Draft Guidance for Industry: Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufactur

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Draft-Not for Implementation

Notifying FDA of a Permanent
Discontinuance in the Manufacture or an
Interruption of the Manufacture of an
Infant Formula: Guidance for Industry
Draft Guidance

This guidance is being distributed for comment purposes only.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to
ensure that FDA considers your comment on this draft guidance before it begins work on the
final version of the guidance, submit either electronic or written comments on the draft
guidance within 75 days of publication in the Federal Register of the notice announcing the
availability of the draft guidance. Submit electronic comments to
http://www.regulations.gov. Submit written comments to the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number [FDA-2024-D-1334] and
with the title of the guidance document.
For questions regarding this guidance, contact the Human Foods Program at 240-402-1200.
Additional copies are available online at https://www.fda.gov/FoodGuidances.
U.S. Department of Health and Human Services
Food and Drug Administration
Human Foods Program
December 2024

Contains Nonbinding Recommendations
Draft-Not for Implementation
Table of Contents
I.

Introduction ......................................................................................................................... 3

II.

Background ......................................................................................................................... 4

III.

Notifying FDA of a Permanent Discontinuance in or an Interruption of Manufacturing .. 4

A.

Who Must Notify FDA? ..................................................................................................... 4

B.

When Should a Manufacturer Notify FDA? ....................................................................... 4

C.

What Information Should Be in a Notification? ................................................................. 5

D.

How Should a Manufacturer Notify FDA? ......................................................................... 7

E.

Failure to Notify FDA......................................................................................................... 7

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Contains Nonbinding Recommendations
Draft-Not for Implementation

Notifying FDA of a Permanent
Discontinuance in the Manufacture or an
Interruption of the Manufacture of an
Infant Formula: Guidance for Industry1
This draft guidance, when finalized, will represent 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 can 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 at the phone number listed on the title page.

I.

INTRODUCTION

Section 424(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
350m(a)(1)) requires manufacturers of a critical food 2 to notify FDA of a permanent
discontinuance in the manufacture or an interruption of the manufacture of a critical food that is
likely to lead to a meaningful disruption in the supply of such food in the United States, and the
reasons for such discontinuance or interruption, as soon as practicable, but not later than 5
business days after such discontinuance or such interruption.
The notification requirements apply to all manufacturers (foreign and domestic) that manufacture
critical foods for sale in the United States, regardless of manufacturer size or market share. This
guidance discusses the notification requirements under section 424(a)(1) of the FD&C Act as
they pertain to infant formula, 3 as well as FDA’s interpretation of key terms in the statute and
provides recommendations for the content of and procedures for submitting such notifications.
These recommendations are informed by FDA’s recent experience involving manufacturer
interruptions of these products and our work to improve the resiliency of the infant formula
market. This guidance covers all infant formulas, including those that are also medical foods
This guidance has been prepared by the Office of Surveillance, Strategy, and Risk Prioritization; the Office of
Critical Foods; and the Office of Policy, Regulations, and Information in the Human Foods Program at the U.S.
Food and Drug Administration.
2
Section 201(ss) of the FD&C Act (21 U.S.C. 321(ss)) defines a “critical food” as a food that is (1) an infant
formula or (2) a medical food as defined in section 5(b)(3) of the Orphan Drug Act [21 U.S.C. 360ee(b)(3)].
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Section 201(z) of the FD&C Act (21 U.S.C. 321(z)) defines “infant formula” as a food which purports to be or is
represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its
suitability as a complete or partial substitute for human milk.
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(i.e., exempt infant formulas 4). FDA intends to continue gathering data regarding the market(s)
for other types of critical food to help inform guidance related to those products. Although this
guidance is specific to infant formula, manufacturers of other types of critical foods are still
required to comply with section 424 of the FD&C Act.
In general, 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 documents means that
something is suggested or recommended, but not required.
II.

BACKGROUND

The Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted on December 29, 2022,
amended the FD&C Act to help address the problem of critical food shortages in the United
States, including by adding requirements related to notifying FDA about critical food
manufacturing discontinuances and interruptions. While some supply disruptions and product
shortages cannot be predicted or prevented, early communication and detailed notifications from
manufacturers to FDA can play a significant role in decreasing the incidence, impact, and
duration of supply disruptions and product shortages. Timely notifications that include specific
information about the situation allow FDA to evaluate the situation and determine an appropriate
course of action. When FDA does not receive timely, informative notifications, FDA’s ability to
respond appropriately is limited.
III.

NOTIFYING FDA OF A PERMANENT DISCONTINUANCE IN OR AN
INTERRUPTION OF MANUFACTURING
A. Who Must Notify FDA?

Section 424(a)(1) of the FD&C Act states that a manufacturer of a critical food must notify FDA
of a permanent discontinuance in the manufacture or an interruption of the manufacture of such
food that is likely to lead to a meaningful disruption in the supply of such food in the United
States.
B. When Should a Manufacturer Notify FDA?
Section 424(a)(1) of the FD&C Act requires manufacturers to notify us “as soon as practicable,
but not later than 5 business days” after a permanent discontinuance or an interruption of the
manufacture of a critical food that is likely to lead to a meaningful disruption in the supply of
such food in the United States. In FDA’s experience, even if it is not possible for a manufacturer
to notify us before a decision to discontinue or an interruption that is likely to lead to a
meaningful disruption in supply, it generally should be possible for the manufacturer to provide
notice within one or two calendar days of the decision to discontinue or the interruption.
An “exempt infant formula” is an infant formula intended for commercial or charitable distribution that is
represented and labeled for use by infants who have inborn errors of metabolism or low birth weight, or who
otherwise have unusual medical or dietary problems. (21 CFR 107.3).

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What Is a Permanent Discontinuance of an Infant Formula?
Section 424 of the FD&C Act does not define “permanent discontinuance,” but, with respect to
infant formula, we interpret the phrase “permanent discontinuance” in section 424 of the FD&C
Act to be a decision by an infant formula manufacturer to cease manufacturing and distributing
its product indefinitely, for any reason. The reason can include business reasons (such as
discontinuing a product due to low sales). All permanent discontinuances must be reported
according to the timeline above (see section 424(a)(1) of the FD&C Act).
What Is an Interruption of the Manufacture of an Infant Formula That Is Likely to Lead to a
Meaningful Disruption in the Supply of Such Food in the United States?
Section 424(a)(4) of the FD&C Act, states that, for purposes of section 424(a) of the FD&C Act,
“meaningful disruption”:
•
•

means a change in production that is reasonably likely to lead to a significant
reduction in the supply of a critical food by a manufacturer that affects the ability of
the manufacturer to meet expected demand for its product; and
does not include interruptions in manufacturing due to matters such as routine
maintenance, changes or discontinuance of flavors, colors, or other insignificant
formulation characteristics, or insignificant changes in manufacturing so long as the
manufacturer expects to resume operations in a short period of time.

In the case of interruptions in manufacturing, when assessing whether a meaningful disruption in
supply is likely to occur, the relevant analysis is whether a change in production is likely to lead
to a reduction in the supply of a product by the manufacturer that is more than negligible and
would affect the manufacturer’s ability to fill orders or meet expected demand for its product. In
other words, the assessment is to be based solely on the reporting manufacturer’s capacity and
supply.
Additional Recommendations
Given the importance that infant formula can have in infant nutrition and health, we encourage
manufacturers to voluntarily notify us at least 6 months before permanently discontinuing
manufacturing an infant formula product.
If a manufacturer is unsure of whether to notify us about a possible permanent discontinuance or
a meaningful disruption in the manufacture of infant formula, we encourage manufacturers to
submit a notification. Timely notifications will allow us to monitor the overall market and take
steps, where possible and necessary, to help prevent, mitigate, or otherwise address potential
infant formula shortages.
C. What Information Should Be in a Notification?

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Section 424(a)(1) of the FD&C Act states that a manufacturer of a critical food must notify FDA
of a permanent discontinuance in the manufacture or an interruption of the manufacture of such
food that is likely to lead to a meaningful disruption in the supply of such food in the United
States, and the reasons for such discontinuance or interruption. With respect to infant formula,
we interpret this to mean that the notification must state:
•
•
•
•

The manufacturer’s name;
The name of each infant formula product impacted;
Whether the notification relates to a permanent discontinuance in manufacturing one
or more infant formula product(s) or an interruption in the manufacture of one or
more infant formula product(s); and
The reason(s) for the permanent discontinuance or interruption in manufacturing.

Additionally, we recommend that a notification voluntarily include the following information
that will help FDA appropriately identify the affected product(s), determine the potential for and
the criticality of a supply chain disruption, and better assess the overall state of the market:
•
•
•
•

•

A point of contact for the notification;
The UPC code(s) for each infant formula product impacted;
Infant formula product alternatives available (or planned) from the manufacturer that
consumers may consider for each infant formula product impacted;
If the manufacturer intends to permanently discontinue manufacturing:
o The date on which it will stop manufacturing the product;
o The production volume of infant formula product(s) that will be or has been
permanently discontinued;
o The estimated amount of product remaining for sale/distribution when
manufacturing stops;
o The shelf life for each impacted infant formula product;
o If known, the geographic distribution impacted by the reduction of the infant
formula product(s); and
o Whether the manufacturer intends to inform the public and/or other
stakeholders regarding the discontinuance.
If the manufacturer anticipates an interruption in manufacturing or an interruption has
already occurred:
o The projected duration of the interruption, including, if possible, the dates on
which the interruption will start and end;
o The size/amount of product reduction anticipated and estimate of amount of
product remaining for sale/distribution when the interruption began or begins;
o The shelf life for each impacted infant formula product;
o The production volume by facility and the potential availability of alternative
production sites;
o Whether the manufacturer can increase and anticipates increasing production
of the impacted product(s) when the interruption ends to replace the lost
supply;
o If known, the geographic distribution impacted by the reduced production of
the infant formula product(s); and
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•

o Whether the manufacturer intends to inform the public and/or other
stakeholders regarding the actual or potential shortage.
Any additional information the manufacture considers helpful.

Notifications can be updated to include additional information at any time after they are
submitted to FDA. Therefore, we recommend that manufacturers not delay notifying FDA until
all information is available, but instead recommend that they provide an initial notification as
soon as practicable and additional information as it becomes available. If manufacturers do not
notify FDA within the timeline specified in the statute (as soon as practicable, but not later than 5
business days), FDA requests that manufacturers explain why notification within such timeline
was not possible.
If information changes after the manufacturer has submitted a notification to us, we recommend
that the manufacturer send us revised or updated information. In the case of a manufacturing
interruption, we also recommend that manufacturers engage with us regarding the specifics of
the disruption to determine what information should be submitted as part of updates and the
frequency of those updates. These updates can help us consider what actions we may take to
address the situation.
D. How Should a Manufacturer Notify FDA?
Manufacturers should submit their notifications to us by email to
[email protected], which we will closely monitor, with a subject line “Infant
Formula – Permanent Discontinuance” or “Infant Formula – Interruption in Manufacturing,” as
appropriate.
To help facilitate FDA’s review of notifications, manufacturers should submit separate
notifications for permanent discontinuances and interruptions in manufacturing. A single
notification (i.e., a notification for permanent discontinuance(s) or a notification for
interruption(s) in manufacturing), however, can include more than one affected infant formula
product. For example, if a manufacturer markets three different infant formula products and
intends to permanently discontinue manufacturing of all three products at the same time, the
manufacturer can submit a single notification covering the three products. If a manufacturer
markets two different infant formula products and intends to permanently discontinue one
product and temporarily stop manufacturing another, we ask that the manufacturer submit one
notification for the permanent discontinuance and another notification for the interruption. After
receipt of notification, FDA will work with the manufacturer to understand the full scope of the
impact and determine appropriate next steps.
E. Failure to Notify FDA
If a manufacturer fails to provide information of a permanent discontinuance or an interruption in
manufacturing as required by section 424(a) of the FD&C Act, we must issue a letter to that
manufacturer (“noncompliance letter”) informing the manufacturer of its failure to notify (see
section 424(c)(1)(A) of the FD&C Act). Within 45 days of sending the noncompliance letter to
the manufacturer, we will post on our website the letter, and, at the request of the manufacturer,
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any response to the letter the manufacturer submitted to us, with appropriate redactions to protect
trade secrets or confidential information (see section 424(c)(1)(B) of the FD&C Act). However,
we will not post the noncompliance letter and response if we determine that the letter was issued
in error, or, after a review of the manufacturer’s response, we determine that the manufacturer
had a reasonable basis for not submitting the notification (see section 424(c)(2) of the FD&C
Act).

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