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GUIDANCE DOCUMENT

Guidance for Industry: Demonstration of the Quality Factor Requirements Under 21 CFR 106.96(i) for "Eligible" Infant Formulas June 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-0033
Issued by:
Guidance Issuing Office
Human Foods Program

The Food and Drug Administration (FDA or we) regulates infant formula under the Federal Food, Drug, and Cosmetic Act and supporting regulations.  On June 10, 2014,  we published a final rule that requires, among other things, that infant formulas satisfy the two quality factors of normal physical growth and sufficient biological quality of the protein component of the formula. The regulations establish quality factor requirements for “eligible” infant formulas (21 CFR 106.96(i)). Under 21 CFR 106.3, an “eligible infant formula” is an infant formula that could be lawfully distributed in the United States on December 8, 2014. 

This guidance provides FDA’s current thinking about the requirements in the final rule for eligible infant formulas. It answers questions about the quality factor requirements, record requirements, and voluntary submission of a citizen petition. In addition to consulting this guidance, we encourage you to discuss the voluntary submission of a citizen petition with us.

We recognize that you, the manufacturer of an eligible infant formula, may need time to develop the data and information needed to meet the specific quality factor requirements in the infant formula regulations. In addition, we want to ensure the continued availability of infant formulas, an essential source of nutrition for infants fed infant formula. Therefore, as discussed below, the final rule establishes a compliance date of November 12, 2015 for you to meet certain requirements related to quality factors. 

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance documents describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidance means that something is suggested or recommended, but not required.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-0033.

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