Exempt Infant Formula Production; GMP; Audits, Records & Records

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

Guidance for Industry1
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
FDA’s 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 “FDA’s Infant Formula webpage.” For general
information about food ingredient and packaging approval and notification programs see “FDA’s 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.
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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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