Short answer: Under MoCRA, the responsible person is the manufacturer, packer or distributor whose name appears on the cosmetic's label. If your label reads "Distributed by [your brand]," that is your company. You list each product with FDA, keep safety substantiation records and report serious adverse events within 15 business days. The factory registers its facility every two years.
A MoCRA "responsible person" is the company named on a cosmetic's label (manufacturer, packer or distributor) that answers to FDA for listing the product, backing its safety and reporting serious adverse events.
Key stats: MoCRA for private label cosmetics
- December 29, 2022: MoCRA became law. [1]
- 15 business days: deadline to report a serious adverse event to FDA after the responsible person receives it. [2]
- 6 years: how long adverse event records must be kept (3 years for qualifying small businesses). [2]
- 120 days: deadline to list a new cosmetic with FDA after it is first marketed. [1]
- Every 2 years: facility registration renewal. [3]
- 14,299 facilities and 992,907 products: active FDA cosmetic registrations and listings as of January 6, 2026. [7]
What is a "responsible person" under MoCRA?
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added new FDA duties for cosmetic companies, and most of them land on one party: the "responsible person." The law defines it as "the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label." [4]
That definition is the whole test. It doesn't matter who wrote the formula, who owns the trademark or who paid for the batch. It matters whose name is printed on the package.
If a manufacturer makes my product, who is the responsible person?
FDA's labeling rule requires every cosmetic label to name the manufacturer, packer or distributor and its place of business. When the company named didn't make the product, the label must say how it is related to the product, for example "Manufactured for ___" or "Distributed by ___." [5]
In a typical private label deal, the label names the brand with "Distributed by" or "Manufactured for." That makes the brand the responsible person. If a label named the manufacturer instead, the manufacturer would be. Either way, decide it before you print labels, and write it into your supply agreement so nothing falls between the two companies.
Who does what: brand vs. manufacturer
| MoCRA duty | Who is responsible | Deadline or frequency |
|---|---|---|
| Facility registration | The owner or operator of the facility (your manufacturer). One registration covers all brands it makes; it can be filed by the facility or by any responsible person whose products it makes. | Renew every 2 years; new facilities within 60 days of starting [1][3] |
| Product listing, including ingredients | Responsible person (the brand on the label) | Within 120 days of first marketing; updates yearly [1][3] |
| Safety substantiation records | Responsible person | Before and while the product is sold [6] |
| Serious adverse event reports | Responsible person | 15 business days; keep records 6 years (3 for small businesses) [2] |
| U.S. address, U.S. phone or electronic contact on the label for adverse event reports | Responsible person | Required since December 29, 2024 [8] |
| FDA access to certain records, including safety records | Whoever holds the records | In certain situations, such as a suspected health threat [9][11] |
- Name on label
- Product listing within 120 days
- Safety file
- Adverse event reports in 15 business days
- Yearly listing update
- FDA facility registration
- Registration number shared with brand
- Adverse event reports shared with brand
- Renewal every 2 years
Arrows show what the manufacturer passes to the brand.
What does the responsible person have to do?
List every product. The responsible person lists each marketed cosmetic with FDA, including its ingredients, and updates the listing every year. [3] A product first sold after December 29, 2022 must be listed within 120 days. One listing can cover formulas that differ only in color, fragrance, flavor or package size, which helps brands with several shades or scents. [1] FDA's Cosmetics Direct tool handles both listings and registrations. [3]
Keep proof the product is safe. The law requires "adequate substantiation of safety": tests, studies, research or other evidence that qualified experts consider "sufficient to support a reasonable certainty that a cosmetic product is safe." [6] Animal testing is not a requirement for marketing a cosmetic. [9] With a stock formula, ask the manufacturer which safety data it can share, and keep your own file for anything you change.
Report serious adverse events. A serious adverse event includes death, a life-threatening experience or a hospital stay, among other outcomes. [4] The responsible person must send it to FDA within 15 business days of receiving it and keep adverse event records for 6 years. [2]
Put a contact on the label. Since December 29, 2024, cosmetic labels must include a domestic address, a domestic phone number or electronic contact information, such as a website, where consumers can report adverse events. [8] Products sold only to licensed professionals also need a clear statement saying so. [8]
Have a product in mind? Ask us directly.
What does the manufacturer have to do?
Any company that owns or operates a facility that manufactures or processes cosmetics for the U.S. market must register it with FDA and renew every two years. [1][3] The registration lists the brand names made there, the product categories, and the responsible person for each product. [1] A contract facility needs only one registration, no matter how many brands it makes. [1]
Ask your manufacturer for its FDA registration number before you list your products. Each product listing must include the registration number of every facility where the product is made. [1]
Does the MoCRA small business exemption apply to my brand?
Maybe, for some duties. A small business is one whose average U.S. cosmetic sales over the previous three years are under $1,000,000 (adjusted for inflation). It is exempt from facility registration, product listing and the future GMP rules. [10]
The exemption doesn't apply to products that regularly touch the mucous membrane of the eye, are injected, are meant for internal use, or are meant to change appearance for more than 24 hours. [10] Small businesses still report serious adverse events (keeping records for 3 years instead of 6), still need safety substantiation and still need the label contact. [2][6][8]
Which MoCRA rules are still pending?
- Cosmetic GMP rules: MoCRA told FDA to write them, but as of April 2026 FDA had not proposed them and listed them as a long-term action. [9][11]
- Fragrance allergen labeling: required by MoCRA; the proposed rule was expected in May 2026 but had not been issued as of April 2026. [8][11]
- Asbestos testing for talc products: FDA proposed a rule in December 2024 and withdrew it in November 2025. [9]
- PFAS: FDA published its report on PFAS in cosmetics on December 29, 2025. [9]
Check FDA's MoCRA page before you finalize labels, since fragrance allergen labeling would change many ingredient lists.
The MoCRA Handoff: 5 steps from label to listing
- 1.Name it. Decide whose name goes on the label and with which phrase ("Distributed by," "Manufactured for"). That company is the responsible person.
- 2.Put it in writing. Your supply agreement says who files the listing, who keeps which safety data, and how adverse event reports are shared within days, not weeks.
- 3.Collect the facility details. Get the manufacturer's FDA facility registration number and confirm it is current.
- 4.Build the safety file. Gather the formula's safety data, test results and expert review before launch.
- 5.List and label. List the product within 120 days of first sale, print a U.S. contact on the label for adverse event reports, and set a yearly reminder to update the listing.
How does PMG handle MoCRA for private label brands?
PMG's partner facilities are FDA-registered and GMP-compliant, with MoCRA-compliant operations for cosmetics, and specific certifications are confirmed per product and per facility before a project is placed. [12] Private label stock formulas start at 1,000 units and reach the shelf in 60–90 days; custom formulas start at 5,000 units. [13] See our skincare and beauty manufacturing and certifications and compliance pages, compare private label vs custom formulation, or, if your product makes drug claims, read cosmetic or OTC drug?
MoCRA Private Label Launch Checklist
Download the fillable checklist (PDF)
Use this list before you print labels or list your product:
Before launch
- Label names the responsible person with “Distributed by” or “Manufactured for” and a full place of business [5]
- Label includes a U.S. address, U.S. phone number or website for adverse event reports [8]
- Supply agreement says who lists the product and who keeps which safety data
- Manufacturer's FDA facility registration number on file and current [1]
- Safety substantiation file complete before launch [6]
- Product listed with ingredients within 120 days of first sale [1]
- Process to send serious adverse events to FDA within 15 business days [2]
- Adverse event records kept 6 years (3 for qualifying small businesses) [2]
- Yearly listing update and 2-year registration renewal on the calendar [1] [3]
- Small business exemption checked, including the product-type exceptions [10]
Glossary
- MoCRA: the Modernization of Cosmetics Regulation Act of 2022.
- Responsible person: the manufacturer, packer or distributor named on the label.
- Facility registration: FDA filing by the owner or operator of a cosmetic manufacturing or processing facility, renewed every 2 years.
- Product listing: FDA filing for each marketed cosmetic, including ingredients, updated yearly.
- Adequate substantiation of safety: evidence qualified experts consider enough for reasonable certainty that a product is safe.
- Serious adverse event: a reaction that results in death, a life-threatening experience or hospitalization, among other outcomes, or needs medical intervention to prevent one.
- Cosmetics Direct: FDA's online tool for registrations and listings.
Frequently asked questions
Can my manufacturer be the responsible person instead of my brand?
Yes, if the manufacturer's name is the one on the label. The responsible person is whoever the label names as manufacturer, packer or distributor. Most private label brands put their own name on the label, which makes the brand responsible. [4][5]
Do I need to register a facility if I don't make the product myself?
Usually not. Facility registration is for companies that own or operate a facility that manufactures or processes cosmetics. A contract facility needs one registration, which the facility or any of its brand clients can file. [1]
How fast do I have to report a serious adverse event?
Within 15 business days after the responsible person receives the report, and the records must be kept for 6 years, or 3 years for qualifying small businesses. [2]
Does MoCRA require animal testing?
No. FDA states that animal testing is not a requirement for marketing a cosmetic. Safety can be supported with other tests, studies and expert review. [9]
Are there GMP rules for cosmetics yet?
Not yet. MoCRA requires FDA to issue cosmetic GMP rules, but as of April 2026 FDA had not proposed them. [11]
Have a product in mind? Ask us directly.
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Read the article →Sources and references
- 1.21 U.S.C. § 364c, Registration and product listing https://www.law.cornell.edu/uscode/text/21/364c
- 2.21 U.S.C. § 364a, Adverse events https://www.law.cornell.edu/uscode/text/21/364a
- 3.FDA, “Registration and Listing of Cosmetic Product Facilities and Products” https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products
- 4.21 U.S.C. § 364, Definitions https://www.law.cornell.edu/uscode/text/21/364
- 5.21 CFR 701.12, Name and place of business of manufacturer, packer, or distributor https://www.law.cornell.edu/cfr/text/21/701.12
- 6.21 U.S.C. § 364d, Safety substantiation https://www.law.cornell.edu/uscode/text/21/364d
- 7.Foley & Lardner, “How MoCRA Is Reshaping FDA Oversight of Cosmetics in 2026” (March 2026) https://www.foley.com/insights/publications/2026/03/how-mocra-is-reshaping-fda-oversight-of-cosmetics-in-2026/
- 8.21 U.S.C. § 364e, Labeling https://www.law.cornell.edu/uscode/text/21/364e
- 9.FDA, “Modernization of Cosmetics Regulation Act of 2022 (MoCRA)” https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
- 10.21 U.S.C. § 364h, Small businesses https://www.law.cornell.edu/uscode/text/21/364h
- 11.Crowell & Moring, “Cosmetics Under the Microscope: FDA's Expanding Regulatory Reach Under MoCRA” (April 8, 2026) https://www.crowell.com/en/insights/client-alerts/cosmetics-under-the-microscope-fdas-expanding-regulatory-reach-under-mocra
- 12.PMG, homepage FAQ https://productmgmtgroup.com/
- 13.PMG, “Private Label vs Custom Formulation” https://productmgmtgroup.com/services/private-label-vs-custom-formulation
MoCRA Private Label Launch Checklist
A fillable 1-page checklist to complete before you print labels or list your product.
PDF · 1 page
About Product Management Group
PMG is a full-service private label manufacturing partner for skincare, nutraceuticals, supplements, personal care, and wellness brands. We handle everything from R&D and formulation through manufacturing, packaging, regulatory compliance, and fulfillment, working with FDA-registered, GMP-compliant partner facilities in Florida, North Carolina, Texas, Minnesota, and Arizona. We work with everyone from first-time founders to established retail brands, with minimums starting at 1,000 units.
Launching a private label cosmetic? Tell us about your product and we'll walk you through the label, listing and facility details.