Tag: What are the FDA rules for cosmetics?
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Cosmetic Good Manufacturing Practices (GMP): Building Compliance Under US FDA and MoCRA
In today’s regulatory environment, product safety begins long before a cosmetic reaches the shelf. It starts inside the manufacturing facility. Cosmetic Good Manufacturing Practices (GMP) are the operational foundation that ensures products are consistently produced and controlled according to quality standards. Under the authority of the US FDA, and reinforced by the Modernization of Cosmetics…
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Asbestos in Talc Cosmetics: US FDA Regulatory Expectations and Compliance Strategy
Talc has long been used in cosmetic products such as face powders, body powders, and certain pressed makeup formulations. However, concerns regarding asbestos contamination in talc have significantly increased regulatory scrutiny in recent years. Under the authority of the US FDA and strengthened by the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic manufacturers must ensure…
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Prohibited Cosmetic Ingredients: Understanding US FDA Restrictions and Compliance Obligations
Cosmetic safety in the United States is grounded in the principle that products must not contain ingredients that are harmful to consumers. Under the authority of the US FDA and reinforced by the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic companies are legally responsible for ensuring that their products do not contain prohibited cosmetic ingredients.…
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US FDA Cosmetic Registration Process: Step-by-Step Compliance Roadmap for Cosmetic Companies
The regulatory environment for cosmetics in the United States has undergone a major transformation with the implementation of the Modernization of Cosmetics Regulation Act (MoCRA). One of the most important outcomes of MoCRA is the establishment of a mandatory cosmetic registration process enforced by the US FDA. Today, cosmetic registration is no longer a voluntary…
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Cosmetics Direct: US FDA’s Centralized Platform for Cosmetic Regulatory Compliance
The Modernization of Cosmetics Regulation Act (MoCRA) has transformed how cosmetic products are regulated in the United States. To support these changes, the US FDA introduced a centralized electronic submission system known as Cosmetics Direct. This platform is designed to receive, manage, and process cosmetic regulatory submissions required under MoCRA. Cosmetics Direct serves as the…
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Responsible Person for Cosmetics Under US FDA: Legal Role, Duties, and Compliance Requirements
The Modernization of Cosmetics Regulation Act (MoCRA) introduced a major structural change in how cosmetic products are regulated in the United States. One of the most important concepts established under MoCRA is the designation of a Responsible Person for cosmetic products. The Responsible Person is the legally accountable party for ensuring that each cosmetic product…