FDA MoCRA is effective from July 2024

The FDA is set to implement a significant legal change in July 2024 under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This act grants the FDA expanded authority to regulate cosmetics, marking the most substantial update since the passage of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. The objective is to enhance the safety of daily-use cosmetic products.

Key Responsibilities for Manufacturers, Brand Owners, Importers/Distributors:

1. Adverse Event Reporting:
• Report serious events within 15 business days.
• Include product label copy.
• Submit new information within 15 days if received within a year.
• FDA access to adverse event reports during inspections.
2. Facility Registration:
• Manufacturers and processors must register and renew every two years.
3. Safety Substantiation:
• Companies must ensure product safety.
• No specific tests are mandated for individual products or ingredients.
4. Responsible Person:
• Manufacturer, packer, or distributor whose name appears on the label.

New FDA Authorities (MoCRA):

• Records Access:
FDA can access and copy certain records related to cosmetic products, including safety records.
• Mandatory Recall Authority:
FDA can order a recall if a cosmetic is adulterated or misbranded and poses serious health risks.

Upcoming FDA Regulations (MoCRA):

• Good Manufacturing Practice (GMP) Requirements:
For facilities manufacturing cosmetic products.
Refer to Public Meeting: Good Manufacturing Practices for Cosmetic Products Listening Session.
Draft Guidance for Industry: Cosmetic Good Manufacturing Practices.
• Fragrance Allergen Labeling:
Compliance with FDA-established regulations.
• Asbestos Testing Methods:
Standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

For more details, please check here.



1. 有害事象の報告:
– 重篤な事象を15営業日以内に報告すること。
– 製品ラベルのコピーを添付すること。
– 1年以内に新たな情報を得た場合は15日以内に提出。
– FDAは査察時に有害事象報告書を閲覧できる。

2. 施設登録:
– 製造・加工業者は2年ごとに登録・更新が必要。

3. 安全性の立証:
– 企業は製品の安全性を保証しなければならない。
– 個々の製品や成分について、特定の試験は義務付けられていない。

4. 責任者:
– ラベルに名前が記載されている製造業者、包装業者、販売業者。


– 記録へのアクセス:

– 強制リコール権限:


– 適正製造規範(GMP)要件:
パブリックミーティングを参照: 化粧品の適正製造規範リスニングセッションを参照。
業界向けガイダンス案: 化粧品の適正製造規範。

– 香料アレルゲン表示:

– アスベスト試験法:


Back to blog