The U.S. Food and Drug Administration (FDA) Begins Carrying Out the 2022 Cosmetics Law: Registration, Product Lists and Injury Reports (2023)

Table of Contents

1. What the U.S. Food and Drug Administration Did in 2023
2. The Law Behind It and Its Key Terms
3. The End of the Voluntary Registration Program
4. Starting Work on Manufacturing Rules
5. Facility Registration and Product Listing
6. Who Is Exempt
7. The Six-Month Enforcement Delay
8. Mandatory Reports of Serious Injuries
9. A Related 2023 Step: Contaminated Tattoo Inks
10. What These Steps Do Not Do
11. Dates and Legal Status as of 18 October 2026
12. How the 2023 Steps Fit Later Cosmetics Actions
13. Primary Documents
14. Key Research Papers
15. Connections
16. Featured Videos

1. What the U.S. Food and Drug Administration Did in 2023

The 2023 steps were a series of notices, guidance documents and constituent updates (short U.S. Food and Drug Administration announcements to the industry and the public), not a single rule. In date order:

• 27 March 2023. The U.S. Food and Drug Administration stopped accepting submissions to its Voluntary Cosmetic Registration Program (VCRP) so that it could build the mandatory registration and listing system the law requires.
• 27 April 2023. A Federal Register notice (88 FR 25663, Docket No. FDA-2023-N-1466) announced a virtual listening session on good manufacturing practices for cosmetics, held on 1 June 2023.
• 12–13 June 2023. The U.S. Food and Drug Administration’s cosmetics program issued a draft guidance on microbial contamination of tattoo inks (88 FR 38516, Docket No. FDA-2023-D-1083).
• 8 August 2023. A draft guidance, “Registration and Listing of Cosmetic Product Facilities and Products,” was announced (88 FR 53490, Docket No. FDA-2023-D-1716), with comments due by 7 September 2023. The same day a second notice (88 FR 53499, Docket No. FDA-2023-N-3107) invited industry volunteers to test the planned electronic submission portal.
• 8–9 November 2023. A final guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing” (88 FR 77323), announced that the U.S. Food and Drug Administration would not enforce registration and listing until 1 July 2024.
• 14 December 2023. The U.S. Food and Drug Administration issued updated instructions for reporting serious adverse events from cosmetic products, a duty it said was enforceable starting 29 December 2023.
• 18–19 December 2023. The registration and listing guidance was finalized (88 FR 87780), and the electronic portal, which the U.S. Food and Drug Administration calls Cosmetics Direct, opened.

A Federal Register docket is the public file for an agency action, held on regulations.gov, where the documents and public comments are collected. A guidance is a document in which the U.S. Food and Drug Administration explains how it reads a law and how it intends to apply it; the duties themselves come from the statute.

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2. The Law Behind It and Its Key Terms

The U.S. Food and Drug Administration’s MoCRA program page says that “On average people use 6 to 12 cosmetics products daily,” giving examples such as makeup, nail polishes, shaving cream, perfumes, face and body cleansers, haircare products, moisturizers and other skincare products. It says the new law “helps ensure the safety of cosmetic products many consumers use daily.”

The page defines the terms used throughout the 2023 documents:

• Facility: any establishment, including an importer’s, that manufactures or processes cosmetic products distributed in the United States.
• Responsible person: the manufacturer, packer or distributor of a cosmetic product whose name appears on its label.
• Adverse event: any health-related event associated with the use of a cosmetic product that is adverse.
• Serious adverse event: defined in section 8 below.

According to the same page, MoCRA gives the U.S. Food and Drug Administration new authorities and places new duties on industry:

• Records access. If certain conditions are met, the U.S. Food and Drug Administration can access and copy certain records related to a cosmetic product, including safety records.
• Mandatory recall. If the agency determines there is a reasonable probability that a cosmetic is adulterated or misbranded and that use of or exposure to it will cause serious adverse health consequences or death, the U.S. Food and Drug Administration can order a recall when the responsible person refuses to recall it voluntarily.
• Registration suspension. The U.S. Food and Drug Administration can suspend a facility’s registration under conditions the law sets out, after which distributing or selling cosmetic products from that facility in the United States is a prohibited act.
• Safety substantiation. A responsible person must keep records supporting adequate safety substantiation of each product. The page states that neither the law nor U.S. Food and Drug Administration regulations require specific tests, and that “Animal testing is not a requirement for marketing a cosmetic product.”
• Regulations still to come. MoCRA requires the U.S. Food and Drug Administration to write regulations on good manufacturing practice (GMP) for cosmetic facilities, fragrance allergen labeling, and standardized testing methods for asbestos in talc-containing cosmetics, and to publish a report on per- and polyfluoroalkyl substances (PFAS) in cosmetics.

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3. The End of the Voluntary Registration Program

The constituent update of 27 March 2023 explains that the VCRP was set up in 1972 so the U.S. Food and Drug Administration could obtain “the best estimate of information available about cosmetic products and ingredients, their frequency of use, and businesses engaged in their manufacture and distribution,” supplied voluntarily by manufacturers, packers and distributors. Foreign companies exporting cosmetics to the United States could also take part.

The U.S. Food and Drug Administration states plainly that the VCRP “was not an approval system,” and that “Because the system was voluntary, the information provided through the VCRP did not present a complete picture of cosmetics in the U.S. marketplace.”

Because MoCRA requires certain companies to register facilities and list products, the U.S. Food and Drug Administration said it was creating a new system to handle the large number of submissions expected. It stopped accepting VCRP submissions effective 27 March 2023, asked companies to wait to register until the new system was announced, and stated that information in the VCRP “will not be transferred” to the new mandatory program.

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4. Starting Work on Manufacturing Rules

Good manufacturing practices (GMP) are the rules for how a factory is run so that its products are made consistently and are not contaminated or mixed up. MoCRA requires the U.S. Food and Drug Administration to write GMP regulations for cosmetic facilities.

The Federal Register notice of 27 April 2023 announced a virtual “Good Manufacturing Practices for Cosmetic Products Listening Session” on 1 June 2023. Its stated purpose was “to consult cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts, to inform Agency efforts to develop regulations to establish good manufacturing practices for facilities that manufacture or process cosmetic products distributed in the United States.” Requests to speak were due by 18 May 2023 and written comments to the docket by 3 July 2023.

The listening session gathered input only; it did not propose any rule text.

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5. Facility Registration and Product Listing

The U.S. Food and Drug Administration’s constituent update of 8 November 2023 summarizes the two duties:

• Facility registration. Cosmetic product manufacturers and processors must register their facilities with the U.S. Food and Drug Administration, update the content within 60 days of any change, and renew the registration every two years.
• Product listing. A responsible person must list each marketed cosmetic product with the U.S. Food and Drug Administration, including the product’s ingredients, and provide any updates annually.

The draft guidance of 8 August 2023 was written, in the Federal Register’s words, to “assist persons submitting cosmetic product facility registrations and product listing submissions to U.S. Food and Drug Administration.” The pilot-program notice of the same day said the U.S. Food and Drug Administration’s Office of Cosmetics and Colors and Office of the Chief Scientist planned to accept up to nine industry participants to test the new portal, with testing to begin on or about 15 September 2023.

On 18 December 2023 the U.S. Food and Drug Administration issued the final guidance. Its constituent update says the guidance describes “who is responsible for making the registration and listing submissions, what information to include, how to submit, when to submit, and certain exemptions.” The U.S. Food and Drug Administration uses its U.S. Food and Drug Administration Establishment Identifier (FEI) number as the required facility registration number; a responsible person needs the registration number of each facility where its products are made in order to list them, or, for an exempt small-business facility with no number, its name and address. The guidance also contained a new draft section, Appendix B, of frequently asked questions, open for comment until 18 January 2024; the rest finalized the August draft.

The same day the U.S. Food and Drug Administration announced that its electronic portal, Cosmetics Direct, was available and “dedicated exclusively to cosmetic product facility registration and cosmetic product listing electronic submissions.” The agency said it was also accepting structured electronic submissions through its existing Electronic Submissions Gateway and developing paper forms (Form U.S. Food and Drug Administration 5066 and Form U.S. Food and Drug Administration 5067) as an alternative.

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6. Who Is Exempt

The U.S. Food and Drug Administration documents state that MoCRA exempts certain small businesses from facility registration and product listing; the MoCRA program page adds GMP requirements to that list. The exemption does not apply to facilities that make, or responsible persons for, these kinds of products:

• products that regularly come into contact with the mucous membrane of the eye under customary or usual conditions of use;
• products that are injected;
• products intended for internal use;
• products intended to alter appearance for more than 24 hours under customary or usual conditions of use, where removal by the consumer is not part of those conditions.

The documents also note exemptions for certain products and facilities already subject to the law’s requirements for drugs and medical devices.

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7. The Six-Month Enforcement Delay

The statutory deadline for registration and listing was 29 December 2023. On 8 November 2023 the U.S. Food and Drug Administration issued a compliance policy, published in the Federal Register the next day (88 FR 77323), announcing its “intention to delay enforcement of the requirements related to cosmetic product facility registration and cosmetic product listing for an additional 6 months after the initial December 29, 2023, deadline.”

The constituent update gives the date: the U.S. Food and Drug Administration “does not intend to enforce” those requirements “until July 1, 2024, to provide regulated industry additional time to comply.” The same July 1, 2024 date applies to facilities that first began making or processing a cosmetic after 29 December 2022 and to products first marketed after that date.

The compliance policy is a statement about enforcement: the registration and listing requirements themselves come from the statute, and the U.S. Food and Drug Administration announced that it would not enforce them before 1 July 2024. The policy covers registration and listing only, not serious adverse event reporting (section 8).

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8. Mandatory Reports of Serious Injuries

The U.S. Food and Drug Administration’s constituent update of 14 December 2023 states that serious adverse event reporting under MoCRA is “enforceable starting December 29, 2023.” Under it:

• a responsible person must report serious adverse events associated with use of a cosmetic product in the United States to the U.S. Food and Drug Administration within 15 business days;
• the report must include a copy of the label on or within the product’s retail packaging;
• new medical or other information received within one year of the first report must be sent to the U.S. Food and Drug Administration within 15 business days.

A serious adverse event, in the U.S. Food and Drug Administration’s wording, is one that results in “death; a life-threatening experience; inpatient hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; an infection; or significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual,” or one that requires, based on reasonable medical judgment, a medical or surgical intervention to prevent one of those outcomes.

For filing, the U.S. Food and Drug Administration said that in November 2023 it had begun pointing companies to its existing MedWatch Form 3500A, the mandatory reporting form of its safety information and adverse event program, and that its December update revised the form’s instructions for cosmetics. It said an electronic reporting process was still being developed. The MoCRA page adds that the U.S. Food and Drug Administration also has access to adverse event reports during an inspection.

The mandatory duty falls on the responsible person. The U.S. Food and Drug Administration’s cosmetics updates also note that consumers and healthcare professionals can report problems to the agency through its cosmetic complaint page.

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9. A Related 2023 Step: Contaminated Tattoo Inks

On 12 June 2023 the U.S. Food and Drug Administration’s cosmetics program announced a draft guidance for tattoo ink manufacturers and distributors, published in the Federal Register on 13 June 2023 (88 FR 38516) under the title “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination.” “Insanitary conditions” means conditions during manufacture, packing or storage that can let germs get into a product.

The constituent update says the U.S. Food and Drug Administration had received multiple reports of illnesses caused by microbially contaminated tattoo inks, that agency testing found microbial contamination in sealed ink bottles, and that “Between 2003 and 2023, firms conducted 18 recalls of tattoo inks that were contaminated with a variety of microorganisms, some of which can cause serious infections.” The draft guidance describes situations in which an ink may become contaminated and steps manufacturers and distributors could take to prevent or correct them. The U.S. Food and Drug Administration finalized it on 25 October 2024 (89 FR 85217, same docket).

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10. What These Steps Do Not Do

• They are not premarket approval. Registering a facility or listing a product does not mean the U.S. Food and Drug Administration has approved the product or its ingredients, just as the U.S. Food and Drug Administration said its old voluntary program “was not an approval system.”
• They ban no ingredient. None of the 2023 documents prohibits any cosmetic ingredient.
• They did not set the manufacturing, fragrance-allergen or talc rules. In 2023 the U.S. Food and Drug Administration only began gathering input on GMP; no GMP, fragrance allergen labeling or talc-testing regulation was issued that year.
• They do not require animal testing. The U.S. Food and Drug Administration states that animal testing is not a requirement for marketing a cosmetic product.
• The enforcement delay did not cancel the duties. It postponed U.S. Food and Drug Administration enforcement of registration and listing to 1 July 2024; it did not apply to serious adverse event reporting.

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11. Dates and Legal Status as of 18 October 2026

• VCRP closed: 27 March 2023.
• GMP listening session: 1 June 2023 (notice 27 April 2023; comments to 3 July 2023).
• Registration and listing draft guidance: 8 August 2023 (comments to 7 September 2023).
• Enforcement delay announced: 8–9 November 2023.
• Final registration and listing guidance and portal launch: 18–19 December 2023 (draft Appendix B comments to 18 January 2024).
• Statutory deadline for registration and listing; serious adverse event reporting enforceable: 29 December 2023.
• U.S. Food and Drug Administration enforcement of registration and listing begins: 1 July 2024.

Status as of 18 October 2026: the statutory duties are in effect. Facility registration, product listing and serious adverse event reporting are legal requirements, and the U.S. Food and Drug Administration’s announced enforcement delay for registration and listing ended on 1 July 2024. The cosmetic GMP and fragrance allergen labeling regulations that MoCRA requires have not been issued as final rules; the U.S. Food and Drug Administration’s MoCRA page (content current as of 10 August 2026) lists a draft guidance on cosmetic good manufacturing practices for GMP. A check of the Federal Register through 18 October 2026 found later documents that build on the 2023 steps but no withdrawal or stay of them: an updated registration and listing guidance (12 December 2024), a proposed rule on asbestos testing of talc cosmetics (27 December 2024) that was withdrawn on 28 November 2025, a draft guidance on mandatory cosmetic recalls (18 December 2025), a draft guidance on records access (22 January 2026), and information-collection notices on cosmetic requirements (July and October 2026).

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12. How the 2023 Steps Fit Later Cosmetics Actions

The 2023 documents set up the reporting and record-keeping machinery that later MoCRA actions rely on. Later Federal Register documents show the sequence:

• 12 December 2024. The U.S. Food and Drug Administration reissued the registration and listing guidance (89 FR 100508, same docket FDA-2023-D-1716), finalizing the Appendix B questions and answers from December 2023, adding three new draft questions for comment until 13 January 2025, and making minor changes for clarity.
• 27 December 2024. The U.S. Food and Drug Administration proposed to require standardized testing of talc-containing cosmetics for asbestos (89 FR 105490), one of the rules MoCRA requires. On 28 November 2025 it withdrew the proposal (90 FR 54603), citing comments that “warrant further consideration and assessment prior to issuing final regulations.” That proposal is reported on U.S. Food and Drug Administration Proposal to Require Asbestos Testing of Talc Cosmetics (2024).
• 18 December 2025. A draft guidance answered questions about the U.S. Food and Drug Administration’s mandatory recall authority for cosmetics (90 FR 59129, Docket No. FDA-2025-D-2246).
• 29 December 2025. According to the MoCRA page, the U.S. Food and Drug Administration published its “Report on the Use of PFAS in Cosmetic Products and Associated Risks,” the PFAS report MoCRA requires.
• 22 January 2026. A draft guidance described the U.S. Food and Drug Administration’s records access authority for cosmetics (91 FR 2779, Docket No. FDA-2025-D-2243).

The MoCRA page also points to the U.S. Food and Drug Administration’s public dashboard of adverse event reports for cosmetic products, the place where the reports gathered under section 8 can be queried. The ingredient side of cosmetic safety is described on the site’s Personal Care and Household pages, including Parabens and Heavy Metals in Cosmetics. Other U.S. Food and Drug Administration actions of the same year are listed on the U.S. Food and Drug Administration Actions of 2023 hub.

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13. Primary Documents

1. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program (VCRP). Constituent Update, 27 March 2023 — fda.gov constituent update
2. Food and Drug Administration, U.S. Department of Health and Human Services (HHS) (2023). Good Manufacturing Practices for Cosmetic Products Listening Session; Public Meeting; Request for Comments. Federal Register 88:25663–25665, 27 April 2023. Docket No. FDA-2023-N-1466 — FR Doc. 2023-08942
3. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Issues Draft Guidance on Tattoo Inks. Cosmetics Constituent Update, 12 June 2023 — fda.gov constituent update
4. Food and Drug Administration, U.S. Department of Health and Human Services (2023). Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Draft Guidance for Industry; Availability. Federal Register 88:38516, 13 June 2023. Docket No. FDA-2023-D-1083 — FR Doc. 2023-12380
5. Food and Drug Administration, U.S. Department of Health and Human Services (2023). Registration and Listing of Cosmetic Product Facilities and Products; Draft Guidance for Industry; Availability. Federal Register 88:53490–53492, 8 August 2023. Docket No. FDA-2023-D-1716 — FR Doc. 2023-16771
6. Food and Drug Administration, U.S. Department of Health and Human Services (2023). Pilot Program for Cosmetic Product Facility Registration and Listing Electronic Submissions User Acceptance Testing. Federal Register 88:53499, 8 August 2023. Docket No. FDA-2023-N-3107 — FR Doc. 2023-16772
7. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Issues Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing. Cosmetics Constituent Update, 8 November 2023 — fda.gov constituent update
8. Food and Drug Administration, U.S. Department of Health and Human Services (2023). Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing; Guidance for Industry; Availability. Federal Register 88:77323–77324, 9 November 2023. Docket No. FDA-2023-D-1716 — FR Doc. 2023-24731
9. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products. Cosmetics Constituent Update, 14 December 2023 — fda.gov constituent update
10. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products. Cosmetics Constituent Update, 18 December 2023 — fda.gov constituent update
11. U.S. Food and Drug Administration (2023). U.S. Food and Drug Administration Announces Launch of Cosmetics Direct for Electronic Registration and Listing of Cosmetic Product Facilities and Products. Cosmetics Constituent Update, 18 December 2023 — fda.gov constituent update
12. Food and Drug Administration, U.S. Department of Health and Human Services (2023). Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability. Federal Register 88:87780–87781, 19 December 2023. Docket No. FDA-2023-D-1716 — FR Doc. 2023-27649
13. U.S. Food and Drug Administration. Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Program page, content current as of 10 August 2026 — fda.gov MoCRA page
14. Food and Drug Administration, U.S. Department of Health and Human Services (2024). Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability. Federal Register 89:100508, 12 December 2024. Docket No. FDA-2023-D-1716 — FR Doc. 2024-29237
15. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal. Federal Register 90:54603, 28 November 2025. Docket No. FDA-2023-N-4225 — FR Doc. 2025-21407
16. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Questions and Answers Regarding Mandatory Cosmetics Recalls: Draft Guidance for Industry; Availability. Federal Register 90:59129, 18 December 2025. Docket No. FDA-2025-D-2246 — FR Doc. 2025-23249
17. Food and Drug Administration, U.S. Department of Health and Human Services (2026). U.S. Food and Drug Administration Records Access Authority for Cosmetics; Draft Guidance for Industry; Availability. Federal Register 91:2779, 22 January 2026. Docket No. FDA-2025-D-2243 — FR Doc. 2026-01159
18. Public docket FDA-2023-D-1716 — regulations.gov FDA-2023-D-1716

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Key Research Papers

1. Filley AR, Woodruff CM (2023). The Modernization of Cosmetics Regulation Act of 2022: What dermatologists need to know. Journal of the American Academy of Dermatology 89(3):629-631 — PubMed PMID: 37085016
2. Kwa M, Welty LJ, Xu S (2017). Adverse Events Reported to the US Food and Drug Administration for Cosmetics and Personal Care Products. JAMA Internal Medicine 177(8):1202-1204 — PubMed PMID: 28654953
3. Cornell E, Kwa M, Paller AS, Xu S (2018). Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants. Pediatric Dermatology 35(2):225-229 — PubMed PMID: 29575075
4. Venkatesh KP, Kadakia KT, Akbarpour A, Nambudiri VE (2025). US Food and Drug Administration recalls of cosmetic and personal products from 2011 to 2023: A cross-sectional study. Journal of the American Academy of Dermatology 92(1):179-181 — PubMed PMID: 39480367
5. Nho SW, Kim SJ, Kweon O, Howard PC, Moon MS, Sadrieh NK, Cerniglia CE (2018). Microbiological survey of commercial tattoo and permanent makeup inks available in the United States. Journal of Applied Microbiology 124(5):1294-1302 — PubMed PMID: 29388315
6. Nho SW, Kim M, Kweon O, Kim SJ, Moon MS, Periz G, Huang MJ, Dewan K, Sadrieh NK, Cerniglia CE (2020). Microbial contamination of tattoo and permanent makeup inks marketed in the US: a follow-up study. Letters in Applied Microbiology 71(4):351-358 — PubMed PMID: 32654157

The first paper is a 2023 summary of MoCRA for dermatologists. The 2017 and 2018 papers analyze adverse event reports about cosmetics and personal care products that reached the U.S. Food and Drug Administration before reporting became mandatory, the second focusing on products marketed for newborns and infants. The 2025 paper reviews U.S. Food and Drug Administration recalls of cosmetic and personal products from 2011 to 2023. The 2018 and 2020 papers are microbiological surveys of tattoo and permanent makeup inks sold in the United States.

PubMed Topic Searches

1. PubMed: Modernization of Cosmetics Regulation Act
2. PubMed: cosmetics adverse events and the FDA
3. PubMed: tattoo ink microbial contamination

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Connections

• U.S. Food and Drug Administration Actions of 2023
• U.S. Food and Drug Administration and Regulation
• Personal Care and Household
• Heavy Metals in Cosmetics
• Parabens
• PFAS
• Asbestos
• Talc Asbestos Testing Proposal (2024)
• Supplement Ingredient Directory (2023)
• Cannabidiol Needs a New Regulatory Pathway (2023)
• Mammography Breast Density Notification (2023)
• Probiotics in Preterm Infants Warning (2023)

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