Compliance Policy for 
Cosmetic Product Facility 
Registration and Cosmetic 
Product Listing 
 
Guidance for Industry 
 
 
Additional copies are available from: 
 
Office of the Chief Scientist 
U.S. Food and Drug Administration 
10903 New Hampshire Ave, Bldg. 1, Room 3317 
Silver Spring, MD 20903 
Phone Number: 301-796-4880 
Email address: QuestionsAboutMoCRA@fda.hhs.gov  
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of the Chief Scientist (OCS) 
 
November 2023 
   
 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 2 
II.   BACKGROUND ............................................................................................................... 2 
III.  DISCUSSION .................................................................................................................... 4 
 
 
 
 
 
   
 
i 
   
 
Compliance Policy for Cosmetic Product Facility Registration and 
Cosmetic Product Listing 
 Guidance for Industry1 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) 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 office 
responsible for this guidance as listed on the title page.   
 
 
I.  INTRODUCTION  
 
This guidance is intended to assist owners or operators of cosmetic product facilities that are 
subject to the requirements related to facility registration and responsible persons that are subject 
to the requirements related to cosmetic product listing under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act). This guidance document discusses FDAs compliance policy for 
these requirements. FDA intends to delay enforcement of these requirements for six months to 
help ensure that industry has sufficient time to submit facility registration and product listing 
information.  
 
This guidance is being implemented without prior public comment because the Agency has 
determined that prior public participation is not feasible or appropriate. 21 CFR 10.115(g)(2).  
This guidance is being implemented immediately, but it remains subject to comment in 
accordance with the Agencys good guidance practices. 21 CFR 10.115(g)(5).  
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys 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 Agency guidance means that something is suggested or 
recommended, but not required.  
 
II.   BACKGROUND 
 
On December 29, 2022, the President signed the Consolidated Appropriations Act, 2023 (Pub. L. 
117-328) into law, which included the Modernization of Cosmetics Regulation Act of 2022 
(MoCRA).  Among other provisions, MoCRA added section 607 to the FD&C Act (21 U.S.C. 
364c), establishing requirements for cosmetic product facility registration and cosmetic product 
listing. 
 
 
 
 
1 This guidance has been prepared by the Office of the Chief Scientist (OCS) in cooperation with the Office of 
Cosmetics and Colors (OCAC)/Center for Food Safety and Applied Nutrition (CFSAN) at the Food and Drug 
Administration. 
 
2 
   
 
Section 607(a) of the FD&C Act requires every person that owns or operates a facility2 that 
engages in the manufacturing or processing of a cosmetic product for distribution in the United 
States to register each facility with FDA.  Section 607(a)(1)(A) provides that owners or 
operators of facilities engaged in the manufacturing or processing of a cosmetic product on 
December 29, 2022, must register each facility no later than December 29, 2023.  Owners or 
operators of facilities that first engage in manufacturing or processing a cosmetic product after 
December 29, 2022, must register such facilities within 60 days of first engaging in such activity 
or by February 27, 2024, whichever is later (Section 607(a)(1)(B)).  
 
Section 607(c) of the FD&C Act requires that for each cosmetic product, the responsible person3 
must submit to FDA a cosmetic product listing or ensure that such submission is 
made.  Section 607(c)(2) of the FD&C Act provides that the responsible person for a cosmetic 
product that was marketed on December 29, 2022, must submit a cosmetic product listing, no 
later than December 29, 2023, or for a cosmetic product that is first marketed after December 29, 
2022, within 120 days of distributing such product in interstate commerce.  
 
Certain small businesses, as defined in section 612 of the FD&C Act (21 U.S.C. 364h), are not 
required to register facilities and list cosmetic product(s). In addition, a facility is not required to 
register if it is also subject to the requirements in chapter V of the FD&C Act (for drugs and 
devices) unless the facility also manufactures or processes cosmetic products that are not subject 
to the requirements of chapter V of the FD&C Act (see section 613 of the FD&C Act (21 U.S.C. 
364i)).  A cosmetic product does not need to be listed if it is also subject to the requirements in 
chapter V of the FD&C Act (for drugs and devices). 
FDA issued a draft guidance entitled Registration and Listing of Cosmetic Product Facilities 
and Products on August 8, 2023 (88 FR 53490). The draft guidance, when finalized, will 
provide recommendations and instructions to assist persons submitting cosmetic product facility 
registrations and product listings to FDA.   
FDA is also developing an electronic submission portal, Cosmetics Direct, to streamline 
submission and receipt of facility registration and product listing information under section 607 
of the FD&C Act, and is developing paper forms (FDA Form 5066 and 5067) as an alternative 
submission tool. FDA will conduct a pilot program to ensure that the new electronic submission 
portal is functional and usable so that industry will be able to meet its statutory obligations.  As 
another alternative, users may transmit SPL-formatted submissions through FDAs Electronic 
Submissions Gateway (ESG),4 or any SPL authoring software including Xforms.5 FDA strongly 
encourages electronic submissions to facilitate efficiency and timeliness of data submission and 
management for the agency.  FDA anticipates that electronic submission, technical assistance 
documents, and paper submission forms will be available in early December 2023.  
 
2 The term facility is defined in section 604(3) of the FD&C Act (21 U.S.C. 364(3)). 
3 The term responsible person is defined in section 604(4) of the FD&C Act (21 U.S.C. 364(4)).  
4 For more information on FDAs Electronic Submissions Gateway, please refer to the webpage at 
https://www.fda.gov/industry/electronic-submissions-gateway.  
5 For more information on Xforms, please refer to the webpage at https://www.fda.gov/industry/structured-product-
labeling-resources/spl-xforms. In addition, the technical details on using SPL for cosmetic product facility 
registration and product listing will be available in the FDAs SPL Implementation Guide with Validation 
Procedures available at https://www.fda.gov/media/84201/download. 
3 
   
 
 
 
 
 III.  DISCUSSION 
 
FDA will be ready to accept registration and listing information by the statutory deadline of 
December 29, 2023, and we encourage companies to meet that deadline if they are able to do so.   
However, FDA does not intend to enforce the requirements under section 607 of the FD&C Act 
related to cosmetic product facility registration and cosmetic product listing for an additional six 
months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide 
regulated industry additional time to comply with these requirements. In addition, FDA does not 
intend to enforce the registration requirement for owners or operators of facilities that first 
engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the 
listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 
2024.  
 
FDA intends to delay enforcement of the cosmetic product facility registration and product 
listing requirements.  Industry has expressed concerns that they need additional time, for 
example to gather the relevant information required for facility registration and product listing, 
including obtaining facility registration numbers to associate with cosmetic product listings, 
obtain access to the electronic submissions database, and enter and submit accurate registration 
and listing information.  
 
 
4