Guidance for Industry 
Exempt Infant Formula Production: 
Current Good Manufacturing Practices 
(CGMPs), Quality Control Procedures, 
Conduct of Audits, and Records and Reports 
Additional copies are available from: 
              Office of Nutrition and Food Labeling, HFS-800 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
(Tel) 240-402-2373 
http://www.fda.gov/FoodGuidances 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to http://www.regulations.gov.  Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.  All comments should be identified with the docket number listed in the 
notice of availability that publishes in the Federal Register. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
April 2016 Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction 
II.  Background  
III.  Discussion  
IV.  Recommendations 
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  Contains Nonbinding Recommendations 
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Guidance for Industry
Exempt Infant Formula Production: 
Current Good Manufacturing Practices (CGMPs), Quality Control 
Procedures, Conduct of Audits, and Records and Reports 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You may use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
for this guidance as listed on the title page.  
 
I.  Introduction 
This guidance is intended to convey to industry the current thinking of the Food and Drug 
Administration (FDA or we) about the manufacturing of exempt infant formulas in relation to the 
requirements for current good manufacturing practices (CGMPs), quality control procedures, 
conduct of audits, and records and reports for nonexempt infant formulas in 21 CFR part 106.2   
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances 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 our guidances means that something is suggested or 
recommended, but not required. 
                                                             
1 This guidance has been prepared by the Infant Formula and Medical Foods Staff, Office of Nutrition and Food 
Labeling, in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.   
2 For general information about infant formula regulations see FDAs Infant Formula webpage.  For general 
information about food ingredient and packaging approval and notification programs see FDAs Food Ingredients 
& Packaging webpage.  
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/InfantFormula/
default.htm and http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm   
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  Contains Nonbinding Recommendations 
II. Background
In a final rule published on June 10, 2014 (79 FR 33057), FDA established requirements
for current good manufacturing practices (21 CFR part 106, subpart B), the conduct of audits (21 
CFR part 106, subpart D), and quality factors (21 CFR part 106, subpart E); and amended 
requirements for quality control procedures (21 CFR part 106, subpart C (formerly subpart B)), 
records and reports (21 CFR part 106, subpart F (formerly subpart C), and notifications for infant 
formula (21 CFR part 106, subpart G (formerly subpart D)), as mandated by section 412 of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350a).  The regulations 
apply, with one narrow exception, requirements for non-exempt infant formulas (i.e., formulas 
intended for use by healthy, term infants).  (Two provisions of  106.150 in the final rule (21 
CFR 106.150) (Notification of an adulterated or misbranded infant formula),  106.150(a)(2) 
and (b), apply both to exempt and non-exempt infant formulas.  See section 412(h)(1) of the 
FD&C Act.) 
Section 412(h)(1) of the FD&C 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 FD&C Act.  These formulas are customarily referred to as exempt infant 
formulas.  Section 412(h)(2) of the FD&C 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 FD&C Act.  FDA has previously established terms and conditions for exemption in 21 CFR 
107.50.  We intend to promulgate regulations to address any new terms and conditions for 
exempt infant formulas in a future rulemaking.  In the interim, this guidance provides our current 
thinking about the significance of the regulations in part 106, as amended, for exempt infant 
formulas. 
As of March 2016, five infant formula manufacturers produce exempt formulas that are 
marketed in the United States.  Of these, four manufacturers produce both non-exempt and 
exempt products in the same facilities, using the same production lines and equipment.  The 
remaining manufacturer produces only exempt infant formulas. 
III. Discussion
Section 412 of the FD&C Act is intended to ensure the safety and nutrition of infant
formulas.  See Pub. L. No. 96-395, 94 Stat 1190, 1190 (1980).  For many infants, formula is the 
sole source of nutrition during the earliest months of life, a critical period of growth and 
development.  Our infant formula regulations have an essential role in helping to ensure the 
integrity and nutritional adequacy of infant formulas.  We issued the regulations in part 106, with 
the narrow exception noted previously in this guidance, to help ensure the consistent production 
of safe and nutritionally adequate infant formulas for healthy, term infants (i.e., for non-exempt 
infant formulas).  More stringent controls are necessary for the production of infant formulas 
than for processing food generally because of the vulnerable nature of the infant population and 
the status of infant formula as the sole source of nutrition for a segment of this population.  
4  Contains Nonbinding Recommendations 
Healthy, term infants are particularly vulnerable to the effects of a nutritional insufficiency or 
deficiency in the diet because of their rapid rate of growth and development during early infancy.  
The infants that consume exempt infant formulas are at even greater risk of adverse outcomes 
due to a nutritional insufficiency or deficiency in the diet due to their relative immaturity or their 
medical condition. 
IV.  Recommendations 
Given the vital role infant formula serves for those infants who consume it, and pending 
our promulgation of a regulation setting forth any new terms and conditions for exempt infant 
formulas, sound public health policy dictates that products for infants who need to consume 
exempt formulas should be produced using manufacturing practices, quality control procedures, 
audit procedures, and records and reporting protocols that are at least equivalent to those used for 
products consumed by healthy, term infants.  However, we recognize that exempt infant 
formulas may need to differ from non-exempt infant formulas, e.g., in nutrient content due to the 
specific medical condition for which the exempt infant formula is used.  Accordingly, we 
recommend that manufacturers of exempt infant formulas follow, to the extent practicable, 
subparts A, B, C, D, and F of 21 CFR part 106, as amended or established by the final rule 
published on June 10, 2014, in the production of their formula products.   
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