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U.S. Department of Health and Human Services

Food

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Regulations and Information on the Manufacture and Distribution of Infant Formula

March 2002

This document provides information about the Food and Drug Administration's (FDA's) regulations relating to the manufacture and distribution of infant formula. It includes 1) the Federal requirements for the manufacture of infant formula for marketing in the United States, including registration requirements, 2) the specific submission requirements for persons responsible for the manufacture or distribution of new infant formula, 3) the requirements for infant formula manufactured in the United States for export, and 4) other pertinent information on these topics.

Requirements for the Manufacture and Distribution of Infant Formula in the United States

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. When clinical studies are performed to demonstrate safety and adequacy of an infant formula, the studies must conform to FDA's regulations on protection of human subjects. 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.

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). The agency has recently proposed to revise its infant formula regulations (21 CFR Parts 106 and 107) to establish quality factors, current good manufacturing practices, and revised quality control procedures.

To link to these documents and other pertinent information, see Infant Formula: Regulatory/Guidance Documents.

Registration and Submission Requirements for Persons Responsible for the Manufacture or Distribution of New Infant Formula, Intended for Distribution within the United States

Registration. Section 412(c)(1) of the act requires persons responsible for the manufacture or distribution of infant formula to register with FDA the name of the responsible person and their place of business, the name of the manufacturer, the manufacturer's place of business, and all establishments at which the manufacturer intends to produce 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 registration and the 90-day notification at the same time will facilitate FDA's review. (See 61 FR 36154.)

Submissions. 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 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 (including any appropriate clinical testing) and the nutrient requirements of the act, and 4) assurances that the processing of the infant formula complies with GMPs. (See Infant Formula: Regulatory/Guidance Documents).

Ordinarily, a person responsible for the manufacture or distribution of infant formula provides these assurances by the results of chemical and biological tests that have been conducted on the final product, including clinical studies documenting that the infant formula promotes infant growth and development, and that it is suitable as the sole source of nutrition for infants. Recommendations from the American Academy of Pediatrics provide some suggestions for conduct of such clinical studies. (See Clinical Testing of Infant Formulas With Respect to Nutritional Suitability for Term Infants) In addition, Guidance for Industry on Good Clinical Practice and Guidance for Industry on Clinical Investigation of Medicinal Products in the Pediatric Population have been prepared by the agency under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). These guidance documents set forth general scientific principles for the conduct, performance, and control of clinical studies of drugs and biologic products. 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. (See Guidance for Industry E6 (available in PDF, 262 Kb) and E11(available in PDF).) 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, 66 FR 20589, and 21 CFR 56.) Protocols developed for such studies may be submitted for agency review prior to initiation of the study. However, review of a protocol by the Center for Food Safety and Applied Nutrition does not guarantee that the data generated will be sufficient to document the safety and suitability of the product.

In addition, the new infant formula submission should include information about the manufacturer's quality control program, the product labels and labeling (including any labeling claims), and the form (concentrated or ready-to-feed liquid and/or powder) of the product to be marketed. (See Current Manufacturing Regulations and Guidelines.)

To ensure compliance, FDA will inspect the infant formula establishment to observe the formula's manufacture and the manufacturer's quality control procedures. During the inspection, the agency will collect samples for nutrient and, when appropriate, microbiological analyses.

Persons responsible for the manufacture or distribution of new infant formula should direct their registration and new infant formula submission to: Director, Division of Nutrition Science and Policy (HFS-830), Office of Nutritional Products, Labeling, and Dietary Supplements, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835.

Requirements for Infant Formula Manufactured 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 61 FR 36154.) This section requires persons responsible for the manufacture or distribution of infant formula to register with FDA the name of the responsible person and their place of business, the name of the manufacturer, the manufacturer's place of business, and all establishments at which the manufacturer intends to produce the new infant formula. However, pursuant to section 801(e) of the act, infant formula manufactured for export is exempt from the act's adulteration and misbranding provisions, if the infant formula:

  1. accords to the specifications of the foreign purchaser,
  2. is not in conflict with the laws of the country to which it is intended for export,
  3. is labeled on the outside of the shipping package that it is intended for export, and
  4. is not sold or offered for sale in domestic commerce.

In addition, in order to comply with section 801(e) of the act, persons responsible for the manufacture or distribution of infant formula should include in their registration submission a statement attesting that the exported infant formula meets each of the four conditions above. This statement acknowledges compliance with section 801(e) of the act.

Additionally, the names and labels of the products intended for export, and the list of intended countries should also be submitted.

Should you have any questions about this information, please call (301) 436-1450.