Infant Formula Transition Plan for Exercise 
of Enforcement Discretion: Guidance for 
Industry 
 
 
Additional copies are available from: 
Office of Nutrition and Food Labeling 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD 20740 
(Tel) 240-402-4487 
 
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 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 FDA2022D0814. 
 
For questions regarding this guidance document, contact the Center for Food Safety and 
Applied Nutrition, Office of Nutrition and Food Labeling, at 240-402-4487. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
September 2022 
     
   
Contains Nonbinding Recommendations 
Table of Contents 
 
 
I. Introduction ............................................................................................ 3
   
II. Background ............................................................................................ 4
   
III. Guiding Principles ................................................................................. 6
   
IV. Discussion ............................................................................................... 7
   
 
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Contains Nonbinding Recommendations 
Infant Formula Transition Plan for Exercise 
of Enforcement Discretion: Guidance for 
Industry1 
This guidance represents the current thinking of the Food and Drug Administration (FDA, the 
Agency, 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 
FDA plays a critical role in ensuring the safety and nutritional adequacy of infant formula in the 
United States.  We work to ensure that infant formula sold in the United States meets the required 
safety and nutritional standards specified in section 412 of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) and in FDAs implementing regulations at 21 CFR parts 106 and 107.  Given 
recent events precipitating a critical shortage of infant formula in the United States, FDA is issuing 
this guidance document to protect public health by helping to stabilize the supply of infant formula 
in the United States and to maintain a consistent supply of a variety of infant formula products.1  
Continued product availability is an issue of particular significance for infants who started on a 
specific formula during the shortage and have come to rely on such formula as an essential source 
of nutrition.2 
The current period of supply shortage and disruption caused by, among other things, the temporary 
shutdown of a major infant formula manufacturing facility, has demonstrated the need for FDA to 
support the availability of an adequate supply of safe and nutritionally adequate infant formula, 
create a more resilient U.S. supply for infant formula products, and help avoid the future risk of 
lack of access to a sole source of nutrition for a vulnerable population.  To help meet these goals, 
FDA intends to temporarily exercise enforcement discretion for certain manufacturers of infant 
formula that continue to introduce into interstate commerce (including through importation) infant 
formula products that may not comply with certain statutory and regulatory requirements if: (1) such 
manufacturers market these products consistent with a letter of enforcement discretion relating to 
information provided under our Infant Formula Enforcement Discretion Policy:  Guidance for 
Industry issued May 2022 (May 2022 Enforcement Discretion Guidance),3 which remains in effect 
until November 14, 2022; and (2) such manufacturers take specific actions to achieve compliance 
 
1  This guidance has been prepared by the Office of Nutrition and Food Labeling and the Office of Regulations and Policy 
in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. 
2  See, e.g., 79 FR 7933 at 8026 (Feb. 10, 2014). 
3  Consistent with the policies described in the May 2022 Enforcement Discretion Guidance, available at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-infant-formula-
enforcement-discretion-policy, certain manufacturers have submitted information to FDA to substantiate the safety and 
nutritional adequacy of specific infant formula products and have been marketing such products under FDAs exercise of 
enforcement discretion.  
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with the statutory and regulatory requirements applicable to their products.  This guidance 
document will help infant formula manufacturers meet the regulatory requirements applicable to 
these products while ensuring continued access to formulas that are currently fulfilling the needs of 
infants consuming such products.  This guidance is intended to advise infant formula 
manufacturers marketing products in accordance with letters of enforcement discretion issued 
under the May 2022 Enforcement Discretion Guidance about: (1) the type of information to 
provide to FDA; and (2) our timing expectations related to such information, if they would like us 
to consider the exercise of enforcement discretion with respect to infant formula products that are 
safe and nutritionally adequate, but that may not comply with all statutory and regulatory requirements, 
during the period described below.  FDA expects that all infant formula products will comply with 
all applicable U.S. requirements by the end of the enforcement discretion period. 
This guidance also allows FDA to refocus resources on reviewing product and manufacturer 
information submitted in accordance with FDA regulations prior to the May 2022 Enforcement 
Discretion Guidance.  Infant formula manufacturers that submitted packages to FDA pursuant to 
the May 2022 Enforcement Discretion Guidance but that did not receive enforcement discretion 
letters may continue to seek FDA review in accordance with FDA regulations. 
 
This guidance document will remain in effect until October 18, 2025, and we will evaluate whether 
any extension is necessary before that date.  We will give public notice if we determine that an 
extension is warranted.   
 
In general, FDAs guidance documents 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 FDA guidances means that something is suggested or recommended, but not 
required. 
 
This guidance is being issued to protect public health by helping to stabilize the supply of infant 
formula in the United States and to maintain a consistent supply of a variety of infant formula 
products.  This guidance is being implemented without prior public comment because FDA has 
determined that prior public participation for this guidance is not appropriate (see section 
701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)).  This 
guidance is being implemented immediately, but it remains subject to comment in accordance with 
our good guidance practices. 
 
II. Background 
The FD&C Act 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 (section 201(z) of the FD&C Act (21 U.S.C. 
321(z)).  Our regulations define infants as persons not more than 12 months old (21 CFR 
105.3(e)).  
 
Infant formula is often used as the sole source of nutrition for a vulnerable population during a 
critical period of growth and development.  In general, the laws and regulations that apply to food 
also apply to infant formula, but additional requirements specific to infant formula appear in 
section 412 of the FD&C Act and in our regulations at 21 CFR parts 106 and 107.  For example, 
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under section 412(i) of the FD&C Act and 21 CFR 107.100, an infant formula must meet specific 
requirements for the levels of protein, fat, essential fatty acids, 15 vitamins, and 12 minerals. 
 
A new infant formula means: (1) an infant formula manufactured by a person that has not 
previously manufactured an infant formula; and (2) an infant formula manufactured by a person 
that has manufactured an infant formula and in which there is a major change in processing or 
formulation from a current or any previous formulation produced by such manufacturer, or which 
has not previously been the subject of a submission under section 412(c) of the FD&C Act 
(21 U.S.C. 350a(c)) for the U.S. market (21 CFR 106.3).  A major change in an infant formula is 
any new formulation, or any change of ingredients or processes where experience or theory would 
predict a possible significant adverse impact on levels of nutrients or bioavailability of nutrients, or 
any change that causes an infant formula to differ fundamentally in processing or in composition 
from any previous formulation produced by the manufacturer (21 CFR 106.3).   
 
Among other requirements applicable to new infant formula products, section 412(c)(1)(B) of the 
FD&C Act (21 U.S.C. 350a(c)(1)(B)) and FDA regulations (21 CFR 106.120) require the 
manufacturer of a new infant formula to submit notice (i.e., a new infant formula submission) to FDA 
at least 90 days before the new infant formula is introduced or delivered for introduction into interstate 
commerce.4  
 
FDA is aware that a voluntary recall and facility shutdown conducted by Abbott Nutrition in 2022 
contributed to a supply disruption with respect to certain types of infant formula, which has been 
exacerbated by the overall strains on supply chains during the COVID-19 pandemic.  As part of 
the Federal governments response to the infant formula shortage, on May 16, 2022, FDA issued 
the May 2022 Enforcement Discretion Guidance discussing our intent to consider, on a case-by-
case basis, the temporary exercise of enforcement discretion for the introduction into interstate 
commerce of infant formula that may not meet certain statutory and regulatory requirements.  The 
May 2022 Enforcement Discretion Guidance describes the information that an infant formula 
manufacturer should provide to FDA if the manufacturer wishes to have FDA consider the 
exercise of enforcement discretion relating to the introduction into interstate commerce (including 
importation) of infant formula that is safe and nutritionally adequate but that may not comply with 
all FDA statutory and regulatory requirements. 
 
Since the issuance of the May 2022 Enforcement Discretion Guidance, several manufacturers of 
infant formula have provided information to FDA as recommended in the guidance and, following 
FDAs thorough review of the information provided, are marketing infant formula products under 
our exercise of enforcement discretion.5   
 
FDAs review of information received in response to the May 2022 Enforcement Discretion 
Guidance is one of several efforts that have enabled FDA to increase infant formula supplies to 
address the shortage, while also protecting the health of infants.  Many companies marketing infant 
formula products under the enforcement discretion policy have expressed interest in continuing to 
 
4  We do not consider the introduction or delivery for introduction into interstate commerce of products under the exercise 
of enforcement discretion to alter the status of such products as new infant formula under 21 CFR 106.3 for purposes of 
the applicability of the new infant formula registration and submission requirements under section 412(c) and (d) of the 
FD&C Act (21 U.S.C. 350a(c) and (d)) and 21 CFR 106.110 and 106.120. 
5  See FDAs website for a list of companies receiving enforcement discretion for regular infant formulas and specialty 
formulas for infants with special medical needs (https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-
information/enforcement-discretion-manufacturers-increase-infant-formula-supplies). 
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serve the U.S. market, which could help protect the public health by creating more resiliency in the 
U.S. infant formula supply and reducing the risk of reliance on too few production facilities.   
 
On July 6, 2022, FDA announced that we were developing a strategy for continued and expanded 
access to infant formula for U.S. consumers (see FDA Developing New Framework for Continued, 
Expanded Access to Infant Formula Options for U.S. Parents and Caregivers).  We determined that 
a more streamlined pathway that leverages information we have received and thoroughly reviewed 
for the infant formula products for which we are temporarily exercising enforcement discretion 
would help provide for the long-term availability of many of these products.  Therefore, we stated 
that we intended to, among other things, provide a pathway for companies that import, sell, and/or 
distribute infant formula under our temporary enforcement discretion policy to continue to supply 
infant formula to the United States past November 14, 2022.  This Infant Formula Transition Plan 
for Exercise of Enforcement Discretion:  Guidance for Industry (Infant Formula Transition Plan 
Guidance) provides information about FDAs current thinking on circumstances under which FDA 
intends to continue exercising temporary enforcement discretion for certain infant formula 
products beyond November 14, 2022. 
 
III.   Guiding Principles 
 
In developing this guidance, we followed several guiding principles: 
 
  Infant formula is an essential food product that is the sole source of nutrition for many infants 
in the United States.  Ensuring that the youngest and most vulnerable individuals have access 
to safe and nutritionally adequate formula products is a top priority for FDA.  It is important to 
diversify and strengthen the U.S. infant formula supply in case of unanticipated disruptions.  
Minimizing disruption in the supply of infant formula products is also important because 
health care providers have recognized the importance of consistency in feeding an infant a 
certain formula once feeding is begun, as variations in infant formula products might not be 
equally tolerated by every infant.  Therefore, continued access to certain formulas currently in 
the U.S. market is important for infants who started on a specific formula during the shortage 
and have come to rely on such products as an essential source of nutrition. 
  This guidance sets forth a transparent pathway that leverages information we have already 
received and thoroughly reviewed for the products for which we are temporarily exercising 
enforcement discretion under our May 2022 Enforcement Discretion Guidance.  This pathway 
is intended to help mitigate the short-term product shortage and provide for the long-term 
availability and marketing of infant formulas that fall within the scope of this guidance and to 
help create a more resilient U.S. infant formula supply. 
  Infant formula manufacturers and their manufacturing facilities must meet rigorous 
requirements to demonstrate that the infant formulas meet the minimum requirements for 
quality factors (see, e.g., 21 CFR 106.96, Requirements for quality factors for infant 
formulas).  Thus, the policies and recommendations in this guidance are consistent with our 
statutory mandate to both protect and promote the public health while responding to the need 
to take action to help alleviate current challenges with the supply of infant formula products 
and create a more resilient infant formula supply.6 
  As in other situations, if FDA deems appropriate, we may, at any time, take action regarding a 
specific infant formula.  FDA may choose to take action if, for example, the infant formula 
 
6  See section 1003(b) of the FD&C Act (21 U.S.C. 393). 
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manufacturer that is receiving enforcement discretion fails to make meaningful progress on the 
timeline detailed in this document or if we otherwise become aware of information that raises a 
concern about the safety or nutritional adequacy of the product. 
 
IV.  Discussion 
 
This guidance document describes the actions a covered infant formula manufacturer should take if it 
wishes to have FDA consider the continued exercise of enforcement discretion relating to the 
introduction into interstate commerce of its infant formula product while this guidance remains in 
effect.  A covered infant formula manufacturer is a manufacturer to which FDA has issued a letter 
of enforcement discretion relating to information provided in response to the May 2022 Enforcement 
Discretion Guidance, which remains in effect until November 14, 2022.  A covered infant formula 
product is an infant formula product that is specifically identified in the letter of enforcement 
discretion issued to the manufacturer in response to information provided under the May 2022 
Enforcement Discretion Guidance. 
 
To facilitate the opportunity for covered infant formula manufacturers to submit a letter of intent to 
pursue completion of all regulatory requirements, FDA is, through this document, announcing our 
intent to extend the period of enforcement discretion for covered infant formula manufacturers to 
January 6, 2023.  FDAs continued exercise of enforcement discretion after January 6, 2023, will be 
made on a case-by-case basis for covered infant formula products that are specifically identified in a 
letter of intent submitted to FDA and that FDA has acknowledged, consistent with the policies 
described below. 
 
A manufacturer to which FDA has issued a letter of 
What is a covered infant formula manufacturer 
enforcement discretion relating to information 
under this Infant Formula Transition Plan 
provided in response to the May 2022 Enforcement 
Guidance? 
Discretion Guidance. 
An infant formula product that is specifically 
identified in the letter of enforcement discretion 
What is a covered infant formula product under 
issued to the manufacturer in response to information 
this Infant Formula Transition Plan Guidance? 
provided under the May 2022 Enforcement Discretion 
Guidance. 
How should a covered infant formula  By submitting a letter of intent to pursue completion 
manufacturer request that FDA continue to  of all regulatory requirements for one or more 
exercise enforcement discretion with respect to  covered infant formula products.  FDA will respond 
covered infant formula products on the U.S.  with a letter of acknowledgement.  (See Phase 1 of 
market under this Infant Formula Transition Plan  this Transition Plan below.) 
Guidance?   
Does FDA intend to continue exercising 
enforcement discretion for covered infant 
Yes, unless the manufacturer receives written 
formula products between issuance of this Infant 
notification to the contrary from FDA. 
Formula Transition Plan Guidance and FDAs 
issuance of a letter of acknowledgment?  
 
This guidance aims to balance the need to ensure that manufacturers of infant formulas sold in the 
United States demonstrate that their products meet the minimum requirements for specified quality 
factors with the need to help ensure the existence of a more resilient infant formula supply and to 
minimize disruptions in the availability of formulas that have become an essential source of infant 
nutrition during recent periods of supply disruption.  We expect all infant formula sold in the United 
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States to comply with all applicable requirements under the FD&C Act and FDA regulations, and we 
intend to continue exercising enforcement discretion for those covered infant formula products for 
which the manufacturer provides information and takes other actions to achieve compliance in 
accordance with the timelines set forth this guidance.  Any manufacturer of a new infant formula 
product, including a manufacturer not currently marketing an infant formula product in accordance 
with a letter of enforcement discretion issued under the May 2022 Enforcement Discretion Guidance, 
also may seek to market the product in the United States by taking actions in accordance with FDAs 
regulatory requirements for infant formula, including by submitting a new infant formula submission 
under 21 CFR 106.120. 
 
Because different regulatory requirements apply to: (1) infant formulas that are subject to the 
requirements of section 412(a), (b), and (c) of the FD&C Act (21 U.S.C. 350a(a), (b), and (c)) (non-
exempt infant formulas) and related FDA regulations, and (2) exempt infant formulas as described in 
section 412(h)(1) of the FD&C Act (21 U.S.C. 350a(h)(1)) (exempt infant formulas),7 which are 
subject to the terms and conditions in 21 CFR 107.50 and other applicable regulations, this guidance 
describes those different requirements and considerations related to the continued marketing of these 
types of infant formula under FDAs exercise of enforcement discretion.   
 
A non-exempt infant formula is an infant formula 
subject toamong other requirementsthe 
requirements of section 412(a), (b), and (c) of the 
What is a non-exempt infant formula?  FD&C Act and related FDA regulations in 21 CFR 
parts 106 and 107.  Non-exempt infant formulas 
typically are intended for consumption by healthy, 
full-term infants. 
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 
What is an exempt infant formula? 
weight, or who otherwise have unusual medical or 
dietary problems.  An exempt infant formula is 
subject to the provisions of 21 CFR 107.50 and 
other FDA regulations. 
 
General expectations relating to the type of information manufacturers should submit and the 
timeframes in which it should be provided to demonstrate meaningful progress toward full compliance 
are set forth below.  However, upon the request of a firm making a good-faith effort to work within 
recommended timelines, we will consider whether firms need additional time to take actions specified 
in the guidance on an individual basis.  We believe some manufacturers may have already started to 
collect the information outlined in this guidance and may complete the process in a shorter time frame 
than outlined in this guidance.  All materials submitted to FDA in accordance with this guidance 
should be in English or translated into English.  In response to materials manufacturers submit in 
accordance with this guidance, we may provide feedback and request additional information needed to 
advise firms on how they can meet the requirements pertaining to their infant formula products. 
 
7  Section 412(h)(1) of the FD&C Act (21 U.S.C. 350a(h)(1)) states that any infant formula which is represented and 
labeled for use by an infant (A) who has an inborn error of metabolism or a low birth weight, or (B) who otherwise has an 
unusual medical or dietary problem, is exempt from section 412(a)-(c) of the FD&C Act (21 U.S.C. 350a(a)-(c)).  Section 
412(h)(2) of the FD&C Act (21 U.S.C. 350a(h)(2)) states that FDA may by regulation establish terms and conditions for 
the exemption of an infant formula from the requirements of section 412(a)-(c); requirements applicable to exempt infant 
formulas are set forth in 21 CFR 107.50. 
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A.  Transition Plan for Covered Non-Exempt Infant Formula Products 
 
Covered infant formula manufacturers that wish to continue to market covered non-exempt infant 
formula products under FDA enforcement discretion should provide information to FDA and take 
other actions in accordance with the phased approach set forth below.   
 
We recognize that covered infant formula manufacturers are at varying stages of providing FDA with 
information that would be required as part of a new infant formula submission in accordance with 
21 CFR 106.120.  To the extent that manufacturers have already provided information recommended 
under the phases set forth below, the manufacturers do not need to resubmit this information unless 
updated information is available.  
 
The following table provides an overview of the phases and timing expectations for information 
related to non-exempt infant formulas.  FDA may choose to take action if the infant formula 
manufacturer that is receiving enforcement discretion fails to make meaningful progress on the 
timeline detailed in this document or if we otherwise become aware of information that raises a 
concern about the safety or nutritional adequacy of the product.  Additional detail regarding each 
phase appears below the table. 
 
Phase  Manufacturer Action Item(s)  Timing Expectation 
1  Letter of Intent  By December 5, 2022 
Plan for Meeting New Infant Formula 
2  By February 28, 2023 
Requirements  
Data Demonstrating Sufficient Biological 
3  Quality of Protein and Plan to Develop Data  By June 16, 2023 
Supporting Normal Physical Growth 
By January 5, 2024 (if seeking exemption from 
21 CFR 106.96(b) under 21 CFR 106.96(c)(1), 
Data Demonstrating Support of Normal  (c)(2)(ii), or (c)(2)(iii)) 
4 
Physical Growth   
By September 6, 2024 (if intending to comply 
with 21 CFR 106.96(b) or (c)(2)(i)) 
By February 16, 2024 (if seeking exemption 
from 21 CFR 106.96(b) under 21 CFR 
106.96(c)(1), (c)(2)(ii), or (c)(2)(iii)) 
5  New Infant Formula Submission  
 
By October 18, 2024 (if intending to comply 
with 21 CFR 106.96(b) or (c)(2)(i)) 
 
1.  Phase 1:  Letter of Intent (by December 5, 2022) 
 
By December 5, 2022, covered manufacturers wishing to continue to market covered non-exempt 
infant formula products under FDAs exercise of enforcement discretion after January 6, 2023, should 
submit to FDA (using the mailbox at Infant_formula_flexibility@fda.hhs.gov) a letter of intent 
identifying the specific covered infant formula products for which the firm intends to comply with all 
applicable regulatory requirements in accordance with this guidance.  Manufacturers may include all 
or a subset of their covered infant formula products in their letter of intent to seek continued 
enforcement discretion with respect to such products. 
 
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In mid- to late November 2022, FDA intends to provide an optional orientation to infant formula 
manufacturers to explain the phased approach of the Infant Formula Transition Plan Guidance, the 
applicable timelines associated with the information to be provided by the firm and achievement of 
other milestones, and steps we intend to take under the guidance.  FDA also intends to provide a 
webinar on the requirements for quality factors for infant formulas, specifically normal physical 
growth (21 CFR 106.96(a)) and sufficient biological quality of protein (21 CFR 106.96(e)). 
 
FDA will review all letters of intent submitted by covered non-exempt infant formula manufacturers 
and communicate with manufacturers, as needed, to clarify any information.  We intend to issue a 
letter of acknowledgement to each manufacturer that has submitted a letter of intent.8  If appropriate, 
the letter of acknowledgement will state that FDA intends to exercise enforcement discretion by not 
objecting to the importation, sale, or distribution of the specified covered infant formula products, 
provided that: (1) the manufacturer continues to adhere to the steps identified in our letter announcing 
the exercise of enforcement discretion relating to information provided under the May 2022 
Enforcement Discretion Guidance; and (2) the manufacturer continues to make meaningful progress 
toward compliance with applicable regulatory requirements in accordance with the Infant Formula 
Transition Plan Guidance. 
 
2.  Phase 2:  Manufacturers Plan for Meeting New Infant Formula Requirements (by 
February 28, 2023) 
 
By February 28, 2023, covered non-exempt infant formula manufacturers should submit the following 
to FDA: 
 
  A copy of product labeling conforming to the requirements of 21 CFR 107.10-107.30 (or a 
proposed time by which the product labeling would be provided); 
  To demonstrate meaningful progress toward establishing that the quality factor of sufficient 
biological quality of protein (21 CFR 106.96(e)) is met, one of the following should be 
submitted: 
  A draft protocol for an appropriate modification of a Protein Efficiency Ratio (PER) rat 
o
bioassay in accordance with 21 CFR 106.96(f),  
  A draft protocol for a proposed alternative method of demonstrating that a formula 
o
supports the quality factor of sufficient biological quality of protein in accordance with 
21 CFR 106.96(g)(3), or 
  An outline of the firms rationale for an exemption from the requirement of conducting 
o
an appropriate modification of a PER rat bioassay under 21 CFR 106.96(f) and 
information supporting the request for exemption in accordance with 21 CFR 
106.96(g)(1) or (g)(2). 
  To demonstrate progress toward establishing that the quality factor of normal physical growth 
(21 CFR 106.96(a)) is met, one of the following should be submitted: 
  A statement of intent to conduct a growth monitoring study (GMS) under 21 CFR 
o
106.96(b),  
  A statement of intent to demonstrate that a formula supports normal physical growth 
o
when the formula is fed as the sole source of nutrition using an alternative method or 
study design that is based on sound scientific principles under 21 CFR 106.96(c)(2)(i), 
or 
 
8  As stated above, covered infant formula manufacturers may continue to market specific infant formula products under 
FDAs exercise of enforcement discretion between November 15, 2022, and January 6, 2023. 
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  A statement that the manufacturer otherwise intends to request an exemption from the 
o
requirements of 21 CFR 106.96(b) under 21 CFR 106.96(c)(1), (c)(2)(ii), or (c)(2)(iii). 
  Other information9 relevant to the non-exempt infant formula product (e.g., stability testing of 
nutrient levels, regulatory status of ingredients, testing of nutrient pre-mixes, product 
packaging information) not previously provided to FDA (or a proposed time by which this 
information would be provided).  
 
To help manufacturers prepare this information, FDA intends to begin meeting with covered infant 
formula manufacturers to discuss the actions each manufacturer should take under this guidance to 
ensure that its covered non-exempt infant formula products meet regulatory requirements, in particular 
for quality factors under 21 CFR 106.96, as well as when the manufacturer should take such actions, 
consistent with this guidance.  In these consultation sessions, FDA intends to identify remaining gaps 
in information required in a new infant formula submission for the manufacturers non-exempt infant 
formula product(s) following our review of information submitted in response to the May 2022 
Enforcement Discretion Guidance, and to discuss a projected schedule for the manufacturers 
provision of this information.  The manufacturer and FDA will also discuss whether the manufacturer 
intends to comply with the requirements of 21 CFR 106.96(b) and (f) to demonstrate that the covered 
infant formula meets applicable quality factors, or whether the firm intends to request an exemption 
from these requirements under 21 CFR 106.96(c) and (g).  Manufacturers may use these consultation 
sessions to present any other questions they might have concerning the information set forth in this 
guidance and the requirements for new infant formula submissions. 
 
3.  Phase 3:  Demonstration of Sufficient Biological Quality of Protein and Plan to Develop 
Data Supporting Normal Physical Growth (by June 16, 2023) 
 
FDA will review the manufacturers draft protocol for an appropriate modification of the PER rat 
bioassay (21 CFR 106.96(f)), draft protocol for an alternative method to demonstrate that the formula 
supports the quality factor of sufficient biological quality of protein (21 CFR 106.96(g)(3)), or draft 
rationale under 21 CFR 106.96(g)(1) or (g)(2) for an exemption from the requirement in 21 CFR 
106.96(f).  We intend to communicate our feedback with the manufacturer in writing and/or in a 
meeting. 
 
By June 16, 2023, each manufacturer of a covered non-exempt infant formula product should submit 
either: (1) a draft report of the appropriate modification of the PER rat bioassay (see 21 CFR 
106.96(f)) or alternative method to the PER it has conducted (or has had conducted on its behalf) (see 
21 CFR 106.96(g)(3)); or (2) a draft narrative explanation of why data and information demonstrate 
that the quality factor of sufficient biological quality of protein is met (see 21 CFR 106.96(g)(1) and 
(g)(2)), along with the data relied on and copies of additional studies cited in support. 
 
In addition, each manufacturer should begin developing its plan for meeting the requirements for the 
quality factor of normal physical growth (21 CFR 106.96(a)) for its non-exempt infant formula 
products as soon as possible after submitting a statement of intent to conduct a GMS or to seek an 
exemption from this requirement.  (We note that manufacturers may begin work on meeting these 
requirements while their efforts to demonstrate sufficient biological quality of protein for their 
product(s) are underway.)  The manufacturers plan for meeting the normal physical growth quality 
factor requirements should include either of the following: 
 
 
9  FDA intends to clarify the type of additional information to be provided, if any, during consultation sessions.   
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  The design of the GMS or clinical study it will conduct (or will have conducted on its behalf) 
(either under 21 CFR 106.96(b) or (c)(2)(i)) and a draft protocol for the study with a statistical 
analysis plan; or 
  A written explanation of the firms rationale for the requested exemption under 21 CFR 
106.96(c)(1), (c)(2)(ii), or (c)(2)(iii). 
 
By June 16, 2023, manufacturers of a covered non-exempt infant formula product should either submit 
a draft protocol for their planned GMS or their written explanation of the rationale for requesting an 
exemption from the GMS requirement in 21 CFR 106.96(b). 
 
4.  Phase 4:  Demonstration of Support of Normal Physical Growth (by January 5, 2024, or 
September 6, 2024) 
 
a.   Narrative Explanation for Reliance on an Exemption from the GMS Requirements in 
21 CFR 106.96(b) Based on 21 CFR 106.96(c)(1), (c)(2)(ii), or (c)(2)(iii)  
 
By January 5, 2024, each manufacturer of a covered non-exempt infant formula product that seeks an 
exemption from the requirement to conduct a GMS as specified in 21 CFR 106.96(b) that does not 
involve an alternative method or study design (see 21 CFR 106.96(c)(2)(i)) should submit a draft 
narrative explanation of why data and information demonstrate that the formula supports normal 
physical growth, along with supporting information and citations (see 21 CFR 106.96(c)(1), (c)(2)(ii), 
and (c)(2)(iii)). 
 
b.  Draft Report Documenting Compliance with GMS Requirements in 21 CFR 106.96(b) 
or the Exemption from GMS Requirements in 21 CFR 106.96(b) for an Alternative 
Method or Study Design (see 21 CFR 106.96(c)(2)(i))   
 
By September 6, 2024, each manufacturer of a covered non-exempt infant formula product that 
conducts a GMS or alternative study to meet the requirement to demonstrate support of normal 
physical growth should submit a draft report on its GMS or alternative study.   
   
5.  Phase 5:  New Infant Formula Submission (by February 16, 2024, or October 18, 2024)  
 
a.  Submission That Includes a Request for Exemption from the GMS Requirements in 
21 CFR 106.96(b) Based on 21 CFR 106.96(c)(1), (c)(2)(ii), or (c)(2)(iii) 
 
By February 16, 2024, each manufacturer of a covered non-exempt infant formula product that seeks 
an exemption from the requirement to conduct a GMS (not involving an alternative method or study 
design) should submit a new infant formula submission for each such product containing the 
information required under 21 CFR 106.120.10  Once the new infant formula submission is submitted 
to FDA, we will review the submission, reach out with questions as necessary, and respond to the 
manufacturer in accordance with 21 CFR 106.120(e).  The date that FDA receives a new infant 
formula submission that is complete is the filing date for such submission.  For infant formulas 
marketed under this Infant Formula Transition Plan Guidance, FDA will not object to the 
manufacturers continued marketing of the new infant formula before the date that is 90 days after the 
 
10  For information on submitting a new infant formula submission, see our website at https://www.fda.gov/food/guidance-
documents-regulatory-information-topic-food-and-dietary-supplements/infant-formula-guidance-documents-regulatory-
information. 
  12   
Contains Nonbinding Recommendations 
date of the filing date for the submission.   
 
b.   Submission That Includes a GMS Compliant with 21 CFR 106.96(b) or an Alternative 
Method or Study Design (see 21 CFR 106.96(c)(2)(i)) 
 
By October 18, 2024, each manufacturer of a covered non-exempt formula that conducts a GMS or 
alternative study to meet the requirement to demonstrate support of normal physical growth should 
submit a new infant formula submission for each such product containing the information required 
under 21 CFR 106.120.  Once the new infant formula submission is submitted to FDA, we will review 
the submission, reach out with questions as necessary, and respond to the manufacturer in accordance 
with 21 CFR 106.120(e).  The date that FDA receives a new infant formula submission that is 
complete is the filing date for such submission.  For infant formulas marketed under this Infant 
Formula Transition Plan Guidance, FDA does not intend to object to the manufacturers continued 
marketing of the new infant formula before the date that is 90 days after the date of the filing date for 
the submission.   
 
B.  Transition Plan for Covered Exempt Infant Formula Products 
 
Covered manufacturers that wish to continue to market covered exempt infant formula products under 
FDA enforcement discretion should provide information to FDA and take other actions in accordance 
with the phases set forth below.  The approach in Phases 1 and 2 is similar to the approach for non-
exempt infant formulas in those phases, while Phases 3, 4, and 5 reflect the different requirements 
applicable to exempt infant formulas as compared to those for non-exempt infant formulas.   
 
We recognize that covered manufacturers are at varying stages of providing FDA with information 
that would be required as part of a new infant formula submission in accordance with 21 CFR 107.50.  
To the extent that manufacturers have already provided information recommended under the phases 
set forth below, the manufacturers do not need to resubmit this information unless updated 
information is available. 
  
The following table provides an overview of the phases and timing expectations for information 
related to exempt infant formulas.  FDA may choose to take action if the infant formula manufacturer 
that is receiving enforcement discretion fails to make meaningful progress on the timeline detailed in 
this document or if we otherwise become aware of information that raises a concern about the safety 
or nutritional adequacy of the product.  Additional detail regarding each phase appears below the 
table. 
 
Phase  Manufacturer Action Item(s)  Timing Expectation 
1  Letter of Intent  By December 5, 2022 
Plan for Meeting Applicable Infant Formula 
2  By February 28, 2023 
Requirements  
Additional Information Pertaining to Covered 
3  By August 1, 2023 
Exempt Infant Formula 
By January 5, 2024 (if a clinical study 
to support use for the intended medical 
Data Related to Exempt Status and Clinical  condition is not required), or June 6, 
4 
Evidence  2025 (if a clinical study to support use 
of product for the intended medical 
condition is conducted). 
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Contains Nonbinding Recommendations 
By February 16, 2024 (if a clinical 
study to support use for the intended 
medical condition is not required), or 
5  New Infant Formula Submission  
July 18, 2025 (if a clinical study to 
support use of product for the intended 
medical condition is conducted). 
 
1.  Phase 1:  Letter of Intent (by December 5, 2022)  
 
By December 5, 2022, covered manufacturers wishing to continue to market covered exempt infant 
formula products under FDAs exercise of enforcement discretion after January 6, 2023, should 
submit to FDA (using the mailbox at Infant_formula_flexibility@fda.hhs.gov) a letter of intent 
identifying the specific infant formula products for which the firm intends to comply with all 
applicable regulatory requirements in accordance with this guidance.  Manufacturers may include all 
or a subset of their covered exempt infant formula products in their letter of intent to seek continued 
enforcement discretion with respect to such products. 
 
In mid- to late November 2022, FDA intends to provide an optional orientation to infant formula 
manufacturers to explain the phased approach of the Infant Formula Transition Plan, the applicable 
timelines associated with the information to be provided by the firm and achievement of other 
milestones, and steps we intend to take under the guidance.   
 
FDA will review all letters of intent submitted by covered exempt infant formula manufacturers and 
communicate with manufacturers, as needed, to clarify any information.  We intend to issue a letter of 
acknowledgement to each manufacturer that has submitted a letter of intent.  If appropriate, the letter 
of acknowledgement will state that FDA intends to exercise enforcement discretion by not objecting to 
the importation, sale, or distribution of the specified covered infant formula products provided that: 
(1) the manufacturer continues to adhere to the steps identified in our letter announcing the exercise of 
enforcement discretion under the May 2022 Enforcement Discretion Guidance; and (2) the 
manufacturer continues to make meaningful progress toward compliance with applicable regulatory 
requirements in accordance with the Infant Formula Transition Plan Guidance. 
 
2.  Phase 2:  FDA Review of Manufacturers Plan for Meeting New Infant Formula 
Requirements (by February 28, 2023) 
 
Covered exempt infant formula manufacturers should submit to FDA, by February 28, 2023, the 
following: 
 
  A copy of the product label and other labeling conforming to the labeling provisions in 21 CFR 
107.10-107.30 (or a proposed time by which the product labeling would be provided), unless 
the firm provides a rationale for deviating from the requirements (as provided in 21 CFR 
107.50(b)(5) and (c)(5)); 
  A statement describing how the manufacturer intends to develop the information required 
under 21 CFR 107.50(b)(3)11 or (c)(4),12 as applicable. 
 
11 Under 21 CFR 107.50(b)(3), to retain the exempt status of an infant formula product generally available at the retail 
level, the manufacturer must submit the label and other labeling of the infant formula, a complete quantitative formulation 
for the infant formula, and a detailed description of the medical conditions for which the infant formula is represented. 
12 Under 21 CFR 107.50(c)(4), to retain the exempt status of an infant formula product not generally available at the retail 
level, the manufacturer shall submit the information required by 21 CFR 107.50(b)(3) and (b)(4).   
  14   
Contains Nonbinding Recommendations 
  Other information13 relevant to the exempt infant formula product (e.g., regulatory status of 
ingredients, testing of nutrient pre-mixes, product packaging information) not previously 
provided to FDA (or a proposed time by which this information would be provided).  
 
To help manufacturers prepare this information, FDA intends to begin meeting with covered infant 
formula manufacturers to discuss the actions each manufacturer should take under this guidance to 
ensure that its covered exempt infant formula products meet regulatory requirements, as well as when 
the firm should take specific actions, consistent with this guidance.  In these consultation sessions, 
FDA intends to identify remaining gaps in information required in a new infant formula submission 
for the manufacturers exempt infant formula product(s) following our review of information 
submitted in response to the May 2022 Enforcement Discretion Guidance, and to discuss a projected 
schedule for the manufacturers provision of this information.  Manufacturers may use these 
consultation sessions to present any other questions they might have concerning the information set 
forth in this guidance and the requirements for new infant formula submissions. 
 
3.   Phase 3:  FDA Review of Additional Information Pertaining to Covered Exempt Infant 
Formula (by August 1, 2023) 
 
By August 1, 2023, each manufacturer of a covered exempt infant formula product should submit 
documentation addressing issues specified in 21 CFR 107.50(b)(3) and (c)(4) regarding a detailed 
description of the medical condition(s) for which the infant formula is represented and a detailed 
discussion of the medical condition(s) for which the product provides dietary management, to support 
that the proposed product is appropriate for the intended population.  In most cases, if the 
manufacturer has not already done so, the manufacturer will need to conduct a clinical study using the 
infant formula product to support its use for the intended medical condition (see 21 CFR 107.50(b)(5) 
and (c)(5)).   
 
Additionally, manufacturers should submit by August 1, 2023, the basis for any deviations from the 
nutrient requirements in section 412(i) of the FD&C Act (21 U.S.C. 350a(i)) and 21 CFR 107.100.  
Under 21 CFR 107.50(b)(5) and (c)(5), an infant formula manufacturer may deviate from nutrient 
requirements only with respect to specific requirements for which it submits to FDA the medical, 
nutritional, scientific, or technological rationale (including any appropriate animal or human clinical 
studies) in support of the deviation.  This includes information on the medical rationale for the 
covered exempt infant formula product and the evidence for its use in the dietary management of the 
disorder. 
 
Manufacturers of covered exempt infant formulas should also submit by August 1, 2023, information 
on compliance with labeling requirements in accordance with 21 CFR 107.50(b)(3) and, if applicable, 
quality control procedure requirements under 21 CFR 107.50(b)(5).  Quality control procedure 
information includes processing (process flow diagrams with equipment, times, and temperatures) and 
stability information that provides the assurance that the product is not adulterated and will meet 
nutrient content levels up to the use-by date. 
 
FDA will review the documentation provided in Phase 3 and will notify the manufacturer as to 
whether the information appears to provide a sufficient basis for a new infant formula submission
including whether clinical studies are required to support the use of the product for the intended 
medical conditionor we may ask for clarification.   
 
13 FDA intends to clarify the type of additional information to be provided, if any, during consultation sessions.   
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Contains Nonbinding Recommendations 
 
4.  Phase 4:  Data Related to Exempt Status and Clinical Evidence (by January 5, 2024, or 
June 6, 2025) 
 
a.  Covered Exempt Infant Formula for Which Clinical Studies Are Not Required (by 
January 5, 2024) 
 
By January 5, 2024, each manufacturer of a covered exempt infant formula product for which a 
clinical study is not required to support use of the product for the intended medical condition should 
submit to FDA documentation specified under 21 CFR 107.50 to support the use of the product for the 
intended medical condition. 
 
b.  Covered Exempt Infant Formula for Which Clinical Studies Are Required (by June 6, 
2025) 
 
By June 6, 2025, each manufacturer of a covered exempt infant formula product for which a clinical 
study is required to support use of the product for the intended medical condition should submit to 
FDA a draft study report(s) and, if applicable, published literature relevant to the medical condition 
for which the product is represented for use and the dietary management of such medical condition.  
Given that these studies may be conducted in populations with limited numbers of infants (e.g., infants 
with inborn errors of metabolism), we have factored in additional time to conduct the study since 
subject recruitment may be more challenging. 
 
5.  Phase 5:  New Infant Formula Submission (by February 16, 2024, or July 18, 2025) 
 
a.  Submission for Which Clinical Studies Are Not Required (by February 16, 2024) 
 
By February 16, 2024, each manufacturer of a covered exempt infant formula product for which a 
clinical study is not required to support use of the product for the intended medical condition should 
submit to FDA a new infant formula submission for its product containing the information required 
under 21 CFR 107.50(b)(3) or (c)(4).14  Once the new infant formula submission is received, we will 
review the submission, reach out with questions as necessary, and respond to the manufacturer upon 
completion of our review.  While FDA conducts its reviews of new infant formula submissions for 
covered exempt infant formulas, FDA does not intend to object to the manufacturers continued 
marketing of such covered exempt infant formula.   
 
b.  Submission for Which Clinical Studies Are Required (by July 18, 2025) 
 
By July 18, 2025, each manufacturer of a covered exempt infant formula product that conducts a 
clinical study to support use of the product for the intended medical condition should submit to FDA a 
new infant formula submission for its product containing the information required under 21 CFR 
107.50(b)(3) or (c)(4).  Once the new infant formula submission is received, we will review the 
submission, reach out with questions as necessary, and respond to the manufacturer upon completion 
of our review.  While FDA conducts its reviews of new infant formula submissions for covered 
 
14  For information on submitting a new infant formula submission, see our website at https://www.fda.gov/food/guidance-
documents-regulatory-information-topic-food-and-dietary-supplements/infant-formula-guidance-documents-regulatory-
information. 
 
  16   
Contains Nonbinding Recommendations 
exempt infant formulas, FDA does not intend to object to the manufacturers continued marketing of 
such covered exempt infant formula.   
  17