Tag: XPRO America
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PFAS in Cosmetics: US FDA Regulatory Expectations and MoCRA Compliance Strategy
Per- and polyfluoroalkyl substances (PFAS) have become one of the most scrutinized chemical groups in consumer products, including cosmetics. Often referred to as “forever chemicals,” PFAS are valued for their water-resistant, oil-resistant, and long-lasting properties. However, concerns about persistence in the environment and potential health risks have drawn increased regulatory attention. Under the authority of…
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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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Cosmetic Ingredient Safety: How US FDA Evaluates and Enforces Safe Cosmetic Formulations
Ingredient safety is the foundation of cosmetic compliance in the United States. Every cosmetic product placed on the US market must be safe for its intended use, and the responsibility for ensuring this safety lies with the manufacturer and brand owner. Under the authority of the US FDA and strengthened by the Modernization of Cosmetics…
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Form FDA 3500A and Cosmetic Adverse Event Reporting: Regulatory Reporting Under MoCRA
The Modernization of Cosmetics Regulation Act (MoCRA) fundamentally changed how cosmetic safety issues must be reported in the United States. Cosmetic companies are now legally required to report serious adverse events associated with their products to the US FDA within defined timelines. One of the primary tools used to fulfill this obligation is Form FDA…
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US FDA Establishment Identifier (FEI) for Cosmetics: What It Is and Why It Matters Under MoCRA
As cosmetic regulation in the United States becomes more structured under the Modernization of Cosmetics Regulation Act (MoCRA), identification and traceability of manufacturing facilities have become central to compliance. One of the key identifiers used by the US FDA is the FDA Establishment Identifier (FEI). The FEI number is a unique numeric identifier assigned by…
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Annual Cosmetic Product Listing Update: Keeping Product Data Current Under MoCRA
The Modernization of Cosmetics Regulation Act (MoCRA) established cosmetic product listing as a mandatory requirement for all cosmetic products marketed in the United States. Beyond initial listing, MoCRA also requires companies to perform an annual cosmetic product listing update with the US FDA. An annual update confirms that product information on file remains accurate and…
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Biennial Cosmetic Facility Registration Renewal: Maintaining Continuous US FDA Compliance
The Modernization of Cosmetics Regulation Act (MoCRA) introduced mandatory cosmetic facility registration with the US FDA, but registration is not a one-time obligation. To remain compliant, cosmetic manufacturers and processors must complete a biennial cosmetic facility registration renewal—a renewal that occurs every two years. This renewal process ensures that the US FDA maintains accurate and…
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Form FDA 5066 and Cosmetic Facility Registration: Practical Guidance Under MoCRA
The implementation of the Modernization of Cosmetics Regulation Act (MoCRA) introduced a mandatory framework for cosmetic facility registration with the US FDA. At the center of this requirement is Form FDA 5066, the official submission mechanism used to register cosmetic manufacturing and processing facilities. Form FDA 5066 is not simply an administrative form. It represents…