apr. 2, 2004] § 107.260 Revision of an infant formula recall. If after a review of the recalling firm’s recall strategy or periodic re ports or other monitoring of the recall, the Food and Drug Administration con cludes that the actions of the recalling firm are deficient, the agency shall no tify the recalling firm of any serious deficiency. The agency may require the firm to: (a) Change the extent of the recall, if the agency concludes on the basis of available data that the depth of the re call is not adequate in light of the risk to human health presented by the in fant formula. (b) Carry out additional effectiveness checks, if the agency’s audits, or other information, demonstrate that the re call has not been effective. (c) Issue additional notifications to the firm’s direct accounts, if the agen cy’s audits, or other information dem onstrate that the original notifications were not received, or were disregarded in a significant number of cases. § 107.270 Compliance with this sub part. A recalling firm may satisfy the re quirements of this subpart by any means reasonable calculated to meet the obligations set forth in this Sub part E. The recall guidance in subpart C of part 7 of this chapter specify pro cedures that may be useful to a recall ing firm in determining how to comply with these regulations. [54 FR 4008, Jan. 27, 1989, as amended at 65 FR 56479, Sept. 19, 2000] § 107.280 Records retention. Each manufacturer of an infant for mula shall make and retain such records respecting the distribution of the infant formula through any estab lishment owned or operated by such manufacturer as may be necessary to effect and monitor recalls of the for mula. Such records shall be retained for at least 1 year after the expiration of the shelf life of the infant formula. [54 FR 4008, Jan. 27, 1989, as amended at 67 FR 9585, Mar. 4, 2002] PART 108—EMERGENCY PERMIT CONTROL Subpart A—General Provisions Sec. 108.3 Definitions. 108.5 Determination of the need for a per mit. 108.6 Revocation of determination of need for permit. 108.7 Issuance or denial of permit. 108.10 Suspension and reinstatement of per mit. 108.12 Manufacturing, processing, or pack ing without a permit, or in violation of a permit. 108.19 Establishment of requirements for ex emption from section 404 of the act. Subpart B—Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Per mit 108.25 Acidified foods. 108.35 Thermal processing of low-acid foods packaged in hermetically sealed con tainers. AUTHORITY: 21 U.S.C. 342, 344, 371. SOURCE: 42 FR 14334, Mar. 15, 1977, unless otherwise noted. Subpart A—General Provisions § 108.3 Definitions. (a) The definitions contained in sec tion 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part. (b) Commissioner means the Commis sioner of Food and Drugs. (c) Act means the Federal Food, Drug, and Cosmetic Act, as amended. (d) Permit means an emergency per mit issued by the Commissioner pursu ant to section 404 of the act for such VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00210 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R ei er A vi le s on D S K G B LS 3C 1P R O D w ith C F R