Food

Infant Formula Registration & Submissions

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 [21 USC 301 et seq.] (the Act) and FDA's regulations implementing the Act. All of FDA's regulations are published in Title 21 of the Code of Federal Regulations (CFR).

Information follows concerning infant formula registration and new infant formula submissions to FDA.


Registration

Section 412(c)(1) of the Federal Food, Drug, and Cosmetic Act requires persons responsible for the manufacture or distribution of a new infant formula, including infant formula for export only, to register with FDA before a new infant formula may be introduced or delivered for introduction into interstate commerce. 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 required submission (discussed below) at the same time will facilitate FDA's review.

Learn more about federal requirements for the manufacture of infant formula for marketing in the United States, including registration requirements.

Written Registration

Manufacturers can provide written registration submissions to the following address:

Center for Food Safety and Applied Nutrition
Office of Nutrition and Food Labeling
Infant Formula and Medical Foods Staff (HFS-850)
5001 Campus Drive
College Park, MD 20740-3835 


New Infant Formula 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 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).

Learn more federal submission requirements for persons responsible for the manufacture of new infant formula.

Written Submissions

Manufacturers can make written submissions to the following address:

Center for Food Safety and Applied Nutrition
Office of Nutrition and Food Labeling
Infant Formula and Medical Foods Staff (HFS-850)
5001 Campus Drive
College Park, MD 20740-3835 


Request for Comments on New Electronic Submissions Form

FDA has 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 opens November 15, 2017 for 60 days. Submit comments electronically to docket folder FDA-2013-N-0545 on http://www.regualtions.gov. For more information on how to comment, see the Federal Register Notice.  

Page Last Updated: 11/17/2017
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