Regulations and Information on the Manufacture and Distribution of Infant Formula
Spotlight
January 17, 2024
The FDA has issued a December 2023 status update on actions the agency has taken, and those underway, to strengthen the safety and resiliency of the supply of nutritious infant formula. The update includes release of a progress report specific to actions the agency has taken to meet the recommendations in the FDA’s Evaluation of the Infant Formula Response.
In September 2022, the FDA issued a guidance for industry on its infant formula transition plan which outlined a path for interested firms selling products in the U.S. under the exercise of enforcement discretion to bring those products into compliance with U.S. requirements, helping to diversify the U.S. infant formula supply. The guidance superseded the May 2022 guidance for industry on the FDA’s infant formula enforcement discretion policy.
This web page contains information about the Food and Drug Administration's (FDA's) laws and regulations relating to the manufacture of infant formula. It includes information about:
- Federal requirements for the manufacture of infant formula for marketing in the United States, including registration requirements,
- Federal submission requirements for persons responsible for the manufacture of new infant formula,
- Registration and submission requirements for infant formula manufactured in the United States for export, and
- Other pertinent information.
Federal requirements for the manufacture of infant formula for marketing in the United States, including registration requirements
Persons responsible for the manufacture or distribution of infant formula that will be introduced into interstate commerce in the United States must comply with the requirements of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC 321 et seq., and FDA's regulations implementing the Act. All of FDA's regulations are published in Title 21 of the Code of Federal Regulations (CFR).
With respect to infant formula, section 412 of the Act (21 USC 350a) provides requirements relating to nutrient content, nutrient quantity, nutrient quality control, recordkeeping and reporting, and recall of infant formulas. In addition, as discussed more fully below, section 412 of the Act requires persons responsible for the manufacture or distribution of infant formula to register with FDA and to make a submission to FDA for any new infant formula, which includes any infant formula that has had a major change in its formulation or processing, ninety (90) days before any charitable or commercial distribution. After the first processing of a new infant formula, but before marketing, persons responsible for the manufacture or distribution of infant formula must submit to FDA a written verification which demonstrates that the formula, as actually produced, complies with the Act's requirements. A summary of test results of nutrients in the formula is required.
Under the authority of the Act, FDA has promulgated regulations that specify infant formula nutrient quality control procedures; records and reports; and submission requirements (21 CFR 106); the labeling of infant formula; the terms and conditions under which certain infant formula may be exempt from some of the Act's requirements; nutrient specifications for infant formula; and infant formula recalls (21 CFR 107). In 2014 the agency revised its infant formula regulations (21 CFR Parts 106 and 107) to establish quality factors, current good manufacturing practices, and revised quality control procedures.
These documents and other pertinent information are available at Infant Formula: Regulatory & Guidance Documents.
Registration
Section 412(c)(1) of the Act requires persons responsible for the manufacture or distribution of a new infant formula to register with FDA. The requirements for registration can be found in 21 CFR 106.110 and include: the name of the new infant formula, the name of the manufacturer, the street address of the place of business of the manufacturer, and the name and street address of each establishment at which the manufacturer intends to manufacture the new infant formula. Manufacturers may register at any time before introducing a new formula into interstate commerce. However, FDA requests that they do so at the same time that they submit notice of their intent to market a new infant formula in accordance with section 412(c)(1)(B) and (d)(1) of the Act. Receiving the registration and the 90-day submission (discussed below) at the same time will facilitate FDA's review.
Federal submission requirements for persons responsible for the manufacture of new infant formula
Section 412(d)(1) requires persons responsible for the manufacture or distribution of infant formula to submit information relative to the manufacture of the new infant formula ninety (90) days before marketing their infant formula (hereinafter referred to as "new infant formula submission"). The new infant formula submission must include: 1) the product name and a description of the physical form, 2) an explanation of why it is a new infant formula, 3) the quantitative formulation of the infant formula, 4) a description of any reformulation of the formula or change in processing of the infant formula, 5) assurances that the infant formula will not be marketed unless it meets the quality factors (the quality factors are normal physical growth and sufficient biological quality of protein, see 21 CFR 106.96 and 21 CFR 106.121) and the nutrient requirements of 21 CFR 107.100, and 6) assurances that the processing of the infant formula complies with section 412(b)(2) of the Act (see 21 CFR 106.120 for details).
Quality factor requirements are described in 21 CFR 106.96 and 21 CFR 106.121. Regarding the growth monitoring study, the following guidance documents set forth general scientific principles for the conduct, performance, and control of clinical studies of drugs and biologic products: Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance and Guidance for Industry E11 Clinical Investigation of Medicinal Products in the Pediatric Population. Although details and examples in these documents are directed to drugs and biologics, the general scientific principles are applicable to clinical studies of infant formulas. Like all clinical studies of FDA regulated products, clinical studies of infant formula must follow regulations of human subject protection, additional safeguards for children in clinical investigations of FDA regulated products, and institutional review boards (see 21 CFR 50, and 21 CFR 56). Protocols developed for such studies may be submitted for agency comment prior to initiation of the study. However, this does not guarantee that the data generated will be sufficient to meet the requirements for the quality factor of normal physical growth.
In addition, the new infant formula submission should include information about the manufacturer's quality control program
To ensure compliance, FDA will inspect the infant formula establishment to observe all aspects of the formula's manufacture. During the inspection, the agency will collect samples for nutrient and, when appropriate, microbiological analyses.
Persons responsible for the manufacture or distribution will be able to submit their registration and infant formula submission electronically in the future; currently they can be directed in writing to:
Infant Formula and Medical Foods Staff (HFS-850)
Office of Nutrition and Food Labeling
Food and Drug Administration
5001 Campus Drive
College Park, MD 20740-3835
Requirements for infant formula manufactured in the United States for export
Persons responsible for the manufacture or distribution of infant formula produced in the United States for distribution outside of the United States must register with FDA in accordance with section 412(c)(1) of the Act (see 21 CFR 106.110 and 21 CFR 106.120). These sections require persons responsible for the manufacture or distribution of infant formula to register with and submit to FDA the same information as for the domestic market with the exception that a manufacturer may submit, in lieu of the information required under paragraphs (b)(5) and (b)(6) of 21 CFR 106.120, a statement certifying that the infant formula meets the specifications of the foreign purchaser, the infant formula does not conflict with the laws of the country to which it is intended for export, the infant formula is labeled on the outside of the shipping package to indicate that it is intended for export only, and the infant formula will not be sold or offered for sale in domestic commerce. Such manufacturer shall also submit a statement certifying that it has adequate controls in place to ensure that such formula is actually exported.
Additionally, the labels of the products intended for export, and the list of intended countries would be helpful for FDA’s review.
Other Pertinent Information
Submission concerning a change in infant formula that may adulterate the product
Under 412 (d)(3) of the Act, once a formula is lawfully marketed, any change in the formulation or processing of that formula that may affect whether the formula is adulterated under section 412(a) of the Act, requires a submission about this change before its first processing. See 21 CFR 106.140 for further information concerning this required submission.
Exempt infant formula
Section 412(h)(1) of the Act exempts an infant formula which is represented and labeled for use by an infant with an inborn error of metabolism, low birth weight, or who otherwise has an unusual medical or dietary problem from the requirements of sections 412(a), (b), and (c) of the Act. These formulas are customarily referred to as “exempt infant formulas.” Section 412(h)(2) of the Act authorizes us to establish terms and conditions for the exemption of an infant formula from the requirements of sections 412(a), (b), and (c) of the Act. FDA has established terms and conditions for exemption in 21 CFR 107.50.
Manufacturers of exempt infant formulas must provide the required submissions as described in 21 CFR 107.50 for FDA’s review.
We have issued guidance about our current thinking about the manufacturing of exempt infant formulas in relation to the requirements for current good manufacturing practices, quality control procedures, conduct of audits, and records and reports for nonexempt infant formulas in 21 CFR part 106. See Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports April 2016.
For more information, see Exempt Infant Formulas Marketed in the United States By Manufacturer and Category.
Infant formula recalls
Regulations concerning infant formula recall can be found in 21 CFR Part 107 Subpart E- INFANT FORMULA RECALLS.
Contact Us
Should you have any questions about this information, please call (240) 402-1450.
Request for Comments on New Electronic Submissions Form
FDA developed a draft electronic form, Form FDA 3978. Form FDA 3978 will prompt a respondent to register and include the required submission in a standard electronic format. This will help the respondent organize their registration and submission to include the information needed for FDA’s review and will give the respondent access to the status of the review as well as access to their previous registrations and submissions.
Manufacturers that prefer to submit paper registrations and submissions in a format of their own choosing will still have the option to do so.
FDA is seeking comments on this draft electronic form. Draft screenshots of Form FDA 3978 and draft instructions are available below for review and comments.
The comment period opened November 15, 2017 for 60 days. View electronically submitted comments in docket folder FDA-2013-N-0545. For more information, see the Federal Register Notice.