Title 21 CFR reference

(a) The criteria in subpart B of this part describe the labeling requirements applicable to infant formula under section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 343). Failure to comply with any regulation in subpart B of this part will render an infant formula misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act. (b) The criteria in subpart C of this part describe the terms and conditions for the exemption of an infant formula from the requirements of section 412(a), (b), and (c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a), (b), and (c)). Failure to comply with any regulations in subpart C of this part will result in withdrawal of the exemption given under section 412(h)(1) of the Federal Food, Drug, and Cosmetic Act. (c) Subpart D of this part contains the nutrient requirements for infant formula under section 412(i) of the Federal Food, Drug, and Cosmetic Act. Failure to comply with any regulation in subpart D of this part will render an infant formula adulterated under section 412(a)(1) of the Federal Food, Drug, and Cosmetic Act. (d) An exempt infant formula is subject to the provisions of § 107.50 and other…

(a) The labeling of infant formulas, as defined in section 201(z) of the Federal 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 consumption: (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, supplied by 100 kilocalories, of each of the following nutrients and of any other nutrient added by the manufacturer: (b) In addition the following apply: (1) Vitamin A content may also be declared on the label in units of microgram retinol equivalents, vitamin 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 milliequivalents. When these declarations are made they shall appear in parentheses immediately following the declarations in International Units for vitamins A, D, and E, and immediately following the declarations in…

(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 prepared for consumption as directed on the container: (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. 652652(d) Vitamin B shall be present at a level of at least 15 micrograms of vitamin B for each gram of protein in excess of 1.8 grams of protein per 100 kilocalories of infant formula in the form prepared for consumption as directed on the container. (e) The ratio of calcium to phosphorus 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 directed on the container when its biological quality is equivalent to or better than that of…

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 indicating that prolonged storage at excessive 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 preparing 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 “Directions for Preparation and Use” a pictogram depicting the major steps for preparation of that infant formula, such as (for a concentrated formula): (c) A “Use by ______” 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…

When the Food and Drug Administration determines that an adulterated or misbranded infant formula presents a risk to human health, a manufacturer shall immediately take all actions necessary to recall that formula, extending to and including the retail level, consistent with the requirements of this subpart.

(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 administer such voluntary recall consistent with the requirements of this subpart. (b) If a manufacturer has determined to withdraw voluntarily from the market an infant formula that is adulterated 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 withdrawal, 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.

(a) The requirements of this subpart apply: (1) When the Food and Drug Administration has determined that it is necessary to remove from the market a distributed infant formula that is in violation of the laws and regulations administered by the Food and Drug Administration and that poses a risk to human health; or (2) When a manufacturer has determined that it is necessary to remove from the market a distributed infant formula that: (i) Is no longer subject to the manufacturer'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 Administration will monitor continually the recall action and will take appropriate actions to ensure that the violative infant formula is removed from the market.

A recalling firm shall conduct an infant 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 disease, injury, or other adverse physiological 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 evaluation 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 individual circumstances of the particular 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 formula; the disposition of the recalled infant formula; and the effectiveness checks that will be made to determine that the recall is carried…

Telephone report.(a) When a determination is made that an infant formula is to be recalled, the recalling firm shall telephone within 24 hours the appropriate Food and Drug Administration district office listed in § 5.115 of this chapter and shall provide relevant information about the infant formula that is to be recalled. Initial written report.(b) Within 14 days after the recall has begun, the recalling firm shall provide a written report to the appropriate FDA district office. The report shall contain relevant information, including the following cumulative information concerning the infant formula that is being recalled: (1) Number of consignees notified of the recall and date and method of notification, including recalls required by § 107.200, information about the notice provided for retail display, and the request for its display. (2) Number of consignees responding to the recall communication and quantity of recalled infant formula on hand at each consignee at the time the communication was received. (3) Quantity of recalled infant formula returned or corrected by each consignee contacted and the quantity of recalled infant formula accounted for. (4) Number and…

CFSAN.RECALL@fda.hhs.govThe recalling firm may submit a recommendation for termination of the recall to the appropriate FDA district office for transmittal to the Recall Coordinator, Division of Enforcement (HFS-605), Office of Compliance, Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, or by email to , for action. Any such recommendation shall contain information supporting a conclusion that the recall strategy has been effective. The Agency will respond within 15 days of receipt by the Division of Enforcement 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. The Agency will send such notification, unless the Agency 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 effective if: (a) The recalling firm's distributors have failed to retrieve the recalled infant formula; or (b) Stocks of the recalled infant formula remain in distribution channels that are not in direct control of the…

If after a review of the recalling firm's recall strategy or periodic reports or other monitoring of the recall, the Food and Drug Administration concludes that the actions of the recalling firm are deficient, the agency shall notify 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 recall is not adequate in light of the risk to human health presented by the infant formula. (b) Carry out additional effectiveness checks, if the agency's audits, or other information, demonstrate that the recall has not been effective. (c) Issue additional notifications to the firm's direct accounts, if the agency's audits, or other information demonstrate that the original notifications were not received, or were disregarded in a significant number of cases.

A recalling firm may satisfy the requirements of this subpart by any means reasonable calculated to meet the obligations set forth in this Subpart E. The recall guidance in subpart C of part 7 of this chapter specify procedures that may be useful to a recalling firm in determining how to comply with these regulations. [54 FR 4008, Jan. 27, 1989, as amended at 65 FR 56479, Sept. 19, 2000]

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 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]

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 formula 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 dietary problems. Manufacturer. A person who prepares, reconstitutes, or otherwise changes the physical or chemical characteristics of an infant formula or packages or labels the product in a container for distribution. The term “manufacturer” does not include a person who prepares, reconstitutes, or mixes infant formula exclusively for an infant under his/her direct care or the direct care of the institution employing such person. References. References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. [50 FR 48186, Nov. 22, 1985, as amended at 79 FR 8074, Feb. 10, 2014]

When containers of ready-to-feed infant 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 requirements 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 requirements of this part; (b) individual containers are securely enclosed within and are not intended to be separated from the retail package under conditions 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 “Individual” in the statement.

Terms and conditions.(a) Section 412(f)(1) of the act exempts from the requirements 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 birth weight or who otherwise has an unusual medical or dietary problem, if such formulas comply with regulations prescribed by the Secretary. The regulations in this subpart establish the terms and conditions that a manufacturer must meet with respect to such infant formulas. Infant formulas generally available at the retail level.(b) (1) These exempt infant formulas can generally be purchased from retail store shelves that are readily available to the public. Such formulas are also typically represented and labeled for use to provide dietary management for diseases or conditions that are not clinically serious 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 respect to each formula covered by this paragraph, comply with the…