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GUIDANCE DOCUMENT

Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant Formula March 2006

Final
Docket Number:
FDA-2020-D-1937
Issued by:
Guidance Issuing Office
Human Foods Program

Comments and suggestions regarding this document may be submitted at any time. Submit comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

For questions regarding this document, contact the Infant Formula Medical Foods Staff at the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1450.

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

Introduction

This list of frequently asked questions (FAQs) is intended to be a convenient place to find answers to common questions about FDA's regulation of infant formula. This FAQ addresses common questions about the regulatory processes and regulatory considerations regarding infant formula. It is not intended to replace information about Regulatory/Guidance Documents & Advisory Meetings, including the Guidelines Concerning Notification and Testing of Infant Formulas, on FDA's Infant Formula webpage or information about Approval and Notification Programs on FDA's Food Ingredient and Packaging webpage. 

List of the questions

  1. What is an infant formula?
  2. How is infant formula regulated in the United States?
  3. Who in FDA regulates infant formula?
  4. Does FDA approve infant formulas before they are marketed?
  5. Does FDA have nutrient specifications for infant formula?
  6. What is a new infant formula?
  7. What is a major change in an infant formula?
  8. What substances may be used in infant formulas?
  9. Who does an infant formula manufacturer contact about infant formula?
  10. What must a manufacturer do before marketing a new infant formula in the United States?
  11. What must an infant formula manufacturer provide to FDA in the notification for a new infant formula?
  12. Does FDA monitor infant formula?
  13. Is an infant formula manufacturer required to register with FDA under the Bioterrorism Act of 2002?
  1. What is an infant formula? 
    The Federal Food, Drug, and Cosmetic Act (FFDCA) defines infant formula as "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" (FFDCA 201(z)). FDA regulations define infants as persons not more than 12 months old (Title 21, Code of Federal Regulations 21 CFR 105.3(e)).
  2. How is infant formula regulated in the United States?
    Because infant formula is a food, the laws and regulations governing foods apply to infant formula. Additional statutory and regulatory requirements apply to infant formula, which is often used as the sole source of nutrition by a vulnerable population during a critical period of growth and development. These additional requirements are found in section 412 of the FFDCA and FDA's implementing regulations in 21 CFR 106 and 107. To view the FFDCA and regulations in 21 CFR, see FDA Federal Register Documents, Code of Federal Regulations & Food, Drug, and Cosmetic Act.
  3. Who in FDA regulates infant formula?
    The Center for Food Safety and Applied Nutrition is responsible for regulation of infant formula. The Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) has program responsibility for infant formula. The Office of Food Additive Safety (OFAS) has program responsibility for food ingredients and packaging. ONPLDS evaluates whether the infant formula manufacturer has met the requirements under section 412 of the FFDCA. ONPLDS consults with OFAS regarding the safety of ingredients in infant formula and of packaging materials for infant formula. Under sections 201(s) and 409 of the FFDCA, OFAS evaluates the safety of substances intended for use in or in contact with infant formula.
  4. Does FDA approve infant formulas before they can be marketed?
    No, FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements and infant formula manufacturers must notify the FDA prior to marketing a new formula. If an infant formula manufacturer does not provide the elements and assurances required in the notification for a new or reformulated infant formula, the formula is defined as adulterated under section 412(a)(1) of the FFDCA and FDA has the authority to take compliance action if the new infant formula is marketed.
  5. Does FDA have nutrient specifications for infant formula?
    Yes, FDA has requirements for nutrients in infant formulas, which are located in section 412(i) of the FFDCA and 21 CFR 107.100. These nutrient specifications include minimum amounts for 29 nutrients and maximum amounts for 9 of those nutrients. If an infant formula does not contain these nutrients at or above the minimum level or within the specified range, it is an adulterated product unless the formula is "exempt" from certain nutrient requirements. An "exempt infant formula" is "any infant formula which is 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" (FFDCA 412(h)(1)).
  6. What is a new infant formula?
    Under section 412(c)(2) of the FFDCA, a new infant formula includes "an infant formula manufactured by a person which has not previously manufactured infant formula." A new infant formula also includes "an infant formula manufactured by a person which has previously manufactured infant formula and in which there is a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer."
  7. What is a major change in an infant formula?
    As described in section 412(c)(2)(B) of the FFDCA and 21 CFR 106.30(c)(2), a major change is a change in either the formulation or processing of an infant formula that could result in a possible significant adverse impact on levels of nutrients or availability of nutrients so they would no longer meet the requirements of the section 412 of the FFDCA. Examples of major changes include:
    • A new manufacturing plant
    • A new production line
    • Employment of significant new technology
    • Fundamental change in the type of packaging used
    • Addition of a new macronutrient (protein, fat, or carbohydrate)
    • A substantial change in the amount of protein, fat, or carbohydrate
    • Addition of new ingredients.

    Greater detail about major changes is provided in Guidelines Concerning Notification and Testing of Infant Formulas.

  8. What substances may be used in infant formulas?
    Substances used in food, including infant formula, must be safe and lawful. Substances that may be used in infant formulas are food ingredients that are generally recognized as safe (GRAS) for use in infant formula and those that are used in accordance with the FDA's food additive regulations (FFDCA 201(s) and 409).
  9. Who does an infant formula manufacturer contact about infant formula?
    FDA encourages infant formula manufacturers to contact ONPLDS with questions about infant formula, including questions whether a substance has previously been used in infant formula in the United States. FDA encourages infant formula manufacturers to work with OFAS to resolve any safety issues concerning the substance new to infant formula before submitting the infant formula notification required by law (section 412 of the FFDCA) to ONPLDS. OFAS has guidance for submitting food additive petitions and GRAS notices. For further information about the criteria for the use of a substance to be GRAS, see Frequently Asked Questions About GRAS. FDA encourages manufacturers to consult OFAS if there are questions about the programs for which OFAS has responsibility.
  10. What must a manufacturer do before marketing a new infant formula in the United States?
    Under section 412 of the FFDCA, a manufacturer who intends to market a new infant formula in the United States must register with, must notify, and must submit written verification to, FDA. Such registration, notification and verification are to be sent to ONPLDS. For further information, seeInfant Formula: Regulatory/Guidance Documents & Advisory Meetings.
    • Registration. Section 412(c)(1) of the FFDCA requires a person who plans to introduce or deliver for introduction any new infant formula into interstate commerce, to register with FDA the name of the person (manufacturer) and their place of business, and all establishments at which the person intends to manufacture the new infant formula. Submission of the required registration and the required notification at the same time will facilitate the agency's review.
    • Notification. Section 412(d)(1) of the FFDCA requires persons responsible for the manufacture of infant formula to submit information relative to the manufacture of the new infant formula at least 90 days before marketing their infant formula. This 90 day notification for a new infant formula must include 1) the quantitative formulation of the infant formula, 2) a description of any reformulation of the formula or change in processing of the infant formula, 3) assurances that the infant formula will not be marketed unless it meets the quality factors and the nutrient requirements of the FFDCA, and 4) assurances that the processing of the infant formula complies with good manufacturing practices, including quality control procedures.
    • Verification. Section 412(d)(2) requires persons responsible for the manufacture of any new infant formula to submit a written verification that summarizes test results that such formula complies with specific requirements of the FFDCA. This written verification is to be submitted after first production and before the introduction into interstate commerce of the new infant formula.
  11. What must an infant formula manufacturer provide to FDA in the notification for a new infant formula?
    Before a new infant formula can be marketed in the United States, the infant formula manufacturer must provide FDA with a notification about the proposed infant formula as required under section 412 of the FFDCA. This premarket infant formula notification must contain detailed information about the formulation, an explanation of what has changed (if it is a reformulation), and nutritional and manufacturing assurances. The infant formula manufacturer must provide assurance that the formula will provide adequate nutrition for infants to thrive, that the formula will be manufactured under current good manufacturing practices including quality control procedures, and that every batch of the formula will meet all of the nutrient requirements under the FFDCA and its implementing regulations in 21 CFR. These regulations include:
    • 21 CFR Part 106 - Infant formula quality control procedures
    • 21 CFR Part 107 - Infant formula
    • 21 CFR Part 110 - Current good manufacturing practice in manufacturing, packing, or holding human food
    • 21 CFR Part 113 - Thermally processed low-acid foods packaged in hermetically sealed containers
  12. Does FDA monitor infant formula?
    Yes, FDA monitors infant formula products as part of its responsibility to implement the provisions of section 412 of the FFDCA. These provisions identify responsibilities for infant formula manufacturers and the FDA.
    • Manufacturers. The FFDCA requires infant formula manufacturers to test product composition during production and shelf-life, to keep records on production, testing, and distribution of each batch of infant formula and to use good manufacturing practices and use quality control procedures. In addition, the FFDCA requires infant formula manufacturers to maintain records of all complaints, some of which are reviewed to reveal the possible existence of a hazard to health.
    • FDA. FDA conducts yearly inspection of all facilities that manufacture infant formula. FDA also inspects new facilities during early production runs. As part of the inspection, FDA collects and analyzes samples of infant formula.
      • In addition, the FFDCA authorizes the agency to initiate a FDA-mandatory recall if the agency determines that an adulterated or misbranded infant formula presents a risk to human health.
  13. Is an infant formula manufacturer required to register with FDA under the Bioterrorism Act of 2002?
    Yes. Like all food manufacturers, infant formula manufacturers must register with FDA under the Bioterrorism Act of 2002. The registration under the Bioterrorism Act of 2002 is separate and distinct from the notification and registration described in question 12. For additional information regarding registration under the Bioterrorism Act of 2002, see The Bioterriorism Act of 2002.

Related Information

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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2020-D-1937.

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