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Aktualności Firmowe O FDA Says MoCRA Registration Is Not Product Approval

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FDA Says MoCRA Registration Is Not Product Approval

2026-09-11
Hair color OEM laboratory quality and compliance review

On September 9, 2026, the U.S. Food and Drug Administration clarified an important point for cosmetic companies and retailers: FDA does not issue certificates or verification letters for cosmetic facility registration or product listing. A registration or listing number also does not mean that FDA has approved a facility or product. For a US hair color brand choosing an OEM hair color manufacturer, this changes the right first question from “Can you show an FDA certificate?” to “Can you support the records and responsibilities behind a compliant market launch?”

Why a Registration Number Is Only One Check

Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), manufacturers and processors generally must register covered cosmetic facilities and renew those registrations every two years. The responsible person—normally the manufacturer, packer, or distributor named on the label—must list each marketed cosmetic product with its ingredients and update the listing annually.

These submissions matter, but the FDA says they are not an approval program or a promotional tool. Buyers should therefore avoid treating a number, screenshot, badge, or seller-created certificate as complete proof of compliance.

What Hair Color Buyers Should Verify

Before approving samples or packaging, brands, distributors, and salon-supply sellers should align with their hair dye factory on five practical items:

  • Which company will be the responsible person named on the US label?
  • Who maintains the final ingredient, shade, warning, and label versions?
  • Which facility makes or processes the product, and who manages registration updates?
  • What safety-substantiation and batch records will support the finished product?
  • How will serious adverse-event information be escalated for the responsible person’s 15-business-day FDA reporting window?

Hair color needs additional label attention. FDA guidance explains that coal-tar hair dyes have specific statutory caution and preliminary skin-test directions, while other color additives must meet applicable approval, use, and labeling requirements. The exact pathway depends on the product and ingredients, so it should be confirmed before artwork is finalized.

A Better OEM Project Brief

A professional private label hair color supplier should start with the target market, product category, intended professional use, shade plan, formula direction, pack size, artwork language, and expected order volume. Famo Kemei Innovation (Guangdong) Cosmetics Co., Ltd. supports OEM, ODM, and OBM discussions for hair color, perm, bleaching, and hair-care products. Compliance documents, responsibilities, and claims are confirmed for each project rather than assumed from a generic badge.

For US-bound sourcing, ask for a project review that connects formula, label, packaging, batch records, and post-market responsibilities before commercial production. Explore our hair color cream range or contact our team with your market and product brief.

Company Information

Company: Famo Kemei Innovation (Guangdong) Cosmetics Co., Ltd.
Contact: Ted, Founder & CEO
Phone / WhatsApp / WeChat: +86 183 4438 3713
Address: 2nd to 3rd Floor, Building D5-3, East of Gongye Avenue, South of Hengsi Road, Zhongqu, Qinghuayuan, Donghua Town, Yingde City, Qingyuan City, Guangdong Province, China

Factory Capability Gallery

Famo Kemei professional hair products factory and company overview
Famo Kemei cosmetic research and development laboratory
Famo Kemei B2B customers and overseas market cooperation
Hair product sampling and wholesale supply capability
Logistics and payment support for international hair product buyers
Factory certification and compliance document overview
OEM ODM OBM hair product cooperation process
Contact Famo Kemei for professional hair product sourcing
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Szczegóły wiadomości
Do domu > Nowości >

Aktualności Firmowe O-FDA Says MoCRA Registration Is Not Product Approval

FDA Says MoCRA Registration Is Not Product Approval

2026-09-11
Hair color OEM laboratory quality and compliance review

On September 9, 2026, the U.S. Food and Drug Administration clarified an important point for cosmetic companies and retailers: FDA does not issue certificates or verification letters for cosmetic facility registration or product listing. A registration or listing number also does not mean that FDA has approved a facility or product. For a US hair color brand choosing an OEM hair color manufacturer, this changes the right first question from “Can you show an FDA certificate?” to “Can you support the records and responsibilities behind a compliant market launch?”

Why a Registration Number Is Only One Check

Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), manufacturers and processors generally must register covered cosmetic facilities and renew those registrations every two years. The responsible person—normally the manufacturer, packer, or distributor named on the label—must list each marketed cosmetic product with its ingredients and update the listing annually.

These submissions matter, but the FDA says they are not an approval program or a promotional tool. Buyers should therefore avoid treating a number, screenshot, badge, or seller-created certificate as complete proof of compliance.

What Hair Color Buyers Should Verify

Before approving samples or packaging, brands, distributors, and salon-supply sellers should align with their hair dye factory on five practical items:

  • Which company will be the responsible person named on the US label?
  • Who maintains the final ingredient, shade, warning, and label versions?
  • Which facility makes or processes the product, and who manages registration updates?
  • What safety-substantiation and batch records will support the finished product?
  • How will serious adverse-event information be escalated for the responsible person’s 15-business-day FDA reporting window?

Hair color needs additional label attention. FDA guidance explains that coal-tar hair dyes have specific statutory caution and preliminary skin-test directions, while other color additives must meet applicable approval, use, and labeling requirements. The exact pathway depends on the product and ingredients, so it should be confirmed before artwork is finalized.

A Better OEM Project Brief

A professional private label hair color supplier should start with the target market, product category, intended professional use, shade plan, formula direction, pack size, artwork language, and expected order volume. Famo Kemei Innovation (Guangdong) Cosmetics Co., Ltd. supports OEM, ODM, and OBM discussions for hair color, perm, bleaching, and hair-care products. Compliance documents, responsibilities, and claims are confirmed for each project rather than assumed from a generic badge.

For US-bound sourcing, ask for a project review that connects formula, label, packaging, batch records, and post-market responsibilities before commercial production. Explore our hair color cream range or contact our team with your market and product brief.

Company Information

Company: Famo Kemei Innovation (Guangdong) Cosmetics Co., Ltd.
Contact: Ted, Founder & CEO
Phone / WhatsApp / WeChat: +86 183 4438 3713
Address: 2nd to 3rd Floor, Building D5-3, East of Gongye Avenue, South of Hengsi Road, Zhongqu, Qinghuayuan, Donghua Town, Yingde City, Qingyuan City, Guangdong Province, China

Factory Capability Gallery

Famo Kemei professional hair products factory and company overview
Famo Kemei cosmetic research and development laboratory
Famo Kemei B2B customers and overseas market cooperation
Hair product sampling and wholesale supply capability
Logistics and payment support for international hair product buyers
Factory certification and compliance document overview
OEM ODM OBM hair product cooperation process
Contact Famo Kemei for professional hair product sourcing