Eligible infant formula – An infant formula that could be lawfully distributed in the United States on December 8, 2014.
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.
Final product stage – The point in the manufacturing process, before distribution of an infant formula, at which the infant formula is homogeneous and is not subject to further degradation due to processing.
Hardware – Means all automatic equipment, including mechanical and electronic equipment (such as computers), that is used in production or quality control of infant formula.
Indicator nutrient – A nutrient whose concentration is measured during the manufacture of an infant formula to confirm complete addition and uniform distribution of a premix or other substance of which the indicator nutrient is a part.
Infant – A person not more than 12 months of age.
Infant formula – A food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.
Infant Formula with Iron – A product that contains 1 milligram or more of iron in a quantity of product that supplies 100 kilocalories when prepared in accordance with label directions for infant consumption.
In-process control system – The production and in-process control system shall cover all stages of processing, from the receipt and acceptance of the raw materials, ingredients, and components through the storage and distribution of the finished product. The system includes:
- Development and implementation of a written plan or set of procedures that is designed to ensure that an infant formula is manufactured in a manner that will prevent adulteration.
- Identification of any point, step, or stage in the production process where control is necessary to prevent adulteration
- Establishment of operational and product specifications to be met
- Monitoring the production and in-process control point, step, or Stage
- Development and implementation of a corrective action plan for use when a specification in this section are not met
- Reviewing the results of the monitoring and evaluate the public health significance of any deviation from specifications that have been established.
- For any specification established that a manufacturer fails to meet, an individual qualified by education, training, or experience shall conduct a documented review and shall make a material disposition decision to reject the affected article, to reprocess or otherwise recondition the affected article, or to approve and release the article for use or distribution
- Establishment of recordkeeping procedures that ensure that compliance with the requirements of 21 CFR 106 and 107 are documented.
- Any article that fails to meet a specification shall be controlled under a quarantine system designed to prevent its use pending the completion of a documented review and material disposition decision.
In-process production aggregate – A combination of ingredients at any point in the manufacturing process before packaging.
Major change – In an existing infant formula already commercially available in the US means any new formulation, change of ingredients or processes where experience or theory would predict a possible significant adverse impact on levels of nutrients or bioavailability of nutrients, or any change that causes an infant formula to differ fundamentally in processing or in composition from any previous formulation produced by the manufacturer. Examples of infant formulas deemed to differ fundamentally in processing or in the composition include:
- Any infant formula produced by a manufacturer who is entering the U.S. market;
- Any infant formula powder processed and distributed by a manufacturer who previously only produced liquids (or vice versa);
- Any infant formula having a significant revision, addition, or substitution of a macronutrient (i.e., protein, fat, or carbohydrate), with which the manufacturer has not had previous experience;
- Any infant formula manufactured on a new processing line or in a new plant;
- Any infant formula manufactured containing a new constituent not listed in section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(i)), such as taurine or L-carnitine;
- Any infant formula processed by a manufacturer on new equipment that utilizes a new technology or principle (e.g., from terminal sterilization to aseptic processing); or
- An infant formula for which there has been a fundamental change in the type of packaging used (e.g., changing from metal cans to plastic pouches).
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.
Microbiologically Acceptable Infant Formula – A powdered infant formula that contains any microorganism that exceeds the M value listed for that microorganism in the table below shall be deemed adulterated
Microorganism n 1 Sample size M value
Cronobacter spp. 3010 g (grams) 20.
Salmonella spp. 6025 g 20.
1Number of samples.
Microorganisms – Yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance.
New infant formula – An infant formula manufactured by a person that has not previously manufactured an infant formula, and an infant formula manufactured by a person that 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, or which has not previously been the subject of a submission under section 412(c) of the Federal Food, Drug, and Cosmetic Act for the U.S. market.
New Infant Formula Notification (NIFN) – The accumulated information required (21 CFR 106) to be assembled and submitted to FDA for the 90-day review which, if no objection is received by FDA, will allow the manufacturer to begin retail sale of the new infant formula in the US marketplace.
Nutrient – Any vitamin, mineral, or other substance or ingredient that is required in accordance with the “Nutrients” table set out in section 412(i)(1) of the Federal Food, Drug, and Cosmetic Act or by regulations issued under section 412(i)(2) or that is identified as essential for infants by the Food and Nutrition Board of the Institute of Medicine through its development of a Dietary Reference Intake, or that has been identified as essential for infants by the Food and Drug Administration through a Federal Register publication.
Nutrient premix – A combination of ingredients containing two or more nutrients received from a supplier or prepared by an infant formula manufacturer.
Production aggregate – A quantity of product, or, in the case of an infant formula produced by continuous process, a specific identified amount produced in a unit of time, that is intended to have uniform composition, character, and quality, within specified limits, and is produced according to a master manufacturing order.
Production unit – A specific quantity of an infant formula produced during a single cycle of manufacture that has uniform composition, character, and quality, within specified limits.
Production unit number or production aggregate number – Any distinctive combination of letters, numbers, symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a production aggregate or a production unit of infant formula can be determined.
Quality factors – Those factors necessary to demonstrate the safety of the infant formula and the bioavailability of its nutrients, as prepared for market and when fed as the sole source of nutrition, to ensure the healthy growth of infants.
Recall (of an infant formula) – The manufacturer and/or brand owner (recalling firm) shall do the following:
- Evaluate in writing the hazard to human health associated with the use of the infant formula including 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
- Devise a written recall strategy suited to the individual circumstances of the recall addressing 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 out.
- Promptly notify each of its affected direct accounts about the recall. The format of a recall communication shall be distinctive, and the content and extent of a recall communication shall be commensurate with the hazard of the infant 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 return the recall infant formula to the manufacturer or otherwise dispose of it.
- The recalling firm shall send a follow-up recall communication to any consignee that does not respond to the initial recall communication.
- If the infant formula presents a risk to human health, the recalling firm shall request that each establishment, at which such infant formula is sold or available for sale, post at the point of purchase of such formula a notice of such recall at such establishment.
- The notice shall be provided by the recalling firm after approval of the notice by the Food and Drug Administration. The recalling firm shall also request that each retail establishment maintain such notice on display until such time as the Food and Drug Administration notifies the recalling firm that the agency considers the recall completed.
- The recalling firm shall furnish promptly to the appropriate Food and Drug Administration district office copies of the health hazard evaluation, the recall strategy, and all recall communications directed to consignees, distributors,
- Telephone report. 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 and shall provide relevant information about the infant formula that is to be recalled.
- Initial written report. 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.
- Status reports. The recalling firm shall submit to the appropriate FDA district office a written status report on the recall at least every 14 days until the recall is terminated. The status report shall describe the steps taken by the recalling firm to carry out the recall since the last report and the results of these steps.
Representative sample – A sample that consists of a number of units that are drawn based on rational criteria, such as random sampling, and intended to ensure that the sample accurately portrays the material being sampled.
Shall – Used to state mandatory requirements.
Software – Any programs, procedures, rules, and associated documentation used in the operation of a system.
System – A collection of components (including software and hardware) organized to accomplish a specific function or set of functions in a specified environment.
Validation – means establishing documented evidence that provides
Traceability – Each production aggregate of infant formula shall be coded with a sequential number that identifies the product and the establishment where the product was packed in order to permit tracing of all stages of manufacture of that production aggregate, including the year, the days of the year, and the period during those days that the product was packed, and the receipt and handling of raw materials used.
Use by ___ date – The month and year selected by the manufacturer, packer, or distributor of the infant formula using tests or other information that demonstrate the infant formula, until that date, under the conditions of handling, storage, preparation, and use prescribed by label directions, will:
- When consumed, contain not less than the quantity of each nutrient, as set forth on its label; and
- Otherwise be of an acceptable quality (e.g., pass through an ordinary bottle nipple).